I’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell people–mostly joking but not completely–these days I am uncomfortable taking a baby aspirin.

Of course that’s not rational. Please hear me: there are important, helpful drugs and medical devices which improve lives, extend lives, and save lives. Paranoia is not your friend when you are facing a serious health issue. That said, it is always prudent to double check anything put into your body when a medical procedure is performed. Read about the product, get a second or third opinion.

In the past few years studies have identified troubling health problems in patients following the administration of gadolinium-based contrast agents (GBCAs) used during MRIs. Some people have gotten debilitating symptoms from these GBCAs. Let’s take a look:

What is an MRI?

MRI is the acronym for magnetic resonance imaging. It is an advanced medical imaging system used to produce detailed images of the inside of a person’s body. MRIs use powerful magnets and radio waves to generate specific images of organs and other parts of the body. MRIs are very effective at producing detailed images, which greatly assist radiologists and physicians in diagnosing illness or injury. For example, an MRI of the heart can detect heart disease or a blockage, and an MRI of the brain can diagnose brain injury, multiple sclerosis, cancer, and other conditions. Unlike X-rays, an MRI does not use radiation. The MRI has been a revolutionary diagnostic tool in medicine.

In some MRIs, your doctor may order a “contrast agent” to be injected into your body to produce more detailed images.

What is a GBCA?

GBCA is gadolinium-based contrast agent. Gadolinium is a chemical agent that is injected through a vein into the body in some MRIs. It serves as a kind of dye which enhances the quality of the images obtained from the MRI. These GBCAs allow radiologists to see more clearly the tumor in the lung, or the brain for signs of concussion, or many other health issues. Once the MRI images are obtained utilizing GBCAs, the gadolinium is supposed to exit the body through the kidneys. Initially radiologists stated that over 90% of gadolinium is released through the urine in the first 24 hours after injection.

So What is the Problem with GBCAs?

This is the concern: research has shown that gadolinium can be retained in tissue, bone, and the brain. In fact, it is now understood that significant amounts of gadolinium can remain in the body and tissue of patients for months or even years. This doesn’t always happen, but when it does it can cause hurt a person’s health. Let’s look at two diseases caused by GBCA retention:

• Nephrogenic systemic fibrosis (NSF). This disease occurs in individuals with reduced kidney function who have retained gadolinium in their bodies. NSF is a serious condition that causes skin thickening, muscle and tendon shortening, organ damage, and other symptoms. Unfortunately, NSF can even be fatal.
• Gadolinium Deposition Disease (GDD). Gadolinium Deposition Disease occurs in patients with retained gadolinium who had normal kidney function. Symptoms of GDD can include: headaches, severe pain in the joints, bones, arms and legs, thickening of tendons, tissue, and ligaments, burning sensation, numbness, nausea, sleeplessness, cognitive decline, and other symptoms. In one publicized case, Gena Norris, wife of actor Chuck Norris, alleges that she suffers from GDD and has sued the manufacturer of the gadolinium product injected in her through several contrast MRIs. Other lawsuits have been filed against manufacturers for harm caused by gadolinium.

By the way, there are two types of GBCAS: linear GBCAs and macrocyclic GBCAs. This gets really scientific and complex, but these distinctions are based on the molecular structure of the GBCAs. Linear GBCAs have elongated molecular “ligand” (an ion bonded to a metal atom), while macrocyclic agents have a structure resembling a cage. The reason I mention this is because the FDA has reported that linear GBCAs may produce more gadolinium retention in the body than do macrocyclic GBCAs. But I don’t think the science has resolved this issue, and in any event this does not mean that macrocyclic GBCAs are safe or even safer than linear GBCAs. If you are heading toward a contrast MRI, do your homework.

There are several brand-name gadolinium products on the market, including:

• Dotarem
• Eovist
• Gadavist
• Magnevist
• Multihance
• Omniscan
• OptiMARK
• ProHance

The FDA has issued an order requiring that all gadolinium-based contrast agents (GBCAs) include a warning that gadolinium can be retained in the body after contrast MRIs. For more information, check out the FDA website on GBCAs. The bottom line: be aware of data showing gadolinium retention in the body from GBCAs. Retained gadolinium in the body is not a good thing. And for many people, the suffering is very real and very serious.

With the rise of Type 2 diabetes in the United States, drug makers have attempted to meet the demand for treatments to lower blood sugar levels in patients. A variety of drugs such as saxagliptin, alogliptin, linagliptin, sitagliptin, exenatide and liraglutide were developed to help patients treat their Type 2 diabetes. Several of these drugs have resulted in unexpected problems. One specific drug in particular is saxagliptin, which goes by the trade name “Onglyza.”

