Last Friday we were treating a client to another stop on our ongoing Philly burger tour. (We know - it's amazing we're not big time rainmakers, right?) We agreed that the brioche bun was a marvel, while the patty was just so-so. We've had a few sandwiches where the outside bread-bits were way better than the innards, but we cannot think of too many where the opposite was true. Delis are mediocre out in our Stepford suburb, so it's entirely possible we've had good lox on a bad bagel. When we were kids, we occasionally had Fluffernutter on Wonder Bread. Tea sandwiches in England are tough to figure out. What's worse - the insipid bread or the combination of tuna and cucumbers? Some people prefer the creamy part of the Oreo to the chocolate cookie wafers. If anyone can think of other examples of a sandwich where the true beauty was underneath, let us know. For an example of a really bad sandwich, check out this clip from a Tom Cruise film. Or better yet, don't check it out.
A legal example of a bad-bread sandwich arrived on our desk last week in the form of Wolfe v. McNeil-PPC, Inc., 2011 WL 1157927 (E.D.Pa. March 30, 2011). The plaintiff claimed that Children's Motrin caused her to develop Stevens-Johnson syndrome (SJS). She pleaded causes of action for failure to warn, negligent failure to test, negligent defective design, strict liability manufacturing defect, strict liability design defect, misrepresentation, express warranty, implied warranty, and a violation of Pennsylvania 's consumer protection law. The plaintiff sought punitive damages on the theory that the defendant had concealed data from the FDA. The court granted summary judgment on most of the claims, but waved the failure to warn and punitive damages claims through. The court's treatment of the first and last issues is crummy, but what's in-between is pretty good.
The facts, as in most SJS cases, are sad. In 1996 the plaintiff was nine years old and living in Maine. After coming down with a headache, her doctor recommended that she take Children's Motrin, an over-the-counter non-steroidal anti-inflammatory drug (NSAID). The plaintiff's mother did not read the warnings when she first administered the Motrin to her daughter. Later, the mother did examine the box to "see if there was anything on there that I should look for." Wolfe, 2011 WL 1157927 at * 2. The plaintiff later contracted SJS and required a liver transplant.
Just as if we were plopped down at the lunch counter, let's size up the outside parts of the sandwich first. They are, to put it mildly, not to our taste. By all rights, the failure to warn claim should be dismissed for preemption and want of causation. But the court held that the defendants had not met their "exacting burden" under Levine of showing that the FDA would have rejected stronger labeling. Id. at * 4. The court also held that even though there were many causation weaknesses in the plaintiff's case (failure to read the warning when administering the first doses,the doctor's recommendation of Motrin, the mother gave the plaintiff a similar NSAID without reading the label, and the mother and her other kids continue to use similar products), a "reasonable jury could conclude that a stronger warning would have been heeded, thus preventing plaintiff's injuries." Id. at *5. It seems to us that the court grabbed on to the presumptions (against preemption and in favor of heeding) and ignored all the other factors. It doesn't have to be that way.
A much more careful analysis of the same issues in a very similar case resides in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010), which we blogged about here and here. That case also involved Children's Motrin and SJS. Judge Posner pointed out that the FDA had specifically decided against an SJS warning, that the label already listed "hives, facial swelling, asthma (wheezing), shock," that additional warnings would have created "informational overload," and that there was no reason to believe that additional warnings, unless far more terrifying than the science warranted, would have made any difference. Put plainly, either Wolfe is right or Robinson is right. One of them is wrong. Guess which we prefer? We think Robinson is a delicious sourdough, while the reasoning in Wolfe is simply stale.
The last part of the Wolfe decision gets another sort of preemption wrong: Buckman. The plaintiff sought punitive damages based on the following "outrageous" conduct: the defendant "concealed from the FDA two cases of SJS found in patients during a massive study it commissioned on the safety of OTC ibuprofen use." Wolfe, 2011 WL 1157927 at * 11. That sounds like fraud-on-the-FDA, right? That runs afoul of Buckman, right? No, says the court, because "[e]vidence that defendants concealed material information from the FDA is not being used to establish liability in this case but to demonstrate that the offending failure-to-warn conduct was not merely sufficient to establish strict liability or negligence but was truly outrageous." Id. at * 12.
Quick - does anyone here know the Heimlich maneuver? We're choking on that last Wolfe-d down morsel. Buckman was premised on the notion that state laws, including state court jurors, are ill-equipped to second-guess the honesty of submissions to the FDA, and that such second-guessing would inevitably result in the FDA getting inundated with protective filings. The incentives for such filings increase, not decrease, if it's punitive damages that are at issue. The Wolfe decision doesn't explore any of that policy. Instead, it merely cites Desiano, a Second Circuit case that we have lambasted again and again. Desiano was a thinly-veiled effort to gut Buckman, and we have been happy to report that most courts have gone the other way. Sadly, not so for Wolfe. Interestingly, the Wolfe opinion doesn't even mention McDarby v. Merck & Co., 949 A2d 223 (N.J. Super. A.D. 2008), a decision from across the river that applied Buckman preemption against punitive damages. So the plaintiff in Wolfe gets to proceed with a failure to warn case seeking punitive damages. It's a mess.
But perhaps one should be grateful it's not even messier. The court did the right thing in dismissing the hodgepodge of other theories:
-- "Pennsylvania does not recognize a tort for negligent failure to test." Wolfe, 2011 WL 1157927 at * 6.
-- "Pennsylvania does not recognize a tort for negligent marketing." Id.
-- There is no duty to design a safer ibuprofen product because the product has "undoubted" social utility, the risk of SJS is "extremely rare," and "there exist no other FDA-approved forms of ibuprofen." Id. at *7.
-- There is no evidence of a manufacturing defect, such as a deviation from design specs. Id.
-- There is no evidence that the plaintiff or her mother relied on any alleged misrepresentation. Id. at * 9.
-- There is no express warranty in sight.
-- There can't be an implied warranty that would "guarantee against every conceivable adverse consequence of taking the drug, however remote, esoteric, or even conjectural; and that is not the law." Id. at *10 (quoting from Robinson). Remarkably, this is the one and only instance in the Wolfe opinion where Robinson is even acknowledged.
-- The plaintiff cannot avail herself of the Pennsylvania consumer protection statute because she lived in Maine when the injury occurred and now resides in Louisiana. The plaintiff cried foul at this point, arguing that the defendant had agreed that Pennsylvania law would govern. But while the parties had agreed that Pennsylvania choice-of-law applied, "Defendants never conceded that plaintiff had pleaded or could prove a valid UTPCPL claim." Id. at *11.
We've gone to restaurants with folks on the Atkins diet and seen them discard the bread and eat only the inside parts of the sandwich. We wish we could do that with the Wolfe decision.