Smith & Nephew Birmingham Hip

The Smith & Nephew “Birmingham” hip litigation is in full-swing. Plaintiffs in this litigation allege they were injured after receiving a Birmingham Hip Resurfacing (BHR) device, or a total hip arthroplasty (THA) utilizing Birmingham Hip components. In the resurfacing procedure, the hip ball bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection. Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and move into the blood and tissue of the patient, causing all kinds of symptoms and problems.

In Smith & Nephew’s Birmingham Total Hip Arthroplasty (THA) the artificial hip is constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the ball-bone with a metal covering as in the resurfacing procedure, the bone is removed and a metal ball component is implanted.

Cases involving failed Smith & Nephew’s resurfacing hips and THA hips are now consolidated in multidistrict litigation No. 2775 in Baltimore, Maryland. Litigation is currently active and the first bellwether trial for a BHR case is scheduled for spring of 2020. In January 2019, mediation was held to attempt settlement for most of the S&N THA cases, but that mediation was not successful (at least, at that time). I suspect the litigation to continue for another eighteen months at least.

Stryker LFIT v40

Unlike other artificial hips currently in litigation, the Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The failure of the Stryker LFIT V40 involves the junction of the neck of the femoral stem and the femoral head or ball. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. In many cases, however, once implanted the V40 femoral head began to corrode. The corrosion occurred at the site of the connection to the neck. Over time the corrosion can cause the taper lock to become compromised and loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. According to one study, the loosening would cause fretting and micro-motion at the taper lock site, and this movement or friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like other patients who received metal-on-metal artificial hips.

In November 2018 Stryker Orthopaedics reached a settlement in the multidistrict litigation involving the LFIT V40 hip. The settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court. Although this agreement settles many lawsuits previously filed in the MDL, there remain many lawsuits that were later filed and have not been resolved, so this litigation is not over. I believe Stryker will work to extend the settlement agreement to the remaining claims, or the litigation will need to ramp up again very shortly.

DePuy Pinnacle and ASR

The DePuy Pinnacle litigation has been slow-going. DePuy Orthopaedics stood by the Pinnacle device in a way it did not with the ASR. For one thing, it did not officially recall the Pinnacle hip, as DePuy did with the ASR. The Pinnacle MDL was formed in March 2011, just six months after the ASR MDL was established. However, while DePuy recalled the ASR device and entered the first ASR settlement agreement in 2013 (see below) it stood defiantly against allegations of defect involving the Pinnacle. Years passed, and thousands and thousands of individuals filed suit against DePuy and Johnson & Johnson for injuries caused by the Pinnacle. One Pinnacle bellwether trial after another came and went, and still the plaintiff and defense teams could not reach a larger settlement. As of today no global settlement has been reached, and the litigation is far from over.

The DePuy ASR hip litigation has been powering along for a decade. On August 24, 2010 DePuy Orthopaedics announced a worldwide recall of the ASR artificial hip system. In November 2013 the first Settlement Agreement was reached in the ASR multidistrict litigation. To qualify for this “first” settlement the injured plaintiff must have had revision surgery to remove the ASR hip by August 31, 2013. The second agreement included plaintiffs whose revision surgery occurred on or before January 31, 2015. The third settlement agreement offered settlements to those injured people who had revision surgery on or before February 15, 2017. And then everything . . . stopped. Many court watchers believed a “fourth” settlement would be reached to resolve the hundreds of cases involving plaintiffs whose ASR revision surgeries occurred after February 15, 2017, but so far, nothing. Currently over 1,600 people have cases filed and pending in the ASR MDL. I expect either a new settlement extension to be announced or an order from the judge remanding these remaining cases to their home courts for further litigation and trial.

Note: All information in this article is distilled from publicly-available information, including media reports, and my previous posts.

Dr. Steven Tower, an orthopedic surgeon in Alaska, recently gave a fascinating (and alarming) talk about the many neurological problems he has observed in hip patients with elevated cobalt levels in the body. For years the focus following hip replacement surgeries has been on the physical condition of the hip itself. Dr. Tower has concluded that this approach is wrong, or at least incomplete, and he has seen that often the first signs of trouble with hip replacement patients are neurological symptoms. He has even given it a name: Arthroplasty Cobalt Encephalopathy, or ACE.

What is Arthroplasty Cobalt Encephalopathy (ACE)?

ACE is meant to identify a brain disease or associated neurological symptoms caused by elevated levels of cobalt from a metal artificial hip. Cobalt poisoning is a common problem in patients with artificial hips. The neurological symptoms that occur with cobalt metal poisoning include:

• tremors
• memory problems
• fatigue
• weakness or imbalance
• mood alterations
• sleep issues
• pain
• weight loss
• executive dysfunction
• blindness
• other symptoms

Dr. Tower did a post-surgical study of his patients with artificial hips containing at least one component made from chromium/cobalt. He discovered that 57 were cobalt positive, meaning the cobalt urine test revealed 1 part per billion (ppb) or higher. Of the 57 patients with a cobalt positive test, 28 had symptoms consistent with Arthroplasty Cobalt Encephalopathy.

One issue Dr. Tower discovered was that ACE could occur with lower readings of cobalt in the body. It has generally been accepted that cobalt readings below 4 ppb was not cause for concern, and some surgeons would not order further testing until the cobalt readings exceeded 7 ppb or even 10 ppb. Dr. Tower found that patients could have serious neurological issues caused by cobalt with readings of 1 ppb.

Among the patients who were diagnosed with ACE, the median length of time for onset of neurological symptoms was around seven years. ACE symptoms usually occurred one year before hip symptoms (pain, weakness, clicking, loosening, etc.) occurred.

Are Neurological Problems From Metallosis Limited to Metal-on-Metal Artificial Hips?

Unfortunately, no. As recently as five years ago, the medical community mostly believed that metallosis derived from metal-on-metal artificial hips. This would include products such as the DePuy ASR hip and the Zimmer Durom hip (and several other metal-on-metal hip products, about which I have written often on this website). But Dr. Tower has observed neurological problems in several patients with metal-on-plastic hips, or hips utilizing a ceramic ball with a metal cup. In fact, if any part of an artificial hip contains chrome or cobalt materials, the patient is at risk for higher metal levels in the blood and neurological symptoms as a result. He notes that the onset of symptoms with metal on plastic or ceramic occurs more slowly, but the symptoms themselves can be just as severe.

This finding, if true, could be a game changer. The medical community has (slowly) accepted that MoM hips were a health problem and have moved away from their use. But now a thoughtful surgeon is saying, “Hold up. We are finding cobalt poisoning in too many patients with metal-on-plastic and metal-on-ceramic hips. The risk to the patient occurs with any artificial hip containing a cobalt component.” Conventional wisdom has been that eliminating the metal on metal contact should eliminate the risk of metallosis, but Dr. Tower at least does not accept this thinking.

In his discussion Dr. Tower noted that after nine of his patients had revision surgeries, seven patients no longer showed signs of being cobalt-positive, and five of those seven improved neurologically. That’s a promising sign.

The Takeaway

Does this settle the questions regarding artificial hip implants and metallosis? Of course not. But we need to start looking much more closely at the things we put into our bodies, whether it’s a Twinkie, a sleeping pill, or a metal artificial hip. Also, it is well past time for medical device companies to slow down and return to more extensive testing of new medical products. Too often the pursuit of a blockbuster medical device or new prescription drug clouds a corporate board’s better judgment. And clouded judgment hurts people.

Remember I am not a doctor and this is not medical advice. I am a product liability lawyer with many clients who were injured by artificial hips containing cobalt and chromium.

In the last three DePuy Pinnacle artificial hip bellwether trials, three juries awarded the following amounts of money: $502,000,000.00, $1,041,311,648.17, and $247,000,000.00. That’s a total of $1.79 billion dollars. The juries awarded plaintiffs compensatory damages (or actual damages) and punitive damages (to “punish” the defendant companies). Remember that these juries settled on these huge amounts of money based on their findings in three separate trials that DePuy and Johnson & Johnson were liable for design and manufacturing defects, that the defendants failed to warn plaintiffs about the risks of the defective artificial hip, and that defendants acted recklessly, intentionally, and even maliciously in marketing and selling the flawed DePuy Pinnacle hip. These last findings permitted the juries to award punitive damages.

In the bellwether trial in March 2016, a jury awarded more than $500,000,000.00 to five plaintiffs. On December 1, 2016 a jury awarded more than one billion dollars to six plaintiffs and four spouses. And finally, just two weeks ago, a jury awarded six plaintiffs (and four spouses) $247,000,000.00 in compensatory and punitive damages. Compared to the total awards, the amounts awarded to the spouses of the hip victims were modest, and appear to have totaled around $6,700,000.00.

Let’s do a little math:

Seventeen plaintiffs participating in the three bellwether trials were injured by the the DePuy Pinnacle artificial hip. Backing out out $7,000,000.00 for payments made to spouses, the total awarded specifically to the seventeen plaintiffs is $1.72 billion dollars. This averages $101,176,470.50 per plaintiff in the three bellwether trials.

I should write this a second time: for each plaintiff whose DePuy Pinnacle hip failed, the juries awarded over one hundred million dollars.

Now consider that more than 9,000 cases remain unresolved in the DePuy Pinnacle multidistrict litigation in Dallas, Texas. If each plaintiff remaining in the MDL were to win one hundred million dollars at trial, DePuy Orthopaedics and parent company Johnson & Johnson would owe more than nine hundred billion dollars.

I did a quick search, and it appears as if Johnson & Johnson is currently worth around 390 billion dollars. Obviously, nine hundred billion dollars would quickly bankrupt J&J.

Should every remaining plaintiff in the DePuy Pinnacle MDL expect to be awarded one hundred million dollars? Of course not. (And in fact, the seventeen plaintiffs who were involved in the three bellwether cases will not ultimately recover $100,000,000.00, because the judge has already reduced the punitive damages awards in two of those cases, which you can read about here and here.) My point is simply this: it is well beyond time for DePuy and J&J to come to the table and negotiate a generous settlement for the remaining plaintiffs and their spouses. These past three bellwether trials could not have gone much worse for the defendant companies, and the more bellwether trials that follow, the worse it may get for DePuy and J&J, which means the more money it will take to settle the remaining 9,000 cases.

If you have been injured by a DePuy Pinnacle artificial hip, give me a call to discuss your options (919.830.5602).

delivered a huge verdict to the victims of the DePuy Pinnacle artificial hip. In this fourth bellwether trial, the jury awarded $247,000,000.00 to six plaintiffs and their spouses. According to news reports, after a two-month, hard-fought trial, the jury found that DePuy Orthopaedics and parent company Johnson & Johnson were liable to plaintiffs for the Pinnacle’s design and manufacturing defects. But the jury went further, concluding that the actions of the companies were fraudulent and deceptive, and that they had acted recklessly and maliciously in manufacturing, selling, and promoting the flawed products.

