Law

As Andy Williams sings, "it's the most wonderful time of the year." This year we made one of those English puddings. We poured cognac over it, set it on fire, and carried it proudly to the table. The flavor was awful (like a barbecued fruit-cake) but the presentation was splendid. Nobody was hurt, putting aside insulted taste-buds. We're at the age now where it's much more fun to give presents than receive them. And when the weather outside really did turn frightful, that just provided an excuse to stay inside, cozy up with family, and watch It's a Wonderful Life for about the 300th time.

On Christmas Eve, our good friends at the Abnormal Use blog mentioned the legal inaccuracies in Miracle on 34th Street. We think It's a Wonderful Life is a much better film and it, too, has a couple of legal aspects to its story. (We're not even taking into account how if George had not intercepted Mr. Gower's poisoned pills, some opportunistic plaintiff lawyer would no doubt have sued both the pharmacist and the drug company.)

But our thoughts were far from drug-and-device law issues. At least they were until we got a peek at the Seventh Circuit's opinion in Bausch v. Stryker Corp., No. 09-3434 (7th Cir. December 23, 2010). It was like somebody dumped a load of coal under our tree. In Bausch, the plaintiff brought claims under Illinois law alleging negligence and strict liability against the manufacturers, distributors, and sellers of the Trident hip replacement system. The district court held that the claims were preempted under Riegel and dismissed the claims without leave to amend. The Seventh Circuit played Grinch by reversing the district court and offering an "analysis" that is jaw-droppingly bad. The sheer awfulness of the opinion is so vast in scope and depth that it warrants a later, longer post by us, perhaps after we pack up the nutcrackers and take down the icicle lights. But here are a few lowlights to tamp down your holiday exuberance:

- We know things are going to end up badly when the court early on says: "The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive."

- The court views Riegel as an inconvenience that must be limited wherever possible. Bausch is one of those parallel claims cases where the plaintiff doesn't specify what the federal violations are that somehow establish negligence per se.

- The court's discussion of Illinois law ignores controlling precedent that rejects FDA-based negligence per se. See Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352 (Ill. 1996), which states specifically about the FDCA:

[T]o determine whether a cause of action for a violation of section [an FDA regulation] exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent. This inquiry forecloses plaintiff's cause of action. Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act (FDCA), under which [this] Federal regulation … was promulgated. . . . [lots of citations omitted]

While plaintiffs concede that Federal courts have held that no private cause of action exists under the FDCA, they suggest that these decisions are irrelevant since plaintiffs rely on the regulation to establish defendant's duty, and do not attempt to bring an action directly under the FDCA or its accompanying regulations. [lengthy discussion of Grove Fresh Distributors, Inc. v. Flavor Fresh Foods, 720 F.Supp. 714 (N.D. Ill. 1989) omitted]

Grove Fresh is of no avail to plaintiffs. The FDA regulation at issue in Grove Fresh was relevant to the issue of whether defendant violated the Lanham Act – an act which, by its express provisions, provided an independent statutory basis for plaintiff's private cause of action against defendant. In contrast, the instant plaintiffs cannot provide any independent basis for their cause of action, thus rendering Grove Fresh inapplicable.

661 N.E.2d at 355-56. The cause of action envisioned in Bausch does not exist under Illinois law.


- The court acknowledges that "a jury deciding a common law claim might apply those requirements more stringently than the FDA intended," but is willing to live with that risk because the court can interpret federal requirements, such questions of law will be "subject to the usual processes for reconciling conflicting views," [huh?], and the requirement of more specific allegations is "more slippery and less workable than its proponents acknowledge." Apparently there is nothing slippery and unworkable at all in letting plaintiffs plead vapors, followed by boundless discovery.

- Buckman does not dislodge "a traditional state tort law claim for an adulterated product," even if that's not really what plaintiff alleged. Get a load of this gobbledy-gook: "The evidence showing a violation of federal law shows that the device is adulterated and goes a long way toward showing that the manufacturer breached a duty under state law toward the patient." That's not analysis, that's rationalization.

- The court goes with the dissent, not the majority opinion, in In re Medtronic, Inc., Sprint Fidelity Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010). The main point of that dissent seems to be that plaintiffs need discovery before they can be expected to plead the sort of facts that TwIqbal require. Discovery solves everything. Never mind that crazily expensive discovery was a major reason that TwIqbal demands that plaintiffs plead more than formulaic recitations.

- The court relies on Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009), a case so bad it made our ten worst of 2009 list. Remember who wrote Hofts? District Court Judge David Hamilton. He was later elevated to the Seventh Circuit. Want to guess who wrote the Bausch opinion? Oh, and want to guess whether we would have included Bausch to our ten worst of 2010 list if it had come out just a wee bit sooner?

Bausch is, in short, a tour de force of bad drug-and-device jurisprudence. It takes some doing to get Riegel, Buckman, and TwIqbal so utterly wrong. Let's turn away from it for now, shake off the dust of that crummy opinion, and wander back to Bedford Falls.

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It's a Wonderful Life hit the screens in December 1946. That meant it had to compete for Best Picture with The Best Years of Our Lives. It didn't win. But it did make more money in 1947 than Miracle on 34th Street. So it's got that going for it, which is nice. Over time, it has become one of the best loved pictures ever. And to think it almost starred Cary Grant or Henry Fonda instead of Jimmy Stewart, almost starred Ginger Rogers instead of Donna Reed, and almost starred Edward Arnold (Green Acres?) instead of the great Lionel Barrymore. It's been sent up by the Muppets (who did, after all, filch the Bert and Ernie names from the film) and the Simpsons.

It's a Wonderful Life used to be replayed endlessly on television in December, because the film had not renewed its copyright and fell into the public domain. But some sharp lawyers ended up successfully enforcing a derivative copyright for the film (based on the underlying story by Philip Van Doren Stern), so now NBC shows it only twice. Lots of us own the dvd, but somehow we crave the communal experience of knowing that millions of people around the country are all at the same time sharing a red letter day with the Baileys, glowering at Mr. Potter, and dabbing their eyes at the end.

About that ending: it was almost quite different. Capra wrote one alternative ending where Uncle Billy remembered how he had mistakenly handed the Building & Loan money to Mr. Potter, who then gets his comeuppance. When you think about it, Mr. Potter should go to jail for keeping that money. But Capra decided to end on a high note.

Every year we sit and watch the movie with the family. Every year something gets into our eye just as George's brother pronounces George to be the "richest man in town." And every year we tick everybody off by saying that Pottersville seems more fun than Bedford Falls, and that George Bailey would still be in serious legal trouble even though the townspeople came forward to donate money to make up for the shortfall. Any prosecutor will tell you that paying money back might help you with the sentence, but it doesn't change the fact that you committed the crime. Yes, that's a very Potter-esque point for us to make. No sentimental hogwash for us.

Oh, who are we kidding? We love sentimental hogwash. We're going to make a donation to the Jimmy Stewart Museum in Indiana, Pennsylvania (which is in serious financial trouble), we're going to ring a few bells and hand out angels' wings, and we're going to take a day or two off from bogus parallel violations, spurious minimizations of preemption, and absurd evasions of TwIqbal.

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Posted By Steve McConnell to Drug and Device Law at 12/27/2010 01:57:00 PM

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