Health care is an industry that, for the most part, is pretty quick to make the most of new technology. One such area is medical records.

With the increased capabilities and reduced costs of computers, networks and electronic storage, electronic health records (EHR) are primed to take full advantage of what information technology has to offer the medical field. These advantages can include better cost efficiency and improved patient care.

That’s one reason why Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH Act). This law set out to promote the use and adoption of EHR and medical information technology.

One of the things the HITECH Act did was establish rules concerning access to patient EHR, including who can access them and how much it costs to obtain a copy of these records. But a court case just made it more expensive for attorneys acting on behalf of patients to obtain these records. This could have a notable impact on a plaintiff’s ability to recover for injuries caused by a negligent company or individual.

Access to Medical Records: An Overview

After the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) created regulations that outlined a patient’s right to his or her medical information.

Specifically, 45 CFR § 164.524 set out how someone could review or obtain copies of his or her health care records. These regulations also set out how much a medical provider could charge individuals for obtaining copies of their records.

Basically, this regulation said that a medical provider could only charge patients a reasonable, cost-based fee (Patient Rate). This meant that the fee could only include actual production costs, such as labor, materials, and postage for producing and sending the documents to the patient.

When passed in 2009, the HITECH Act made a few changes. It not only streamlined a third party’s ability to get a copy of a patient’s EHR (with the patient’s permission, of course), but it further limited the fee that the medical provider could charge patients.

In 2013, HHS released new regulations relating to access to EHR. One of the things these regulations did was allow a patient to get a medical provider to send any of his or her medical records to a third party, even if it wasn’t an EHR.

Then a big change came in 2016, when the HHS release its Guidance titled “Individuals’ Right under HIPAA to Access their Health Information 45 C.F.R. § 164.524.” This provided additional information on how to calculate the Patient Rate, including the option for a flat rate of $6.50. But most importantly, the 2016 Guidance allowed third parties to pay the Patient Rate only as long as they were getting the documents at the request of the patient.

But a court case from January 2020 changed all this.

Ciox Health, LLC v. Alex Azar

Ciox Health, LLC (Ciox) is in the business of processing patient medical information on behalf of health care providers. Ciox’s pricing model relied on the understanding that the Patient Rate only applied to individuals who were asking for copies of their own medical records. But when patients asked that their records go to a law firm or insurance company, Ciox could charge a fee that far exceeded the Patient Rate.

But thanks to HHS’ 2016 Guidance, third parties only had to pay the Patient Rate, which was sometimes just $6.50. This was a problem for Ciox because it meant a significant loss in revenue.

So what did Ciox do? It did what almost any other business might do when the government makes a law or rule that cut into their profits – it sued.

Ciox won its case when the U.S. District Court for the District of Columbia concluded that HHS was not allowed to apply the Patient Rate to third parties and that patients could only ask for their EHR to be sent to a third party (as opposed to any medical records, regardless of format).

What the Ciox Case Means for Plaintiffs

This case means that injured plaintiffs will now have the added burden of not just requesting their medical information, but once receiving it, forwarding it to their attorney. Or if plaintiffs want the information sent directly to their attorneys, there will be a much higher fee, often in the hundreds of dollars.

Many attorneys will probably be the ones to advance this large hard-cost expense. But in the end, everyone will pay.

The plaintiff will be expected to pay litigation hard-costs from the proceeds of any settlement or trial verdict. If the case is lost, the attorney usually pays these litigation costs, which could make attorneys less likely to take on winnable but risky cases in the future. If it’s just one case, it’s not a big deal. But many injury law firms could have dozens or hundreds of cases where they have this new expense. Now we’re talking tens if not hundreds of thousands of dollars in hard cost expenses.

The defendant will also eventually pay, because these added costs for obtaining medical records will indirectly factor into any verdict or settlement.

Congress or HHS should make changes that make it more affordable for patients to get copies of their complete medical records to their lawyers, insurance companies or other third parties. Until then, plaintiffs and defendants can expect the litigation process to get even more expensive.

In 2009 Mary McGinnis was implanted with the Avaulta Solo Support System and Align Trans-Obturator Yrethral Support System, two pelvic mesh products manufactured and sold by C.R. Bard, Inc. and other defendants. Ms. McGinnis was implanted with these mesh products in an attempt to treat Ms. McGinnis’ stress urinary incontinence and to provide bladder support. Shortly after implantation of the mesh, Ms. McGinnis began having severe pains from nerve damage and pain during sex. She had to undergo several surgeries to attempt to correct the problems.

Ms. McGinnis and her husband filed suit in 2011, alleging that C.R. Bard knew the pelvic mesh was unsafe at the time the products were implanted in Ms. McGinnis, and that Bard failed to warn doctors about the dangers of the Avaulta and Align pelvic mesh. At trial lawyers for Bard argued that the Defendants met all industry standards and requirements for placing the Avaulta and Align mesh products on the markets.

Compensatory Damages

On April 12, 2018, after a four-week trial, the McGinnis family finally got some justice. The jury in New Jersey state court awarded $33 million in compensatory damages. These damages were broken down this way: Ms. McGinnis received $23 million for her specific injuries, medical costs, and pain and suffering, and her husband received $10 million for his derivative “loss of consortium” claim. (Let me add here that loss of consortium claims can be substantial in these kinds of cases, as one of the key mesh injuries is pain during sex, often leading to couples abandoning marital relations altogether. That kind of injury has real value for most couples.)

Punitive Damages

On April 13, 2018, the jury returned to court to consider whether to impose punitive damages on C.R. Bard. Plaintiffs’ lawyers argued that Bard acted “maliciously” and in “wanton and willful disregard” for the rights of Ms. McGinnis and her husband when Bard placed these flawed products in the market. Ms. McGinnis’ lawyers argued that corporate profits should never take precedence over the health of patients. Again, Bard lawyers countered that Bard complied with industry standards, that $33 million (in compensatory damages) was compensation enough, and that anyway the vast majority of of medical devices reach the market without clinical trials. Therefore, said Bard, the jury should not impose punitive damages.

The jury then awarded the Mary and Thomas McGinnis $35 million in punitive damages. The two-day verdict reached $68 million. Of course it can never repair Ms. McGinnis’ internal injuries, the pain she suffers during intercourse, or her incontinence, but the money may at least provide the best medical care going forward and some comfort as she grows older.