These last terms have special meaning in law: findings of fraud, deception, recklessness, and malice indicate that the companies went beyond mere negligence, that the defendants misbehaved intentionally or with a reckless disregard to the fact that their actions would harm innocent people. Because of these special findings, the plaintiffs were entitled to receive “punitive damages” from DePuy and J&J, which are money damages intended to punish defendants for especially bad behavior.

The jury awarded $90 million dollars in punitive damages to be paid by J&J, and $78 million in punitive damages to be paid by DePuy. That’s $168 million in total punitive damages. It is a lot of money.

The jury also awarded “compensatory damages” for the six individual plaintiffs. These are damages meant to compensate individuals for actual injuries. The jury awarded $77 million for such actual injuries as pain and suffering, past and future medical expenses, and other damages. This money award will be divided among the six plaintiffs based on an agreement among the parties.

Finally, the jury awarded the four spouses in the bellwether case “loss of consortium” damages of $1.7 million. Loss of consortium is a claim that arises when a spouse or close family member of the person injured by the defendants suffers separate losses, such as a loss of companionship or intimacy.

The jury in this case found DePuy and J&J intentionally misrepresented the product to the surgeons who would go on to implant the defective devices in patients. The jury also found that the defendants fraudulently concealed important information from the plaintiffs and their surgeons. The jury found that DePuy and J&J failed to adequately warn the plaintiffs and their surgeons about the risks involved in using the artificial hip. Finally, the jury found for the plaintiffs with the claims of design defect, manufacturing defect, and several claims of negligence.

It was another big win for the victims of the DePuy Pinnacle artificial hip.

Fourth Bellwether Trial Was Contentious From the Start

Before the case even started, Defendants asked the Fifth Circuit Court of Appeals to stop the fourth bellwether trial on the grounds that the defendants did not waive their objections to holding the trial outside New York, which is where the plaintiffs lived. In multi-district litigation, the MDL is not permitted to try any case where venue is not otherwise proper unless the parties waive their objections to the improper venue. The DePuy Pinnacle MDL Judge Kinkeade ruled that Defendants had waived their objections to trying the case in the MDL court.

In reviewing the defendants’ writ of mandamus, two of three judges on the Fifth Circuit found that Defendants had not waived their objections. The Fifth Circuit encouraged but did not require that Judge Kinkeade postpone the fourth bellwether trial. Judge Kinkeade decided to move forward with the trial, but this will surely be one ground for appeal by DePuy and J&J.

At the trial Plaintiffs argued that DePuy and J&J rushed the medical device to market, failed to undertake adequate premarket studies, did not provide sufficient warnings about the dangers of the hip implants, and defectively manufactured these MoM artificial hips. Defendants countered that the Pinnacle hip is safe and that the failure rates are in line with industry standards.

Several weeks into trial a startling allegation emerged: that a lawyer for DePuy may have tried to influence the testimony of a surgeon who treated three of the plaintiffs. Dr. David Shein submitted an affidavit on October 14, 2017 stating that a DePuy sales rep was being pressured by DePuy lawyers regarding Dr. Shein’s upcoming trial testimony. Dr. Shein reported that the sales rep said the DePuy lawyers were “on him like crazy” and were putting “big time pressure” on him. According to Dr. Shein’s affdavit, the sales rep stated that “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial.

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. Following a hearing on the issue, Judge Kinkeade denied plaintiffs’ request to introduce the allegation of witness tampering to the jury. The judge decided that there was insufficient evidence that tied DePuy and Johnson & Johnson to the alleged actions of their lawyers. It also appears the DePuy sales rep backed off some of his most alarming comments reflected in the affidavit.

You can read more about the alleged witness tampering here.

Three Pinnacle Hip Bellwether Trials Have Resulted in Huge Awards for Plaintiffs

On March 17, 2016, in the second bellwether trial, a Texas jury awarded five plaintiffs $502,000,000.00, which included $360 million in punitive damages, for the injuries the plaintiffs sustained after the DePuy Pinnacle failed. The jury concluded that the Pinnacle hip sold by DePuy was defective and that DePuy knew about the flaws but did not warn patients and their doctors of the risks.

On December 1, 2016, in the third bellwether trial, the jury awarded six plaintiffs $1,041,311,648.17, which included $28,311,648.17 in compensatory damages and $4,000,000.00 in loss of consortium damages to the spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for the four spouses.

With the fourth bellwether trial now complete, three juries have now awarded $1.79 billion dollars in consecutive bellwether trials. Plainly, several juries have concluded that DePuy and J&J acted with reckless disregard to the safety of innocent people, who simply needed a functioning, non-defective artificial hip.

I believe it is past time for DePuy and J&J to come to the table and offer to settle the thousands of DePuy Pinnacle cases that remain in this litigation.

If you have a DePuy Pinnacle hip that may have failed and injured you, give me a call today.

By all accounts, each of the three bellwether trials in the DePuy Pinnacle artificial hip MDL has been contentious. In the fourth bellwether trial, which should wrap up this week, the litigants have been in a fierce battle again. The most recent skirmish has centered on allegations by plaintiffs suggesting that lawyers for DePuy Orthopaedics may have been trying to influence the testimony of a witness for the plaintiffs.

I want to share with you the affidavit submitted by Dr. David Shein, a surgeon who treated three of the six plaintiffs involved in the current trial. Dr. Shein was once expected to be called as a fact witness in the case by the plaintiffs.

Affidavit of David Shein, M.D.

1. On Friday, October 13, 2017, at approximately 11:00am while was scrubbing in for surgery at the Montefiore Hospital, I met with my DePuy sales representative Glen Swajger in connection with a procedure that required his involvement.
2. Mr. Swajger looked terrible and appeared stressed, so I asked him what was going on. He said the day before (October 12, 2017), he had been contacted by the DePuy lawyers and that discussion made him anxious. He said the lawyers were “on him like crazy.” They were putting “big time pressure” on him.
3. Mr. Swajger told me that as a result of the conversations with DePuy attorneys, he was worried there could be ramifications for me in my practice in connection with my upcoming Dallas testimony.
4. He indicated the lawyers were “peppering him.” He said the “business in Dallas was freaking [him] out.” He said he had a “terrible” day on Thursday as a result of this and my going to Dallas was driving him crazy. He said “I care about you.”
5. Mr. Swajger also told me on Friday that he knows as much about metal on metal as I do, and that he would still want metal on metal because the wear characteristics are better than metal on poly, and he would want me to do his surgery.

What Does All This Mean?

Frankly, this affidavit is astonishing. It suggests that lawyers for DePuy Orthopaedics may have reached out to a DePuy employee, medical device sales representative Glen Swajger, for the purpose of using Swajger to influence the testimony of Dr. Shein, who was scheduled to give testimony in the fourth DePuy Pinnacle bellwether trial.

In the affidavit Dr. Shein states under oath that the DePuy sales rep “looked terrible,” that the DePuy lawyers were putting “big time pressure on him,” and that Swajger stated “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial. Plainly, this would send up a huge red flag to any lawyer trying a case against DePuy. The implication is that the DePuy lawyers wanted to know what Dr. Shein was going to reveal at trial, and possibly wanted to alter what Dr. Shein intended to say. Granted, this affidavit represents hearsay statements attributed to a DePuy employee, and at this point it cannot be taken as anything more than an allegation. But it looks awful, and it suggests an attempt to intimidate a key witness.

The last paragraph may be the most alarming. In it Dr. Shein recounts that Swajger made unsolicited statements about the safety of metal-on-metal hip implants, and that if Swajger were to undergo hip replacement surgery he would want metal-on-metal “because the wear characteristics are better than metal on poly [polyethylene, or plastic] . . . .”

This is jaw-dropping.

If this statement were actually made by a DePuy employee to a surgeon who is preparing to testify in a case about the safety and effectiveness of the metal -on-metal Pinnacle hip, it is hard not to see it as anything other than an attempt to influence the witness’s testimony. Even the judge presiding over the DePuy Pinnacle MDL stated that the affidavit was “disturbing” and “disconcerting.”

If the allegations are proven to be true, a mistrial could be issued, and sanctions could be imposed on the defense team. Further, any lawyer found guilty of witness tampering could be prosecuted and/or disbarred. It is a very serious matter.

So What Did the Judge Do?

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. This means that FBI agents and federal prosecutors will question Dr. Shein, Swajger, and the lawyers involved in connection with the affidavit. Following a hearing on the issue yesterday, Judge Kinkeade denied plaintiffs’ request to introduce the allegation of witness tampering to the jury. The judge decided that there was insufficient evidence that tied DePuy and Johnson & Johnson to the actions of their lawyers. It also appears the Swajger backed off his most alarming comments reflected in the affidavit.

The Takeaway?

The FBI investigation has not been completed. The affidavit, however, is troubling, and the call for an FBI investigation is the right one. At the very least this incident underscores how aggressive cases can become on the national stage. Billions of dollars may be at stake, not only for the six plaintiffs in this trial, but also for the thousands of plaintiffs that still have not resolved their cases in the MDL. With so much at stake, the takeaway so far is that both sides must remain vigilant at every turn to possible wrongdoing.

I will keep you posted on the outcome of the DePuy Pinnacle bellwether trial. Closing arguments in the case begin today, and the jury could reach a verdict by the end of the week.

This article was written based on my review of court documents, several news reports, and my previous writing on the subject.

In this post Suzanne recounts her slow recovery from artificial hip revision surgery. Suzanne received a metal-on-metal artificial hip, and four years later the hip was recalled. Suzanne was forced to undergo revision surgery a year later.

Part 3

Sitting on my night stand next to me here at home is a shiny steel sphere resting in rougher textured steel “cup.” When I hold it in my hand my fingers will not close around it and when I pick it up, the shiny steel ball is heavy and rolls back into the cup revealing a flat bottom with a hole in the middle of it. It was attached to an artificial titanium femur in my left leg just three days ago–prior to my revision surgery–and looks and feels so smooth and shiny it is hard to believe that it has wreaked such havoc on my unsuspecting body: staining the surrounding tissues an ugly gray, whipping up metal particles and spewing them into the orbit surrounding my recalled body parts and, worst of all, destroying any and all chances I may have had to develop a “J-Lo” like posterior due to irreparable damage to my gluteus medius and minimus muscles. Truthfully, I am more concerned with my ability to flow into a left legged lunge from a downward dog than to see my butt standing at attention, but that is too much to think about too soon and so instead I turn to my beautiful daughter who is giving me a bedside serenade on her guitar and think about how much I love my family and all my friends and the taste of lime popsicles.

