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.”

more

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.

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

Judge Forced to Reduce Punitive Damages Award

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

Thank You, Tort Reform! more

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

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

So What’s Next in Texas?

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

Thousands of Depuy Pinnacle Cases Remain

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

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

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

The Takeaway

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

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

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)

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.