April 2015

Photo of Rachel B. Weil

A couple of days ago, we watched the lovely “St. Vincent.”  The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood.  Disrepair has turned Vincent’s house into an eyesore.

Vincent is eluding his threatening bookie, who is seeking repayment for money Vincent has lost on the horses. Vincent is unkempt and rude, and we are led to believe that his only “soft spot” is reserved for his white Persian cat.

Enter a subdued and quietly effective Melissa McCarthy (compare “Bridesmaids”), as a newly-single mother moving next-door to Vincent with her (flat-out adorable) young son in tow.   We’ve recently been the victims of spoilers ourselves (see McDreamy), so we won’t reveal more except to note that Vincent is not quite the unredeemed ne’er-do-well he seems to be.  The movie reminds us to reserve judgment and not to allow initial impressions to obscure nuance.  Sometimes, there is good buried among the bad.

Such is not the case for Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  There are few, if any, silver linings in this Massachusetts Supreme Court decision affirming an eye-popping jury award of $50 million in compensatory damages to a child whose devastating toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin.  The Court also affirmed loss-of-consortium awards of $6.5 million to each of the child’s parents.

Continue Reading Freehand Line-Drawing in Affirmance of Huge Verdict in Children’s Motrin/TEN Case

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That didn’t take long.  Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014 (discussed here and here, and named #1 worst decision of 2014 here).  Here is a copy of the enrolled bill.  The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.  Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.Continue Reading Alabama Legislature Abolishes Weeks Innovator Liability Theory

Photo of Eric Alexander

This is from the non-Dechert side of the blog.

We do not write too often about tobacco decisions. While FDA has added a Center for Tobacco Products and there are still lots of cases against tobacco manufacturers, we are more likely to talk about some consumer protection or preemption issue from a food case than any issue from a tobacco case.  Rather than discussing the reasons why we typically ignore the tobacco cases in our nearly never-ending search for bloggable cases, we will say what interested us in Berger v. Philip Morris USA, Inc., No. 3:09-cv-141567 (M.D. Fla. Apr. 23, 2015).  First, the decision is a grant of a post-trial motion for partial judgment after essentially the same motion was denied without prejudice at the end of the plaintiff’s case.  For readers who have not gone through this particular emotional roller coaster, it can be analogized to watching your playoff basketball or hockey team be up three games to two, fail to clinch the series in game six, and then take game seven.  You were sure that your team would lose game seven after the earlier missed opportunity.  Then, your relief at the ultimate win is somewhat tempered by the thought that you could have avoided significant progress toward an ulcer. Still, this is much better than taking the loss.  Ask any Caps fan.  Second, it involved a verdict of more than $20 million going away.  And, third, it involved the issue of the plaintiff’s reliance on representations by the defendant—representations that the court had no trouble characterizing in the most damning ways.  Going back to the basic principles of tort law—Palsgraf, anyone?—even decades of an industry-wide “disinformation campaign” does not create liability unless it can be tied to the plaintiff’s use of the product.Continue Reading Fraud In The Smoke Will Not Do

Photo of Michelle Yeary

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

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases.  Think of it like taking a shot on goal.  The shot deflects off the goalie’s stick and goes wide – that’s express preemption.  The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements.  You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion.  Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot.  Wrong. No free shot.  No empty net.  All the obstacles remain in place.  Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series.  Go Capitals!).Continue Reading InFuse State Court Appellate Win

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This post comes only from the Cozen O’Connor side of the blog.

The Vioxx MDL is still alive.  But not really kicking.  The master settlement agreement ended the mass tort portion of this litigation, leaving behind a vastly smaller number of cases filed by plaintiffs who chose not to “opt in” to the settlement.  The MDL court is still managing some of those cases.  But, if Levitt v. Merck Sharp & Dohme Corp., 2015 U.S. Dist. LEXIS 52756 (E.D. La. Apr. 21, 2015), is any indication, it won’t be for much longer.

