It’s football season! That means beautiful fall weather, tailgating, pots of chili, rooting your favorite team to victory, and wallowing in their losses. It’s Army v. Navy and Ohio State v. Michigan. It’s Packers v. Bears and Steelers v. Ravens. If you are a true fan of the game, it doesn’t matter that in a 3-and-a-half-hour game there are only actually 11 minutes of action. The other 199 minutes are for second guessing the coach, yelling at the other team, drink refills and bathroom breaks. You wear your jersey, you paint your face, you stand in the frigid cold in the middle of December in Wisconsin. And at the end of 18 weeks, no matter how your team did, you know you’ll do it all again next year.
Well, it wouldn’t be football season without some words of wisdom from the great Vince Lombardi Jr. – Football is a game of inches and inches make the champion. Too true for football. Partially true for summary judgment decisions. Winning summary judgment doesn’t get you to the end zone, but legal battles too can be games of inches. Like when a defendant moves for summary judgement on manufacturing defect, design defect, failure to warn, fraud, and punitive damages and when the dust settles all that is left is a design defect claim built on less than solid evidence of causation. Plaintiff may have moved the chains, but he’s still got a long drive to be in scoring position.
Today’s matchup is Jarrett v. Wright Med. Tech., 2021 U.S. Dist. LEXIS 180843 (S.D. Ind. Sept. 22, 2021). The opponents have been delayed in facing off because the case, filed in 2012, was part of an MDL until it was remanded in 2018. Plaintiff underwent a hip replacement in 2006 in which his surgeon chose to use defendant’s medical device. Id. at *8. After a fall four years later, plaintiff had to undergo a revision surgery during which it was determined the device had loosened and rotated. Id. at *16. Plaintiff now alleges that a design defect caused the loosening and caused excessive metal ion release. Id. at *1. The device was explanted, but not tested or retained. Pathology tissue samples from the revision surgery, however, did not show the presence of metallic particles. Id. at *16.
Products liability claims in Indiana are governed by the Indiana Products Liability Act (“IPLA”). While plaintiff originally pleaded a manufacturing defect claim under the IPLA, he abandoned it in his response to the summary judgment motion so that claim was dismissed. Id. at *22n.2. On design defect, expert evidence is required. Id. at *25. So, the first question for the court was whether plaintiff had proffered sufficient expert evidence to raise a genuine factual dispute on design defect. The court found that he did. Plaintiff’s expert offered an opinion on the components used to make the device, on the metal-on-metal design of the device, and on the testing of the device all which he claims led to a defective design. Id. at *26.
But that only got plaintiff 5 yards. He still needed evidence of causation to convert. Here, the court acknowledge it was a “closer question.” Id. at *27. No testing of the explanted device was done and no metal was found in his pathology. Id. Plaintiff’s experts relied on two things to establish causation. First, that the post-operative diagnosis was a “pseudotumor related to metal-on-metal articulation.” Id. at *28. But further investigation revealed the suspected pseudotumor was in fact not. Id. at *29. That left the court to find that plaintiff’s expert’s claim that “hallmark signs of metallosis” were present created a jury question on causation despite the lack of contemporaneous evidence. Id. at *29-30.
No contemporaneous evidence. Sound familiar Bears fans? Let’s take a short detour to the November 5, 1989 Bears v. Packers game. Chicago was winning with just seconds left when the Packers’ quarterback, Don Majkowski, threw a touchdown pass to Sterling Sharpe. An official, however, thought that Majkowski had crossed the line of scrimmage before throwing the ball. On review, the replay official ruled that — even without clear indisputable video evidence — Majkowski was behind the line and awarded the touchdown (and victory) to the Packers. I bet that still stings.
While that was the end of that game, our decision goes on and the rest goes in favor of the defense. For instance, plaintiff’s failure to warn claim was dismissed. The Instructions for Use that accompanied the device warned of the very risk that plaintiff alleges occurred – the wear of the metal components, the potential of a reaction to particle release, and the loosening of the components. Id. at *31-32. Leading the court to find that defendant’s warnings were adequate as a matter of law.
But, even if they were not, plaintiff’s failure to warn claim fails on causation. Plaintiff’s surgeon, the learned intermediary, was independently aware of the risks alleged to have caused plaintiff’s injuries. Id. at *33. In fact, plaintiff’s surgeon had been involved in a clinical trial on the issue. Further, the additional information plaintiff argues should have been provided to the surgeon was not known at the time of plaintiff’s surgery. “[M]anufacturers do not have a duty to warn of risk not yet known.” Id. at *34-35. Finally, plaintiff’s surgeon testified that he did not rely on materials from defendant in deciding to use the device. Rather he relied on his experience and research. So, even if a stronger warning had been included, the learned intermediary would not have seen or relied on them. Id. at *36.
Plaintiff’s fraud claims suffered a similar fate. Plaintiff alleged no statement or omission on which he personally relied, so any alleged misrepresentation must have been made to his physician. To the extent those allegations mirror the failure to warn allegations, summary judgment was warranted. Id. at *37-38. Next plaintiff argued that defendant marketed a component of the device that did not have FDA clearance. To the extent that claim is based on alleged misrepresentations made to the FDA during the regulatory process, it is preempted under Buckman. Id. at *38.
Finally, plaintiff asserted punitive damages claim based on allegations of failure to warn and “actively misleading” physicians. But, since summary judgment was granted on failure to warn and fraud, the punitive claim fell as well. Id. at *41.
The game may not be over, but plaintiff is looking at a third and long with only one claim and shaky causation left.