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.

Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women.

As with all other drugs, Fosamax had side effects, one of which was actually increasing the risk of femoral (thigh) bone fractures. Thousands of users of Fosamax suffered this side effect and sued Merck.

Even though there were a lot of plaintiffs suing, many of their cases became consolidated into a multi-district litigation, or MDL, in New Jersey.

Initially, things didn’t go well for the injured plaintiffs, with Merck winning the first bellwether trial. Then things got worse for the plaintiffs when the trial court granted Merck’s motion for summary judgment to dismiss all the MDL lawsuits. However, this week plaintiffs won a big decision on appeal, restoring hundreds of cases.

But let’s back up.

The Fosamax Litigation

The crux of the plaintiffs’ argument against Merck was that under state law, Merck failed to issue revised drug warnings that would properly warn potential Fosamax users of the risk of femoral fractures. Merck’s primary defense was that the Food and Drug Administration (FDA) would not have approved the required revised warnings and therefore, Merck should not be liable for violating any state “failure-to-warn” laws.

Before we go any further, we’ll need to explain why the FDA would need to approve any revised drug warnings. It sounds odd, but drug companies are not allowed to add notice of possible problems with their drug unless the FDA approves the revised warnings.

There are two reasons for this. First, if a possible risk for using a drug is not supported by evidence, it may discourage the use of a useful drug. Second, by adding certain risks and side effects that are not supported by proper scientific evidence to a drug’s warning label, users of the drug may not recognize the more important and scientifically proven drug risk information. In other words, if there are too many meritless or marginal warnings for a particular drug, users of the drug will either ignore all the warnings or not properly consider the more serious ones.

What Happened at the Trial Court?

Before trial, Merck filed a motion for summary judgment. Merck’s primary argument was that plaintiffs’ lawsuits should be dismissed because their failure-to-warn claim was preempted by the FDA’s federal regulations. Preemption refers to the legal concept that where when a state law and federal law conflict, or where it’s impossible to comply with both laws, the federal law will apply and the state law will not.

The applicable FDA regulation had to do with approving a revised warning for Fosamax. Merck argued that it had discussed the risk of femoral fractures with the FDA and whether a revised warning was required. Merck claimed that the FDA told Merck during those discussions that a revised warning to reflect the risk of femoral fractures would not be approved.

Merck claimed that based on this discussion with the FDA, Merck believed that had they asked the FDA to approve a revised warning label warning users of the risk of femoral fractures, the FDA would never have approved it. Since FDA regulations overrode state laws thanks to preemption, and the FDA regulations would not have allowed a revised warning label about femoral fractures, Merck could not be in violation of state failure-to-warn laws.

Essentially, Merck’s position was: “We asked the FDA to let us revise the Fosamax warning label, but the FDA wouldn’t allow it. So we can’t be responsible.”

The trial court agreed with Merck and granted its motion for summary judgment, effectively dismissing every single Fosamax MDL lawsuit against Merck. Hundreds of people with severe femur fractures, many caused by low-stress activities like walking or getting into a car, were now, temporarily, dismissed from court.

What Happened on Appeal?

The appeals court acknowledged that the trial court was correct in that an FDA regulation could preempt a state law. However, in order for preemption to apply in this case, Merck had to prove it would be “highly probable” that the FDA would not have approved a change to Fosamax’s warnings.

According to the appeals court, Merck could not meet this high evidence standard and that such a decision was for a jury to decide, not a judge, who usually rules solely on issues of law, not fact. The appeals court concluded that plaintiffs had:

“…produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures…[this] is enough for Plaintiffs to defeat summary judgment and proceed to trial.”

Needless to say, this is a huge win for Fosamax plaintiffs. After years of delay, they may finally get their day before a jury.

What’s Next?

With Merck’s motion for summary judgment now dismissed, plaintiffs’ lawsuits can move forward to trial. There are also many other Fosamax lawsuits in New Jersey and California state courts. This federal appeals decision does not directly affect those state court cases, although it will surely influence the outcomes.

Note: Photos for illustration purposes only.

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

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

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

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

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

Depuy Appeals to Fifth Circuit

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

Depuy Claims Plaintiffs’ Evidence was “Highly Inflammatory”

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

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

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

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

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

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

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

Will Depuy Win Its Appeal?

