As anyone following the Pain Pump litigation knows, the state-of-the-art issue – whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff’s surgery – is critical. Well, today the first court of appeals to consider that question has affirmed summary judgment. Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).
The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable). It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:
When all is said and done, not one of [plaintiff’s] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage. [Defendant] had no duty to understand what the relevant medical literature did not.
Rodriguez likewise found that the plaintiff’s expert couldn’t make anything more out of the same 13 articles than the articles themselves:
[Plaintiff’s] theory requires two speculative leaps. It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm. And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely. Both are far too conjectural and too many steps removed from the problem that developed.
The court went on to demolish plaintiff’s regulatory theory – that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.
The FDA’s action means only that no other device on the market carried that indication for use. It does not mean that the pump was (or might potentially be) dangerous to use in the joint space. The 510(k) process does not comment on safety.
Slip op. at 8. Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Plaintiffs were thus prevented from having their cake and eating it, too. That is, plaintiffs who deny preemption because a §510k clearance doesn’t address safety, can’t play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.
Rodriguez also becomes the last in a very long line of cases to confirm that an independent “duty to test” does not exist at common law. Rather, such a duty “collapses into the failure-to-warn claim.” Slip op. at 8. A plaintiff cannot resort to a “duty to test” to avoid the state-of-the-art defense. “The law does not require a company to test for hidden risks that neither it nor the medical community had a reasonable basis to suspect.” Id.
Nor can a claim of off-label marketing succeed where plaintiff’s other theories have failed. The common law is unconcerned with mere off-label marketing. It would be concerned with concealment of risks (regardless of on or off-label), but once again, the state of the art precluded the concealment claim:
[I]t makes no difference that [defendant] knew surgeons would use its pump in the joint space or even encouraged them to do so since [plaintiff] has failed to show that Stryker knew or should have known that the use was dangerous.
Slip op. at 9.
Next, putting state of the art and legal theorizing aside, the claim in Rodriguez failed independently on the facts of the case because the implanting physician knew all about this device (having used it many times) and thus did not rely on any of the defendant’s warnings – so the opinion is also a good “already knew” learned intermediary warning causation case. Slip op. at 10-11 (citing one of Bexis’ Bone Screw summary judgment wins).
Finally, we’ve commented on plaintiffs’ attempts in other cases to create some new duty to send a “Dear Doctor” letter in cases where their warning claims fail. Well, last and least, the plaintiff tried that tack in Rodriguez – and got nowhere.
[Plaintiff] argues that [defendant] should have known that it needed to “revise its instructions or at least circulate a Dear Doctor Letter” when the FDA rejected its requests to approve the pump specifically for use in a joint. As shown, however, the FDA position did not obligate [defendant] to send any such letter.
Slip op. at 11. “Dear Doctor” letters are a regulatory invention. If the FDA doesn’t require them in a particular situation, the court in Rodriguez wasn’t about to create some new, broader common-law Dear Doctor letter theory.
We can only hope that other courts are as sensible as the Sixth Circuit was in Rodriguez. Slip op. at 7 (emphasis added). The expert had improperly attempted to substitute “hindsight negligence” for “common law negligence. Id.Slip op. at 5. Actually, the court had a lot more to say, but that’s the bottom line.