A nifty new decision, Kester v. Zimmer Holdings, Inc., 2010 U.S. Dist. Lexis 110403 (W.D. Pa. Oct. 18, 2010), popped up on one of our automatic searches this morning. It’s a sequel to the even niftier Kester v. Zimmer Holdings, Inc., 2010 WL 2696467 (W.D. Pa. June 16, 2010), that we reported on
October 2010
The learned intermediary doctrine comes to South Dakota
Lawyers and their clients can win cases in all kinds of ways, from the cheap victories won by default or gross mistakes by the other side to the total domination victories won on every single point. Some victories come after bad rulings that encourage future claims, causing the client to echo the lament of Pyrrhus…
Aredia/Zometa Trial Win in New Jersey
We’ve been hyperactive members of the peanut gallery when it comes to the Aredia/Zometa litigation. We’ve griped about motions and rulings on Daubert and learned intermediary (see, for example, here), and we’ve criticized plaintiffs’ lawyers for trying to have it both ways on confidentiality of company documents (see here). (A plaintiff lawyer-blog issued…
Yessssssss … Medtronic Really on a Roll
We’ve just learned that the Eighth Circuit as affirmed the preemption-based dismissal of the entire Sprint Fidelis Multidistrict Litigation. This is the first major appellate test of PMA preemption post-Riegel – and we passed. Here’s a copy: Bryant v. Medtronic, slip op. (8th Cir. Oct 15, 2010). Thanks to Ken Geller at Mayer…
Wellbutrin – Only Permanent Interests
Not too long ago we offered considerable criticism of certain aspects – specifically the treatment of Pennsylvania consumer fraud claims – in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, ___ F. Supp.2d ___, 2010 WL 3527601 (E.D. Pa. Sept. 7, 2010) (“SMW I”). It turns out that the Rule 12 decision in SMW I was only prologue to the main event. Several weeks later, the court outright denied class certification in the same litigation. Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 2010 WL 3855552, slip op. (E.D. Pa. Sept. 30, 2010) (“SMW II”).
You might expect that, as defense attorneys, we’d think a lot more highly of SMW II than we did of SMW I.
You’d be right. We agree with Lord Palmerston: We have no permanent friends, or permanent enemies, only permanent interests – those of our clients. Thus, we have no quarrel with any particular judge, we’d much rather praise any judge. Our critiques are limited to legal reasoning and outcomes. We have no problem with either in SMW II.
That being said, we’re not going to delve too deeply into large portions of SMW II. A lot of it’s antitrust-specific economic analysis, involving a comparison between what actually happened in the real world versus what supposedly might have happened in this shadowy “but for world” postulated by the plaintiffs’ economic expert. Antitrust economics is rather outside of our sweet spot, so as to that we can only hope that our colleagues for whom this kind of thing is a hanging slider over the middle of the plate eventually explain it to us.
However, SMW II does involve class actions, consumer fraud claims, and allegations about drug marketing. That means there are things in it that are relevant to what we do. We’ve extracted five take home points from the opinion that we think are worthy of comment.
One of the things that immediately struck us about SMW II is how long the class certification motion had been pending. The opinion candidly admits that right up front. 2010 WL 3855552, at *2 (“Plaintiffs’ class certification motion has been long pending”). How long is “long”?
How about more than four years?Continue Reading Wellbutrin – Only Permanent Interests
Bruesewitz Blow By Blow
OK, not really. But we have had a chance to review yesterday afternoon’s oral argument transcript in Bruesewitz v. Wyeth, and here’s what went down (for a lot of Bruesewitz backstory, click here for our prior posts).
David Frederick argued on behalf of the petitioners. Adhering to the rule of three, Frederick said the Third Circuit was wrong for three reasons when it ruled that the Vaccine Act expressly preempts state-law design defect claims. First, argued Frederick, the language of the Act itself does not explicitly preempt design defect claims. Second, the question of whether or not an injury was “unavoidable” should be determined on a case-by-case basis, rather than triggering a broad express preemption of all design defect claims (Section 22(b)(1) of the Vaccine Act, which lies at the heart of this dispute, states that manufacturers are not liable if the side effects were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”). Finally, Frederick advanced the “think about the children” policy argument – i.e., preemption of design defect claims exposes kids to unnecessary safety risks. He also suggested that it will be very rare to see a design defect case get out of vaccine court and go to a state court jury, because proving causation and the availability of an alternative design is not easy. In other words, don’t worry about disincentivizing manufacturers with the specter of massive liability, because it is unlikely to happen.