I made it to the couch today! Yesterday I encircled and scrutinized the curvaceous crimson sectional several times, a bit unsteady, all the while trying to reconcile my personal vision of my recuperation–me all cozy on the couch in front of the fire reading and sipping ginger ale on ice, while the family bustles around me baking and cooking in the kitchen, busying themselves with holiday projects–with the realization that the couch was too low for me to sit on, not a comfortable chair was anywhere in sight and navigating the narrow passageways on my crutches between the couch and the Christmas tree, the coffee table and the couch, over computer chords and the like, even without medication, would be dangerous! I was facing the possibility of spending my recuperation holiday in my bedroom alone where the temperature seemed to grow colder as the fire in the living room grew warmer.

This morning I knew as soon as I moved from the bed to my crutches that my body had healed just a little bit more through the night. I felt lighter and moved more fluidly, as fluid as one can on meds and in skin-tight support stockings. I know that my nursing care–my husband John–has a lot to do with my comfort and progress. He has been my nurse, keeping track of my medication and administering it too, including daily shots in my stomach, my physical therapist, making sure I go through all of my exercises and moving my leg for me when I can’t, a parent, stroking my hair and cooing kinds words when I need them and a husband, the kind of person who looks at me with love as he kindly makes sure I am safe and have everything I need for my first shower in five days. Bliss. So now I am on the sofa, tucked in a corner of this giant, plush red nest that our family of four plus Weenie, our cat, fits on quite comfortably. The room is warmed by the fireplace and I’m getting ready to doze some more, wondering what tomorrows healing will bring.

Emerging from this drug induced haze, malaise, apathetic daze, it’s hard to want to do anything. Today I had a severe reaction to what I can only guess was caused by pain medication, Oxycodone to be exact. I’m not a medicine consumer. I had two natural childbirths and one of them in my own home and although I’ll take a sleep aid once or twice a year, ibuprofen is my drug of choice. So I was surprised to find myself covered in welts, looking like an avatar with the corners of my eyes and the bridge of my nose appearing as one facial feature, and itching uncontrollably, after scaling down my oxycodone intake to only two small pills at bedtime. Now it is after two in the morning and sleep eludes me. I am twelve days into my recovery after having a faulty artificial hip removed from my body in a revision surgery and replaced with a hopefully better model, and I’m angry.

Ironically the hip and site of the operation itself is not bothering me as much as a strange patch located just above my left knee on my quadriceps muscle. It is a site for searing pain that appears as fire, daggers and heat when I move my leg a certain way. Nerve pain. It causes blood-curdling, uncontrollable screams when it happens. I let one out at the medical center today after the nurse and my husband tried to get me off a ridiculously high examining table I had no business being on. I somehow managed to get on it without screaming. After several attempts at inserting an IV unsuccessfully, which required another nurse to give it a try, then lying for what seemed like an eternity on this sketchy, antiquated piece of medical hardware that was obviously not functioning, the contents of the IV dripping agonizingly slow, me completely uncomfortable, when it was time to be released, I couldn’t get off the table. All efforts to assist me were unsuccessful. I let out a good one. The nurse had no idea what to do and ended up leaving the room to let my husband and me deal with it. Soon we were walking, me hobbling along on crutches, out the door with the entire staff just looking at us as we exited their torture chamber. I guess blood curdling screams are not uncommon there. It did not really seem to faze anyone and to be honest, once the pain subsided, I kind of liked the feeling of this unbridled, wild and scary sound coming out of me.

Postscript

This entire journey from my first hip replacement surgery until today has been almost ten years. I was only 42 when I received my first hip replacement. The trauma and the drama around the recall, physical damage and physical and financial aftermath consumed the entirety of my forties. What should have been some of my best and vibrant years. Today I am 51. The damages I sustained from the second surgery have left me with a partially paralyzed left leg. I have to pick it up with my hands to put my shoes and socks on. I live with chronic nerve pain and hip joint pain that I manage with ibuprofen. With that said, I can walk and I can bike. I also recently became a certified yoga instructor, and although many of the postures are unavailable to me, I have a strong practice that I share with other people who have physical limitations and who are searching for a way to move their bodies as best they can.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

Part 2

I woke up before the sun feeling wide awake, but not ready to face the day, I forced myself to fall back asleep re-entering the world of dreams and mystery. My dreams have been fraught with intrigue, dysfunction, insanity and all kinds of craziness and no wonder! My life is a bit crazy these days. As crazy as my dreams can be, they are never too crazy for me to say. “Hey, wake up, this has gone too far!” I relish in the scenarios, the unconscious connections between everything that is happening in my life being played out in random dream dramas. It’s better than soaps.more

I had planned to travel today to settle in and enjoy some time before checking in to the hospital before my surgery on Thursday, but after sleeping until 11:00 am and working on things on the home front, we decided to head out tomorrow and instead spent the afternoon working out, John running on the treadmill and me swimming a mile in the pool of our local YMCA. Swimming for me is an old friend. My father introduced me to the water at a very young age–it was in fact in a pool. Being landlocked in rural Wisconsin, my father, an avid swimmer himself, took his children–at that time five girls–to any public pool in the winter months that he could find. Summer in Wisconsin, of course, afforded days of fresh water swimming in a multitude of lakes and that is where we could be found, coolers full of drinks and sandwiches camped out for the day. I was a competitive swimmer in high school, but not very dedicated. I think I was voted the least likely to succeed in the sport or something along those lines, but the swimming, the style of it, the finesse of breathing and reaching out for the stroke, always stayed with me. To this day I have great form and probably good potential as a distance swimmer. Today, I was happy knocking out a mile, but I am also integrating swimming as something important to my future physical well being and it feels good to conquer!

The rest of the evening was spent finding the best oysters in town, and why not? I am facing at least five days of no eating and no drinking so John and I set out to eat as many steamed local crab slough oysters as we could, all washed down with healthy amounts of beer and wine. All I can say is I hope those post surgery days of not eating balances out my present over-indulgences! It’s hard to resist eastern North Carolina oysters in season.

Yesterday I noticed small raised bumps on my ankles and I am thinking it must be fleas, so I spent my last minutes at home before checking in to surgery cleaning blankets, vacuuming carpets and this morning before leaving for the hospital, kidnapping my unsuspecting cat, zipping her quickly into a small cat carrier and dropping her off at the vet. Two things happened. The vet called–no fleas–and the bumps on my body are slowly but surely taking over. I have hives. It is amazing the utter lack of control one can have over ones body when it comes to stress. I am a person who usually can maintain a semblance of calm and fortitude even during the worst of times, but for some reason this time, my body has its own plan. It started having anxiety attacks a few weeks ago, commanding my attention just enough to procure a prescription for Xanax, my very first, and after becoming completely catatonic after taking just one, it is my last.

I wanted so bad to blame this current outbreak on fleas, spiders or even bed bugs. The thought of having a rogue body acting on its own accord frightens me. Anxiety ruled my day today. My husband encouraged me to breathe through my stress and to try to avoid taking any drugs. I complied, wanting to have a last night of fun, connection and clarity. So we roamed around town eating and drinking in some amazing local establishments, eating local food, talking to local folk, counting down the hours to when we had to surrender to the “system.”

The time is now. It is after midnight and I can no longer eat, drink or even swallow water when I brush my teeth. Tomorrow at 10:00 am I will have revision surgery, where a recalled hip device will be removed from my body and in its place, hopefully, a safe, functional replacement will be implanted. As for now, John is dozing beside me, I am itching like crazy and almost ready to have this all behind me no matter what it entails. The support and love I feel from all of my friends and family is palpable and I am grateful. And ready.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

Behind every metal-on-metal (MoM) artificial hip that fails, there is a person and a story. Artificial hip manufacturers may see only a faceless crowd of victims. These defendant companies may attempt to resolve the claims in bulk and move on to market the next blockbuster medical device. But in that crowd of plaintiffs are thousands of individuals uniquely injured by a product that was implanted in their bodies. The product failure often requires revision surgery, and the injuries that result from the artificial hip failures change lives forever: accomplished tennis players no longer play tennis; couples no longer travel or walk together on a beach; others have to resign from jobs they love because they cannot sit a desk for any length of time. Each of these people has a unique story to tell.

In the next three posts, I will share one woman’s story. “Suzanne” [not her real name] received a metal-on-metal (MoM) artificial hip in 2006 after years of pain from arthritis. The hip was recalled in 2010, and Suzanne was forced to undergo revision surgery in 2011. This is her story:

Part 1

I have been home in North Carolina from my two month sabbatical in Costa Rica for almost four months now. The memories of my time there, the simple routines, new friendships and the feeling that I would return home and make significant changes in my life after “re-entry” have faded into the urgency of daily demands from work, family, relationships and most urgently: my body. Any time I am away from home I look forward to the pile of mail waiting for me when I return, most of it is junk, I know, but I still get excited by post that is addressed to me personally. Now after two months away from home my stack of mail was significant and I settled into the comfort of my screened in porch in anticipation of what I had missed.

After separating the junk from the catalogs, the catalogs from the bills, the personal emerged and that is where I started. What was waiting for me on that September afternoon among the pile of letters that were a combination of known and unknown, was a curious letter from Duke Diagnostic Clinic. I read it twice to make sure that what I was reading was true and then with an unsettling feeling growing in the pit of my stomach, I looked for my husband John [not his real name]. “John, you are never going to believe what I am reading here in this letter from Duke University. It seems that the artificial hip I received four years ago has been recalled.”

The letter went on to say that only a small percentage of recipients would have complications, but I didn’t need to read any further to know that these were going to be my complications–my life–starting now. Since then I have been traveling the two hundred plus miles back and forth to Durham, the home of Duke University and the Duke medical complex to find that every test that I have taken indicates my device has not only failed, but has been poisoning my blood, damaging surrounding tissue, and quite possibly–we will not know for certain until the surgeons are inside–infecting me.

In the past I spoke of bold action and, with trust, falling into the arms of the universe. Now, faced with major surgery in four days and all of the unanswered questions surrounding this endeavor, I feel like I am falling, but I’m not sure where.

Today was my last day at work before embarking on a two month medical leave to have my left hip re-replaced due to a device “recall.” I left work feeling almost completely satisfied that I could face the impending circumstances with almost no work-related stress or unfinished business. I just have to let it go. I’m finding that I am letting go of a lot of things these days. I will no longer be able to run after my bionic-titanium parts are replaced with more fragile parts. Ceramic, plastic and metal will probably not invoke words from my surgeon like the words after my first hip replacement: “Do whatever you want as long as it does not cause you pain.” Not that pain has ever stopped me before. No pain, no gain, right?