“Most Medical Devices Do Not Undergo Clinical Trials”

As noted above, this was one of the main arguments offered by attorneys for C.R. Bard and the other defendants. Because so many similar mesh products were already on the market, Defendants argued, clinical studies on these new products were not necessary.

This is crazy talk. Clinical testing is critically important for new medical devices. And this is a major problem in our medical device device industry. It goes like this: ‘because this new product, let’s say a metal-on-metal (MoM) artificial hip looks very similar to an older, metal on ceramic hip, we don’t need to test our MoM hip. Let’s just put it on the market now, without testing.’ (Over a decade later, ask the many thousands of people injured by MoM artificial hips whether clinical testing was unnecessary.) The same holds for pelvic mesh, IVC filters, artificial knees, and virtually all other medical devices.

This subject is too important to ignore. If a company wants to sell a product that is to be implanted in a human body, the company should do all that it can to ensure that the product is safe.

Fortunately, the Avaulta and Align mesh products implanted in Mary McGinnis have been taken off the market. But not before thousands of women were severely injured by these flawed pelvic mesh products. Thousands of cases have been filed and more trials are scheduled for 2018 and beyond. I’ll keep you posted.

Note: This post was drafted from review of several news reports on the McGinnis trial.

There have been two major developments in testosterone replacement therapy litigation in the past week. Last Thursday Eli Lilly & Co., the maker of the testosterone product Axiron, announced to Judge Matthew Kennelly in Illinois that an agreement had been reached to settle claims by people injured by Axiron testosterone. In the second development, the same judge tossed a jury verdict awarding $150,000,000.00 in punitive damages to a man who suffered a heart attack while taking Androgel testosterone.

Let’s take a quick look at both litigation developments:

Axiron Testosterone Global Settlement

Two bellwether trials in the Axiron testosterone litigation had been scheduled for January and March 2018. In one case, a plaintiff alleged that Axiron had caused his heart attack. In the second case, the plaintiff alleged that the testosterone product had caused deep vein thrombosis (DVT). These two cases were going to be the first trials over injuries sustained by Axiron in the multidistrict litigation, or MDL. Nevertheless, on December 21, 2017 Eli Lilly announced to the judge that a framework for settling all Axiron lawsuits had been reached by the executive committees for the plaintiffs and defendants.

The terms of the proposed settlement were not announced. The judge gave both sides forty-five (45) days to finalize the terms of the settlement. The Axiron testosterone cases are part of more than 6,000 lawsuits brought against several testosterone makers, including Eli Lilly, AbbVie, and Auxilium.

On the strength of this settlement announcement, Judge Kennelly postponed the upcoming Axiron bellwether trials and all trial deadlines. In a way this is a shame, as several bellwether trial verdicts give all sides a clear picture of how juries view the harm done. Of course, there is serious risk on both sides in trying these cases. If a jury awards a huge amount of damages, the defendant company will eventually pay more in the larger settlement. If several juries find no link to the product and the injury, the plaintiffs suffer. We will not get to see what juries thought of the Axiron testosterone product at this point.

I will update you here as soon as the Axiron Master Settlement Agreement is released.

Androgel: $150,000,000 Jury Award Set Aside

I must admit I saw this coming. I essentially predicted it. I wrote about Mr. Mitchell’s large punitive damages award in August, which you can read here. You may recall that I pointed out then the serious problem with the jury’s verdict: that it awarded punitive damages without any award for compensatory damages. As I explained months ago, to support an award for punitive damages, there usually must be some award for actual damages. Think of this way: in order for a plaintiff to qualify for a punitive damages award, that plaintiff must show that he has been directly harmed by the product, even if the harm is minimal.

In this case, Mr. Mitchell suffered serious harm: a heart attack. However, the jury could not agree that the heart attack was caused by the Androgel testosterone. Nevertheless, the jury did believe that AbbVie, Inc., the maker of Androgel, should pay for its fraudulent misrepresentation. The jury agreed with Mitchell’s claim that AbbVie targeted middle-aged men with misleading marketing that Androgel could treat low testosterone and improve lives. The jury then awarded a huge punitive damages award, with no underlying compensatory damages award. The jury appeared to find that AbbVie should be punished for fraudulent marketing, even though it could not connect Androgel to Mitchell’s heart attack.

As I said then, this was a “glaring problem” with the jury’s verdict. And Judge Kennelly, last Friday, tossed out the award altogether. He wrote that it was illogical to assert “simultaneously” that Mr. Mitchell had been damaged and not damaged. The judge wrote that the verdict was “internally inconsistent.” He makes a point.

Plaintiff Jesse Mitchell will get a new day in court. Judge Kennelly ordered a new trial in the case, although a new trial date has not been set. But again, as I wrote above, there is risk for all sides in any trial, and Mr. Mitchell’s case is an excellent example of this risk.

If you took any testosterone product in the past and suffered injuries, give me a call ((919) 830-5602) to discuss your potential case.

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.

The Second Testosterone Bellwether Trial

Mr. Konrad was in his late forties when he began using Androgel in 2010. He was prescribed testosterone to treat a decrease in his testosterone levels. Two months later he suffered a heart attack. He filed suit years later, alleging that AbbVie knew about the link between testosterone use and heart attacks but sold the product anyway, and without sufficient warnings. The jury did not find that Mr. Konrad proved the connection between his use of Androgel and his heart attack. Other factors, such as Mr. Konrad’s obesity, high blood pressure, and family history, could have caused his heart attack. Nevertheless, the jury found that AbbVie was liable for damages based on AbbVie’s negligence and misrepresentation.

After a two week trial, the jury awarded Mr. Konrad $140,000.00 in compensatory damages and $140,000,000.00 in punitive damages. Compensatory damages represent payment for actual losses, to compensate a plaintiff for a proven physical injury or financial loss. In Mr. Konrad’s case, according to reports, the jury awarded $40,000.00 for repayment of medical expenses following his heart attack. The remaining $100,000.00 award represented pain and suffering damages, which you can read more about here.

Punitive damages are a different animal. This category of damages is meant, quite simply, to punish, and the message the jury sends is essentially this: you defendants hurt this person, and your actions were intentional or at least reckless, and you need to be punished financially for your extremely bad behavior. A jury typically can award any amount for punitive damages (after all the point is to punish), though many states have laws capping the amount defendants ultimately must pay in punitive damages.

This is the second straight testosterone trial where the jury awarded a huge amount of punitive damages. I wrote about the first bellwether trial and the large punitive damage award here.