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

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

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

I have written about the maddening ways a product liability case can go on (seemingly) forever. An injured person may wait years to get to a jury trial. And then, if the individual wins the trial and the jury awards a substantial amount of money for the plaintiff’s injuries, the product manufacturer will appeal. You can read about appeals here. But the appellate courts are not there solely to protect big business. When the injured person loses her jury trial, she also has the opportunity to appeal. Often this is more difficult for the individual than it is for the large corporation, which has much more money and time, but appeals courts are there, in theory, for all of us, the powerful and the less-powerful. A week ago, an injured woman won her appeal and was granted a second opportunity to try her transvaginal mesh (TVM) case against Boston Scientific Corporation, which she had lost in 2014.

Let’s back up.

Boston Scientific’s Pinnacle Pelvic Floor Repair Kit transvaginal mesh was implanted in Diane Albright in 2010 to treat her pelvic organ prolapse (POP). Rather than make her well, the TVM caused her many other problems and serious injuries. In 2012 Ms. Albright sued Boston Scientific Corporation in Massachusetts over its failure to warn of the risks of the Pinnacle mesh product, as well as the defective design of the mesh.

What Happened at Trial?

After three weeks of trial in 2014, the jury returned a verdict in favor of Boston Scientific, effectively concluding that Boston Scientific’s warnings were not inadequate, and that the Pinnacle transvaginal mesh was not defectively designed. Importantly, the trial judge did not allow Ms. Albright’s legal team to present evidence of a “material safety data sheet,” along with FDA letters discussing the fast-tracked approval of the Pinnacle transvaginal mesh. It was this decision by the trial judge which prompted Ms. Albright to appeal to jury verdict.

What Did the Appeals Court Say?

On September 13, 2016, the Massachusetts Appeals Court agreed with Ms. Albright, holding that the trial judge should have permitted Ms. Albright to introduce this key evidence. The material data sheet contained information that polypropylene, which Boston Scientific used to manufacture the Pinnacle TVM, was not healthy for permanent implantation in women. The appeals court wrote in its opinion: “the jury did not have the complete picture of the information bearing on the safety of the Pinnacle device that BSC knew of . . . or should have known about.”

The appeals court also held that the trial court should have allowed the introduction of the letters from the FDA demanding that Boston Scientific conduct a post-market surveillance study of the Pinnacle TVM. The Massachusetts Appeals Court then remanded the case to the trial court for a new trial with the instructions permitting introduction of the excluded evidence. You can read the full appellate opinion here.

It is important to understand that the Pinnacle transvaginal mesh was “approved” for sale to consumers under the fast-track 510(k) process. I have written often about this streamlined procedure for getting products to markets, and you can read more about 510(k) here. My general view is that 510(k) has caused many problems, and that companies in some cases have used the 510(k) clearance procedure to rush products to markets.

So What Happens Now?

Ms. Albright has won a new trial. This doesn’t mean the two sides will pick a new jury on Monday. It can take months to get back on a trial calendar. Still, it is a big victory for Ms. Albright and for all women injured by Boston Scientific’s transvaginal mesh. With the introduction of the new evidence, Ms. Albright could win this second trial.

Albright v. Boston Scientific Corp.

That is exactly what happened in one of the first important Depuy ASR Hip trials in California.

The Jury Trial

On March 8, 2013, a jury in Los Angeles Superior Court awarded $8,338,236.12 for a man injured by the failure of the Depuy ASR Hip. Loren Kransky alleged that the Depuy ASR hip components were negligently designed, that the components had a design defect, and that Depuy failed to warn him and his doctors about the potential risks involved in implanting the device.

After a five-week trial in 2013, the jury in the California case awarded Mr. Kransky $338,236.12 in “economic damages” and $8,000,000.00 in “pain and suffering” damages. Jurors in the case found that the device was defective at the time of sale, and that it injured the plaintiff. The jury found in favor of Mr. Kransky and awarded damages for medical costs and for emotional suffering and distress.

The jury did not award punitive damages to Mr. Kransky. The jury did not find that Depuy acted with fraud or malice, which prevented an award of punitive damages. Which was good for Depuy, as Mr. Kransky’s legal team aggressively argued for punitive damages in amounts that could have exceeded $100,000,000.00.

more The Appeal

After the jury verdict, Depuy filed a flurry of post-trial motions, which the trial court rejected. Depuy then filed appeal. Depuy argued several issues on appeal, but I want to focus on the most important defense argument: that the trial court made a fatal error when it prevented Depuy from entering evidence at trial that the U.S. Food and Drug Administration approved the Depuy ASR device for sale and marketing. Let me explain.