I will miss running though, and I’ll have to face other limitations head-on as they come. Since I am returning home from the hospital mere days before Christmas, I am letting that go too. My family, my husband, and our two children have been trying to create a family holiday experience as far from the consumer, commercial version as we can, spending our time making gifts, cooking food, playing games and music–and if we are not on a traveling adventure–staying home and just having fun. Two years ago our kids, they are twenty six and twenty one now, squirreled away and wrapped random objects from our home so when we woke on Christmas morning, John and I really thought Santa had come. The gifts were spilling out from under the tree, until I looked closer at the bicycle with the big red ribbon tied around it, noticing the rust and dirty tires–who’s bike was that?

In the days leading up to this week I have amassed a stack of books to read while recovering. I have selected various tomes for friends and family as gifts this season and that is all I am doing. Cooking, traveling, creating, taking care of family and friends, I’m letting it go. The first time I had total hip replacement surgery was four years and four months ago. John and I are amazed that we have almost no recollection of what happened the first time I had surgery. We are trying to put the pieces together in order to prepare ourselves this time around, but we have hardly any memory of the experience. This time I have the full support and care of a loving man–my husband of almost twenty seven years. And it’s funny because this second surgery, this “do-over” is like another chance to make all my stories right, to let go of those stories and parts that “no longer serve me,” as one of my wise friends noted.

And so here it is, another chance to let go, another chance to continue creating my story.

Disclaimer: This narrative is not intended to represent any specific person or specific product. Names and details have been changed.

Fourth Bellwether Trial Underway

The short answer is yes, the fourth bellwether trial began on Monday (September 18, 2017). Six plaintiffs injured by the Depuy Pinnacle hip (and four spouses) are bringing their claims against defendants in Dallas, Texas before Judge Kinkeade. You can read about previous Pinnacle bellwether trials and their huge jury awards here and here.

In the present case, plaintiffs are bearing down on the high failure rate of the Pinnacle Ultamet metal-on-metal artificial hips. Plaintiffs contend that Depuy and Johnson & Johnson rushed the medical device to market, failed to undertake adequate premarket studies, did not provide sufficient warnings about the dangers of the hip implants, and defectively manufactured these poorly designed medical devices. The New York Plaintiffs bring claims for negligence and negligent misrepresentation, fraud, breach of express and implied warranties, and other claims. Plaintiffs seek compensatory damages and punitive damages.

Defendants Depuy and Johnson & Johnson, as you can guess, have countered that the Pinnacle hip is safe and that the failure rates are in line with industry standards. In opening statements, according to reports, Defendants alleged that the Pinnacle is one of the best artificial hips on the market, and that all artificial hips wear down and typically require revision or replacement surgeries. Finally, Defense counsel stated that Depuy relied on reliable scientific evidence at the time, and should not be punished for selling a product doctors and researchers believed was safe.

In considering these defense statements, however, keep in mind that the FDA approved the Depuy Pinnacle metal-on-metal artificial hip for sale by means of the 510(k) process in 2000. Utilizing the streamlined 510(k) procedure, Depuy was not required to undertake clinical trials with the Pinnacle hip. You can read the FDA’s approval letter here. By representing to the FDA that the Depuy Pinnacle hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.

This fourth bellwether trial is expected to last up to two months, so we will not get a jury verdict until November.

Depuy and Johnson & Johnson Tried to Stop Trial

This fourth trial almost did not happen, at least in Texas. It was originally scheduled to begin September 5, but Defendants filed what’s called a writ of mandamus. Let’s stop here for a bit of law school: a writ of mandamus is a petition to a higher court asking for an order requiring a lower court to perform a duty owed to the petitioner. The writ of mandamus is a “drastic” remedy reserved for “exceptional circumstances.” It is granted to a party to a lawsuit when the party establishes that its legal rights will be permanently impaired or stripped away if immediate affirmative action by a higher court is not taken. It is a very high standard to achieve, and in this case the Defendants did not win their petition. Defendants asked the Fifth Circuit Court of Appeals to stop the fourth bellwether trial on the grounds that the defendants did not waive their objections to holding the trial outside New York, where original jurisdiction is situated. In multi-district litigation, the MDL is not permitted to try any case where venue is not proper unless the parties waive their objections to the improper venue. MDL Judge Kinkeade ruled that Defendants had waived their objections to trying the case in the MDL court. In reviewing the defendants’ writ of mandamus, two of three judges on the Fifth Circuit found that Defendants had not waived their objections. The Fifth Circuit encouraged but did not require that Judge Kinkeade postpone the fourth bellwether trial. So in that sense, the writ of mandamus was denied.

One word about the decision on the petition for the writ of mandamus: it was no slam dunk. The three judges on the panel each wrote a separate opinion, with one concurring in the result and another dissenting in part. By no means should the decision be read as the last word on the question of the waiver of objections to venue or jurisdiction. In fact, Plaintiffs immediately sought a rehearing on the writ before the full Fifth Circuit. This means that the plaintiffs believe the narrow majority decision was handed down by judges more sympathetic to defendants than to the merits of the writ, and wanted the full Fifth Circuit to rehear the matter. This petition for rehearing was denied, and Judge Kinkeade rescheduled the trial for September 18. Plaintiffs are putting on their case now.

No matter the outcome of the current trial, with the mandamus business it is a certainty that an appeal on the verdict is imminent.

I will keep you posted with trial updates as they happen. And if you have a Pinnacle hip you think may have failed, give me a call.

1995: Study on Metal-on-Metal Hips Released

For all metal-on-metal artificial hips, we have to start with the central question: what did the manufacturer know, and when did the manufacturer know it? In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained that the performance of MoM hip implants was “unpredictable,” that the hips may work well for some time “before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics should have known about the metal-on-metal risk factors in 1995. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” That’s not good.

October 13, 2000: Depuy Pinnacle Gets 510(k) Approval

Despite the study above, the FDA approved the Depuy Pinnacle metal-on-metal artificial hip for sale by means of the 510(k) process in 2000. The FDA did not require the Depuy Pinnacle to undergo clinical trials. You can read the FDA’s approval letter here. By representing to the FDA that the Depuy Pinnacle hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.

Depuy began selling the Pinnacle metal-on-metal hip shortly thereafter.

2000-2013: Depuy Pinnacle Hips Sold

Between October 2000 and August 2013, thousands of Depuy Pinnacle metal-on-metal artificial hips were implanted into unsuspecting patients. Depuy and Johnson & Johnson earned many millions of dollars on the sale of these Pinnacle hips. Many of these Pinnacle hips later failed, requiring painful and expensive revision surgeries. The lawsuits followed.

March 28, 2011: Depuy Pinnacle MDL Created

The Judicial Panel on Multidistrict Litigation (JPML) approved a multidistrict litigation site for injury claims involving the Depuy Pinnacle in 2011. The MDL is situated in the North District of Texas (3:11-md-02244) and presided over by federal judge Ed Kinkeade.

August 31, 2013: Depuy Stops Selling the Pinnacle

Depuy voluntarily stops manufacturing and selling the Depuy Pinnacle metal-on-metal artificial hip in August 2013. Importantly, however, Depuy never issued a recall. If you had hip replacement surgery in 2013 or before, you may possibly have the Depuy Pinnacle hip implanted.

October 23, 2014: First Depuy Pinnacle Bellwether Trial Ends with Defense Verdict

Kathleen Herlihy-Paoli sued Depuy Orthopaedics as part of the Depuy Pinnacle MDL in Texas for injuries she suffered after her Depuy Pinnacle metal-on-metal hip implant failed. Ms. Herlihy-Paoli said she felt severe pain shortly after the Depuy Pinnacle hip was implanted in 2009. She also alleged that she suffered from extremely high levels of cobalt and chromium in her blood stream. At trial, DePuy argued that Ms. Herlihy-Paoli’s injuries were not caused by product defects but instead were caused by improper surgical technique. The jury eventually found that the device was not defectively designed and that Depuy’s warnings about the risks of the device were not inadequate. So Depuy won round one.

March 17, 2016: The $502 Million Dollar Verdict in Second Bellwether

In the second Depuy Pinnacle bellwether trial, a Texas jury awarded five plaintiffs $502 million dollars, including a stunning $360 million in punitive damages, for the injuries the plaintiffs sustained after the Depuy Pinnacle failed. The jury based this award in part on findings that Depuy hid critical defects in the design of the Depuy Pinnacle artificial hip system and hid these risks from doctors and patients. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not warn patients and their doctors of the risks. The jury awarded $142,000,000.00 in actual damages and $360,000,000.00 in punitive damages. In all five cases the artificial hips failed, requiring revision surgeries and causing pain and suffering. In each case, the plaintiffs alleged that cobalt and chromium from the metal hip components were released into their bloodstreams, causing toxic metal levels in the blood.

December 1, 2016: The Day of the Billion Dollar Verdict

In the third bellwether case in the Depuy Pinnacle MDL, a Texas jury awarded six plaintiffs over one billion dollars for injuries they suffered following the failure of the Depuy Pinnacle artificial hip. Opening arguments began on October 3, 2016. Both sides argued their cases aggressively, and spent many days cross-examining the opponent’s expert witnesses. There were 21 expert witnesses who testified in this trial. After closing arguments, the jury “received” case on November 30, which means it was finally time for the jurors to sit in a conference room and decide whether the plaintiffs had proven their cases, and if so, how much money they were entitled to receive.

After just one day of deliberation, the jury delivered its staggering verdict. The jury award totaled $1,041,311,648.17, and included $28,311,648.17 total in personal injury (“compensatory”) damages for the six plaintiffs, and $4,000,000.00 in loss of consortium damages to the four spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for four spouses of the plaintiffs.

The jury found that DePuy and J&J were negligent in designing the Pinnacle Ultamet artificial hip. The jury also found against the defendants on the plaintiffs’ strict liability claim (failure to warn), negligence (failure to warn), negligence (failure to recall), negligent misrepresentation, negligent misrepresentation to the plaintiffs’ physicians, intentional misrepresentation, intentional misrepresentation to the plaintiffs’ physicians, fraudulent concealment, and fraudulent concealment to the plaintiffs’ physicians.

