Law

We've been following Timberlake for a while. See here and here. We mean the product liability case against Synthes, not the pop singer (though, in truth, his appearances on SNL have been consistently superb and have convinced us, against all expectation, that he really is a talented fellow). The plaintiff Timberlake claimed injuries from an allegedly defective artificial intervertebral spinal disc (the ProDisc). What first caught our attention was that the plaintiff sued not only the manufacturer but also a couple of doctor-entrepreneurs who formed the company that researched and developed the ProDisc. We thought the theory of fraud liability against non-manufacturers was worse than novel; it was "funky." The court agreed and dismissed those defendants.

What was left was no longer funky. It became merely familiar. The ProDisc is a Class III medical device. It went through the FDA's rigorous premarket approval (PMA) process. The FDA made many requests for information and insisted on numerous revisions. The ProDisc's full application was approximately 8800 pages long. On August 14, 2006, ProDisc received premarket approval by the FDA. The FDA-approved labeling consisted of a number of documents, including a package insert, technique guide for surgeons, and a patient guide -- the contents of all of which were specified by the FDA.

So why aren't the plaintiff's product liability claims preempted? Last week, the court held that the claims are preempted, and that they are not saved by the dreaded "parallel" claim exception. Timberlake v. Synthes Spine, Inc., 2011 U.S. Dist. LEXIS 17034 (S.D. Texas February 18, 2011). It's a well-reasoned, clear decision, with no strings attached.

In addition to claims for product liability in strict liability and negligence, the plaintiff also alleged breach of express warranty and fraud/misrepresentation. The court concluded that those claims rested either on assertions that the product was defective -- even though the FDA had found the ProDisc was safe and effective -- or that patients and physicians had not been properly warned -- even though the the PMA process necessarily involves a determination that the FDA-approved label for the device is neither "false nor misleading." Timberlake, 2010 U.S. Dist. LEXIS 17034 at *22-24. The plaintiff's argument is in a box. The box is not quite the same box that Justin Timberlake and Andy Samberg sang about, though it is similar because it is a sort of gift for drug and device defendants. It is a preemption box.

But not so fast, said the plaintiff, who offered two arguments: (1) the FDA approved the product and labeling only because it had been lied to, and (2) the defendants violated FDCA requirements, thus committing a parallel" violation. The first argument takes about as long to get rid of as it takes to mouth the two syllables Buck-man. Id. at 26.

The second argument takes a little longer, if only to unpack the plaintiff's argument and scan the evidence ... or the lack of it. To the extent that the plaintiff alleged parallel claims based on violations of the FDA approval process, that would be "equivalent to fraud on the FDA claims, and thus Buckman preemption applies." Id. at * 28. The plaintiff also suggested that the defendants did not manufacture or label the ProDisc in a manner consistent with that approved by the FDA in the ProDisc's PMA. Note our use of the word "suggested." The problem is that the plaintiff failed to offer proof sufficient to create an issue of fact on the parallel claim. The plaintiff "failed to cite to any evidence in the record, including his own experts' testimony, showing that Defendants violated the specifications imposed by the FDA as part of the ProDisc's PMA with respect to the manufacturing and labeling of his ProDisc." Id. at * 33-34 (emphasis in original). The plaintiff's expert stated that the defendants failed an FDA inspection at one of their manufacturing facilities. But the plaintiff offered no evidence that the particular device in question had been manufactured at the facility that failed the FDA inspection. Id. at *34 n. 8.

Timberlake is the latest in a recent string of decision where courts have required specificity to support invocation of the parallel claims exception. See here, for example. Maybe it's a trend. Or maybe it's a case of what goes around comes around. (Yeah, at this point we're sacrificing all logic just to squeeze in another Timberlake song title. Just be grateful that, given the device at issue, we didn't allude to Sexyback. Oops -- darn it.) It reminds us of another pop culture icon, Charlie Sheen, and one of the odd parts of his recent radio rant (okay, the whole thing was plenty odd) where he blurts out that he is "winning." It's nice to be winning and we'd like to think that we're not delusional or intoxicated. Rather, the summary judgment result in Timberlake, especially the hemming in of parallel claims, seems fully justified.

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Posted By Steve McConnell to Drug and Device Law at 2/28/2011 07:30:00 AM

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