October 2014

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We don’t discuss damages much, except to fulminate about punitive damages.  Why is that?  We’re not entirely sure, but to some extent not discussing damages means not discussing losing.  We “win” for our clients when we prevail on liability, and that’s what we like to do most.  Getting into damages means that we didn’t achieve our primary goals in litigation, which are to win all the cases we can and settle the rest.

But not every case is a good case.  Sometimes, particularly in real (not made up “parallel claims”) manufacturing defect cases, there simply isn’t a good defense on the merits.  Give credit to the other side’s skill, too.  They can often make hay with bad cases.  Even when our side doesn’t think there’s liability, there can still be damages.

Continue Reading Of Phantom Damages, Collateral Sources, and Windfalls

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We wanted to take a moment to let you know about the Drug and Device Defense Forum coming up on October 22nd.  Two of our bloggers (McConnell and Yeary) are speaking along with a host of other excellent private practice attorneys and in-house counsel.

The agenda includes topics such as the current state of…

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October 8 is a fine day to reflect on American heroism.  Eddie Rickenbacker was born on October 8, 1890.  He became America’s ace fighter-pilot in World War I, with 26 aerial victories.  Rickenbacker won the Congressional Medal of Honor. The French gave him the Croix de Guerre.  Rickenbacker was also a race-car driver.  He later headed Eastern Airlines.  Ninety-six years ago on this selfsame date, Alvin York led an attack on a German machine gun nest.  He killed 28 enemy soldiers and captured 132.  He, too, earned the Congressional Medal of Honor and the Croix de Guerre, along with many other honors.  York had to struggle with his strong religious belief in pacifism before he could bring himself to kill for his country.  Good thing he did, as he was a keen shot and saved many American lives.  He was a corporal at the time of his amazing act of bravery, but was forever known by the rank he attained at the end of the war:  Sgt. York.  In 1942, Gary Cooper won an Academy Award playing Sgt. York. There is a statue of Sgt. York on the grounds of the Tennessee Capitol building in Nashville.

Without people like Rickenbacker and York, it is not clear that we would have the freedom to haggle over fine points of law. So today we will discuss a mixed bag of a case with gratitude for the good points and restraint on the not-so-good.  We are in a no-snark zone.Continue Reading S.D. Illinois Dismisses Some Mirena Claims and Allows Others to Linger

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Usually our posts have a fairly singular focus.  We think that helps keep them more useful – short, topical, easy to search.  It is also the result of most opinions generally being issue-specific as well. But, occasionally we find a case that says a little bit about several topics.  When that happens, our standard procedure…

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We just read with interest the recent DC Court of Appeals decision in Ivy Sports Medicine, LLC v. Burwell, ___ F.3d ___, 2014 WL 4801283 (D.C. Cir. Sept. 26, 2014).  In Ivy Sports, the FDA drew back a nub when it argued that it had “inherent authority,” beyond that granted by statute (specifically 21 U.S.C. §360c(e)) to change the classification of a medical device.  The court of appeals held that, where the statute mandated procedures that the FDA had to follow in revisiting a previously-adopted device classification, the FDA couldn’t ignore those procedures by asserting unbounded “inherent” power to do what the statute governed.  In the words of the court:
Continue Reading Another Preemption Thought

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We typically leave it to others to review movies or television shows in the course of a post.  Sure, we will throw in a quote or reference from time to time, but that is about it.  We had the misfortune to watch the purported “thriller” I, Frankenstein recently and we thought we should share.  The film had more holes than a hunk of emmentaler.  It featured Aaron Eckhardt in another film with his face disfigured and Miranda Otto in a role not befitting a shieldmaiden of Rohan.  Its plot was tied loosely to the familiar Frankenstein story, itself based on older golem tales. Doctor Victor Frankenstein combined parts of corpses into a monster, which he animated with the charge from electric eels (without explanation of their importation to Eastern Europe).  The monster is not human, mortal, or terribly pleased to exist at all.  (He also does not enjoy hot soup ladled into his lap.)  Things go wrong, many years pass, and there is some ludicrous eternal battle between demons and gargoyles/angels into which the monster becomes embroiled.  Anyway, with omitted air quotes throughout, the monster is special because he was dead, is now alive, lacks a soul, and cannot die (except maybe if a demon skewers him).  The movie ends without anything particularly surprising or interesting happening, let alone anything that would make the viewer care about any character in it.

The plaintiff in Keeton v. Ethicon, Inc., No. 2:13-cv-24276, 2014 U.S. Dist. LEXIS 135327 (S.D. W. Va. Aug. 8, 2014), tried to reanimate her claim with a “Frankensteined” complaint—the court’s novel term and inspiration for our oh-so-clever post.  In, perhaps, a mild surprise, she was utterly unsuccessful, at least if the Report and Recommendation (R&R) of the Magistrate is followed.  It looks like it took more effort that it should have, in part because the plaintiff was now going pro se, and the recommended dismissal of the pending case would be without prejudice for some reason, but res judicata acted as monster bane.Continue Reading Pre-Halloween Demise of a Frankenstein Plaintiff

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Only a short post today, because Bexis is so blasted busy right now.  When we were preparing our program for our recent Reed Smith side teleseminar about Recent Trends in Drug and Device Litigation, we looked at a lot of different preemption cases involving a lot of different products.  One aspect that landed on the cutting room floor was preemption involving OTC drugs, since the express preemption clause for drugs sold over the counter is so limited.  Specifically, 21 U.S.C. §379r(e) expressly preempts state law on one hand, but another section, §379s(d) excludes precisely the claims that interest us the most −  product liability, by providing “[n]othing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.”

That’s bad if you’re representing OTC drug manufacturers, as we sometimes do.  While there is still preemption of non-personal injury actions (such as for fraud or consumer fraud, as we’ve discussed here), that’s it.  Indeed, §379s(d) is also a bad thing when a court takes the unfortunate position, as happened in Wyeth v. Levine, 555 U.S. 555 (2009), that if Congress wants express preemption it can say so, therefore to heck with implied preemption.  See id. at 574 (“[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision”).  Indeed, Levine footnoted §379s(d) later in the same paragraph.  Id. at 575 n.8.

Continue Reading An Express Preemption Thought

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Last November we took note of a case where a federal court sought clarification from the Arkansas Supreme Court about the scope of claims for “illegal exaction.”  Now we have the answer, and lo, it is good.

For those of you who do not commit our old posts to memory, here is a refresher on Arkansas v. Takeda Pharmaceuticals North America, Inc.,  2013 U.S. Dist. LEXIS 160593 (W.D. La. Nov. 7, 2013).  The plaintiff (named Bowerman) brought an action against Actos manufacturers/sellers to recover costs borne by Arkansas and its citizens for injuries allegedly caused by Actos.   Bowerman never purchased or used Actos, but claimed standing simply by virtue of being an Arkansas taxpayer. The plaintiff sought a refund of money spent by the state to purchase Actos and to treat the injuries.  The theory relied upon by the plaintiff is called “illegal exaction,” which arises under the Arkansas Constitution and is defined as “any exaction that is not authorized by law or is contrary to law.”  That is broad language, but the theory was typically limited to allegations that public officials misappropriated public funds.  Unfortunately, there was enough muddiness in Arkansas law to prompt the federal court to certify questions to the Arkansas Supreme Court as to whether the “illegal exaction” theory was so vast or elastic as to permit Bowerman’s case to proceed.Continue Reading Final Answer: Arkansas “Illegal Exaction” Theory Does Not Reach Drug Reimbursement

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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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