What Is Onglyza?

Onglyza was co-developed by Bristol-Meyers Squibb and AstraZeneca and is a DPP-4 inhibitor. It works by increasing the levels of incretin (a type of hormone) in the body. Incretins lower blood glucose levels by reducing the amount of sugar the liver makes and increasing the amount of insulin released by the pancreas.

In conjunction with diet and exercise, Onglyza is supposed to help adults with Type 2 diabetes control their blood sugar levels and avoid long-term health issues, such as nerve damage, blindness, kidney damage and heart problems. Ironically, it ended up increasing the risk of suffering from some of these ailments.

Are There Health Problems?

In a small number of drug users, there is an increased risk of headache, upper respiratory tract infection, urinary tract infection, severe joint pain and hypoglycemia (low blood sugar).

More serious problems include an increased risk of heart failure and a potential link to pancreatitis and pancreatic cancer. A 2013 study found a 27% increased risk of hospitalization due to heart failure. As a result of this data, the US Food and Drug Administration’s (FDA) set up a special panel to review Onglyza. Out of the 15 panel members who voted, 14 of them voted to update the drug’s warning label to reflect this heart failure risk. The lone holdout? That panelist voted to remove Onglyza from the US market entirely.

There were also studies involving DPP-4 inhibitors that found an increased risk of pancreatitis (inflammation of the pancreas) and pancreatic cancer. To be fair, the connection between the DPP-4 inhibitor family of drugs and pancreatitis and pancreatic cancer is not conclusive. However, precancerous cells and benign tumors (called adenomas) have been found in the pancreases of patients who had been taking DPP-4 inhibitors.

Are There Any Lawsuits Involving Onglyza?

Currently, there are a few lawsuits in the court system, but this number will increase. Most industry watchers expect an increase because of post-release studies involving Onglyza.

During clinical testing, Onglyza met the FDA cardiovascular safety requirements, but barely. So the FDA wasn’t fully convinced that the drug was safe for the heart and ordered the drug makers to conduct additional testing once Onglyza was approved for sale to the general public.

A test of over 16,000 individuals over approximately two years revealed the 27% increased risk of hospitalization due to heart failure. This means that there are a lot of patients who took Onglyza before updated heart failure warnings were ordered by the FDA.

Additionally, there is much more extensive litigation of other, related drugs. Drugs with brand names such as Victoza, Januvia, Byetta and Janumet are already in multi-district litigation, or MDL. Given the similarities between these drugs and Onglyza with respect to how they work and problems associated with taking them, it’s probable that the makers of Onglyza will see themselves in a comparable legal fight.

The Future of Onglyza

Determining whether Onglza and its makers face large scale litigation is impossible to predict with certainty, but it is anticipated. If there are any significant developments, I’ll be sure to provide an update.

Originally touted as a wonder drug, a new class of medications based on SGLT2 inhibitors promised to help those suffering from Type 2 diabetes by increasing their ability to lower and control their blood sugar, while also lowering body weight and blood pressure. Pharmaceutical companies were hoping that these new products could potentially become blockbuster drugs. Invokana and Farxiga are two examples of SGLT2 inhibitors.

But just a few years after the release of these drugs in the United States, the drug companies started facing stiff competition among themselves. Additionally, the public learned of the serious risks of taking SGLT2 inhibitors. The purpose of this blog post is to provide a quick overview of SGLT2 inhibitor drugs and the status of their litigation.

What Is a SGLT2 Inhibitor?

SGLT2 is short for sodium/glucose co-transporter 2, which is a type of protein found in the human body. The SGLT2 protein plays a major role in the body’s ability to reabsorb blood glucose through the kidneys.

Drug makers created a new class of medications called gliflozins. These were recently approved by the FDA. Gliflozins are SGLT2 inhibitors, which mean they restrict the SGLT2’s role in the human body. This results in lower blood sugar, since glucose that would normally be retained by the body is now eliminated in the urine.

What Gliflozin Medications Are Currently on the Market?

There are a number of SGLT2 inhibitor medications currently sold in the United States. They include:

• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin)
• Farxiga (dapagliflozin)
• Xigudo XR (dapagliflozin and metformin extended release)
• Jardiance (empagliflozin)
• Glyxambi (empagliflozin and linagliptin)

What Are Some Problems with Taking an SGLT2 Inhibitor?