In Levitt, the MDL court denied Merck’s motion for summary judgment, instead ordering that discovery be reopened.  While that might not sound like the decision of a court looking to end its involvement in the Vioxx litigation, remanding the case to the original transferor court for further proceedings sure does.  And the MDL court did that too.  Id. at * 30.Continue Reading Yes, There Is Still Vioxx Litigation

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We’ve got the expression “the dog that didn’t bark” stuck in our heads today, and it’s not just from that phrase being used in the recent Caplinger decision. See Caplinger v. Medtronic, Inc., ___ F.3d ___, 2015 WL 1786742, at *9 (10th Cir. April 21, 2015) (blogged about here). No, it’s also our reaction to another preemption decision handed down almost simultaneously with Caplinger – by the Supreme Court – in Oneok, Inc. v. Learjet, Inc., 2015 WL 1780926 (U.S. April 21, 2015).  Both Oneok and the majority’s opinion in Caplinger share something in common beyond being decided on the same day and being about preemption.  Neither so much as breathes a word about the embattled “presumption against preemption.”

That the Caplinger majority doesn’t mention any presumption (or assumption, or whatever) against preemption isn’t really surprising, since it affirmed preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in which the Supreme Court majority did likewise.  It is surprising that Oneok didn’t rely, or even reference, such a presumption.  First, Oneok found no preemption, and we’ve noted elsewhere, the presumption against preemption is one of those result-oriented things that tends to pop up when consistent with a no-preemption result and vanish where preemption is found.  Second, Oneok is a field preemption case (one reason why nothing else in it is terribly pertinent), and field preemption is where the presumption against preemption originated.  As we said in one of our very first posts:

The presumption asserted by the Lohr plurality originated in preemption discussions involving neither express nor conflict preemption – but rather “field” preemption.  Thus, in Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), the Court noted, “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 230 (citations omitted). . . .  Rice involved the most sweeping form of preemption – field, not conflict preemption.

The Rice assumption became a presumption in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985), and Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977) (cases also cited in Lohr).  Both of these cases rejected field preemption before turning to additional preemption arguments raising actual conflicts with federal regulation.  Both courts invoked a “presumption” against preemption solely in their discussions of field preemption.Continue Reading Is The Presumption Against Preemption Dead?

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Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.Continue Reading Still No Duty To Supply Drugs – In 22 States

Photo of Michelle Yeary

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

We’ve been reporting on the amazing success Medtronic has had in the InFuse litigation for over two years.  And, it all started with Caplinger.  Caplinger was the first (and arguably one of the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted.  What more could we have asked for?  A Tenth Circuit affirmance.  Now we’ve got it.

In an extremely well-written decision the Tenth Circuit (2-1) affirmed the complete dismissal of Caplinger v. Medtronic, Inc., No. 13-6061, slip op. (10th Cir. Apr. 21, 2015). It is so well-written we really could quote from most of it verbatim.  But we’ll try to resist that urge and give you an abbreviated version today (we do however recommend reading the whole thing, we think you’ll enjoy it).Continue Reading It All Started With Caplinger

Photo of Stephen McConnell

Today’s date is rich in literary history.  It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors’ mastery and our pedestrian scribblings.  Perhaps the biggest laugh-out-loud moment a book ever gave us was from Lolita, when the Humbert character travels a long way to visit a family that has at least one member he is especially, um, interested in, only to be greeted at the train station by the patriarch, who shared “the news that his house had just burned down – possibly, owing to the synchronous conflagration that had been raging all night in my veins.”

Today is also the birthday of Henry Fielding, the great British novelist of the 18th century.  In high school we were forced to read Joseph Andrews and Tom Jones, and we grumbled about it, especially upon getting a peek at the girth of Tom Jones (we mean the book).  But the joy, wisdom, and energy of Fielding’s words, often propelling the most ribald adventures, converted our dread into a wholly unforced pleasure, indeed. There is a sentence in Tom Jones that stopped us abruptly in our tracks. Fielding on many occasions spoke directly to the reader, and at one point he explained his intention to “fill my pages with humour till mankind learn the good nature to laugh only at the follies of others and the humility to grieve at their own.”  Has any writer ever articulated a more noble goal?Continue Reading Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

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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