If somebody were to ask us whether as a general proposition it’s relevant to the presentation of a product liability case about a prescription medical product that the FDA had approved/cleared the product and the defendant had complied with FDA regulations, our immediate reaction would be “Duh, of course, it’s relevant.”  We may have an overriding preemption or standing argument under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but relevance?  Particular aspects of FDA approval or compliance might not pertain to the particular defect allegations in a given case, but in general, the relevance of the fact the FDA has allowed the product on the market, and that the manufacturer complied with pertinent FDA regulations, seems unassailable.

Ask that to the other side, however, and the answer will be “only if it helps me win.”  Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance.  If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it.  That happened to us recently, hence this post.

When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’  Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective.  For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.

Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.

[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.

Restatement (Third) of Torts, Products Liability §4(b) (1998).  The supporting Reporters’ Note to §4(b) confirms:

The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.


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This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.

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Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.”  As we said back then:

[W]e never thought about lighting a candle in our ear.  That seems a little strange.  Maybe even a little risky.  We can’t think of a good

Bexis gave blood last weekend at the Red Cross – not just any old donation, either, but pheresis, a procedure that takes a couple of hours to complete.  Because pheresis takes that long, the Red Cross supplies donors with movies to watch.  This time it was the 2006 James Bond remake, “Casino Royale,” the type of movie that Bexis waits for the Red Cross rather than actually spends money to see.  In “Casino Royale” a delectable baddie poisons 007’s martini with digitalis, nearly causing him to die from a v-fib.

Bexis being Bexis, James Bond’s digitalis overdose got him wondering about whatever happened to the Digitek MDL, which involved an FDA-approved form of digitalis, called Digoxin.  We hadn’t posted anything about it in well over a year, since the court blew out some meritless economic loss class actions.  Before that, we were impressed by the MDL court’s Rule 11-based order requiring the plaintiffs’ counsel to demonstrate that they’d done a bare minimum of investigation of their clients’ supposed “cases” before filing suit.

Turns out, we didn’t have long to wait.  Yesterday, Madeleine McDonough over at Shook Hardy was good enough to tip us off to the ignominious end of that MDL.  Yesterday, the MDL court filed three orders (documents 70, 149, and 608) that, frankly, all look pretty much the same to us.  They all go under the general description of PTO (that’s “pre-trial order” for you laypeople) 87, so we’re only attaching the one that’s actually called that.

Our first reaction:  My God!  Has there ever been a more meritless MDL?  We thought Bone Screw was bad, since the plaintiffs never in ten years of litigation were able to find a practicing orthopedic surgeon who would opine on defect.  But at least in (some of) those cases there were broken screws.  In Digitek, the plaintiffs couldn’t even prove exposure to the allegedly defective product!  The alleged “defect” was that some Digitek tablets were manufactured bigger than they were supposed to be and thus contain too much of the active ingredient (see James Bond).  But it turns out that, after years of litigation, no plaintiff ever proved that a single one of the supposedly defectively too large Digitek tablets was ever sold to any consumer.


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Last week, the court in a pain pump case, Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), denied ten plaintiff motions in limine. That, in itself, is good news. The rulings aren’t especially intricate. You might even call them easy. Some of the language employed by the court to explain why the rulings were so easy might give some of us defense hacks reason to pause. We’ll get to that in a moment.

We’re not saying the Musgrave case isn’t interesting — it is. But we have to admit that it’s not nearly as interesting as the Martin Scorsese documentary on George Harrison that aired on HBO last week: Living in the Material World. Harrison is the Drug and Device Daughter’s favorite Beatle, and it’s easy to respect that choice. The Quiet Beatle was spiritual and cool. It was inevitable that he would be overshadowed by the Lennon/McCartney songwriting juggernaut, but Harrison did pretty well in his own write. “Don’t Bother Me” was a great early Beatles song, and “Something” was a great late one. Moreover, Harrison’s post Beatles career suggests that he was a better collaborator than the others. George worked successfully with Clapton, Dylan, Petty, and Orbison. By contrast, John worked with Yoko. Paul worked with Linda. Ringo has worked with assemblies of All Stars, but only to redo old hits, not to create something new. And Harrison single-handedly saved Monty Python’s Life of Brian.

So as a silly way of honoring Harrison and keeping ourselves amused, we’re going to ‘cite’ some Harrison songs while discussing the Musgrave rulings.

It Don’t Come Easy – Yes, it’s a Ringo song, and Harrison isn’t credited, but Harrison actually co-wrote it and a demo exists of George performing it with a guide vocal for Ringo. Before the Musgrave court issued its rulings, it spent time – way too much time – emphasizing how tough it is to preclude evidence via in limine motions: “To obtain the exclusion of evidence under such a motion, a party must prove that the evidence is clearly inadmissible on all potential grounds.” 2011 U.S. Dist. LEXIS 113661 at *5. The court expressed a strong preference not to issue in limine rulings but, rather, to wait for trial proceedings to supply “proper context.” Id. at *6. It almost sounds like a presumption against in limine rulings. But waiting for “context” isn’t always necessary. It can make trial preparation and/or settlement more difficult, and that “context” might mean that the inadmissible, prejudicial material has already been paraded in front of the jury. So while we like this court’s rulings, we aren’t fans of the prologue.


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As much as we like blogging, first and foremost we’re lawyers who represent clients in court.  Our clients tell us how much we can say about litigation we’re involved in, and when they say “not much,” that’s what we do.  If that has the odd effect that we’re sometimes more effusive about other lawyer’s wins

Most of the opinion in Riley v. Medtronics [sic], Inc., C.A. No. 2:10-01071, slip op. (W.D. Pa. Aug. 8, 2011), is a fact-specific statute of limitations discussion – oddly occurring in the context of a motion to dismiss – about a less-than-diligent plaintiff who did next to nothing until the statute had almost expired

So says the unanimous Supreme Court today in Matrixx Initiatives, Inc. v, Siracuso, 09-1156, slip op. (U.S. March, 22, 2011).  We’re not securities lawyers, so we’re primarily concerned with how Matrixx could affect product liability litigation.

We don’t think it will have all that much, since the court makes pretty sure that “materiality” for 

We defense lawyers enjoy reading lengthy opinions that analyze key defense issues and rule in our favor. But it can be more satisfying to read a short opinion in favor of the defense on an issue we care about. Short opinions usually show that the law on a particular point is settled. Rounds v. Genzyme