January 3, 2017: Judge Reduces Billion Dollar Verdict by $500,000,000.00

The billion dollar award did not last long. Judge Kinkeade issued his post-trial court order reducing the amount of punitive damages awarded to the six families, writing that “constitutional considerations limit the amount a plaintiff may recover in punitive damages.” The relevant portion of the Order states:

“Although the jury awarded $84,000,000 in punitive damages from Defendant DePuy Orthopaedics, Inc. and $84,000,000 in punitive damages from Defendant Johnson & Johnson, constitutional considerations limit the amount a plaintiff may recover in punitive damages. See State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 425 (2003) (“[F]ew awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process. . . . Single-digit multipliers are more likely to comport with due process, while still achieving the State’s goals of deterrence and retribution . . . .”). The Court has reduced the punitive damages accordingly.” See Depuy Pinnacle Order.

The U.S. Supreme Court has limited punitive damages in certain situations, but there is no explicit federal law requiring strict limits on punitive damages, and all reductions such as the current one intrude aggressively on the power of the jury to make its own findings and awards. In any evident, Judge Kinkeade held that the punitive damages award by the jury was “excessive.”

Fortunately, Judge Kinkeade upheld the jury’s conclusions that the Depuy Pinnacle hip implants were defectively designed and that Depuy and Johnson & Johnson failed to warn consumers adequately about the risks involved.

September 18, 2017

The fourth Depuy Pinnacle trial began on September 18, 2017. Unlike with the Depuy ASR cases, Depuy and Johnson & Johnson have made no attempt (yet) to reach a global settlement with the thousands of remaining cases. There is pressure on DePuy to settle the remaining Pinnacle cases, especially in light of the last two bellwether verdicts. Another big jury verdict will cost multiples of that amount for Depuy, as the eventual settlement would most likely increase.

As always, I will keep you posted on developments.

If you have been the victim of a failed medical device like a metal-on-metal artificial hip, you may not ever think about preserving evidence. But it is essential to your product liability case. In this post I want to give you some tips about preserving medical device components that have been removed (“explanted”) from your body in a revision surgery. This information is important for all those undergoing revision surgery, but especially those of you who hope to pursue a product liability case without a lawyer.

Here is a quick illustration: You undergo hip replacement surgery in October 2009. In August 2010, you receive a letter from the manufacturer of the artificial hip stating that a recall has been issued on the medical device implanted in your body. Since the device is implanted in your body, you can’t easily turn it back in for a refund. So you monitor the situation. Ten months later, you begin to feel discomfort, and then outright pain. After a few more months you and your orthopedic surgeon decide to have the device removed in a revision surgery. In this operation, the surgeon will remove the defective parts of the artificial hip and replace them with new, non-defective parts. Those removed parts will sit on a surgical tray, and after the surgery they will end up . . . somewhere. They could be thrown out; they could be placed in a Ziploc bag and abandoned in a storage room; they could be handed over to the medical device manufacturer’s representative, who is often in the room during your surgery.

But they need to go to you.

Quite simply, before the revision surgery, the patient should take steps to ensure that he or she will be given the explanted medical device components. This usually involves careful conversations with the surgeon and the surgeon’s nurse or other staff. Unfortunately, most patients have no idea that need to take this step.

more If You Have a Lawyer

To start with, I highly recommend that you hire a product liability lawyer to handle your medical device drug case, because there are simply too many steps in the process. You can read my thoughts on that subject here. If you hire a lawyer, he or she will be responsible for gathering all available evidence. If you have hired your attorney before you undergo revision surgery, your lawyer will need to send a Preservation of Explanted Components Letter to your surgeon and the hospital or surgery center prior to the scheduled surgery. This letter must be delivered along with an authorization for the release of medical information signed by you. (Without the release, the attorney will have no power to obtain your protected medical information, or to get possession of the explanted components.)

The Preservation Letter will spell out what you as the patient expect with respect to the identification and preservation of the components after surgery. It should include language similar to this:

• Please be advised that we represent Patient “X” in a potential product liability claim against Manufacturer “Y” related to the “Z” artificial hip components. Enclosed is an Authorization for Release of Medical Information signed by Ms. X.
• It is our understanding that Patient X is currently scheduled for hip revision surgery to be performed by Dr. “A” on [date] at “B” Hospital in “C” City. Because of Ms. X’s potential claim against Manufacturer Y, any hardware components that are explanted must be preserved for possible use as evidence and delivered to my office.
• This letter is to serve as notification that Ms. X wants to retain possession of any and all components removed during this surgery and that these components are not to be destroyed, disposed of, or returned to Manufacturer Y or its representative.
• Please take care to identify the explanted components, indicating the patient’s name and date removed. A compliant biological substance shipping kit will be provided to the hospital by our office.
• Additionally, if during the surgery any intra-operative photographs and/or video are taken, we ask that those also be preserved as well.

Following this letter and shortly before the scheduled revision surgery, your attorney may follow up with the surgeon and/or hospital to confirm that the surgical team is aware of and understands the component preservation request.

But Stay Involved in the Process

I advise my clients to stay actively involved in the process when trying to preserve explanted components. Doctors and hospitals can be flaky about these requests. Some nurses or hospital staff may not understand what you are hoping to accomplish, and medical malpractice alarms often sound in their heads. In other cases, medical care providers simply forget about the preservation letter and may hand off the components to the manufacturer’s sales rep, or may even simply toss the components in the trash. But you have a right to obtain these removed components (with or without a lawyer) so you need to (nicely but firmly) remind the surgeon and the surgical nurse that you desire to take possession of the components after the revision surgery.

If You Do Not Have a Lawyer

If you choose to represent yourself in the product liability lawsuit, you will need to make sure that you seek to preserve the explanted components on your own. This means that you should write a letter detailing most of the points listed above, and you should persistently remind your surgical team that you want the explanted components. Make sure the components are delivered to you with identification stickers establishing that the components were removed from your body in a revision surgery on a specific date. When you get them home, place the components in a safe and secure and remembered location.

Please note: I use artificial hip components as one example in this post, but preserving explanted device components is important in any medical device case, including those involving defective hips, knees, shoulders, surgical mesh, or IVC filters. Often, the surgeon cannot remove and preserve the entire defective device (as with mesh or IVC filters); in those cases, take as much as the surgeon could remove.

Why Is It Important to Preserve Explanted Components?

Here’s the thing: you may settle your case without ever needing to hand over the explanted components. But I have seen cases where the hospital did not preserve the product stickers from the original implant surgery. In that case there is no absolute evidence for what exact medical components were implanted in the patient. After all, the person injured by a failed medical device must establish which recalled or failed medical device was implanted. In those cases, you will need your surgeon to submit an affidavit testifying to the specific medical device components implanted in your body, and/or you will need the actual components when they are removed in the revision surgery. So even if you do not ever need to “hand over” the explanted components as part of your lawsuit or your settlement, it is always the best practice to make sure you or your lawyer obtain the components after the revision surgery.

Note: this is not legal advice.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

more The Incriminating Documents

The Daily Telegraph recently published a story, based on internal documents recently made available, that show Depuy actually knew it had serious problems with its MoM hip implants for years. The company deliberately took steps to ignore the problems. The released documents include:

• A paper written by Graham Isaac, Ph.D., discussing problems with MoM hip implants.
• A letter from Dr. John F. Irving, MD, to Depuy’s head of US marketing (Paul Berman).
• Depuy corporate meeting minutes where Depuy executive met to discuss various topics, including MoM hip implants.
• Internal Depuy e-mail exchange discussing MoM hip implant problems.
• A July 2008 paper on the topic of MoM hip implant problems.

These papers are especially incriminating because they show what Depuy knew (or should have known) and when they knew it.

What Did Depuy Know?

In Dr. Graham Isaac’s paper, he explains how metal wear debris created from MoM hip joints were a serious problem due to poor design and manufacturing of the metal components. However, Dr. Isaac goes on to state that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were still “as unpredictable as ever, working well for a period of time before suffering catastrophic breakdown…accompanied by a release of a large volume of debris.”

Dr. Isaac went on to conclude that metal-on-polyethylene hip implants performed significantly better than MoM implants. He also mentioned that using ceramics can produce hip implants that perform better than MoM hip implants.

In Dr. John Irving’s letter to Paul Berman, he spoke of his data collection which shows that Depuy’s MoM hip implants were dramatically underperforming other types of hip implants. When looking at metal-on-polyethylene hips from the last 10 years, Dr. Irving had a 1.2% failure rate, or eight revisions out of 660 hip implants.

Contrast this with Depuy’s MoM hip implants, where out of 262 implants, 31 required revision surgery. This was an 11.8% failure rate, almost 10 times that of the conventional metal-on-polyethylene hip implants.

As if that wasn’t bad enough for Depuy, Dr. Irving complained about Depuy’s “lack of attention and head-in-the-sand response to this problem.” Dr. Irving went on to state that “these products are harming patients,” that he “did not feel Depuy [was] doing enough to understand the extent of the Pinnacle MoM hip disease” and it would be “unethical to continue to market the product.”

And in 2010, when Depuy finally starting taking action with its MoM hip implants, there was an e-mail exchange among Depuy executives and experts acknowledging a “link to a failure pattern of the ASR XI to the Pinnacle with 36 mm heads when used with metal liners” and that “the problem may be widespread” with “evidence of metal on metal and ceramic on metal failings.”

There was also the recognition that when a hip implant failed, it was “sometimes catastrophic.” One of the e-mails ended with the belief that Depuy should “investigate and manage this growing problem.”

When Did Depuy Know?

So these internal documents go to what Depuy knew, but how long did Depuy know this? Corporate minutes show Depuy most likely knew of the MoM risks in 1995, over twenty years ago. One of the meeting’s attendees, Dr. Paul Peters, noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.”

Additional notes from the corporate minutes indicated that Depuy observed the following problems with MoM hip implants:

• Large volume of metal particles being released from the hip implants
• Metal ions being released into the body
• Poor wear results
• Metal scratches in the components taking the form of peaks and valleys (as opposed to just valleys, which would result in the hip implant lasting longer).

What Does All this Mean?

These documents appear to be from discovery in recent litigation concerning the Depuy Pinnacle hip implants, and they may have been used in Depuy Pinnacle bellwether trials. However, it’s somewhat unusual that these have been made public (by sources other than this website). The level of incriminating evidence contained in these documents is also quite unusual. If Depuy had all this information at its disposal more than twenty years ago, the injuries to patients who received the Depuy ASR and Depuy Pinnacle artificial hips in the years since then are particularly horrifying and egregious. I hope such bad publicity will further motivate Depuy to resolve its pending Depuy Pinnacle lawsuits as soon as possible.

*Note: The documents referenced and linked in this post are widely available from other news sources and were released prior to the publication of this article. The Daily Telegraph originally published “End Game” and other documents. I can not and do not verify the authenticity of these documents, nor can I confirm the truth of the statements made in the documents.