Kathleen Sullivan argued on behalf of Wyeth. Although she was immediately beset by questions, primarily from Justice Sotomayor and Justice Ginsburg, Sullivan was able to argue (persuasively, in our opinion) that the petitioners’ reading of the statute ignores its plain language and meaning. In essence, there are three types of products claims one could bring against a manufacturer: manufacturing defect, design defect, and warning defect. Section 22(b)(1), read as a whole, makes clear that only manufacturing and warning defect claims survive; manufacturers are not liable for unavoidable risks where the vaccine was “properly prepared” and accompanied by proper…warnings.” In other words, if the vaccine wasn’t made right, you lose the protection of 22(b)(1). If you didn’t slap an appropriate warning on the vaccine, you lose the protection of 22(b)(1). Otherwise, you’re protected, since the statute did not include any clauses recognizing design defect claims. Sullivan also hit hard on the policy arguments supporting preemption of design defect claims, highlighting that the legislative history shows Congress was concerned about a vaccine “crisis,” where “manufacturers were being driven out of the vaccine business, imperiling the nation’s…vaccine supply by design defect claims that did survive summary judgment.”
So how did the Justices react to these core arguments? Of course, we have to offer the caveat that it is often a Talmudic exercise to guess at the meaning behind a particular Justice’s question, but the following patterns seem to have emerged:
Statutory Construction:
Chief Justice Roberts, Justice Alito, and Justice Scalia appeared to be most concerned about the plain language of the statute, and the extent to which the Court may go beyond that language to infer (or not infer) that Section 22(b)(1) has preemptive effect. For example:
Chief Justice Roberts asked whether the compensation scheme set up in the Vaccine Act evidenced a Congressional intent to preclude state law claims. Justice Sotomayor, on the other hand, asked Sullivan why Congress did not simply make vaccine court the exclusive forum for recovery, thereby foreclosing state lawsuits.Continue Reading Bruesewitz Blow By Blow
Medtronic On A Roll
A couple of weeks ago, we featured Medtronic’s Connecticut Supreme Court win in Hurley v. The Heart Physicians, P.C., ___ A.3d ___, 2010 WL 3488962 (Conn. Sept. 14, 2010).
Yesterday, we blogged about Medtronic’s defeat of a qui tam action based upon allegations of promotion of off-label use, and the significant ruling that off-label…
Off-label promotion by itself does not support a qui tam action
Qui tam plaintiffs can make money under the False Claims Act if they can show that a defendant caused the submission of false claims to the government. As we have discussed before, some qui tam plaintiffs, usually former sales reps, have tried to turn allegations of off-label promotion into false claims cases. In United States ex rel. Bennett v. Medtronic, Inc., 2010 WL 3909447 at *1 (S.D. Tex. Sept. 30, 2010), the court considered “the question of when a manufacturer’s promotion of a medical device for an ‘off-label’ use may provide the basis for a qui tam action by private plaintiffs suing under the False Claims Act.” The court answered this question in a careful, thorough opinion, which we recommend to anyone interested in this area.
The relators in Bennett were not exactly classic whistleblowers. Bennett was a sales rep for Boston Scientific for all of four months and then filed five qui tam actions against seven medical device companies, including Medtronic. Fellow relator Boone had worked for a couple of device companies. Neither ever worked for Medtronic. They claimed that they were “industry insiders” with knowledge of unlawful activities by a company they never worked for. The government was not too impressed with their evidence and declined to intervene in their suit, which is a pretty good sign that the government didn’t feel that it had been defrauded.
The device at issue was Medtronic’s Cardioblate system, which the FDA had approved for ablating tissue to control bleeding and to coagulate cardiac tissue during general surgery. The relators claimed that Medtronic promoted the Cardioblate for the off-label use of surgical ablation to treat atrial fibrillation.
But off-label use or even promotion of off-label use does not amount to a False Claim Act violation, the court said. Off-label use of medical devices is an accepted medical practice and may be eligible for Medicare and Medicaid reimbursement if medically necessary. Id. at *3-5. Off-label promotion is unlawful, but does not amount to an FCA violation. Id. at *14, 28. An FCA violation requires a showing that the defendant caused the submission of false claims to the government. Id. at *2.Continue Reading Off-label promotion by itself does not support a qui tam action
Warning Causation to the Rescue
The Fifth Circuit affirmed summary judgment in Pustejovsky v. Pliva, Inc., 09-10983, slip op. (5th Cir. Oct. 8, 2010), the other day. We covered the original summary judgment, here. The defendant, a generic manufacturer of metoclopramide, first lost on preemption. Slip op. at 5. That’s not a surprise since generic preemption’s been…
Richard Nagareda, 1963-2010
We mourn the passing of Richard Nagareda, the David Daniels Allen Professor of Law and Director of the Cecil D. Branstetter Litigation and Dispute Resolution Program at Vanderbilt University. Professor Nagareda was perhaps the preeminent scholar in the field of mass tort litigation. It was impossible to labor in this field without encountering Nagareda…