This post comes from only the Dechert side of the blog, as Reed Smith is involved in this litigation.

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The New Jersey NuvaRing litigation, which involves a combination hormonal contraceptive, recently produced an opinion that granted the defense summary judgment in seven separate cases.  That’s a pretty big win for the defense.  But a broader win can be found in the reasoning of the court.  The defense didn’t win on one overarching argument.  It won for a variety of reasons.

Failure to Warn

Two of the seven cases were dismissed because the court found that the NuvaRing label’s warning on venous thromboembolism (VTE), the alleged side effect, was adequate as a matter of law.  The plaintiffs in these two particular cases were New Jersey residents, and so the court applied the New Jersey Product Liability Act (PLA).  The PLA contains a presumption for adequacy of any FDA-approved warning:

If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration . . . a rebuttable presumption shall arise that the warning or instruction is inadequate.

Slip Op. at 31 (citing NJSA §2A:58C-4).  New Jersey caselaw has established two types of evidence that can rebut this statutory presumption, both relate to post-approval actions by the defendant: (1) evidence that the defendant deliberately concealed or failed to disclose after-acquired knowledge of harmful effects of the drug (the Perez exception), or (2) evidence that the manufacturer engaged in an economically-driven manipulation of the post-market regulatory process (the McDarby exception).  Id.

Continue Reading The New Jersey NuvaRing Litigation Summary Judgment Decision

We honor Labor today by doing very little labor ourselves. If we had our druthers, today would consist of little more than barbecue and indolence. But some members of the family seize upon every holiday as a cue for shopping. There are sales upon sales. For at least a part of today, we expect to

First the Digitek MDL gave us a new weapon – the “Digitek Order” – to ensure plaintiffs’ counsel comply with their Rule 11 obligations to actually investigate their clients’ claims before filing thousands of cases. Novel concept, right? And now we have another helpful opinion – a new decision out of the MDL

A longtime correspondent (who wishes to remain nameless – but we thank you anyway) sent along overnight a new medical device preemption win, Wheeler v. DePuy Spine, Inc., No. 06-21245, slip op. (S.D. Fla. March 9, 2010).

You know the drill.  Class III PMA Device = preemption.  The Charite Artificial Disc (a spinal implant) is that.  So essentially the only thing left would be a “parallel violation” claim.  Concerning a implied warranty/product liability claim, the plaintiff didn’t even try.  Rather, plaintiff “specifically disavows any reliance on a statutory violation claim as to his strict liability claim.”  Slip op. at 5.  Why bother then?  After Riegel, that’s sort of like leaning in to your opponent’s best punch.  The result was predictable – summary judgment granted.  Id.

The plaintiff put up a little more fight on the negligence claim.  At least there was an allegation that the defendant violated something – although the allegations were maddeningly vague.  Wheeler was a 2006 filing – these days that kind of claim would be likely be knocked out of the starting box by a Twombly/Iqbal motion.  Again, however, plaintiff’s argument wasn’t very good.  The complaint “states that [plaintiff] seeks to ‘enforce the requirements of the FDA.’”  Slip op. at 6.  Oops.  Rarely has a plaintiff been so up front about doing something that he’s not allowed to do.  There is no private right of action to “enforce” the FDCA.  Not only that, Florida law is quite explicit that negligence per se isn’t available unless there was legislative intent to allow private enforcement.  Id. at 6-7.  So plaintiff’s “enforcement”-based violation claim goes by the boards for both federal and state-law related grounds.  Id. at 9.

Continue Reading Device Preemption Win In Florida – Off-Label Use

We’ve figured out how to settle a pending case!

And we’ll share our solution at the end of this post!

Read on for the details.

In Hunt v. DePuy Orthopaedics, No. 03-900 (RWR), 2009 U.S. Dist. LEXIS 61644 (D.D.C. July 20, 2009), Martha Hunt, a citizen of Maryland, underwent hip replacement surgery with a DePuy

The fascinating, and ultimately frustrating, pair of decisions in Guinan v. A.I. duPont Hospital for Children, ___ F. Supp.2d ___, 2009 WL 307019 (E.D. Pa. Feb. 6, 2009) (“Guinan I“), and Guinan v. A.I. Dupont Hospital for Children, ___ F. Supp.2d ___, 2009 WL 311113 (E.D. Pa. Feb. 6, 2009) (“