June 2014

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While most of the buzz late last week concerned the Darvocet affirmance, we also recommend that defense counsel check out this case:  Amos v. Biogen Idec, Inc., 2014 WL 2882104 (W.D.N.Y. June 25, 2014).  Amos involved the prescription drug Tysabri.  The allegation in Amos, as in most Tysabri, cases, is that the drug caused an opportunistic type of CNS infection.

That’s not what interests us about Amos, but rather the product being an innovator drug, not a generic.  That’s why we’re pleased with Amos’s first holding – that design defect claims are preempted.  Ever since our first reading of Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), we have believed that Bartlett’s rationale mandates impossibility preemption of design defect claims with any drug.  That’s because no drug manufacturer, generic or innovator, can change the design of its drug in any way that alters its safety or effectiveness without getting prior FDA approval of the change.  That’s precisely what the court held in Amos, preemption of design defect claims as to any drug in “interstate commerce,” albeit without much resistance from the plaintiffs:

Continue Reading Interesting Case On A Couple Of Issues

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We have discussed before (here and here) how the defendant manufacturer in Fosamax litigation took advantage of a fairly unique regulatory history to meet the Supreme Court’s unprecedentedly high “clear evidence” standard from Levine and preempt an entire MDL’s worth of warnings claims from before the drug’s label changed in 2011. For us, this was noteworthy and welcome. Prescription drug cases are fundamentally about warnings and many plaintiffs base their claims on the purported need for labeling that never would have been approved in the real world. Without devolving into a Bexisish rant on why Levine was wrong and many courts have been unduly frightened away from applying preemption because of facile readings of Levine—our own version of Charybdis—we can say that a clean preemption win in a prescription drug case was long overdue.

The Fosamax plaintiffs, not surprisingly, did not share our view and persisted in trying to keep their litigation going with post-labeling change cases. Well, they kind of persisted. Mostly, it seems that they desperately wanted to avoid a consideration of the merits of their remaining claims while keeping the litigation pending. This required a series of maneuvers that ultimately ended up with the plaintiff in In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 12-1492, 08-08, 2014 U.S. Dist. LEXIS 82003 (D.N.J. June 17, 2014), squarely between—you guessed it—a rock and a hard place when the defendant moved for summary judgment. We suspect many other plaintiffs in the litigation will end up in the same place.

A brief recap of the labeling and litigation history is in order. The drug had been on the marker for osteoporosis for more than a dozen years when FDA asked all manufacturers of the class of drugs to report back on the issue of atypical femur fractures (AFF) based on adverse events it had received. Even though defendant and FDA agreed there was no evidence that Fosamax increased the risk of such fractures, in September 2008, the defendant proposed to revise its label to add Precautions and Adverse Reactions information about reports of them. FDA allowed the Adverse Reactions change, but rejected the Precautions change in May 2009. By this point, it looks like the plaintiffs had already started bringing their AFF suits. In 2010, FDA issued three Drug Safety Communications on AFF with the class of defendant’s drug, shifting from a position of no established increased risk to requiring manufacturers to add Precautions on AFF and limit the duration of use in the Indications and Usage section based on a report from the American Society of Bone and Mineral Research stating there was an association between long term use of the drugs and AFF. Defendant responded in January 2011 by adding a detailed section in Warnings and Precautions—we assume PLR reformatting was due—in the physician label and language in the patient Medication Guide. Based on this, in a two-step process, all labeling claims for AFF before the 2011 labeling change were held to be preempted. Thereafter, the court wanted to bring to a head the issue of whether there could be a warnings claim for cases where the plaintiff took the drug with the revised label. And then the plaintiffs started dancing.Continue Reading Fosamax Plaintiffs Between A Rock And A Hard Place

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The Sixth Circuit has just affirmed 99.9% of the defendants’ wins in the Darvocet litigation.  The result is the biggest one-two punch (generic preemption/no non-manufacturer liability for the innovator drug) decision to date.  The opinion involves 68 plaintiffs and the law in 22 states.

Here’s a link to the opinion, which is encaptioned In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014).