Before the start of the 2013 trial, Mr. Kransky filed a motion in limine asking the court to exclude evidence that the Depuy ASR device was approved by the FDA. Kransky argued that because the Depuy ASR hip hit the market under the abbreviated and less rigorous 510(k) process (which I’ve written about often), that mentioning FDA “approval” would confuse the jury and unfairly prejudice the Plaintiff’s case. The judge agreed, noting that the 510(k) was a limited review process which was not as rigorous as the comprehensive Premarket Approval process, and that it could confuse the relevant issues and consume too much time for a limited purpose.

On appeal Depuy hammered away at this decision by the trial judge, arguing that it was prejudicial to Depuy not to be allowed to present evidence that the FDA approved the device. On July 21, 2016, the California Second District Court of Appeal upheld the decision of the trial judge on this issue, writing that evidence of the FDA’s 510(k) device approval “was not relevant to, or had little probative value in, a Montana products liability design defect claim.” California Appeal Decision, July 21, 2016.

Although the appellate court in California was required to interpret Montana law for this appeal (because Kransky was a Montana citizen and first filed suit in Montana), I believe the decision is very important for all future cases because it shines a light on the rather easy road a medical device can travel to the marketplace under the limited 510(k) review process.

The Takeaway: Rejection of 510(k) as Valid “FDA Approval”

The Opinion should be read as a rejection of the defense “don’t blame me judge; the FDA approved our medical device.” The appeal’s court shut down that argument, clearly recognizing that Depuy chose to seek approval of the Depuy ASR hip through the much easier 510(k) process, which is inherently less credible than a full blown Premarket Approval (PMA) process. Because of the decision by Depuy to opt for the 510(k) process, the FDA had much less evidence to guide its ultimate decision to approve a device for sale. If Depuy wanted the full value and protection of “FDA approval,” Depuy should have put the ASR Hip through rigorous testing and clinical trials, which are required under PMA.

Depuy can’t have it both ways. It can’t choose a limited review process to get its ASR product quickly to the market, then when the device fails, defend itself by saying it received approval from the FDA. In California, the trial court and now the appellate court rejected that sleight of hand argument by Depuy.

Further Takeaway: Justice Delayed

But note the key dates in this case: Mr. Kransky received the Depuy ASR hip implant in 2007. He then suffered pain and high metal levels in his blood. By 2012 the device had to be removed. In 2013 Kransky won an $8.3 million jury verdict from Depuy. Now here we are, more than three years after the trial, and the appellate court has finally rendered a decision on Depuy’s appeal. Depuy can certainly attempt to appeal further, but the hope is that this decision ends the case and Depuy pays Mr. Kransky his money. After all, it’s been nine years since the defectively designed Depuy ASR hip was surgically implanted in his body. The man has suffered enough.

Finally, the hope is that with this appellate decision upholding a large jury award, Depuy will work more generously to resolve the remaining lawsuits over the Depuy ASR hip. We will see.

The case is Kransky (Ellis) v. DePuy Orthopaedics (Los Angeles Superior Court)

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.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.

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.

Transvaginal mesh lawsuits are finally getting their day in court. This is a good thing for the thousands of women who were injured, some severely, by the failure of the transvaginal mesh products sold by Ethicon (Johnson & Johnson), Boston Scientific, and other companies. In Part 1, we looked at three TVM jury verdicts from 2013 and 2014. In this post, we look at two jury verdicts and an appeal decision from November 2014.

Many other cases are moving to trial. In Part 3, I will discuss several jury verdicts from 2015.

more Eghnayem, et al. v. Boston Scientific Corp. (Federal Court, Florida)

Product: Pinnacle Floor Repair Kit Transvaginal Mesh

Jury Award: $26,744,443.00 to four women

Date of Jury Verdict(s): November 13, 2014

This was a case brought by four women from Florida who sued Boston Scientific Corporation for the failure of Pinnacle Floor Repair Kit (TVM). Among other claims, the four injured women alleged that Boston Scientific’s Pinnacle TVM was defectively designed, that Boston Scientific failed to warn the plaintiffs about the potential risks and dangers of the Pinnacle TVM, that Boston Scientific was negligent.

All four women were implanted with the Pinnacle TVM between 2008 and 2011. Following implantation, the women began to suffer serious injuries caused by the Pinnacle TVM, including scarring, damage to nerves, infections, and organ perforation. The Plaintiffs specifically alleged that Boston Scientific knew or should have known that the material used in the Pinnacle TVM—polypropylene—was not safe for implantation in the body.