AbbVie announced that it would appeal last week’s jury verdict. This always happens when, as here, plaintiffs win big.

Androgel has been on the market since 2000. In 2004 it began to be sold for “off-label uses”; namely, to treat men with low testosterone. It is now one of the most popular TRT products on the market. Last year AbbVie sold $675 million worth of Androgel testosterone.

In 2015, after many years of complaints (and many heart attacks), AbbVie finally added a warning about the risk of heart attacks to its Androgel drug label.

Studies Show Increased Risk of Heart Attacks From Testosterone

Studies have shown a relationship between testosterone use and the increased risk for heart attacks. In 2010 The New England Journal of Medicine published the results of a study on the effects of testosterone replacement therapy. More than two hundred men with a mean age of seventy-four were studied over a six-month period. In the study the group undergoing testosterone replacement therapy had higher rates of dermatological, respiratory, and cardiac events that the group receiving a placebo. The study revealed that twenty-three men receiving testosterone had “cardiovascular-related adverse events” compared with five in the placebo group. This is a remarkable finding: those men receiving testosterone were almost five times more likely to suffer a heart attack or other heart issue than were the men taking sugar pills. The findings were so alarming that the study had to be terminated early, most likely because it would have been unethical to keep having men take testosterone with such an elevated potential for heart attacks and other health problems.

What is Testosterone?

Testosterone is a naturally occurring hormone vital to the development of masculine characteristics and male growth. It is mainly produced in the testicles (though women produce smaller amounts of testosterone). Testosterone increases during male puberty; it operates to deepen the male voice and increase muscle mass; it also functions to increase facial and body hair, and to spark the sex drive. It’s the thing that helps the boy become the man (at least physically).

Testosterone can also be produced synthetically. FDA-approved testosterone products include gel or patches applied to the skin, an injection, and another method of delivering testosterone through application to the upper gum or inner cheek. The FDA has approved these products for men who “who lack or have low testosterone levels in conjunction with an associated medical condition.” Examples of an “associated medical condition” include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.

Physicians Recommend Lifestyle Changes Instead of Testosterone Use

Many physicians have been skeptical of the need for testosterone replacement therapy. Many doctors advise that the first thing a man should do when he believes he may suffer from low testosterone is to lose weight, exercise, get more sleep, and get retested after making these lifestyle changes. In many cases, these positive changes will increase testosterone levels naturally. Testosterone levels in men typically fall by only one or two percent per year after age forty, which is not alarming. Most physicians and other experts believe there is no epidemic of low testosterone among men.

More than 6,000 lawsuits have been filed against manufacturers for injuries allegedly caused by testosterone. More trials will follow, and I will keep you posted here. Call me any time if you have specific questions: (919) 830-5602.

If you are injured by a defective or faulty medical device or medication, you may be able to recover damages from the responsible manufacturer. Depending on the facts of your case, these damages can compensate you for things such as medical bills, pain and suffering and lost wages. In cases where the manufacturer acted in particular nasty ways, such as burying a product study which showed an increased risk of injury, punitive damages may even be possible.

For plaintiffs who are able to obtain a damage award from the responsible medical device or pharmaceutical company, they understand they will not be able to keep every penny received. For example, some of it will go to their attorney (if they have one) and some of it may be subject to taxes. But sometimes, an unexpected “bill” comes from their health insurance company.

Why Do I Have to Pay My Health Insurance Company?

This is sometimes an unpleasant surprise, and you might be wondering if there is some sort of mistake; it usually isn’t. Even though your health insurance may have paid for much of your medical care resulting from the defective medical device or medication, you could still be on the hook for paying those bills indirectly. To effectively explain how this is so, let’s take a step back and see how insurance works.

How Insurance Works

Individuals sign up for health insurance to avoid the risk of a serious medical problem creating healthcare related financial burdens the individual can’t afford. Insurance companies agree to take on this risk so they can make a profit from it. An insurance company’s profit can be understood with the following simple mathematical equation:

Insurance premiums – covered losses = profit

The insurance companies decide how much of a profit they want, use actuaries and fancy computer programs to predict their covered losses, then set their premiums accordingly. This is an oversimplification as to how insurance companies make a profit, but it gives you a general idea.

However, insurance companies can lower the premiums, yet still maintain their profit, by reducing what they pay for covered losses. One way they do this is with subrogation.

What is Subrogation?

The term subrogation means to stand in the place of another. In the context of insurance, it usually refers to the insurance company standing in the place of the insured. When might this happen? When the insured has a legal claim against a third party, such as a medical device or pharmaceutical company.

Most insurance policies have special language that gives insurance companies this subrogation right. You may already be familiar with the concept of subrogation when dealing with your car insurance company. For instance, if you were injured in a car accident due to the fault of another and your car insurance company pays you for your covered loss, the car insurance company also has the right to go after the responsible party to recover what it paid you. Basically, subrogation gives car insurance companies the right to reimbursement.

Many health insurance policies give health insurance companies this same right. So if you get hurt, requiring the use of your health insurance benefits, your health insurance company may be able to recover from the responsible party what it paid to you. When a health insurance company exercises this right, they will place a healthcare lien on your settlement or judgment amount. It may not seem fair, but whether you know it or not, you actually agreed to this arrangement.

But I Never Agreed to Subrogation!

Actually, you probably did, but just didn’t know it. When you signed up for your health insurance and paid your premiums, you agreed to the terms of your insurance policy, which is a contract. Theoretically, you could have renegotiated a few of the terms in your insurance policy, including taking out the part that gives your health insurance company the right of subrogation.

But reality doesn’t allow for an individual consumer looking for health insurance to have this type of negotiating leverage. So if you really didn’t like the subrogation provision in your health insurance policy, your only option was to find another insurance policy that didn’t have it (which would have been unlikely).

Is There Any Good News?

The good news is that if your attorney negotiates a settlement with the medical device or pharmaceutical company, your attorney will make sure that any settlement amount will include money to pay any healthcare liens you may have. This is particularly true in multidistrict litigation (MDL) settlements. In some MDL global settlements, the wrongdoing manufacturer will agree to compensate the plaintiff for his or her injuries, and will also agree to cover the subrogation demands of the person’s health insurance coverage. This important benefit, for example, was part of the Depuy ASR Settlements.

