A few weeks ago we blogged about courts that adhere to the Twiqbal pleading standard in deciding whether a defendant has been fraudulently joined and therefore whether a case should remain in federal court or be remanded. The focus of our post was on whether courts were applying Twiqbal or some lesser federal standard for
Back in December we blogged about a medical device case that was dismissed for failure to state a claim – it involved a voluntarily recalled heart pump (which is a Class III medical device that received premarket approval). At that time, the court found plaintiff’s claims preempted by Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA preempted) and Riegel v. Medtronic, Inc., 522 U.S. 312 (2008) (§360k of Medical Device Amendments expressly preempts claims against manufacturers of Class III medical devices). However, the court afforded plaintiff an opportunity to amend her complaint to see if she could state a parallel state law claim of the type found not preempted by Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011). Guess what – according to the court, she did.
We have not hidden our dislike for Hughes (here) and we are not overly fond of Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (here) – and therefore, are not particularly enamored of the Fifth Circuit’s track record on PMA preemption. Both of those decisions push open wider the door the Supreme Court left slightly ajar in Riegel – allowing a state law claim “premised on a violation of FDA regulations” as “parallel” to rather than in addition to federal requirements. Riegel, 552 U.S. at 330. Both of those cases involved allegations of failure to comply with “generally applicable” FDA regulations – incident-reporting regulations in Hughes and quality-control regulations in Bass. And, so for her second bite at the apple, plaintiff in Bush v. Thoratec Corp., 2012 U.S. Dist. LEXIS 89685 (E.D. La. June 27, 2012), found her own “generally-applicable” regulation and alleged it as the basis for her state law failure to warn claim.
Now, on a positive note, we have to acknowledge a fairly thorough analysis by the court of whether there is a parallel state law claim. Unfortunately, we don’t agree with the result. Under Louisiana law, a manufacturer has a post-sale duty to warn “of a characteristic of the product that may cause damage and the danger of such characteristic.” La. Rev. Stat. §9:2800.57(C). So plaintiff needed to find a “federal hook on which to hang the parallel state law failure-to-warn claim.” Bush, 2012 U.S. Dist. LEXIS 89685 at *14. Her “hook” was 21 U.S.C. §7.49 – “guidelines” for medical device recall notices (remember, we said the product was voluntarily recalled). Guidelines? Can “guidelines” really be the basis for a claim of violation of federal law? Aren’t guidelines by definition not “requirements”? Don’t guidelines offer non-specific guidance without establishing any hard and fast rules? No definitions? No parameters? So, how exactly do you violate a “guideline”? And, who’s to say a jury’s interpretation of a guideline wouldn’t be more stringent than the FDA’s interpretation – making the claim no longer parallel? These were the types of questions/arguments raised by the defendant in Bush. We don’t find the court’s answers particularly satisfying.Continue Reading Plaintiff’s Second Bite at the Apple Leaves a Sour Taste in Our Mouth
We’ve chronicled many times the largely unsuccessful attempts of third-party payers (in unholy alliance with plaintiffs’ lawyers) to sue derivatively over alleged off-label promotion of prescription drugs and medical devices. Basically, these insurers, having already set their premiums and recovered for their expenses, take “free shots” at trying to get money back for what are
When we had the Monday gig we had the option of blogging on most of the major holidays. We say “option” because we could have honored the holiday by not blogging at all, but that seemed too indolent even for us. We usually split the difference by not doing any heavy lifting. There would be some
The thing about personal injury claims is that they’re personal. Each case has distinctive details, such as why the plaintiff used the product, what she relied on, what harm resulted, and what caused the harm. That’s why personal injury claims are not fit for class treatment. They are almost never certified.
In fact, nowadays, they are not only rejected; they are rejected hard. That’s what happened in Haggard v. Endogastric Solutions, Inc., 2012 U.S. Dist. LEXIS 89767 (W.D. Pa. June 28, 2012). The defendant manufactures a device (EsophyX) that is inserted without an incision to treat GERD. The plaintiff had it inserted, choosing it over a competitor’s surgically implanted device (Nissen). When the device didn’t work, his doctor couldn’t completely remove it, and the plaintiff claimed that this eliminated certain other treatment options that had been available to him. He reluctantly tried the competitor’s Nissen device, but his symptoms got worse. Plaintiff then filed his class action, claiming that the defendant had misrepresented that the insertion procedure was reversible, when in fact it was only “revisable” (apparently something less than reversible). Id. at *1-3.
If this sounds like a situation rife with unique personal facts, that’s because it is. And so plaintiff’s attempt to put a class together failed miserably.
Plaintiff first tried to certify a class that consisted of everyone who had used the defendant’s device. The court rejected this class for a bunch of reasons, many of which are obvious. It failed the “typicality” requirement. The class rep had “marked” differences with the other putative class members as to the information received and relied upon, as well as the harm suffered, particularly given that plaintiff admitted that, unlike with him, the device worked for most of the class members:
Evidence of record indicates there would be numerous, inevitable questions regarding the information received by individual patients – from their physicians or other sources – and their reliance on particular representations. . . . More importantly for purposes of a typicality analysis, Plaintiff’s theory of harm because he was informed as to and relied on representations of its “reversibility” in electing a surgical procedure is harm of a fundamentally different nature – i.e., it is different in kind – from the inchoate harm, if any, of being subject to misrepresentations in the abstract.
Id. at *14, *17.Continue Reading Another Personal Injury Class Action Goes Down in Flames