One of the above drugs that has been in the news lately is Invokana. We recently discussed some of the problems associated with Invokana and the lawsuits that resulted. Some of the problems with Invokana and other SGLT2 inhibitors include:

• Acute kidney injury, resulting in sudden kidney (renal) failure
• Diabetic ketoacidosis, where the blood contains high levels of ketones, a blood acid
• Urinary tract infections
• Stroke
• Yeast infections
• Increased risk of foot and leg amputations

The exact side effects will vary depending on the specific gliflozin a patient is taking. For example, the FDA has only issued a Safety Announcement regarding amputation risks for the drugs using canagliflozin. However, the FDA has issued a Safety Announcement concerning diabetic ketoacidosis for SGLT2 inhibitors in general and a Drug Safety Communication concerning acute kidney injuries for both canagliflozin and dapagliflozin-based medications.

Due to the severity of these problems, along with the high number of individuals taking them, a number of lawsuits have been filed.

SGLT2 Inhibitor Lawsuits

Currently, the number of lawsuits is relatively limited. There are several hundred lawsuits involving Invokana which are still in the early stages of litigation. However, they have reached multi-district litigation, or MDL status. The cases are in the discovery stage, with the first bellwether trial scheduled for early in 2018.

But Invokana isn’t the only drug that’s in litigation. Farxiga is also in MDL before Judge Lorna G. Schofield in the Southern District of New York. As of April 2017, there were only eighteen cases in the Farxiga MDL, although this number will likely be higher by the time you read this. The plaintiffs’ allegations center around Farxiga causing diabetic ketoacidosis and acute kidney injuries, as well as the drug maker’s failure to adequately test the medication and warn patients of Farxiga’s risks.

What Now?

Both the Invokana and Farxiga MDLs are early in their life-cycles. I am currently investigating new cases involving Invokana, Farxiga and other SGLT2 drugs. Feel free to give me a call if you have been injured by SGLT2 inhibitors. When there are any notable developments concerning SGLT2 drugs or the litigation, I will provide updates on this website. Stay tuned.

Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it does not belong. Depending on how bad the hernia is, surgery may be required to fix it. Because hernias involve a hole in a muscle or other tissue, additional reinforcement is thought to be needed to close the opening and keep it from reopening. This is where hernia mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

But not all hernia mesh is effective. And some don’t work.

Some Key Facts About Physiomesh

Physiomesh is a multi-layer mesh with layers of polypropylene and film. Ethicon hoped that the film layers would resist adhesions (scarring), permit mesh ingrowth into the abdominal wall, and maintain separation between the mesh and internal organs.

Physiomesh is a product intended to be used in laparoscopic surgeries. This is the less-invasive surgical technique using fiber-optic instruments and tubes. A laparoscopic surgical procedure is illustrated in the photograph to the left. In hernia repair operations, the tubes enter the abdominal wall and, using small cameras and other medical instruments, the surgeon is able to repair the hernia surgically, including in some cases implanting hernia mesh. Obviously laparoscopic procedures are less traumatic to the patient and easier from which to recover. That is, if the implanted devices are not defective.

Unfortunately, Physiomesh has been shown to cause scarring around the mesh, inflammation, implant folding and curling, and other serious complications. Physiomesh causes adhesions but does not permit adequate ingrowth into the abdominal wall.

Sadly, these results would have been available to Ethicon if it had done adequate premarket testing on the Physiomesh instead of rushing it to the market.

In April 2010 Physiomesh was approved to treat hernias in patients. It was approved by the FDA through the 510(k) process, which I have written about often on this site. The 510(k) process is a way around the more complex (and safer) premarket approval process. Under 510(k), the manufacturer notifies the FDA of its intent to market a device like hernia mesh and explains the device’s “substantial equivalence” to a device already on the market. The FDA may then approve the medical device for sale in the United States without extensive premarket testing. This is how Physiomesh made it to the market, in October 2010.

Physiomesh was on the market from October 2010 until the product was withdrawn in May 2016. This means that if you had surgery for hernia mesh repair between October 2010 and May 2016, and mesh was implanted, it could possibly be Ethicon’s Physiomesh.

Want to Learn More About Physiomesh?

