We’re pleased to report that in Caronia v. Philip Morris, No. 227, slip op. (N.Y. Dec. 17, 2013), the New York Court of Appeals refused to create a new tort cause of action for medical monitoring. The money quote:
We conclude that the policy reasons set forth above militate against a judicially-created independent cause
Last year we lauded the District of Massachusetts’s dismissal of the False Claims Act (FCA) qui tam complaints filed in U.S. ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., 2012 U.S. Dist. Lexis 156752 (D. Mass. Nov. 1, 2012). The relator was a contract physician who had performed medical reviews of adverse event reports for Takeda. She alleged in her two complaints that Takeda had asked her to misreport adverse events types for four different drugs and to change her “causal” medical conclusions to “non-serious” or “unrelated.” According to her, this resulted in false claims for payment submitted to the
government.
Seems like a big, big stretch, right? It is. The district court found so much wrong with the complaints that the deficiencies are too numerous to re-list. Suffice it to say that the relator pleaded nothing to show that the alleged misreporting was somehow connected to a material precondition of Medicaid payment, or that the defendants knowingly caused the submission of false claims. In fact, she made no particular factual allegations as to the existence of false payments.
We were pleased with the decision, particularly since it dismissed a “fraud-on-the-FDA” claim that wasn’t subject to Buckman preemption because FCA claims are federal. Yet we remained concerned. The appeal would be to the First Circuit, which has at times been more forgiving to FCA relators than we would like.Continue Reading Gee, First Circuit Upholds Dismissal of Ge
This post is written by our Reed Smith colleague, Adam Masin, who is solely responsible for its content. He gets all the credit and all the blame.
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This blog has previously written about Tennessee’s unusual statute of repose, here, here, and here, which bars claims “within one (1) year after the expiration date of the anticipated life of the product.” Tenn. Code Ann. Sec. 29-28-103. “Anticipated life” is a curious term. For example, the season finale of Homeland had many of its main characters wondering what their own “anticipated life” might be like given their circumstances. But we are not here to discuss the rather unrealistic-yet-compelling Homeland universe in which a bipolar CIA agent who never follows orders and is carrying the baby of the brainwashed former almost-terrorist who may not have bombed the CIA but still pretty much murdered the Vice-President can somehow find herself sent to Iran on purpose to oversee an impossible mission that involves trying to save her magically detoxed boyfriend (no spoilers here!). That’s a different blog post we’d like to write. We are here now to talk about “anticipated life” as it refers to products in Tennessee, the state that shares a border with the state where Homeland is filmed.
In Tennessee, “anticipated life of the product” is the “expiration date placed on the product by the manufacturer when required by law but shall not commence until the date the product was first purchased for use or consumption.” Id. at Sec. 29-28-102. In Wahl v. General Electric Company, 2013 U.S. Dist. LEXIS 162320 at *19 (M.D. Tenn. Nov. 14, 2013), that meant that the plaintiff’s claims were barred by the statue of repose well before the plaintiff knew she had developed the condition she based her lawsuit on. The same was true in Montgomery v. Wyeth, and Spence v. Miles Lab. Other states have carved out latency or similar exceptions to their statues of repose that might apply to prescription medical products for various reasons, but Tennessee has not chosen that path.
Perhaps the only thing more unusual than Tennessee’s “anticipated life” statute of repose, however, is how courts have reacted to it. In Montgomery, the trial court began its opinion by questioning the propriety of the law:
Rarely does this Court suggest that a legislative body reconsider one of its enactments. The Court believes its role is simply to apply the law applicable to the case before it and not concern itself with the merits of the case. However, because of the result in this case, this is one of those rare cases where the Court believes it is appropriate to urge the Tennessee legislature to look closely at the law governing this case.
The court in Wahl ended its own opinion doing the same thing:
the court views the result in this case as manifestly unjust. Through no fault of her own, Wahl is left with an essentially incurable degenerative condition for which she has no recourse, because Tennessee extinguished her claims against GE before she could have discovered them. The time period here between the procedures at issue and Wahl’s NSF diagnosis was only about four years, which is not a time period that shocks the conscience. This court, as did Judge Collier in Montgomery, 540 F. Supp. 2d at 936 and 945, urges the Tennessee General Assembly to revisit the TPLA and its effect on Tennessee citizens injured by pharmaceutical products.
Today we bring you a third case in one week regarding prosthetic hip implants. Here and here we reported on courts correctly ruling that plaintiffs had not adequately pleaded product liability claims involving their hip prostheses and/or that federal law expressly preempted claims involving devices approved through the FDA’s rigorous Premarket Approval (“PMA”) process. We
We blogged before about the Third Circuit resolving a long-running dispute over the citizenship of GSK in favor of Delaware, thereby affirming that suits filed against GSK were, in fact, diverse and properly removed to federal court. We then blogged about a Pennslyvania federal district court rejecting the plaintiffs’ attempt to leverage the prior district
We’ve made no bones on this blog about our distaste for the “cy pres” rationale that keeps finding its way into class action litigation. Indeed, we consider resort to cy pres as a virtually conclusive indication that the litigation in question is bogus. Our philosophy is “Cy Pres – No Way!”
For those
A few days ago we concluded the litigation strategy class we co-teach at Penn Law School. This year’s students were the best yet at understanding the importance of reducing any case to its most basic story bits. One of the case studies we teach is a drug/device lawsuit. Big surprise there. It contains the usual
Yesterday we blogged about Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013) – a hip implant case that was dismissed because the court found the complaint woefully deficient. Keeping with the same subject matter, today we have another hip implant case, from a neighboring court, with another insufficient complaint, plus a positive preemption ruling. Sort of a variation on a theme.
In Simon v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 170413 (S.D.N.Y. Dec. 3, 2013), plaintiff also alleged that she was injured by implantation of the R3 Acetabular System. It’s important to the preemption discussion to know a little bit more about the device. The R3 System includes a liner component made of cross-linked polyethylene (non-metal). Id. at *6. The R3 System, with its non-metal liner, received §510(k) approval (“substantial equivalence”) from the FDA. Id. Defendant also manufacturers the Birmingham Hip Resurfacing (“BHR”) System — a separate PMA-approved device. The BHR System was designed to be used with a metal liner. As part of the BHR System, the metal liner also received PMA approval. Id. at *7. Plaintiff’s surgeon opted to implant the R3 System with the metal liner from the BHR System. Id. at *2.
Plaintiff alleged three causes of action: negligence, strict liability design defect, and breach of implied warranty. The court dismissed all three for roughly the same reasons. If the crux of plaintiff’s allegations are that her injury was caused by the R3 System as a whole – her complaint fails to state a claim. If she is alleging injury from the metal liner component alone – her claims are preempted.Continue Reading Hip Implant Litigation Part II – TwIqbal Plus Preemption
Today’s case comes with a lesson: don’t be easily discouraged from filing your TwIqbal motion. Consider it carefully, even if your case is part of a mass tort with a challenging background, including product recalls and FDA investigations. In fact, under those circumstances, it may be more important to scrutinize the plaintiff’s allegations. A filing
“Necessity is the mother of invention.” “Desperate times call for desperate measures.” “Bad facts make bad law.” We see two of three of these adages play out in Carik v. U.S. Dept. of Health and Human Services, No. 12-272 (BAH), 2013 U.S. Dist. LEXIS 168714 (D.D.C. Nov. 27, 2013). To the great credit of