Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues. Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses. We also felt that way while we were involved in the Fagan v. AmsourceBergen litigation involving the then novel concept of liability of non-counterfeitors for injuries caused by counterfeit drugs.
We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way. We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.
Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field. The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling. 2011 WL 4470701, at *3. Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use: the reprocessing and reuse of products whose labeling is limited to single use. Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices). After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart. Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own). Plaintiff sued both the aftermarket and original equipment manufacturers.
The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.
Futile Dear Doctor letters: In a claim analogous to what we’ve been seeing post-Mensing against generic drug manufacturers (indeed, the court references generic drugs explicitly, 2011 WL 4470701, at *24), the plaintiff claimed that the original manufacturer should have issued a Dear Doctor letter warning against use of reprocessed products.
The court assumed a duty and then assumed that such a letter was permissible under FDA regulations – but still blew out the claim. There was no possible causal effect in warning heart surgeons to be especially careful during heart surgery:
"[I]f a plaintiff's proposed warning would not have changed anyone’s behavior, a product cannot be defective for lacking that warning. Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”? Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart."
2011 WL 4470701, at *24. Whoop! Whoop! Common sense alert!
There was also “not a shred of evidence” that this kind of content-free advice would have changed the result, id., particularly since, after learning the hard way the very information the Dear Doctor letter would have provided, the surgeons in question hadn’t changed their behavior in any way. Id. at *25.
Regulatory informed consent asserted against a manufacturer. Say what? We've seen plaintiffs sue doctors claiming that they wouldn’t have consented to a treatment if they knew it was off-label. That’s one of the claims we killed in Bone Screw. In Kapps, however, the plaintiff tried to turn the same argument on a manufacturer, claiming that since the prescriber testified he wouldn’t have used the product had he known there was no FDA approval (this argument assumes that minor modifications = unapproved), then the learned intermediary rule gives him a cause of action against the manufacturer. 2011 WL 4470701, at *20.
Umm.... No it doesn't.
First we find a ringing endorsement of the learned intermediary rule as a shield, not a sword:
"The learned-intermediary doctrine is a defensive doctrine, not an offensive one. It is raised by makers of drugs or medical devices who are accused of failing to warn about the dangers associated with their products."
2011 WL 4470701, at *20. The court follows with equally good language about the limits of the duty to warn under the rule:
"A manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products. For example, a manufacturer does not have to communicate that the product was made with child labor or that the manufacturer’s president has been convicted of fraud, even though such “warnings” might induce customers not to use the product. The duty to warn is much narrower . . . .: (1) The duty to give adequate instructions for safe use; and (2) the duty to warn of dangers inherent in improper usage. [Defendant’s] alleged failure to warn that its reprocessing techniques had not been approved by the FDA breached neither of these duties."
Id. (citation and quotation marks omitted) (emphasis added). We love it when FDA-regulatory-status claims get dismissed.
Buckman-FDCA private right of action. In a unique setting, plaintiffs challenged the reprocessor’s decision to “extend” its line of reprocessed products to include the catheter in question by means of a “minor modification” procedure (it wasn't one of the 68 that the FDA actually approved for reprocessing). We’ve always had some liability worries about the minor modification process, where the device manufacturer decides to act, essentially unilaterally, by means of its own memo to file. The court refused to allow the claim, first finding that approval-related violations couldn’t possibly prove a tort:
"Whether [defendant’s] reprocessing procedures damaged the failed catheter is an entirely separate question from whether [it] sought FDA approval for those procedures through the proper route. That is, even if [defendant] had received 510(k) approval for reprocessing [the] catheters, [it] could still be liable for selling a defective . . . catheter if, in reprocessing a particular catheter, [defendant] damaged the catheter and rendered it defective. And, conversely, if [defendant] did not damage a catheter during reprocessing, then even if [it] should have sought 510(k) approval for its reprocessing procedures, [its] failure to seek such approval would not render an undamaged catheter defective."
2011 WL 4470701, at *19. This is an important point, since practically any claim founded on a “you didn’t get the right FDA approval” argument will fail under the same analysis. The court went on to hold that allegations of misuse of the minor modification procedure were nothing more than an improper attempt to enforce the FDCA despite its lack of a private right of action. Id.
Meeting a similar fate is an alleged duty to warn doctors about the purported FDA lack of approval. Such a warning has nothing to do with a state-law tort claim, but rather is “superfluous,” since if the product was defective, no FDA regulatory status warning could save the manufacturer, and if it’s not defective, then the FDA regulatory status couldn't create liability. 2011 WL 4470701, at *21.
Negligence per se. You can’t have negligence per se under the FDCA unless there’s an analogous state law claim. We’ve harped on this, so we’re always pleased to encounter additional supportive precedent.