Also, depending on which state laws apply to your health insurance policy, a health insurance company’s subrogation rights may be restricted. For example, some states have laws that limit the amount the insurance company can recover from you. This area of law is extremely complex, however, and beyond the scope of this post. But be aware that health insurance companies are powerful entities, and they work constantly to protect their rights to subrogation and ever higher profits. So at the end of the day, be prepared to pay health insurance liens from your personal injury recovery.

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.

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.

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).

To paraphrase Yogi Berra, your lawsuit ain’t over till it’s over.

In a product liability case, most lawsuits end in a settlement. The plaintiff and the defendants work the case for a period of time, and eventually they sit down and hammer out a resolution to end the case. However, some product liability cases make it all the way to trial. I have written about jury verdicts in medical device and drug cases often on this site. Recently, for example, a young boy and his family won a whopping $70,000,000.00 verdict against Johnson & Johnson based on the boy’s disfigurement caused by the drug Risperdal. In that case, as in so many others, you may think that after years of litigation and after winning a complex jury trial that the plaintiff can finally leave the court system behind and get on with his life. But the case, sadly, may just be getting started. When medical device manufacturers and drug makers lose a big case with a large money award, expect them to throw the kitchen sink at you after the jury reaches its verdict. Let’s look a few things a defense team could do if it loses a big product liability case.

more Post-Trial Motions

The first thing defendants will do if they lose a trial is to file every possible post-trial motion.

• Judgment Notwithstanding the Verdict (JNOV)

This is a motion directed to the judge which asks for judgment in defendants’ favor despite the fact that the jury found in favor of the plaintiff. The argument basically goes like this: Never mind what the jury concluded. The defendants are entitled to judgment in their favor based on the applicable law. This motion first arises at the end of the plaintiff’s evidence, when the defendants ask for a judgment as a matter of law. The defendants argue, “see judge, you’ve heard all their best evidence, and given that evidence, and without putting on any defense evidence, we deserve to win this case.” If the judge denies the JMOL, defendants then put on their case. Once that is done, the jury decides who wins. If defendants lose the jury decision they can “renew” their motion for judgment as a matter of law after the verdict, which is the JNOV. Essentially, the judge at that point is not asked to tamper with the jury’s verdict, but rather to reconsider his previous decision on the original motion for judgment as a matter of law.

• Motion for New Trial

Defendants may also seek a new trial. They will argue that there were legal defects in the original trial which unfairly, even unlawfully, prejudiced the defendants and rendered the original trial void. In a recent artificial hip case in Georgia, defendants filed a motion for a new trial based on post-trial arguments that the jury verdict was inconsistent with law and flawed based on juror confusion or bias. The judge rejected that motion, but severely reduced the overall award based on a different motion, which I write about below.

• Motion to Strike Jury Awards

Motions to strike awards are pretty straightforward. The arguments go something like this: “Judge, please strike the punitive damages award because of [blank].” The “blank” could be many things: a state statute which puts a cap on punitive damages awards, or simply that the punitive damages award is unreasonably large. Unfortunately for the plaintiff, this latter reasoning prevailed in a recent Wright Conserve artificial hip case, In Re: Wright Medical Technology Inc. Conserve Hip Implant Products Liability Litigation (MDL No. 2329); Christiansen, No. 13-00297 (N.D. Ga.). In that case, the federal judge held that the evidence supported a finding that Wright Medical engaged in reprehensible conduct, which thus supported an award of punitive damages. However, he then somehow concluded that the reprehensible conduct was nevertheless well-meaning, and then randomly reduced the punitive damages award from $10,000,000.00 to $1,100,000.00, a figure he claimed was “’reasonable and proportionate to the amount of harm to the plaintiff and to the general damages recovered.’”

I still shake my head over this decision. It was a crippling blow to the plaintiff, stripping her of $8,900,000.00. Beware of post-trial motions to strike awards.

Appeals

This article focuses on actions the defendants will likely take if they lose a product liability case, but of course any losing party can utilize post-trial motions or appeals. For consistency I will stick with the fact pattern that the defendants have lost the product liability case.

If the post-trial motions are not successful, the defendants can appeal to the next highest appellate court. If the product liability trial was held in a state court, the losing party can appeal to that state’s court of appeals or to the state supreme court (whichever court is in position to review the case next). If the case was tried in federal district court, the defendants will appeal to the appropriate circuit court. There are thirteen circuit courts of appeal in the federal court system.

Regardless of whether the product liability case was tried in state or federal court, the defendants will bring similar appellate arguments and issues to the reviewing appellate court. Defendants will likely argue that the judge made a fatal error in permitting certain evidence, that other evidence unfairly prejudiced the defendants in the eyes of the jury, that the jury instructions were wrong, that the plaintiff did not prove actual or punitive damages, on and on and on.

If the defendants lose their appeal at the circuit court or at the highest state appellate court, the defendants have the right to ask for review by the United States Supreme Court. This will be a discretionary decision by the U.S. Supreme Court, and in most cases will be denied. The Supreme Court hears about eighty (80 ) cases per year, despite several thousand requests for cases to be heard. Unless the defendants can show some problematic issue of law that affects most of the states, or some overarching constitutional concern, the U.S. Supreme Court will not agree to hear the case. If that happens (or if the Supreme Court somehow chooses to hear the case and renders an opinion) the case is finally over. There is simply no where else to go.

But that can take years. At any time during that maddening drawn out appellate journey, the sides can come together and settle the case. It is as simple as this really:

Defendants: “You just won a $1,500,000.00 jury verdict against us. We plan to appeal. But if you will take $850,000.00, we will pay that and forfeit our right to appeal.” Plaintiff: “Will you pay $1,200,000.00 instead?” Defendants: “OK.” Case closed. (OK, it’s never that simple. But you get the idea.)

The post-trial life of a lawsuit can feel endless. It can easily take several years to work its way through all possible appellate courts. Settlements often result during this period. But if your case yields a big number at trial, expect to face post-trial motions and one or more appeals. After all, medical device and drug companies have plenty of money to pay good appellate lawyers.

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.

more

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.

A request by Depuy Orthopaedics Inc. to delay more trials concerning its Depuy Pinnacle hip implants is pending in the federal court in charge of thousands of cases against the company. The request came from Depuy on May 24. Depuy asks the Court to hold off on further trials until an appeal of one large case tried in March is resolved. That case, which I wrote about here and here, resulted in a stunning $502 million verdict for five people injured by the defective artificial hip components. So Depuy is plainly motivated to delay, if not overturn, the award. If the request is granted it will take much longer for other plaintiffs to have their cases tried, as complex appeals like this one can take years to resolve. As the saying goes, justice delayed is justice denied. I hope federal judge Ed Kinkeade in Texas denies Depuy’s motion. These remaining cases deserve their day in court.