Here’s a quick summary:Continue Reading Breaking News: Big Darvocet Appellate Win – Multistate One-Two Punch

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Happy birthday, Justice Sotamayor.  Her autobiography, My Beloved World, is now in paperback and the Justice has been all over the airwaves for the inevitable promotional push.  Every time we see Justice Sotamayor interviewed, we like her more.  We learned that she shops at Costco, where she recently ran into Secretary Clinton, who was signing copies of her own book.  That makes us think that Justice Sotomayor is a real, down-to-earth person.  She is also smart and direct.  She reminds us of the old adage that the most effective politicians are tough liberals and cuddly conservatives.  Sotamayor was a prosecutor for a while, so we confess to harboring an undeniable bias in her favor.  She also makes a point of admitting her fallibility up front.  She points to retired Justice Stevens and his acknowledgment that he regrets some of his opinions and would now write them differently.  She says she fully expects to feel the same way about her judicial oeuvre in 20 years.

We do not have to wait so long to regret Justice Sotamayor’s opinions in an area close to our heart, FDA preemption.  Those opinions make for unpleasant reading. Luckily, they are dissents.  Justice Sotamayor wrote lengthy dissents in the Mensing and Bartlett cases.  Those dissents seem to turn on two fundamental notions: (1) hostility to conflict preemption, with a conviction that there is a conflict only when compliance with both federal and state law is impossible not only in a practical sense, but in a complete, almost metaphysical sense.  One gets the distinct impression that in Justice Sotamayor’s world view, it would be pretty much impossible for a manufacturer to show impossibility preemption. (2) Justice Sotamayor is irked that purchasers of generic products might be ousted from court while purchasers of branded products could still buy a ticket to the litigation lottery.  Big surprise: we think she is wrong about that, too.  Such distinct treatment of consumers of distinct products is not inherently unfair or illogical.  One could come up with a rational system where consumers could trade lower prices for reduced litigation options. Maybe that is what we have.  We certainly have it with respect to limited tort auto insurance policies.Continue Reading Ninth Circuit Applies One-Two Punch to Prevent Claims against Brandeds, and Preempt Claims against Generics

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This post is from the non-Reed Smith side of the blog.

Plaintiffs seeking sanctions in the Actos litigation is nothing new.  We’ve covered the absurd federal MDL spoliation ruling here and the saner result from the Illinois state court proceeding here.   Apparently, the MDL plaintiffs weren’t satisfied with their win on spoliation or with their equally ridiculous trial verdict, so this time they went after Eli Lilly asking the court to use its inherent power to strike Lilly’s answer to the complaint and to enter default judgment in favor of plaintiffs.  In re Actos Prods. Liab. Litig., 2014 U.S. Dist. LEXIS 81305 at *19 (W.D. La. Jun. 11, 2014).  Fortunately, the court denied the motion in its entirety – in large part because plaintiff overreached on the sanctions it wanted imposed and under-reached on the legal theories it used to support its arguments.  But, at the core of the motion was something no defendant or defense counsel wants to have to face – allegations of perjury by a former employee.

We don’t know exactly how Lilly found itself in the situation we are about to describe.  But, the words of every trial advocacy professor we’ve ever had sprang immediately to mind:  Don’t lose because you failed to thoroughly prepare your witnesses.  You never want to be surprised at trial by what your witness is going to say.  And while that gets trickier with a former employee, if you are identifying them on your witness list as someone who will testify on your behalf, you better have considered things like:  was the witness prepared by counsel, does the witness make a good appearance, has the witness provided testimony elsewhere that is concerning or problematic.  And, if the reality is that this is “the” witness on a central issue regardless of how some of these questions are answered – then you better prepare, prepare, prepare and prepare again.Continue Reading Actos — Another Motion for Sanctions

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Today, the United States Supreme Court decided Halliburton Co. v. Erica P. John Fund, Inc., No 13-317 (U.S. June 23, 2014).  Here’s a link to the
opinion.  As we mentioned in our prior post, one of the questions the Supreme Court took the case to decide was whether to abolish altogether the so-called “fraud on the market” presumption of reliance in securities cases that the Court had recognized, 4-3, in Basic, Inc. v. Levinson, 485 U. S. 224 (1988).

