[Drug and Device Law] InFuse Update
We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint. And almost as often, we refer to this as plaintiff getting a “second bite at the apple.” Not overly creative, but it conveys the point nicely. In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted. Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies.
Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart. Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.
To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims. So, we aren’t going to reiterate all the details. You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.
In Martin, the court dismissed all of plaintiff’s claims. The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice. Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty. Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014). She didn’t fare much better on the second go-round. First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again. Id. at *11-12.
Second, the flaw in plaintiff’s failure to report adverse events claims was a failure to plead a causal nexus to plaintiff’s alleged injuries. The amended complaint did not cure that deficiency.
Plaintiffs still have not alleged how defendants' alleged failure to warn the FDA about adverse events contributed to their injuries. What is missing from [plaintiff’s] adverse events claims is any connection between defendants' alleged failure to report adverse events and her surgery. Plaintiffs also have not alleged any factual support for these claims, such as any details (the date, nature of injuries, or method of implant) about any adverse events that should have been reported. Without such factual detail, it is not possible to tell if timely reporting would have affected the off-label use of the Infuse device during [plaintiff’s] surgery.
Id. at *14-15. Nor did plaintiff remedy the problem with her breach of express warranty claim. “In order to state a plausible claim, plaintiffs needed to allege that defendants made affirmations directly to [plaintiff], which they have not done.” Id. at *23. The court dismissed both of these claims with prejudice this time.
The only claim that survived plaintiff’s second attempt was fraud based on misrepresentation in off-label promotion. But even here, plaintiff was admonished for poor pleading. While plaintiff did include specifics about a particular article on which her surgeon allegedly relied (just enough to survive a motion to dismiss) and which allegedly contained mis-information, id. at *16-17, the complaint also contained numerous allegations about misrepresentations that were not tied specifically to plaintiff or her surgeon – which the court did not appreciate:
[T]hese allegations suggest that what plaintiffs are attempting to do here is advance a "fraud-on-the-market" theory, with the "market" being the medical community at large. But courts have generally found such theories inapplicable to product liability cases. Plaintiffs cannot pursue a "fraud of the market" theory.
Id. at *21. This type of over-pleading is what caused the court to once again dismiss plaintiff’s complaint in its entirety. The court was unimpressed with plaintiff’s 675-paragraph complaint. Given that only one of plaintiff’s claims survived, “it would be unfair to require defendants to answer the amended complaint.” Id. at *24. So, plaintiff is being given one last chance to file a proper complaint containing only the permissible claims and allegations to support those claims.
The court in Hawkins v. Medtronic, 2014 U.S. Dist. LEXIS 1627221 (E.D. Cal. Nov. 20, 2014) was more liberal in its review of plaintiff’s second attempt. For instance, it appears that the Hawkins’ complaint was equally as over-inclusive as the Martin complaint, but the Hawkins’ court was not as equally offended. Id. at *32-33. Additionally, the court found that plaintiff Hawkins’ amended complaint contained sufficient allegations of a causal nexus between failure to report adverse events and his alleged injuries for the claim to survive. Id. at *49-52. We disagree, but won’t belabor the point here.
Instead, we want to focus on the positive things the court said. Like, “state law causes of action related to off-label promotion all require a finding that [defendant’s] misrepresentations were false or misleading in order to find liability.” Id. at *17. In other words, off-label promotion in and of itself is not enough. Plaintiff cannot base his fraud and misrepresentation claims on the mere fact that the promotion at issue was off-label, it also has to be untrue.
Another good take away from Hawkins is that California does not recognize a claim for strict liability misrepresentation. Id. at *38-40.
Finally, the court held that plaintiff’s failure to warn claim premised on over-promotion was expressly preempted. Plaintiff alleged that defendant’s over-promotion of the InFuse device for off-label uses “negated and nullified” the warnings given to surgeons. Id. at *42. Fortunately, the court didn’t lose sight of the fact that this is still a failure to warn claim:
In order to provide liability, an overpromotion claim must show that the Plaintiff or his physician was not adequately warned of the danger posed by the device. A finding of inadequacy of warning cannot be made without the necessary corollary that an additional or different warning should have been given to remedy the failure to adequately warn.
Id. at *45. Since the over-promotion claim would require a jury to find that the defendant’s FDA-approved warning was inadequate – the claim is preempted.
While the plaintiff in Hawkins may have been given a little more room to maneuver, both plaintiffs have had their claims significantly trimmed.
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Posted By Michelle Yeary to Drug and Device Law at 12/02/2014 03:15:00 PM --
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