We wish everyone a nice Martin Luther King Day. Today not only honors a great American, it has also evolved into a day of service. That says something profound and wonderful about the honoree. We’ll do our best to observe the spirit of the day. There are all sorts of service. A friend in SoCal is helping to paint a lifeguard station. That makes us wildly jealous, given that we are staring outside at sheets of ice and awaiting the next visit of “Wintery Mix.”
Frankly, we were a little worried about whether this blog could render any real service today. There’s been a Monday curse of late, as we’ve opened the last couple of weeks with kvetch-fests on truly dreadful opinions (Bausch, Stevens, and Bartlett). But recently the Middle District of Tennessee rode to the rescue and delivered a useful opinion in a pain pump case, Rodriguez v. Stryker Corp., 2011 U.S. Dist. LEXIS 1252 (Jan. 5, 2011). It grants summary judgment to the defendants and supports its ruling with common sense and clear thinking.
The plaintiff in Rodriguez underwent shoulder surgery in 2004, including installation of a pain pump. A follow-up procedure in 2008 showed that the cartilage in the plaintiff’s shoulder had been destroyed. The plaintiff filed a lawsuit claiming that the pain pump had caused chondrolysis (a condition marked by destruction of the articular cartilage). The plaintiff alleged causes of action for strict liability, negligence, and breach of implied warranty.
The court applied Comment K to the strict liability claim, concluding that with “unavoidably unsafe products” such as a prescription medical device, the only issue was whether the manufacturer had failed to supply appropriate warnings. Rodriguez, 2011 U.S. Dist. LEXIS 1252, * 19. See how straightforward that was? Unlike the Bartlett case, the court didn’t conflate design defect and failure-to-warn theories.
The Rodriguez court focused on whether the defendant had failed to disclose a risk about pain pumps that it should have known as of 2004. Right away that makes this a less scary plaintiff case than usual. Most plaintiffs isolate and distort a few internal documents to support an argument that the defendant actually knew of the risk and hid it. Not here. “There is nothing in the record to indicate that Stryker was actually aware of the risk of chondrolysis stemming from the use of its pain pump at the time of the plaintiff’s November 2004 surgery.” Id. at * 19-20. The issue was whether the FDA’s rejection of the particular use in question, plus the medical literature up through 2004, offered enough clues on the dangers of chondrolysis such that the defendant should have connected the dots.
The court disposes of the FDA point easily; there is no hint that the FDA was making any sort of safety determination. Id. at * 22. The medical literature point is more interesting. Aided by hindsight, the plaintiff was able to select a few articles that suggested a cartilage issue. Let’s face it: there are plenty of courts out there that would seize upon the scant medical literature as a “jury issue” and would then quickly push the eject button on the summary judgment motion. It’s the path of least resistance. But this judge appreciated the importance of context. Hind-sight and cherry-picking are simply not fair bases for assessing what a defendant should have known. The court gives us a quote that we might insert in some of our future filings:
While the pre-2004 medical articles raise the general notion that the health of (usually animal) cartilage could be weakened by prolonged exposure to certain ‘foreign elements,’ it is a bridge way too far to say that Stryker — in the context in which infusion pumps were broadly used and medically accepted without reservation — should have, prior to marketing the pain pump, culled through seven decades of literature, found the sporadic articles raising this concern, ignored all authority/evidence to the contrary, and then independently concluded that its pain pump could cause chondrolysis, particularly where no one in the medical community connected the destruction of cartilage to the use of pain pumps until after the plaintiff’s surgery.
Id. at * 21-22. Accordingly, the court concluded that the defendant could not be found liable for failing to warn of a risk that wasn’t reasonably “knowable” prior to the plaintiff’s surgery.
That’s a correct ruling, and it’s important in a practical litigation sense. The court was doing its job as a gatekeeper. If jury research tells us anything about how jurors view large corporations, even putting aside Enron- and Wall Street-fueled general animosity, it is that jurors hold corporations to a higher standard in terms of what they should have known and what they should have disclosed. Even if no reasonable person could have done what nobody else did and somehow sifted through the pre-2004 medical literature to perceive the chondrolysis risk, many jurors will find that a corporation (which is made up of, at best, reasonable people) should somehow have figured things out. A corporation might be found liable just for being fallible — or less than perfect. (All of this reminds us of the debate about whether the federal government should have foreseen the 9/11 threat based upon certain intelligence reports — even though the amount of “noise” surrounding those reports makes the task stunningly difficult. But we don’t mean to digress too much, especially on such an unhappy subject.)
The Rodriguez court observes that its conclusion that the chondrolysis risk was not knowable in 2004 is consistent with other pain pump decisions holding that the state of medical knowledge as of 2005 and even February 2006 did not warrant a warning. Id. at *24-25. Both logic and precedent support the Rodriguez ruling.
The court dismissed the negligence claim on similar grounds. The plaintiff contended that the defendant negligently failed to test for chondrolysis. But first of all, Tennessee law does not recognize a general duty to test. Id. at *29. More fundamentally, the plaintiff’s argument that the defendant “should have tested the product for an unknown risk ignores its clear hindsight bias.” Id. at * 31. Again, sporadic medical literature “spread out over decades,” when read against the wide usage of the pain pumps without issue, could not trigger a duty to test or warn. Id. at * 33. In any event, the plaintiff’s negligence claim fails for want of warning causation. The prescriber’s testimony showed that he was uninfluenced by any representation that the defendant made or failed to make. Id. The doctor made it clear that he made the decision to use the pain pump “entirely on his own.” Id. at *34. It is true that the doctor testified that he would not have used the pain pump if he had been warned of chondrolysis, but the court refused to charge the defendant with a responsibility in 2004 with “the responsibility for uncovering a heretofore unknown medical phenomenon.” Id. at *35.
Once the court determined that the pain pump was not unreasonably dangerous, and once it determined that the defendant’s failure to warn was not the proximate cause of the plaintiff’s injury, the implied warranty claim is fully foreclosed. Id. at * 36. Simple, obvious, and inescapable — just like the rest of the opinion.
We can’t take any credit in anyway for the Rodriguez opinion. We didn’t work on the case. We probably can’t take credit for explaining the case, since the opinion itself is a model of clarity. All we did was call it to your attention. We hope we’ve been of service.