The Court didn’t do that.  The vote on that point was six-to-three.  A combination of stare decisis (slip op. at 4, 7-8, 11), that Congress could have abolished the presumption itself but hadn’t (id. at 12-13, 15-16), and the Court’s emphasis on the rebuttable nature of the presumption – its “modest premise” (id.
at 10, see id. at 7, 10, 14-15) preserved it in cases where the evidence supported the existence of an “efficient” securities market.

We’re not securities lawyers here.  We’re interested in Halliburton primarily for its effect in keeping “fraud on the market” presumptions out of our sandbox – the manifestly non-“efficient” market for prescription medical products, where patients cannot even buy these products without a learned intermediary physician first prescribing them.  As we laid out at some length in a prior post (one of our 50-state surveys) back in 2010, the fraud on the market theory has been roundly rejected by courts applying state law, even in securities cases.  Our chief concern at present isn’t state law, but rather the abominable RICO-based liability theories that the First Circuit embraced in its Neurontin trilogy.  We discussed at length here how that court had allowed expert testimony that didn’t just presume reliance in a RICO case claiming off-label promotion, but allowed expert testimony amounting to a conclusive presumption of reliance – a presumption that that court held overcame the testimony of every prescribing physician who testified that they had not relied on the promotion.  What’s more, the First Circuit in Neurontin even allowed that expert to impugn the credibility of the physician witnesses before the jury.

What happened in Neurontin was unprecedented, and we hope that, after what we gleaned from today’s Supreme Court decision, it remains that way.  There’s a chance of that because the Supreme Court today had a lot to say about rebuttable presumptions of reliance, even in the sometimes “efficient” securities market.Continue Reading Supreme Court Dents, But Keeps, “Fraud on the Market” in Securities Cases

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We’ve been blogging now for well over seven years.  Our first substantive posts went up on November 15, 2006, and by now about 2450 have followed. We use this blog regularly as a research tool.  A lot of you probably do, too.  Even for us, it’s getting hard and harder to find what we’ve already…

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This post is not from the Dechert side of the blog, as Dechert handled the successful appeal of the case being discussed.

We haven’t really covered “Average Wholesale Price” (“AWP”) litigation very much because, while it is typically brought against pharmaceutical defendants, it’s about as far from product liability litigation as, say anti-trust or securities law.  But it’s hard to ignore when a state supreme court blows out such claims (as here).  It’s even harder to ignore when the state supreme court in question is ours.  So here’s what the Pennsylvania Supreme Court recently did to an AWP
“verdict.”

Briefly, and at the risk of oversimplification, “average wholesale price” is a term used to describe a much-tinkered-with basis for determining how much manufacturers may charge governmental purchasers of drugs used in public programs.  Governmental plaintiffs claim that drug manufacturers manipulated the AWP to overcharge them.  Manufacturer defendants counter that AWP is a misnomer, and was not intended or calculated to be as limited as the governmental plaintiffs claim.  Manufacturers also point out, with lots of evidence to back them up, that governmental units were at all times well aware of
what the drawbacks and complexities of what AWP quotation did (or did not) mean.  There are many other issues in AWP litigation, but these are the biggies.

First of all, we wish to point out that the trial result in Pennsylvania was not really a verdict.  In Commonwealth v. TAP Pharmaceuticals (Bristol Myers Squibb Appeal), No. 85 MAP 2011, slip op. (Pa. June 16, 2014), the jury had the good sense to enter a defense verdict on all the claims submitted to it.  Id. at 16.  However, Pennsylvania’s consumer protection statute is quirky, and does not provide for a jury trial.  So the trial judge got snookered.

Second, before we get accused of affording this decision too much significance, yes we know that it’s styled as an “opinion in support of reversal” by an evenly divided (3-3) court.  However, all six sitting justices agreed entirely with the rationale reversing the lower courts.  The only disagreement was that the OAJC would have dismissed the case outright and entered judgment n.o.v., whereas the concurring opinion – not an opinion in support of affirmance – wanted a remand.  So as not to have the bizarre result of a 3-3 split resulting in an affirmance by operation of law of a decision that nobody thought should stand, the OAJC gave in as to that outcome.  OAJC at 23.Continue Reading Pennsylvania Supreme Court Blows Out AWP Verdict

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We used to spend a lot of time defending against medical monitoring claims – cases where the plaintiff has not suffered any actual injury, but claims he or she is at risk of a future injury and demands that the defendant pay for future medical surveillance.  We do not, however, see these kinds of cases so much anymore.  The plaintiffs’ bar seems to have figured out that there is little money in medical monitoring in the drug and medical device context because the claimed future monitoring – say an annual blood test – often costs only a few hundred dollars.  Medical monitoring cases therefore pencil out for the plaintiffs’ attorneys only when brought as class actions.