Now it’s the plaintiffs’ turn. The five victims of the Depuy Pinnacle artificial hip have answered the appeal of Depuy Orthopaedics and Johnson & Johnson in the Fifth Circuit Court of Appeals. And as they did at trial, the plaintiffs have come out fighting.

Recap of Depuy’s Appeal

A few weeks ago I wrote about the appeal brought by Depuy and Johnson & Johnson after a Texas jury awarded $502 million dollars to five plaintiffs. You can read about the Defendants’ appeal here. But to recap, Depuy and J&J argue that they were unfairly prejudiced by the plaintiffs’ team aggressive tactics at trial. They argue that Defendants are entitled to a new trial because the plaintiffs’ team had “a strategy” to “inflame the jury through highly prejudicial evidence and wholly inappropriate argument.”

A focus of Depuy’s appeal is that the companies were deeply prejudiced in the eyes of the jury based on “highly inflammatory, irrelevant, and prejudicial evidence” presented by the plaintiffs. Depuy contends that plaintiffs’ reference to payments made by Depuy to “henchmen of Saddam Hussein” was unfairly prejudicial (and thus violated Rule of Evidence 403). Turns out affiliates of Defendants had made improper payments to the Iraqi government. Judge Kinkeade, who presides over the Depuy Pinnacle litigation, allowed the improper payment evidence because Depuy made “character” an issue in the trial by repeatedly characterizing itself as a wholesome company with small town values.

Plaintiffs’ Appeal Brief

On Friday (March 31, 2017), the plaintiffs’ team filed its legal brief in response to Depuy’s appeal. It is a spirited document, and sets out the long (unhappy) history of the Depuy Pinnacle metal-on-metal hip and the injuries it has caused. The plaintiffs refute every issue Depuy raises in its appeal. Further, the plaintiffs asks the Fifth Circuit to restore the $360,000,000.00 in punitive damages awarded by the jury. I wrote about that jury verdict here and Judge Kinkeade’s reduction of the punitive damages award here.

Ultamet Metal Liner

The focus in the Depuy Pinnacle litigation has been on the company’s (aggressive) marketing and sale of the Ultamet metal insert liner in the Pinnacle artificial hip system. Plaintiffs have argued that this metal liner has created the conditions for the metal-on-metal grinding that has caused so many injuries. The plaintiffs do not argue that the polyethylene or plastic liners have negligently caused injury. Rather, it is the metal insert liner that has caused the thousands of premature artificial hip failures and the thousands of lawsuits against Depuy and Johnson & Johnson. The plaintiffs’ brief sets out this history of Depuy’s pushing this metal-on-metal hip system onto the market, despite evidence that the metal-on-metal hips caused too many problems.

Reference to Saddam Hussein

The plaintiffs also argue aggressively that their use of the term “henchmen of Saddam Hussein” was not unfairly prejudicial to Depuy. First, despite Depuy’s argument that plaintiffs used the term repeatedly, the plaintiffs point out in their response brief that the phrase was used just once in a nine-week trial. Further, the reference to unlawful payments to Iraq was presented as character evidence against the company, evidence the judge allowed because Depuy characterized itself as a “virtuous” company whose “sole goal” was to”produce products that help people get better.” Plaintiffs’ Brief. As it turns out, corporate affiliates of J&J had been sanctioned for making unlawful payments to the Iraqi government when Saddam Hussein was alive and well and the leader of Iraq. Judge Kinkeade noted at trial that Depuy had opened the door for the jury to hear this character evidence against Depuy when the defense team introduced evidence of Depuy’s wholesome reputation. Finally, the plaintiffs on appeal argue that the one reference to “henchmen” could not have been “unfairly prejudicial” because Judge Kinkeade gave the proper jury instruction that required the jury to consider only admitted evidence and explaining that a lawyer’s comments are not evidence.

Plaintiffs Ask Appeals Court to Restore $360 Million in Punitive Damages

The jury in this case originally awarded the five plaintiffs $360,000,000.00 in punitive damages (over and above actual, compensatory damages). Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. After the trial, Judge Kinkeade reduced the $360,000,000.00 punitive damages award to $9,646,256.00. Judge Kinkeade wrote that he was bound by a Texas statute which puts a “cap” on the amount of punitive damages a jury can award. In Texas, the limit on the amount of punitive damages that can be awarded “may not exceed an amount of two times the amount of economic damages; plus an amount equal to any noneconomic damages found by the jury, not to exceed $750,000; or $200,000, whichever is greater.” So the statute benchmarks punitive damages on the amount of other money damages awarded to the injured person.

The plaintiffs now ask the Fifth Circuit Court of Appeals to reverse this reduction in punitive damages and to find that the Texas statute capping punitive damages is unconstitutional. The plaintiffs make a compelling argument, because the statutory cap potentially harms certain injured plaintiffs more than others. Because the Texas statute calculates punitive damages based the individual plaintiff’s actual damages, wealthy or young plaintiffs would ultimately recover more punitive damages than those plaintiffs who do not earn a lot of money or who received fewer compensatory damages for other reasons, such as old age.

In their brief, plaintiffs argue: “A plaintiff with a large income who is injured or killed by another’s wrongdoing will likely have far more “economic damages” than a plaintiff with a modest income. Further, retirees, persons with disabilities, or spouses not working outside the home will likewise have minimal “economic damages” under Texas law.” Plaintiffs’ Brief. What this means is that in Texas punitive damages will be awarded differently if the injured person is unemployed, retired, or disabled; and that the plaintiff who is young or who earns a lot of money may end up with more punitive damages than the low earning person, even though the jury intended to punish the defendants equally for the companies’ very bad behavior. This does not seem fair. The statute could well be ruled unconstitutional.

The Fifth Circuit will take several months to decide this appeal. I will keep you posted, as always. And if you have a Depuy Pinnacle hip with a metal liner that is giving you problems, give me a call to discuss further.

I will not forget my first jury trial. It was many years ago, not long after I graduated from law school, and let’s just say I was in over my head a bit. It was a simple car crash case. I represented a driver who was rear-ended and injured (but not seriously). I walked my client through his direct examination, and I thought it was going well. Then the insurance defense lawyer was given the opportunity to cross-examine my client. He asked simple questions about the severity of the injuries (“were you able to return to work a week later?”) and after eight or ten of these questions, I objected. The judge peered down at me over his reading glasses:

“Counselor?” “Yes your honor, I object.” “On what grounds?” “This line of questioning is prejudicial.” “Prejudicial?” “Yes, your honor. I move to strike the testimony as prejudicial.”

The judge sat back in his chair. “Mr. Hodges, wouldn’t every question on cross-examination be prejudicial to your case?” This query reminded me of the complete language of Rule of Evidence 403: The court may “exclude relevant evidence if its value is substantially outweighed by a danger of . . . unfair prejudice.” I had remembered most of the rule, but not the key word: unfair. All evidence presented in any court case is supposed to be prejudicial to the other side’s case. To exclude evidence under Rule 403, the testimony must be unfairly prejudicial.

But the judge was still waiting for my answer. The jury waited too. I tried my best: “Well, yes, your honor. But this testimony is unfairly prejudicial.” At least I had finally wedged in the key word. “I don’t think so, counselor, objection overruled.”

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The judge of course was correct. And in most trials, excluding evidence on the grounds of unfair prejudice is difficult. Each side is supposed to present evidence that is aggressively prejudicial to other side’s case. And the prejudicial evidence, even if unfair, can be excluded only if the unfairness substantially outweighs the value of the evidence.

Depuy Appeals to Fifth Circuit

Depuy Orthopaedics, manufacturer of the Depuy ASR hip and the Depuy Pinnacle hip, is arguing to a federal appellate court that it was prejudiced by the evidence presented in a 2016 Depuy Pinnacle trial. That trial ended in a whopping $502 million dollar verdict in favor of five plaintiffs. Depuy’s attorneys now argue to the Fifth Circuit Court of Appeals that Depuy is entitled to a new trial because the plaintiffs’ team had “a strategy” to “inflame the jury through highly prejudicial evidence and wholly inappropriate argument.” For Depuy to win this argument, Depuy must show that the totality of the evidence was not only unfairly prejudicial, but also that the unfairness substantially outweighed its “probative” value (probative is the ability to show or prove something).

Depuy Claims Plaintiffs’ Evidence was “Highly Inflammatory”

Depuy makes many legal arguments in its appeal to the Fifth Circuit. Primarily Depuy argues that the case should have never been allowed to be presented to a jury based on state and federal law, and because the statute of limitations had run for two of the five plaintiffs. I write about the statute of limitations here. I won’t address those arguments in this article (the brief is one hundred pages long), but I wanted to touch on a separate ground for appeal: that Depuy is entitled to a new trial based on “highly inflammatory, irrelevant, and prejudicial evidence” presented by the plaintiffs.

According to the appeal brief, Depuy alleges that plaintiffs’ attorneys referenced payments made by Depuy to “henchmen of Saddam Hussein.” This language is certainly colorful, but plaintiffs presented evidence at the trial indicating that affiliates of Defendants had made improper payments to the Iraqi government. Depuy argues that this evidence was unfairly prejudicial because the issue at trial concerned simply a defective hip product. But the trial judge allowed the improper payment evidence because Depuy made “character” an issue in the trial by referring to the company’s small town values. Plus, the case involved many other claims besides design and manufacturing defects, including a robust punitive damages claim.

Depuy also objects to the plaintiffs’ reading from a book titled Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health. The book, among other things, analyzed many of the product failures and toxic tort cases that have harmed thousands of people over the years.

Depuy objects as well to the plaintiffs’ attorney referencing a connection between the failure of metal-on-metal hip implants and the potential risk for cancer. Depuy argues that any reference to cancer violated Rule of Evidence 403.

Depuy continues in its appellate brief to object to testimony of “thousands” of other pending Depuy Pinnacle lawsuits. Depuy states that this evidence was inflammatory and unfairly prejudicial.

Depuy also alleges that plaintiffs made unfair reference to a letter written by a former employee accusing other Depuy employees of racism. Racism, Depuy argues, had nothing to do with the defective hips at issue. However, plaintiffs counter that the evidence is presented as character evidence.

Finally, Depuy argues that the attorney for the plaintiffs should not have been allowed to argue “unit of time” in arguing for a standard by which to award damages to the plaintiffs. This is a technique whereby the attorney suggests a method to calculate pain and suffering over time. For example, a lawyer may ask the jury to assign a value to the pain caused by a failed artificial hip over a week or even each day. Defense lawyers hate this concept; they protest that it leads to “excessive verdicts.” Plaintiffs’ lawyers counter that if a person suffers pain each day, then each day has a distinct value when determining pain and suffering damages.