Depuy and the other defendants claim their planned appeal could have “far-reaching implications” on how future cases are tried. Defendants claim the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

more $502 Million Dollar Verdict

The jury in the U.S. District Court for the Northern District of Texas in Dallas awarded $142 million for actual damages (harm and losses the plaintiffs suffered). The jury then awarded $360 million in punitive damages (meant to punish defendants for their actions or failures to act) to five plaintiffs. They claim their hips failed and needed to be surgically removed, according to Bloomberg. Depuy’s attorneys claim that under Texas law the punitive damages award should be reduced to about $10 million.

Allegations Against Depuy, J&J

Johnson & Johnson, which owns Depuy, is accused of covering up defects which caused the hips to fail. These defects caused pain and other complications and required additional, “revision” surgeries. The jury found for five plaintiffs, deciding:

• The hips were defective, and
• Depuy knew about the problems, but
• Failed to warn patients and physicians about the risks.

The jury found for the defendants in a sixth case. Depuy claimed that plaintiff’s problems were caused by the physician improperly implanting the hip.

Johnson & Johnson and Depuy are facing about 8,000 lawsuits concerning the Depuy Pinnacle artificial hips. They feature a metal ball and socket joint. Plaintiffs claim the metal-on-metal design grinds together inside the body, releasing cobalt and chromium metals into the blood.

Appeals Take Time

An appeal in a federal case can be costly and time consuming. But the defendants don’t really have a choice after getting crushed with a $502 million dollar jury verdict. And the upside for Depuy and the other defendants can be huge: If they are successful they may avoid paying tens if not hundreds of millions of dollars in damages. These appeals can take a very long time, especially if,

• The losing party eventually appeals to the U.S. Supreme Court, or
• The appellate court agrees with the appeal and orders the cases be re-tried.

If the rest of the artificial hip claims are put on hold until the appeals process concludes it might be years before the next group of cases goes to trial.

These “bellwether” cases have been consolidated in similar groupings to see how they play out in front of a jury.

• As the verdicts are decided the parties have a better idea what their settlement value is, and
• Once the parties have a better grip on that it’s hoped the rest of the cases can be settled without trials.

If the request to delay the rest of the cases is approved the appeal will delay other trials, it could take longer to settle the cases and take more time for thousands of plaintiffs to be fairly compensated. Stay tuned.

Let’s get back to a look at recent developments with transvaginal mesh lawsuits. In two big victories recently, a Georgia jury awarded $4.4 million to a woman injured by transvaginal mesh, and a New Jersey appeals court upheld an $11.11 million dollar jury verdict.

Transvaginal mesh (TVM) is a plastic mesh product that has been implanted in women for many years to support weakened vaginal walls. Many women suffer from pelvic organ prolapse or stress urinary incontinence, and makers of TVM have insisted that TVM could repair these medical problems. Unfortunately, not long after TVM was marketed and sold, women began complaining of serious health problems, including erosion of the vaginal wall, infections, painful sex, and bladder perforation. The lawsuits followed.

Now let’s take a look at a recent jury trial and an appeal decision of an earlier jury verdict.

more Taylor v. Mentor Worldwide LLC (Middle District Georgia, Columbus)

Products: Mentor ObTape Sling Pelvic Mesh

Jury Award: $4,400,000.00 ($400,000.00 compensatory damages; $4,000,000.00 in punitives)

Date of Jury Verdict: February 18, 2016

Key Takeaway: First win for injured woman against Mentor Worldwide, LLC (which is owned by Johnson & Johnson), with a substantial punitive damages award.

Teresa Taylor is from Marianna, Florida. The Mentor ObTape Sling Pelvic Mesh was implanted in her body in 2004 to treat her stress urinary incontinence. Following implant surgery she began having physical problems, including lower back pain, vaginal burning, painful sex, and incontinence. The ObTape Mesh was surgically removed in 2011. Ms. Taylor filed suit in 2012.

After a nine day trial, the Georgia jury found that Ms. Taylor had demonstrated that the ObTape had a design defect, and that Mentor Worldwide failed to warn her physician of the risks involved in using the ObTape Mesh.

The jury awarded $400,000.00 in compensatory damages (for actual injury, actual pain and suffering), and a noisy $4,000,000.00 in punitive damages.

Among other findings, the jury concluded that Mentor Worldwide was solely motivated by “unreasonable financial gain” in marketing the product. The jury also found that Mentor had intent to harm Ms. Taylor. These findings supported the punitive damages award.

Unfortunately, Florida state law caps punitive damages at $2,000,000.00.

Over 350 ObTape cases remain in the Mentor ObTape MDL. Most of these cases will be settled, but a few may still reach a jury trial.

Mentor Worldwide sold the medical devices between 2003 and 2006. Johnson & Johnson purchased Mentor Worldwide in 2009.

Unless Ms. Taylor can now work out a settlement with Mentor and Johnson & Johnson, the defendants will likely appeal the verdict in the Taylor case. I will keep you posted on these developments.

Gross v. Ethicon, Inc., et al. (New Jersey Superior Court, Appellate Division)

Product: Gynecare Prolift Pelvic Floor Repair System

Appeal Decision: Appellate court in New Jersey upheld jury verdict in favor of injured woman totaling $11.11 million dollars. Court refused to disturb an impressive $7,760,000.00 punitive damages award.

Date of Appeal Decision: April 1, 2016

Recap of the Jury Trial:

In 2006, the Prolift transvaginal mesh was implanted in Linda Gross to treat pelvic organ prolapse. Following implantation, Ms. Gross suffered from mesh erosion, scarring and inflammation. Ms. Gross has eighteen surgeries to repair damage caused by the Prolift TVM.

In 2008 Ms. Gross filed suit in state superior court in Atlantic City, New Jersey. She brought claims against Ethicon, Inc., and Johnson & Johnson for failing to warn her and her doctor about the potential risks of using the Prolift transvaginal mesh product. Ms. Gross also brought other claims, including misrepresentation, defective design, manufacture, and instructions.