"In a negligence per se case, the plaintiff seeks to hold the defendant liable because the defendant violated a statute. And that is why a claim of negligence per se cannot be based on a violation of the FDCA . . . . [T]o avoid preemption under Buckman, a state-law tort claim must be premised on the type of conduct that would traditionally give rise to liability under state law – and that would give rise to liability under state law even if the FDCA had never been enacted. A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment. Such a claim is preempted under Buckman".
2011 WL 4470701, at *19. The context may be new, but the principle isn’t. Approval-based claims can’t be negligence per se because they’re a form of licensing claim, and tort law has nothing to do with licensing.
Warning claims in a reprocessing situation: The opinion offers some interesting dictum that, since the reprocessor had removed the original manufacturer’s warnings and substituted its own, the reprocessor had “usurped” the manufacturer’s “function” and any prior failure to warn would be non-causal:
"[I]f [plaintiff’s] claim depended on an argument that [defendant] negligently failed to include certain warnings in its instructions for use, [that] warning-defect claim against [defendant] would fail for lack of causation: [Plaintiff’s] damages could not have been caused by the omission of a warning from [defendant’s] instructions for use, because [the reprocessor] replaced [the manufacturer’s] instructions with its own, and thus [the original] instructions did not accompany the catheter that injured [Plaintiff]."
2011 WL 4470701, at *23.
Nor was the original manufacturer obliged to warn that reprocessing was dangerous. The label already explicitly stated that the devices were intended for single use only:
"Even if it is true that reprocessing renders [defendant’s] catheters unsafe, the Court finds, as a matter of law, that in light of the fact that [defendant] warned doctors not to use reprocessed catheters at all, [it] had no duty to emphasize that it was serious about its warning or to elaborate on the reasons for its warning."
2011 WL 4470701, at *25. More common sense.
Can someone become a manufacturer by estoppel? The reprocessor gave its own manufacturer’s warranty and had marketing materials in which it stated “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.” 2011 WL 4470701, at *4. Even though the reprocessor claimed that it only provided a service, and had contracts to that effect, the court held that it could be considered a manufacturer for purposes of strict liability:
"[S]everal aspects of [the reprocessor’s] business strongly suggest that it should be treated as a manufacturer. First, [it] removed [the manufacturer’s] instructions for using the . . . catheter and substituted its own instructions. . . . Second, [the reprocessor] removed [the manufacturer’s] lot number from the catheter, thus preventing subsequent users from learning about the catheter’s manufacturing history. Third, [the reprocessor’s] entire marketing strategy depended on convincing customers that devices reprocessed by [it] were exactly equivalent to, and perfect substitutes for, devices made by original equipment manufacturers. . . . Fourth (relatedly), [the reprocessor] warranted the functionality of the catheter. And finally, [the reprocessor] tells doctors that “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices."
Id. at *30. If it quacks like a duck, it’s a duck. We don't begrudge the plaintiff this one.
The expert who didn’t do his homework. The court blew out most of a really horrible expert report. The expert invented some pretty wild hypotheses about a smear of polyurethane glue on the recovered part of the product, but didn’t bother to learn anything about polyurethane or how it interacted with the chemicals useds in reprocessing. There’s nice “ipse dixit” language. 2011 WL 4470701, at *16. Ultimately some of the expert’s testimony was allowed in support of a res ipsa manufacturing defect theory – which, since oftentimes an expert’s testimony isn’t needed at all – is just about the lowest and worst use of an expert. Id. at *18.
Punitive damages: Reprocessing a single use medical device isn’t enough to support a punitive damages claim, since the FDA allows this to be done:
"Given that the FDA regulates the medical-device-reprocessing industry and [finds benefit to reprocessing], the fact that [defendant] reprocesses catheters that [the original manufacturer] markets for a single use cannot be a basis for awarding punitive damages."
2011 WL 4470701, at *33. We like decisions that find FDA regulatory approval preclusive of punitive damages. Nor was a mere “regulatory mistake” (plaintiff’s attack on the minor modification process) anything suggesting “deliberate disregard” for patient rights. Id. We like that even better.
Res ipsa: You can’t bring a res ipsa claim against the original manufacturer of a reprocessed medical device, because the reprocessing and reuse, contrary to labeling, are an obvious other cause for any post-reprocessing malfunction. 2011 WL 4470701, at *22.
Heeding presumption: Minnesota doesn’t recognize a heeding presumption, but in any event, warning someone to be careful, when they probably already are, doesn’t show any different result whether the warning is heeded or not. 2011 WL 4470701, at *25 n.22.
Some of the issues in Kapps are completely novel. None of them have (as far as we know) been raised in the context of the reprocessing of single use devices. For this reason, Kapps should be required reading for anyone defending a case involving a reprocessed device – whether representing the original manufacturer or the reprocessor.