There are studies you can access online which drills down on the subject of hernia meshes and the causes of hernia mesh failure:

Long-term evaluation of adhesion formation and foreign body response to three new meshes. Authors: Vogels RR, van Barneveld KW, Bosmans JW, Beets G, Gijbels MJ, Schreinemacher MH, Bouvy ND. Published in Surgical Endoscopy, 2015 August 29 (8):2251-9. Among other findings, this study concluded that “[f]ractioning of the Physiomesh(®) coating over time led to an increase in interfilamentary granuloma formation, leading to scar plate formation, but with only minimal to no abdominal wall adherence” and that Physiomesh is not “superior in all aspects required for effective and safe incisional hernia repair.”

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Authors: Pawlak M, Hilgers RD, Bury K, Lehmann A, Owczuk R, Smietananski M. Published in Surgical Endoscopy, 2016 Mar 30 (3):1188-97. This study was stopped due to safety reasons, which is alarming. Conclusion: ” . . . the obtained results from the enrolled patients indicate that the [Physiomesh] system associated with significantly greater hernia recurrences and postoperative pain compared with the [Ventralight ST/SorbaFix] system.”

There are other studies out there, and plenty of other information on Physiomesh and the problems it has caused.

So What’s Next?

One estimate indicates that as many as 160,000 patients received the Physiomesh hernia mesh in the United States between October 2010 and May 2016. It is expected that hundreds of people will eventually file suit against Ethicon for injuries caused by Physiomesh.

On May 25, 2017, the Judicial Panel on Multidistrict Litigation (JPML) conducted a hearing on a motion brought by Physiomesh plaintiffs, who asked the JPML to create a new multidistrict litigation specifically for Physiomesh cases. I will let you know when a decision has been reached on that motion, though I suspect we will see a Physiomesh MDL.

In the meantime, if you have had any surgical mesh implanted in your body to treat a hernia, and particularly if you know you received a Physiomesh hernia repair product, you should speak with your doctor as soon as possible. This is important, even if you aren’t aware of any problems with the mesh. You may be fine, but you should monitor your situation carefully.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Despite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

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It should be noted that there are other Mirena lawsuits against Bayer that were started earlier, but they allege different problems with the IUD, such as the uterine wall becoming punctured when the Mirena IUD migrates in the uterus. The lawsuits alleging fluid buildup and brain pressure (IH) are a recent development.

What’s the Status of the Mirena IH Lawsuits against Bayer?

Dozens of women who used Mirena and subsequently suffered from IH have sued Bayer, alleging that the hormone levonorgesterel has caused the buildup of fluid in the brain.

These cases are very early in the litigation process and are currently in the procedural stages, such as consolidation and transfer to a central federal court district and evidentiary hearings. A hearing regarding a motion to consolidate and transfer is currently scheduled for March of 2017.

If you are a woman who has used the Mirena IUD and experienced any of the above mentioned symptoms, you may be suffering from intracranial pressure. You should see your doctor to determine if you have too much cerebrospinal fluid and learn how to treat it.

Lawsuits have been filed, resulting in large, eye-catching verdicts and settlements for plaintiffs. One recent settlement applies to approximately 1,300 lawsuits involving hip implant products made by Wright Medical Technology (“Wright”).

Wright Hip Background

Wright produces medical devices, including the Conserve, Dynasty and Lineage line of hip implant products. There have been an unusual number of problems with these hip implants, resulting in pain, premature implant failure, metallosis, tissue necrosis and revision surgery.

As a result, thousands of lawsuits have been filed. Many of these lawsuits have been consolidated into one multi-district litigation, or MDL. MDL is not the same as a class action lawsuit, but without getting into the details, the purpose of the MDL is similar to a class action lawsuit in that it exists to resolve as many similar lawsuits as efficiently as possible. Still, in the MDL each case stands alone.

As a part of a MDL, a handful of cases will actually go to trial until a verdict is reached. One such bellwether case was Robyn Christiansen’s lawsuit against Wright, where she was awarded $11 million by a jury (although this was reduced to about $2 million and is still being appealed). However, there are thousands of cases that involve one of Wright’s defective hip replacement products. The recent settlement is intended to resolve approximately 1,300 of them.

Wright Settlement Agreement

On November 1, 2016, Wright entered into a settlement agreement totaling $240 million and affecting 1,292 specific lawsuits. In order to be included in this settlement, a plaintiff must have received revision surgery within eight years of getting the original Wright implant and the plaintiff’s lawsuit must not have a likely statute of limitation issue.

Another requirement for the $240 million settlement agreement to be implemented is that 95% of plaintiffs must agree to accept it. There are still several hundred lawsuits involving a Wright implant that are not subject to this settlement and these will continue to be litigated.

Should I Take Part in the Settlement?