Following trial the jury found that the companies failed to warn Ms. Gross of the risks involved with the device, and that this failure to warn caused her injuries. The jury awarded $3,350,000.00 in compensatory damages and $7,760,000.00 in punitive damages. The total award was $11,110,000.00.

Ethicon, Inc. and Johnson & Johnson appealed the jury verdict.

Appeal’s Court Upholds Jury Verdict

In a huge (second) win for the plaintiff, Ms. Gross, the New Jersey Appellate Court upheld the jury’s verdict in a court decision issued on April 1, 2016. The grounds for appeal were complex, and I won’t try to report all the arguments here. But I will say that one key argument was that the learned intermediary doctrine should have applied. The doctrine goes like this: a manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (such as the implanting surgeon), who is then expected to communicate with the patient about the benefits and risks of a medical device. The appeals court ruled that it was not error to instruct the jury that the doctrine did not apply in Ms. Gross’s case.

Next, the appeals court held that Ms. Gross and her attorneys provided sufficient evidence to link the lack of adequate warnings about the pelvic mesh to the injuries Ms. Gross suffered. Ms. Gross’s surgeon testified that he would have spent much more time going over the risks involved if he had known about the problems of the Prolift mesh.

Finally, the appellate court held that the evidence presented was more than adequate to support the jury’s decision to award punitive damages.

This is the second big win for Linda Gross. Three years ago her team won a courtroom victory, and now she protected the court victory by successfully fighting off an aggressive appeal by Ethicon, Inc. and Johnson & Johnson. Perhaps this appellate victory will improve the settlement results for the many transvaginal mesh cases that are still in court system and unresolved.

A lawsuit can be a minefield. For one, it can go on for years. And in that time opposing counsel can (and will) challenge a person’s lawsuit in large and small ways. By large I mean bringing “dispositive motions,” which are motions that “dispose” of a case, like a motion to dismiss and a motion for summary judgment. These motions are defensive attempts to kick a lawsuit out of court before it reaches a jury. By small I mean opposing counsel may refuse to produce certain documents or information in the “discovery” process, or may simply use motions or other tools to slow down and delay the plaintiff’s opportunity to have her case reach a jury.

But the fight is not over when the jury reaches a verdict in a product liability case. If a plaintiff wins her lawsuit, the defense will typically file “post-trial motions,” and after those motions are heard will likely appeal to a higher court. Merely getting a good jury verdict is by no means the end of the story.

Two weeks ago, a federal judge in Georgia stepped in after a jury verdict and stripped almost nine million dollars of punitive damages from the amount of money the jury awarded to the injured plaintiff.

But I need to back up.

In Re: Wright Medical Technology Inc. Conserve Hip Implant Products Liability Litigation (MDL No. 2329); Christiansen, No. 13-00297 (N.D. Ga.) more

Robyn Christiansen is a Utah woman who received a Wright Medical Technology “Conserve” artificial hip in 2006. In 2012, while doing yoga, she heard a “crunching sound” and felt sudden pain in her right hip. Ms. Christiansen was eventually diagnosed with having a loose acetabular cup which required revision surgery and removal of the cup.

In 2013 Ms. Christiansen sued Wright Medical Technology, Inc., and Wright Medical Group, Inc. in federal court for design defects, negligence, fraudulent misrepresentation, punitive damages, and other claims. The case was later moved to the multidistrict litigation site created for Wright Conserve Hip Implant System cases in Atlanta, Georgia (MDL No. 2329). Ms. Christiansen’s case was eventually selected as one of the bellwether cases for the Wright Conserve MDL.

After two weeks of trial, an Atlanta jury found in favor of Ms. Christiansen and awarded her $1,000,000.00 in compensatory damages (damages for actual injury and actual loss) and $10,000,000.00 in punitive damages. This was a big win.

Not surprisingly, the defense team filed post-trial motions, one for “judgment as a matter of law,” and another motion for a new trial, both based on the defense’s post-trial theories that the jury verdict was inconsistent with law and flawed based on juror confusion or bias. Wright Medical also moved to strike the punitive damages award.

Well-Meaning Reprehensible Conduct

Judge William S. Duffey, Jr., federal district judge in Atlanta, Georgia, presides over the Wright Conserve MDL. He denied all but one of Wright’s post-trial motions, but granted (in part) Wright’s motion to strike the punitive damages award. In his Order (which ran 100 pages), Judge Duffey held that the evidence supported a finding that Wright Medical engaged in reprehensible conduct, which in turn supported an award of punitive damages. See Order. Nevertheless, the judge then reached a curious conclusion, holding that Wright’s actions “did not display an extremely high degree of malice” or an “actual intent to harm.” Order, p. 92. Judge Duffey wrote that although the evidence presented at trial was “sufficient to support a finding of reprehensibility, Defendant’s conduct was motivated by a patient-centered objective to introduce a device to improve life quality for people like Plaintiff.” Order. p. 93.

I don’t know about you, but it seems odd to me that a medical device manufacturer’s actions could be viewed as “reprehensible,” and then conclude that the Defendant’s motivation was to improve the quality of life for hip replacement patients like Robyn Christiansen. Either the Defendant’s actions are reprehensible or they are not.

In any event, the judge then reduced the punitive damages award from $10,000,000.00 to $1,100,000.00, a figure which he claimed is “’reasonable and proportionate to the amount of harm to the plaintiff and to the general damages recovered.’” Order, p. 93. And the judge gets to make this call.

This is a reduction of $8,900,000.00, an astonishing result from a post-trial Order.

Judges Have Enormous Power

As you can see, judges have enormous power over the journey of every lawsuit assigned to them. A judge’s simple decision on the scope of discovery at the start of litigation can change the outcome of a case. And, when a jury trial is complete, a judge can change the results, as was the situation in the Christiansen case.

With this post-trial decision, the plaintiff’s team will undoubtedly file an appeal of Judge Duffey’s Order reducing the punitive damages award. The plaintiff’s appeal, if she brings one, will likely take a year or longer to move through the Eleventh Circuit Court of Appeals. In that time, the parties could come together and “settle” the matter pending the appeal. But make no mistake, after this post-trial decision, Wright Medical will not pay Ms. Christiansen the $11,000,000.00 the jury decided she should be paid. To get that amount of money, Christiansen will have to win her appeal and have the post-trial order reversed.