But medical monitoring class actions don’t work either.  Every plaintiff treated with a drug or medical device has a medical condition, usually requiring follow-up medical care.  The trick then is determining which follow-up (if any) is attributable to a drug or device risk and which is attributable to the plaintiff’s existing medical condition.  You also have to look at the adequacy of the warnings, and at their impact, and at what monitoring the patient might actually need, and at whether the claimed monitoring actually promises medical benefit, etcetera, etcetera.  Because these will be different inquiries for every patient, individual issues are the undoing of medical monitoring class actions, which is why they don’t get filed anymore.

We provide this preface because of the latest rejection of medical monitoring, this time in the First Circuit.  The plaintiffs in Genereux v. Raytheon Co., No. 13-1921, 2014 WL 2579908 (1st Cir. June 10, 2014), claimed workplace exposure to beryllium.  (Yes, we know it’s not a drug or medical device, but it’s a really interesting opinion with crossover appeal, so bear with us.)  Beryllium is a useful substance with known hazards:  Exposure can cause Chronic Beryllium Disease, which damages the lungs and can impair organ function.  Id. at *2.  The precursor to Chronic Beryllium Disease is something called “beryllium sensitization,” which is regarded as a testable, abnormal medical finding.  People with multiple positive tests for beryllium sensitization are at a higher risk of Chronic Beryllium Disease.  Id.

The critical part of Genereux is that the plaintiffs claimed neither beryllium sensitization nor Chronic Beryllium Disease.  No injury at all.  Nothing.  Nada.  Zilch.  How do we know that?  Because the plaintiffs’ expert said so – he could not confirm that any plaintiff or any class member had developed even the precursor condition.  Id. at *3.Continue Reading Money for Nothing? Not Here

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This post is from the non-Reed Smith side of the blog.

We’ve had the United States’ amicus brief opposing Medtronic’s petition for certiorari in Stengel for a few weeks now.  See 2014 WL 2111719 (May 20, 2014).  We turned it over on our desk the way you flip a sofa cushion with a red wine stain.  You simply can’t stand to look at it.  But, like with that stain – you know it’s there and you know you are going to have to deal with eventually.  So, why not today?

You don’t have to look too hard on this site to find our repeated criticism of Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), the wrongly decided Ninth Circuit opinion allowing the plaintiff to allege state law failure-to-warn claims based on the purported failure to report adverse events to the FDA. (see post here)  Finding that the state law claim was neither different from nor additional to federal regulations requiring adverse event reporting, the court concluded plaintiff alleged a “parallel” claim that was neither expressly nor impliedly preempted.  Putting aside our view on parallel claims generally, certainly a claim that the manufacturer did something wrong by failing to report adverse events to the FDA is nothing more than a private party trying to enforce federal drug and medical device regulations, which the FDCA prohibits and which is preempted under Buckman.

Our dislike of Stengel may be outdone by our new dislike for the government’s position on Stengel.  If we had to sum it up, the U.S. brief says essentially two things:  every court to have considered Riegel (including the Stengel court) has gotten it wrong and Riegel should be overturned.  The government reaches this conclusion by eliminating and/or ignoring the differences between §510k clearance and pre-market approval and the differences between drug and device law – essentially the entire reason why Riegel was decided differently than Lohr v. Medtronic, 518 U.S. 470 (1996) and Wyeth v. Levine, 555 U.S. 555 (2009).  And based on its interpretation of Riegel preemption – plaintiffs would be allowed to bring direct failure to warn claims — something that every court since Riegel has found preempted.Continue Reading U.S. Changes It’s Preemption Tune

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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