Plaintifff Amal Eghnayem was awarded $6,722,222.00 in compensatory damages.

Plaintiff Juana Betancourt was awarded $6,722,222.000 in compensatory damages.

Plaintiff Margarita Dotres was awarded $6,766,666.000 in compensatory damages.

Plaintiff Maria Nunez was awarded $6,533,333.00 in compensatory damages.

Unfortunately, the jury in this case did not award punitive damages. The jury determined that the plaintiffs did not prove that Boston Scientific was liable for intentional misconduct or gross negligence, which are requirements to trigger consideration of punitive damages.

Scott et al., v. C.R. Bard, Inc. (California Appeals Court, 5^th District)

Product: Avaulta Plus Transvaginal Mesh

Appeal Decision: Upheld award of $3,610,000.00 verdict to Christine Scott and husband

Date of Appeal Decision: November 19, 2014

Trial Court Decision: July 2012 (originally $5,500,000.00 verdict)

This was an appeal of a jury trial verdict reached in July 2012. An appeal is permitted to either side following jury trials. Usually, the losing person or company will appeal to the proper appellate court to argue that the jury verdict should be reversed, set aside, or altered based on mistakes of law that took place during the trial. In this case, C.R.Bard, Inc., manufacturer of the Avaulta Plus TVM, appealed after jury awarded $3,610,000.00 to Christine Scott and her husband.

The Avaulta Plus TVM was implanted in Ms. Scott in 2008 to treat pelvic organ prolapse (POP) and incontinence. After implantation she suffered vaginal mesh erosion and the TVM was eventually removed. She has since endured nine surgeries to remedy problems caused by the Avaulta TVM.

At trial, the jury awarded $5,500,000.00, but found the surgeon was 40% at fault and thus reduced the verdict against C.R. Bard specifically to $3,610,000.00. (This is known as comparative negligence, and I will explain comparative negligence in a later post.)

As is often the case when major corporations lose jury verdicts in trials over failed medical devices, C.R. Bard appealed the trial verdict. On appeal Bard argued that the theories of negligence which were submitted to the jury were erroneous (wrong) as a matter of law. Essentially, Bard’s argument was this: the trial judge instructed the jury on the law governing the case and got it all wrong, or wrong enough to prejudice Bard at the trial. (Bard also argued other issues on appeal.)

The California Appeals Court found that Bard was not denied a fair trial and that Bard’s negligence was supported by substantial evidence. Basically the appeal decision means this: there were no mistakes made at the trial level significant enough to void the jury verdict and order a new trial.

An appeal is a useful tool if the losing party genuinely believes mistakes of law were made at the trial level. However, deep-pocketed companies often use the technique of appealing verdicts they do not like as a means to delay payment of a large jury verdict to an injured person like Christine Scott. I’m not saying that it what happened here. But it happens often, and large companies are notorious for appealing a verdict they don’t like, even when they know winning the appeal is very unlikely.

Tyree et al. v. Boston Scientific Corp. (Federal Court, West Virginia)

Product: Obtryx Midurethral Sling Transvaginal Mesh

Jury Award: $18,500,000.00 to four women

Date of Jury Verdict(s): November 20, 2014

Four women brought lawsuits against Boston Scientific for the failure of the Obtryx Midurethral Sling Transvaginal Mesh; the lawsuits were joined for one trial in federal court in West Virginia. The primary claims against Boston Scientific were that the Obtryx TVM device was negligently designed and that Boston Scientific failed to warn the injured women and their surgeons about the risks involved in using the transvaginal mesh.

The women suffered infestions, vaginal wall erosion, inflammation, scarring, organ perforation, nerve damage, and other injuries following implantation of the Obtryx TVM.

Plaintiffs Jacquelyn Tyree and Carol Sue Campbell were awarded $3,250,000.00 in compensatory damages.

Plaintiff Chris Wilson was awarded $3,750,000.00 in compensatory damages.

Plaintiff Jeanie Blankenship was awarded $4,250,000.00 in compensatory damages.

The difference in monetary awards typically results from evidence showing the severity of the injuries suffered by the individual plaintiffs. Plainly, the jury weighed the evidence and concluded that Wilson and Blankenship’s injuries were more severe than Tyree and Campbell.

In addition, the jury found that Boston Scientific’s actions were fraudulent, malicious, oppressive, and/or willful and wanton, and on the basis of those findings awarded each plaintiff an additional $1,000,000.00 in punitive damages.

More transvaginal mesh jury verdicts will follow in Part 3.