Maybe, maybe not. Assuming you are a plaintiff in a Wright hip replacement lawsuit and are eligible to take part in the settlement, the answer to this question will depend on the specific facts of your case. Most plaintiffs will receive around $120,000 or $170,000 under the terms of the settlement agreement.

This may not seem like much, especially due to the severe injury you’ve probably experienced. Additionally, in light of the results of Robyn Christiansen’s bellwether lawsuit, getting less than 10% of what Christiansen has been awarded seems unfair.

However, one thing to keep in mind is that Wright is not the most financially sound company. In fact, Wright doesn’t immediately have the cash to fund the entire settlement. Wright will have to raise capital and receive money from some of its insurance companies. It might be unfair to accept a lot less than you feel you deserve, but you have to consider the possibility of getting less or nothing at all, should you lose your lawsuit against Wright or Wright’s financial position continues to worsen. A company’s bankruptcy, for example, can extinguish your case, no matter how strong it is. Wright has not threatened bankruptcy, but it often lurks in the shadows when major companies are faced with large payouts after a major blunder, such as introducing a flawed artificial hip into the marketplace.

What’s Next?

Assuming you are eligible to take part in this settlement, you probably already have an attorney who will give you advice on what to do. So ask her. And don’t forget, even if you agree to the settlement, if not enough plaintiffs agree along with you, the settlement agreement will be cancelled.

California is a beautiful, diverse state. It has everything from wide, sandy beaches to snow-capped mountains, deserts, thick forests, wide open spaces and massive cities. It also has laws and a court system that’s seen as friendly to those injured by prescription medications. And after a recent court decision, more people in other states may be heading there to try their product liability cases.

The California Supreme Court issued a decision in August which may encourage people harmed by prescription medications and medical devices from all over the country to file legal actions in the state. At issue is whether the state’s court system has jurisdiction over legal claims by people who’ve never been in California. In cases involving the drug Plavix, the answer was yes.

The eight lawsuits in question have 86 California residents and 592 people from 33 other states as plaintiffs. The defendant, Bristol-Myers Squibb, sought the dismissal of the claims by the 592 non-Californian plaintiffs.

Jurisdiction: The Power of a State to Hear a Legal Dispute

The question facing the court was whether state courts have jurisdiction over legal claims involving these plaintiffs. A key element to any civil case is whether the court has jurisdiction over the parties, whether it has the power to make decisions affecting those involved. The court decided that while the defendant’s “home” was not California, it also concluded that,

• Because of its “extensive contacts with California, encompassing extensive marketing and distribution of Plavix, hundreds of millions of dollars of revenue from Plavix sales, a relationship with a California distributor, substantial research and development facilities, and hundreds of California employees,”
• Jurisdiction over the non-California plaintiffs in state court was appropriate and consistent with Constitutional due process protections because these out of state claims arise from the same alleged conduct and actions which are the basis of those by the California plaintiffs.

The U.S. Constitution requires that government can’t take away property (such as a court ordering Bristol-Myers Squibb to pay plaintiffs’ damages) without due process of law. The defendant argued that having to litigate cases in California which originated in a number of other states is unconstitutional.

Why Do Plaintiffs Prefer California?

Why would 592 people from around the country want their Plavix legal claims litigated in a state where they may have never set foot?

• California state courts have a reputation as being more open to those suing drug makers.
• California’s consumer protection act offers better protections than other state laws.
• These are high stakes lawsuits and plaintiffs may be willing to put up with some practical inconveniences to benefit from any advantages they can get.

Defendant Prefers Other States

The defendant not only would prefer cases in states where plaintiffs would have a harder time proving their cases due to less favorable laws but there would also be practical advantages for Bristol-Myers Squibb:

• Having all these cases in one place saves resources for plaintiffs and their attorneys.
• If multiple cases are heard all over the country the Defendant may be better able to leverage its greater resources to be in a stronger position to defend itself and pressure plaintiffs into agreeing to a lower settlement.

This could be a win-win for plaintiffs. They may not only enjoy a better chance of winning their cases, or favorably settling them, but also take some time to visit California’s many famous sites. After a court room win plaintiffs (and their attorneys) could see Big Sur, Ghirardelli Square or do a tour of Hollywood.

Plavix is a blood thinning drug used prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. People who have taken the drug have alleged that Plavix has caused internal bleeding, heart attack, stroke, and cerebral hemorrhaging. Lawsuits allege that Bristol-Myers Squibb failed to warn patients and their doctors about the risks of taking the drug.

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.