Last week I wrote about the dreaded post-trial life of a product liability lawsuit. If an injured person wins the jury trial, and particularly if the jury awards a large amount of money, the plaintiff should expect to face an onslaught of post-trial motions and the inevitable appeal to the next highest appellate court.
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.
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)