Will Depuy Win Its Appeal?

I would say Depuy has an uphill slog to win this appeal. The brief is certainly well-written. After all, Depuy employs some of the strongest (and highest priced) defense law firms in the country. But at the end of the day, Depuy must show that the value of the evidence presented above was substantially outweighed by the danger of unfair prejudice. Plus, the trial judge gave explicit instructions to the jury about what evidence they could consider and how they could consider it. As the trial judge told me years ago, the evidence presented against my client is supposed to be prejudicial to my client’s case.

I will keep you posted on the outcome of Depuy’s appeal. And if you have a Depuy Pinnacle hip that is causing you problems, give me a call to discuss your legal options.

Note: The appeal brief in this case was one hundred pages long. I have had to distill much information into a brief article. I do not take a position on the evidence presented at trial or to the strength of Depuy’s appellate arguments. This post is for general informational purposes only.

Imagine going to sleep the night after making the decision to strip five hundred million dollars from six families. I imagine it would be unsettling. On Tuesday, Judge Ed Kinkeade, a federal judge in Texas overseeing the Depuy Pinnacle MDL, made the decision to cut $500,000,000.00 from a jury award presented to six families after a grueling ten-week trial last fall. You can read about the trial and the jury’s verdict here. In that post I wrote that the jury’s verdict was “staggering,” and it was. It may be more staggering that a judge, less than a month later, would wipe out half a billion dollars of the jury’s award.

“Single-Digit Multipliers”

On January 3, 2017, Judge Kinkeade issued his post-trial court order reducing the amount of punitive damages awarded to the six families, writing that “constitutional considerations limit the amount a plaintiff may recover in punitive damages.” The relevant portion of the Order states:

“Although the jury awarded $84,000,000 in punitive damages from Defendant DePuy Orthopaedics, Inc. and $84,000,000 in punitive damages from Defendant Johnson & Johnson, constitutional considerations limit the amount a plaintiff may recover in punitive damages. See State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 425 (2003) (“[F]ew awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process. . . . Single-digit multipliers are more likely to comport with due process, while still achieving the State’s goals of deterrence and retribution . . . .”). The Court has reduced the punitive damages accordingly.” See Depuy Pinnacle Order.

I have to say this is a powerfully thin explanation for stripping half a billion dollars from a jury award: “single-digit multipliers”? Really? The U.S. Supreme Court has limited punitive damages in the past, but there is no overarching federal law limiting punitive damages, and all reductions such as the current one intrude aggressively on the power of the jury to make its own findings and awards. Further, as I discuss below, the controlling law in this case came from California, which does not have a punitive damages “cap.” In any evident, Judge Kinkeade held that the punitive damages award by the jury was “excessive.” Media reports calculate that the judge reduced the punitive damages award to nine-times the plaintiffs’ actual or compensatory damages.

Fortunately, Judge Kinkeade upheld the jury’s conclusions that the Depuy Pinnacle hip implants were defectively designed and that Depuy and Johnson & Johnson failed to warn consumers adequately about the risks involved.

The Third Depuy Pinnacle Bellwether Trial

The first Pinnacle bellwether trial ended in a defense verdict, which means the plaintiffs lost and received no award. The second bellwether trial ended with a $502 million dollar verdict for five plaintiffs. It seemed unlikely that the third bellwether trial could yield a result similar to the second bellwether trial verdict. Turns out, the third bellwether trial was the biggest one of all.

Each of the plaintiffs in this case lived in California and received the Depuy Pinnacle artificial hip in surgeries in California. Because of this California citizenship, the laws of the state of California governed the case, even though the case was being tried in federal court in Texas. In each case that reaches trial, the substantive law of the state where the plaintiff resides controls. This was important (I thought!) because California, unlike many states (including Texas and North Carolina), does not have a cap on punitive damages awarded by juries.

The Jury’s Punitive Damages Award

The jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 for the four spouses of the plaintiffs. The odd thing about Judge Kinkeade’s court order is that California has no statutory cap on punitive damages. In the second bellwether trial, Judge Kinkeade, utilizing Texas law, reduced the total jury award by $350 million, which you can read about here. But the judge should not have been able to disturb this latest award. I believed that the one billion dollar punitive damages award in this case should stand. Either I got it wrong, or Judge Kinkeade did. Of course we will see on appeal.

Were You Implanted with the Depuy Pinnacle Hip?

The Depuy Pinnacle Hip was first sold in 2000. Soon thereafter, complaints arose that the metal components of the Pinnacle hip would grind together and release metal particles into the body, often leading to extremely high blood metal levels. Depuy stopped manufacturing and selling the device in 2013. But it can take years for serious trouble to occur with a failed Pinnacle hip, which means many people are likely still out there with failing devices that don’t yet know the device is failing.

Quick example: let’s say you have the Pinnacle hip implanted in 2012, before it stopped being marketed and sold. You feel little pain in the first few years, but in 2016 you begin to feel a new discomfort. The pain gets worse over time. Then after a routine blood test, your doctor tells you that your metals levels are 17 parts per billion, which is high and not healthy. Your doctor recommends revision surgery in 2017. In that case, you should qualify for participation in the Depuy Pinnacle MDL.

The Depuy Pinnacle hip bypassed the normal premarket testing for a new medical device through the 510(k) process. This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the medical device’s “equivalence” to a device already approved and marketed. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.

The Takeaway

Punitive damages awards play a vital role in consumer protection. If companies like Johnson & Johnson do not fear large punitive damages awards, or even the freedom and power of juries, they will be less likely to take adequate precautions to protect the public. In my view, the jury’s punitive damages award should stand.

Staggering. It’s really the only word for it. Yesterday a Texas jury awarded six plaintiffs over one billion dollars for injuries sustained following the failure of the Depuy Pinnacle metal-on-metal artificial hip. And that comes out to more than $170,000,000.00 per plaintiff. The verdict was handed down last night following ten weeks of punishing trial.

This trial was the third “bellwether” case in the Depuy Pinnacle MDL (multidistrict litigation). The first Pinnacle bellwether trial ended in a defense verdict, which means the jury did not find negligence on the part of the defendants, Depuy Orthopaedics and Johnson & Johnson, and therefore the plaintiffs received no compensation. The second bellwether trial resulted in a huge $502 million dollar verdict for five plaintiffs, which I wrote about here. In fact, much of the speculation about this third bellwether trial was whether the plaintiffs’ team could put on the same powerful case that they did in the second bellwether trial, or whether the $500 million verdict in March was simply a bizarre outlier, one of those remarkable unicorn verdicts that come along once and never again.

Today, the $500 million dollar verdict seems modest compared to yesterday’s jury verdict. Plainly, juries are sending a huge message to Depuy and J&J that they hurt many people when they marketed and sold the Depuy Pinnacle Hip.

21 Expert Witnesses

The trial involved six consolidated cases: Andrews, Davis, Metzler, Rodriguez, Standerfer, and Weiser. Each of these plaintiffs lived in California and received the Pinnacle in hip replacement surgeries in California. Because of this California citizenship, the laws of the state of California governed the case, even though the case was being tried in federal court in Texas. Essentially, Texas was chosen as the Pinnacle MDL venue, but in each case that reaches trial, the substantive law of the state where the plaintiff resides is utilized. This is important because California, unlike many states (including Texas and North Carolina), does not have a cap on punitive damages awards.

The trial was hard fought. Opening arguments began on October 3. Along the way, both sides argued their cases aggressively, and spent many days cross-examining the opponent’s expert witnesses. I counted 21 expert witnesses who testified in this bellwether trial. One attempted defense for Depuy was that the surgeons implanted the Pinnacle hip in these plaintiffs incorrectly. Depuy and J&J also asked for a mistrial a few days ago, which Judge Kinkeade in Dallas denied.

The Jury Verdict

After closing arguments, the jury “received” case on November 30, which means it was finally time for the jurors to sit in a conference room and decide whether the plaintiffs had proven their cases, and if so, how much money they were entitled to receive. After just one day of deliberation, the jury delivered its staggering verdict. The jury award totaled $1,041,311,648.17, and included $28,311,648.17 total in personal injury (“compensatory”) damages for the six plaintiffs, and $4,000,000.00 in loss of consortium damages to the four spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for four spouses of the plaintiffs.

The jury found that DePuy and J&J were negligent in designing the Pinnacle Ultamet artificial hip. The jury also found against the defendants on the plaintiffs’ strict liability claim (failure to warn), negligence (failure to warn), negligence (failure to recall), negligent misrepresentation, negligent misrepresentation to the plaintiffs’ physicians, intentional misrepresentation, intentional misrepresentation to the plaintiffs’ physicians, fraudulent concealment, and fraudulent concealment to the plaintiffs’ physicians.

J&J was also found by jurors to have aided and abetted with DePuy, concluding that the defendant knowingly gave “substantial assistance or encouragement” of the negligence of DePuy that ultimately caused injury to the plaintiffs under claims of negligence, failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation, and fraudulent concealment.

Plaintiffs won every claim except one. The jury found that J&J did not conspire with Depuy to commit negligence as to the design of the implant.

As I said, it was a staggering win for the plaintiffs, and by extension, the thousands of other victims still waiting in the Pinnacle MDL.

Remember that California has no statutory cap on punitive damages. In the second bellwether trial, Judge Kinkeade invoked Texas law to reduce the total jury award by $350 million, which you can read about here. But Judge Kinkeade can’t do that with this latest award, as California law does not authorize courts to invade the province of the jury. Thus, the one billion dollar verdict should stand. Again, staggering.

The Jury Award

Plaintiffs Andrews, Davis, and Metzler underwent single hip replacements, which then failed, and each were awarded over $4 million in personal injury damages, $84 million in punitive damages against Depuy, and $84 million in punitive damages against J&J. Their spouses separately received $1 million in loss of consortium damages, $125,000 in punitive damages against DePuy, and $125,000 in punitive damages against J&J.

Plaintiffs Rodriguez, Standerfer, and Weiser underwent bilateral hip replacements (when means both hips were replaced), which then failed, , and each was awarded personal injury damages ranging from $4 million to $6 million, plus $84 million in punitive damages against Depuy, and $84 million in punitive damages against J&J. Spouses received $1 million in loss of consortium damages, $125,000 in punitive damages against DePuy, and $125,000 in punitive damages against J&J.

Do You Have a Depuy Pinnacle Hip Implant?

The Depuy Pinnacle Hip was originally designed to replace your natural bone “ball-and-socket” with artificial ball-and-socket parts. The Pinnacle was supposed to provide more range of motion and to be more useful to an active group of patients undergoing hip replacement surgery. The Pinnacle system was supposed to give surgeons different options in the materials to be used for the hip replacement: metal-on-metal, or ceramic-on-metal, or other combinations. One of the major complaints against the Pinnacle is that the metal components grind and release metal particles into the body and blood of the patient, often leading to extremely high metals levels.