The Takeaway

As Yogi Berra said, “it ain’t over till it’s over.” And for a lawsuit it may often seem that the case is never over. In Ms. Christiansen’s case, even after three years of litigation, two weeks of trial, and a jury verdict, the results can change, either through post-trial motions or later on appeal to a higher court. It reminds me of the funny line from a comedian about the randomness of dreams, “you’re falling down a mineshaft now you’re in a parade.” Things can change abruptly in lawsuits too. Be vigilant, be prepared for uncertainty, and do not underestimate the immense power of your presiding judge.

I’ve written about this case before (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas)). Five plaintiffs (Aoki, Christopher, Greer, Klusmann, Peterson) agreed to have their cases tried together. This was not a “class action” lawsuit. Rather, because the five individual cases had sufficient similarities, the judge, parties, and attorneys 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. Boy did they.

$360,000,000 in Punitive Damages

Five patients implanted with the Depuy Pinnacle artificial hip were awarded $502,000,000.00. 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.

Depuy is owned by parent company Johnson & Johnson, who will be on the hook for paying this judgment.

more

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 was released into their bloodstreams, causing toxic metal levels in the blood.

Beyond the physical injuries, the five plaintiffs alleged that Johnson & Johnson rushed the Pinnacle hip on the market, despite knowing the defects of the product, so the company could reap billions in sales as quickly as possible.

A Real Donnybrook

The trial was a real donnybrook. The jury heard 37 days of testimony in this case, and the defendants made seven motions for mistrial. Judge Kinkeade denied every one. Depuy and J&J made repeated allegations that the plaintiffs’ team presented prejudicial, inflammatory evidence to the jury. It is a common defense tactic, but the reality is this: all evidence presented by your opponent is prejudicial and intended to be so. The judge found that the plaintiffs’ evidence was not unfairly prejudicial.

While this result is a stunning victory for these individuals and a positive sign for victims of the Depuy Pinnacle hip, the jury verdict does not guarantee that Johnson & Johnson will have to pay big for all future Depuy Pinnacle hip failures. J&J previously won a jury trial against a person who claimed similar injury based on the failure of the Depuy Pinnacle hip. In that case the jury found that Depuy was not negligent and that the plaintiff (Ms. Herlihy-Paoli) was not entitled to any compensation. You can read about that case here.

Further, Johnson & Johnson stated after the five hundred million jury verdict that it would appeal. Among other things, J&J has noted that Texas law places a cap of ten million dollars on punitive damages. On appeal, Johnson & Johnson will likely claim it did not receive a fair trial, and even if it did the final monetary award should be reduced considerably.

Shockwaves

Still, the $360 million in punitive damages had to send shockwaves through the suits at Depuy and Johnson & Johnson. Plainly, this jury became convinced that these defendants engaged in reprehensible conduct and wanted to send a loud message of outrage. This award should favorably impact settlements for the 8,000 other plaintiffs who have filed suit and are still waiting to have their cases tried to a jury (or settled).

Depuy stopped selling the Pinnacle in 2013. The good news is that if you received an artificial hip in 2014 or after, it should not be the Pinnacle. If you had hip replacement surgery in 2013 or before, you may need to figure out if you are walking around with the Depuy Pinnacle hip, especially if you are having pain or other complications.

It’s important to remember that (unlike the Depuy ASR hip) the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. Depuy has taken the position that the Pinnacle is different and safer than the ASR hip components. But this latest jury verdict does not help J&J advance that narrative.

The Depuy Pinnacle system was allegedly designed to provide better range of motion and to be attractive to an 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. And 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 Takeaway

This is a great result for these five plaintiffs but also for the thousands of people who had hip replacement surgery where the Depuy Pinnacle was implanted. The plaintiffs’ executive committee now has a huge verdict to use as leverage when the committee negotiates a global settlement with Depuy and J&J attorneys. There is now a much better chance that the plaintiffs will be fairly compensated for their injuries.

I will continue to provide updates on future Depuy Pinnacle trials and settlement discussions as they occur.

There is a very important Depuy Pinnacle hip case being tried in Dallas, Texas as I write this.

The federal court system has consolidated many of the Depuy Pinnacle lawsuits into one multidistrict litigation in the North District of Texas (3:11-md-02244) presided over by federal judge Ed Kinkeade.

Bellwether Cases

Back in August, Judge Kinkeade selected certain cases as “bellwether selections” and ordered the parties to organize those cases for jury trials. Bellwether cases are representative cases which have broad characteristics in common with many of the remaining cases.

So Judge Kinkeade ordered that five separate cases would be consolidated into one (very large) jury trial, to start January 8. Those five plaintiffs are:

• Aoki
• Christopher
• Greer
• Klusmann
• Peterson

One jury will hear all the evidence in these cases, but the judge will allow the jury to consider liability in each case, and to award separate damages in each case. Based on court filings, all five plaintiffs are from Texas, and each case has many similarities, thus making them amenable to trying together. In the language of the law, these five cases have “common issues of law and fact.” Opening arguments began January 11. The case is supposed to last three months.

more Slugfest

By all accounts, this trial has already become a slugfest. Depuy and the other defendants jumped out of the gate by filing motions to exclude key evidence and exhibits offered by the five plaintiffs. Clearly, one of the strategies of the defense team is to focus on the differences between the Depuy Pinnacle hip and the Depuy ASR hip. Among other things, the Pinnacle has three parts, while the ASR has two (essentially, a cup and a ball that fit inside the cup). The ASR has had an awful history, and already two sweeping settlement agreements have been reached in the ASR cases, which settled thousands of cases. Depuy does not want the ghosts of the Depuy ASR hip to enter the federal courtroom in Dallas, Texas in the current trial.

Last week Depuy made a motion to exclude one of the plaintiffs’ key experts in the case, Dr. Bernard F. Morey. Dr. Morey is supposed to testify “generally” about metal-on-metal hip implants. The defendants argued that because Dr. Morey did not provide an expert report during the “discovery” phase, he should not be allowed to provide testimony in front of a jury. It may sound petty or hyper-technical, but it actually flows from a reasonable position in most civil cases, and goes like this, “Hey wait a minute. Both sides were supposed to identify all trial witnesses and all testifying experts well before trial so we could take depositions and figure out what the witnesses were going to say at trial.” This is the essential reason civil litigation has a lengthy period of discovery—not only does it prepare both sides for trial, but it also allows both sides to evaluate the strength of cases as the litigation moves forward so each side can decide whether to try the case or settle it.