The Pinnacle Hip was first sold in 2000. Depuy stopped manufacturing and selling the device in 2013. But it can take years for serious trouble to occur with a failed Pinnacle hip, which means many people are still out there with failing devices that don’t yet know the device is failing. Quick example: you receive the Pinnacle hip in surgery in late 2012 or early 2013, prior to the device being taken out of the marketplace. Your hip feels OK in the first few years, but in 2016 you begin to feel a new discomfort. The pain gets worse over time. Then after a routine blood test, your doctor tells you that your metals levels are 12 parts per billion, which is very high and not healthy. Turns out you are developing metallosis from the metal particles leaching into your body. Your doctor recommends revision surgery in January 2017. In that case, you should qualify for participation in the Depuy Pinnacle MDL.

Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).” This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.

In any event, yesterday’s jury verdict will send shock waves through medical device industry. Stay tuned here for more information.

The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.

Third Depuy Pinnacle Bellwether Trial

Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.

Depuy has attempted several times to postpone the current trial. Judge Kinkeade has denied those motions. After jury selection, both sides made opening statements to the jury earlier this week. One major defense for Depuy seems to be that the surgeons implanted the Pinnacle hip in these plaintiffs incorrectly. In addition, there have already been several skirmishes between the plaintiffs’ attorneys and the defense team.

It is important to note that the current case is being tried under the laws of California. A case is typically governed by the laws of the state in which the plaintiffs originally file suit. A federal court in any state is often asked to consider a case with another state’s laws. The previous bellwether trial was governed by the laws of the state of Texas, which has a statute capping punitive damages. But California has no such statute. If the jury in this present case awards a large punitive damages award for the seven plaintiffs, the award will most likely stand.

So as I said, this is an important case, and a lot is at stake for both sides.

The Depuy Pinnacle Hip

The Depuy Pinnacle Hip was originally designed to replace your natural bone “ball-and-socket” with artificial ball-and-socket parts. The Depuy Pinnacle system was supposed to provide more range of motion and to be more useful to an active group of patients undergoing hip replacement surgery. The Pinnacle system gave surgeons different options in the materials to be used for the hip replacement: metal-on-metal, or ceramic-on-metal, or other combinations. One of the major complaints against the Pinnacle is that the metal components grind and release metal particles into the body and blood of the patient, often leading to extremely high levels of cobalt and chromium (metallosis). You can read more about metallosis here.

The Depuy Pinnacle Hip was first sold in 2000. Depuy stopped manufacturing and selling the device in 2013.

Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).” This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.

Second Bellwether Trial Was Remarkable

Depuy needs a win in this third bellwether trial, as the company got walloped in the second bellwether trial. On March 17, 2016 a Dallas-area jury ordered Depuy Orthopaedics and Johnson & Johnson to pay five injured people $502 million dollars, including $360 million in punitive damages. The jury based this award on several factors, including findings that Depuy hid critical defects in the design of the Depuy Pinnacle artificial hip system and hid these risks from doctors and patients. Remember that a bellwether trial, even with several plaintiffs, is not a class action lawsuit. Rather, because the five individual cases had sufficient similarities, the judge, attorneys, and litigants agreed to try all five cases in one jury trial. The single jury heard all the evidence in these cases, but Judge Ed Kinkeade instructed the jury to consider liability in each individual case, and to award separate damages for each plaintiff. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not warn patients and their doctors of the risks. The jury then awarded $142,000,000.00 in actual damages and $360,000,000.00 in punitive damages. The punitive damages award was later reduced (by operation of a statute capping punitive damages) to $9,646,256.00. To put it another way, the statute stripped $350,000,000.00 from the punitive damages award a jury of twelve individuals, after a 42 day trial, decided was appropriate. So much for the sanctity of the jury.

Even with this staggering reduction in the jury’s money damages award, the second bellwether trial was a huge win for the plaintiffs. Depuy and Johnson & Johnson have appealed, but they must also recognize that juries do not look favorably on rushing a dangerous product to market, particularly when more than eight thousand people are later injured by the device.

Stay tuned.

In March 2016 five people injured by the Depuy Pinnacle metal-on-metal artificial hip scored a huge courtroom victory. In that case a Texas jury awarded five plaintiffs $502,043,908.00 for injuries suffered by the failure of the Depuy Pinnacle hip. That figure was divided in different ways to the five injured people. Of that amount, $360,000,000.00 was awarded by the jury for punitive damages. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not adequately warn patients and their doctors of the risks. Like I said, this was a huge win. Unfortunately, the punitive damages award did not last long.

Judge Forced to Reduce Punitive Damages Award

Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. Judge Kinkeade, who is the federal judge presiding over the Depuy Pinnacle multi-district litigation (MDL), stated that he was bound by a Texas statute which puts a limit or “cap” on the amount of punitive damages a jury can award. Thus, Judge Kinkeade was required by law to reduce the punitive damages award, which a jury of twelve individuals, after a 42 day trial, thought was appropriate.

Thank You, Tort Reform! more

This Texas statute, like many across the country, was enacted in the great tort reform push of the last few decades. Legislators, often pressed by the insurance and big business lobbies, wrote statutes that put caps on the amount of punitive damages that a court could award, no matter what the jury thought was proper and necessary. In Texas, the limit on the amount of punitive damages that can be awarded “may not exceed an amount of two times the amount of economic damages; plus an amount equal to any noneconomic damages found by the jury, not to exceed $750,000; or $200,000, whichever is greater.” So the statute benchmarks punitive damages on the amount of other money damages awarded by the to the injured person. Never mind the fact that the intent of punitive damages is not to compensate the injured person but to send a loud message to the bad acting defendant. Legislatures have essentially said to juries: “we’ll let you know how loud your message can be to a defendant who injures one of our citizens.”

In North Carolina, where I live, there is a similar cap on punitive damage awards. N.C. Gen. Stat. § 1D-25(b) states that punitive damages “shall not exceed three times the amount of compensatory damages or two hundred fifty thousand dollars ($250,000.00), whichever is greater.” I can tell you that this statute has had a chilling effect on injury cases in North Carolina.

So What’s Next in Texas?

Judge Kinkeade reduced the $360,000,000.00 punitive damages award to $9,646,256.00. The five injured persons now have a verdict, after the operation of the Texas statute, of $151,646,256.00, down from the original jury verdict of $502,043,908.00. As astonishing as the original jury verdict was when it was announced in March, this reduction is almost equally stunning. Admittedly this jury verdict still represents a very large award and a big success for the plaintiffs. But the attack on the jury’s verdict is not over. Despite winning a $350,000,000.00 reduction in the jury award, Depuy and Johnson & Johnson immediately filed an appeal in the case, arguing that mistakes were made at the trial level and that the entire award should be voided and a new trial granted. Appeals like this one will take many months to resolve.

Thousands of Depuy Pinnacle Cases Remain

Depuy stopped selling the Pinnacle in 2013. Remember that—unlike the Depuy ASR hip—the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. Depuy still takes the position that the Pinnacle is different and safer than the ASR hip components. But this latest jury verdict makes it harder for J&J to advance that narrative.

The Depuy Pinnacle system was allegedly designed to provide better range of motion for a more active group of patients undergoing hip replacement surgery. One of the major complaints from injured patients is that the metal components grind and release metal particles into the body and blood of the patient. Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).”

The next “bellwether” Depuy Pinnacle case is scheduled to go to trial in September 2016.

The Takeaway

Punitive damages awards play a vital role in consumer protection. If companies do not fear large punitive damages awards, or even the freedom and power of juries, they will be less likely to take adequate precautions to protect the public. And as we’ve seen again and again, companies often rush products to market which they believe will make them great profits. The 510(k) process is one of these shortcuts that have caused unnecessary injuries from many flawed consumer products. Tort reform advocates speak of the protections of business and the money these statutes will save companies and insurance companies. But these legislative limitations come at a cost, and in my view will lead to more careless behavior from profit-first corporations.

In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas).

Depuy Orthopaedics and its parent company Johnson & Johnson filed their “motion to stay” on May 24, 2016. They asked the court to delay all further trials in the Depuy Pinnacle MDL until an appellate court rules on their appellate issues. (It is very common for a company in any case to appeal a trial verdict when the jury awards significant damages to the plaintiffs.) Depuy claimed there were significant errors made at the trial. Depuy also argued that the decision in the appeal could have “far-reaching implications” on how future Pinnacle cases are tried. Defendants claimed the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

Judge Kinkeade, who presides over the Depuy Pinnacle MDL in Dallas, Texas, denied the motion to stay the trials. In his order Judge Kinkeade selected seven bellwether cases to be tried beginning September 6, 2016. You can read that Order here.

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A “stay” would have created a long delay in resolving the remaining cases that are ready for trial. A complex appeal in a federal circuit court can take over a year to conclude. Judge Kinkeade apparently did not see any reason to delay other cases that are ready for trial.

Defense: The Pinnacle Ain’t the ASR

Depuy Orthopaedics has so far refused to negotiate a global settlement arrangement with lawyers for injured plaintiffs. Depuy has argued that the Depuy Pinnacle is not defective and is different from the Depuy ASR hip, which was a metal-on-metal hip that resulted in two large settlement agreements. One defense seems to be: “the Pinnacle ain’t the ASR.” Depuy has argued that the Pinnacle is not flawed in the manner the ASR was flawed.

Plaintiffs disagree, and thousands with the Pinnacle implant have filed suit for many of the same injuries that the ASR inflicted on individuals. Plaintiffs have argued that if Depuy refuses to negotiate a global settlement of the Pinnacle cases, then the court should fast track all remaining cases, as there are more than 8,000 cases remaining to be resolved.

Punitive Damages Award Sends Message

It appears the $500 million dollar verdict will be reduced in part. Texas law places a $10 million dollar limit on punitive damages, so the $360,000,000.00 in punitive damages awarded by the jury will likely be severely reduced. Still, the large punitive damages award serves a value for plaintiffs as it sends a strong signal that the jury was sufficiently offended by the actions of Depuy that it awarded a huge amount of punitives, whether or not Texas law permitted such an award.

Depuy and Johnson & Johnson are accused of covering up defects which caused the hips to fail. The hip component manufacturers still face more than 8,000 lawsuits concerning the alleged failure of the Depuy Pinnacle artificial hips. Judge Kinkeade’s Order was a victory for injured people and a rejection of unnecessary delays in the Depuy Pinnacle MDL.