Stakes Are High

The current court room battles are intense because the stakes are so high. If Depuy wins the trial, or persuades the jury to award very modest damages, the result will likely impact thousands of future settlements. If, however, the plaintiffs win a big victory, the fallout will extend beyond the handsome compensation to the five trial plaintiffs; in addition, the plaintiffs’ executive committee in the MDL will be able to negotiate larger settlements for the 8,000 other plaintiffs who are still waiting to have their cases heard by a jury (or settled). So millions of dollars, possibly even billions, are at stake, all flowing from the current jury trial being conducted in Dallas. It’s kind of a big deal.

Pinnacle Never Recalled

It’s important to remember that, unlike the Depuy ASR hip, the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. In my view, this is a dangerous game for Depuy to play, but plainly the company is taking the position that the Pinnacle is different and safer than the ASR hip components. I think this is a mistake, but Depuy didn’t ask me.

Prior to the current five-plaintiff trial taking place in Texas, one Pinnacle case was tried to a jury. You can read about it here. Unfortunately for the injured woman in that case, the jury found that Depuy was not negligent and that Ms. Herlihy-Paoli was not entitled to any money.

The Depuy Pinnacle system was designed to provide better range of motion and to be more useful to a more active group of patients undergoing hip replacement surgery. One of the major complaints is that the metal components would grind and release metal particles into the body and blood of the patient, leading to extremely high levels of cobalt and chromium. Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through the 510(k) process.

I will continue to provide updates on the Depuy Pinnacle Trial in Texas. Stay tuned.

We’ve been looking at recent trial results in transvaginal mesh cases. In this (fourth) post we review two verdicts from October 2015, where juries concluded that the mesh manufacturers were not negligent. Thus, these injured women received no money for the failure of the transvaginal mesh. In a third case, decided on December 21, 2015, the jury awarded $12,500,000.00 to an injured woman. I will take a look at all three cases:

Cavness v. Kowalczyk et al. (Texas District Court, Dallas)

Product: Gynecare Prosima Pelvic Floor Repair System

Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.

Jury Award: zero.

Date of Jury Verdict: October 5, 2015

Key Takeaway: A big win for Ethicon and Johnson & Johnson, defendants in the case.

more

Carol Cavness was implanted with the Gynecare Prosima Pelvic Floor Repair System in April 2012. The transvaginal mesh began causing her serious health problems, including pain, incontinence, infections, bleeding, odors, and other problems. Eventually, the mesh product was partially removed in an “explant surgery.”

Ms. Cavness sued Ethicon and Johnson & Johnson, claiming that the companies were negligent in manufacturing and selling the transvaginal mesh. She also brought claims for design defects, manufacturing defects, and a failure to warn her and her doctors about the risk of the mesh product. She also sued her doctor and the hospital where the surgery was performed.

As with so many of the failed medical products on the market these days, the Gynecare Prosima product was approved for the marketplace under the 510(k) process, where a product can be approved for sale if an existing product that is substantially the same has already been tested and approved.

A major part of Ms. Cavness’ case was her claim that the polypropylene material was not appropriate for implantation in the human body.

The jury rejected Ms. Cavness’ claims, finding that Ethicon and Johnson & Johnson were not negligent and that Ms. Cavness’ injuries were not caused by the Gynecare Prosima transvaginal mesh product.

Carlson v. Boston Scientific Corp. (Western District North Carolina)

Product: Uphold Vaginal Support System

Jury Award: zero

Date of Jury Verdict: October 16, 2015

Key Takeaway: “Learned intermediary doctrine” is a formidable defense for product manufacturers.

Martha Carlson was implanted with the Uphold Vaginal Support System transvaginal mesh. She then suffered vaginal pain, incontinence, and sexual discomfort. She also alleged that the TVM shrunk and hardened inside her and could not be removed (explanted).

Ms. Carlson sued in federal court in North Carolina. The case was moved to the multidistrict litigation (MDL) venue in West Virginia. In the MDL, the reviewed Boston Scientific’s motion for summary judgment and awarded partial summary judgment in favor of Boston Scientific on the failure to warn claim.

As with the Frankum case, which I wrote about in a previous post, summary judgment was awarded to Boston Scientific (the TVM manufacturer) on the failure to warn claim based in large part on the “learned intermediary doctrine.” Again: a manufacturer (like Boston Scientific) cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (in this case the implanting surgeon), who then must communicate with the patient about the benefits, risks, etc. The surgeon in Ms. Carlson’s case did not rely on the directions for use (DFU) with the Uphold TVM product.

The MDL transferred the case back to North Carolina, and in October 2015 trial was held as to Ms. Carlson’s negligent design claim and her breach of implied warranty claim. As with many of these cases, Ms. Carlson’s attorneys argued that the polypropylene was not a suitable material for implantation in the body, and that the rubbery material hardens and degrades when implanted.

Hammonds v. Ethicon, Inc., et al. (Pennsylvania Court of Common Pleas, Philadelphia)

Product: Gynecare Prolift Pelvic Floor Repair System

Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.

Jury Award: $12,500,000.00 ($5,500,000.00 compensatory damages; $7,000,000.00 punitives)

Date of Jury Verdict: December 21, 2015

Key Takeaway: A strong statement from the jury in support of the injured woman, Ms. Hammonds, with a large punitive damages award.

Patricia Hammonds was implanted with the Gynecare Prolift Pelvic Floor Repair System in 2009 to treat pelvic organ prolapse and stress urinary incontinence. You know what happened next: Ms. Hammonds began to suffer debilitating pain, particularly pain during intercourse, and other problems. She underwent revision surgery, but the pain and incontinence continued. The surgeon then attempted to remove the Prolift TVM but found that it was compressed near Ms. Hammonds’ bladder, and which likely was the cause of a hole (perforation) in the bladder. The Prolift TVM could not be removed surgically.

The Gynecare Prolift Pelvic Floor Repair System was approved for sale under the 510(k) process which I have written about repeatedly on this site. Check it out if you are interested.

The jury awarded Ms. Hammonds $5,500,000.00 in compensatory damages, which are damages related to actual loss and actual harm suffered by the plaintiff, and an impressive $7,000,000.000 in punitive damages, damages which serve as a kind of punishment to the negligent defendant, and is used as a tool to discourage negligent or other harmful actions in the future.

In any event, after the two defense verdicts from October 2015, it was encouraging to see a strong result for Ms. Hammonds in Philadelphia.

More transvaginal mesh information will follow in this blog. Stay tuned.