This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to
Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly
In Looney v. Moore, 2018 WL 1547260 (11th Circuit Mar. 30, 2018), the Eleventh Circuit confirmed Alabama law’s rejection of an “increased risk of harm causation standard and established that lack of informed consent plaintiffs must have a physical injury.
Looney is a clinical trial case. Parents of several infants who were born
We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone in between – to read (aloud) the lengthy prayer service that precedes the meal. The
The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what
As the calendar turns from August to September, it is time once again to concede the strength of the Southeastern Conference. You probably think we are referring to college football or basketball, in which teams from Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, and Texas prevail with grinding monotony. [We have a feeling that OJ’s old college squad, USC, will have an ugly time of it against Alabama in the ostensibly neutral site of Jerry World this weekend.] But, no, we are talking about product liability law. [For the moment, we are pretending that the Weeks innovator liability abomination in Alabama never happened. Moreover, the Alabama legislature eventually cleaned up that mess.] Today we are focusing on the safer alternative requirement in design defect cases. It occurs to us that some very good cases on this issue come out of the SEC. In the beginning of the year, we discussed a Mississippi case, Mealer v. 3M, where the court dismissed a case on the ground that an elastomeric respirator was not a safer alternative to a cheap paper respirator mask. They were two entirely different products, fundamentally different in terms of operation, longevity, and expense. Consumers might have all sorts of important reasons, aside from safety, to choose one over the other.
[Readers who are especially nerdy or possess especially good memories might point out that in July we bemoaned a Louisiana opinion permitting a plaintiff to suggest that other drugs could constitute a safer alternative to the drug at issue. To our mind, different drugs, which consist of different molecules with entirely different risk-benefit profiles, are separate products and cannot be treated as a safer alternative that can shame other drugs out of existence. Under the plaintiff’s (and, unfortunately, the Louisiana court’s) theory, jury verdicts might drive all drugs that treat, say, diabetes, out of the market except one. And even that one would not be safe from attack. Or, to veer away from drugs and devices, we might as well shut down Harley-Davidson, since motorcycles are less safe than other modes of motorized transportation. Live to ride, ride to live? Not anymore. But don’t worry too much. You can still sing “Born to be Wild” on your Hydra Glide. The recent Louisiana error stands as an aberration. As Bexis pointed out in a magnum opus blogpost that strolled down bone screw memory lane back in 2013, Louisiana has quite a lot of good safer alternative decisions.]
Today’s case, Hosford v. BRK Brands, Inc., 2016 Ala. LEXIS 91 (Ala. August 19, 2016), sees the Alabama Supreme Court apply an even stricter test in pouring out a plaintiffs’ case on the ground that the proposed safer alternative was a separate product altogether. The facts of Hosford are grim. A four-year-old girl died in a fire that destroyed her family’s mobile home in May 2011. The fire began in a faulty electrical outlet in the girl’s bedroom. Her family sued the manufacturer of the smoke alarms in their mobile home. The theory was that the smoke alarms were defectively designed because they relied solely on ionization technology which, the plaintiffs alleged, failed to give adequate warning to allow an escape in the event of a slow smoldering fire. There are dual sensor smoke alarms on the market that employ both ionization and photoelectric technology. According to the plaintiffs, such alarms would have roused the family in time to save the little girl. After the plaintiffs presented their case at trial, the defendant moved for judgment as a matter of law. The trial court mostly granted that motion, and only one claim went to the jury. The jury ultimately returned a verdict in favor of the defendant.
Continue Reading Alabama Supreme Court Imposes Tough Standard on Safer Alternative Design
Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else. The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff. Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.” Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.
Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug. Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015). Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability. Id. at *13. We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”
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
It feels like we have been talking about Weeks for years. Two slightly different versions of the same decision have allowed the “innovator liability” theory of recovery to survive in Alabama against manufacturers of drugs that the plaintiff did not take. Each appeared on our bottom ten list over the last two years.
Too many posts to link have discussed how Weeks is on the wrong side of the weight of authority on what started with Conte years ago. In the first five months after its feeble re-do, we did not see cases considering whether to extend Weeks. We now have, with Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073 (N.D. Ala. Jan. 14, 2015). And that led us to find an older Weeks case that took a while to appear in “print,” Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014). So, we present an end-of-the-week two-fer on Weeks from the federal judges in the northern part of this southern state.
Both cases involve plaintiffs who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, and who sued various manufacturers, including the company that brought the branded drug to market long before the plaintiff got the generic. Both cases also involve other issues we often discuss, like TwIqbal, preemption, and the learned intermediary doctrine, but we are not discussing those issues here. Instead, we are limiting ourselves to how these cases limit Weeks and do not allow the plaintiffs to proceed against the branded manufacturer on the allegation that it owed a duty to each plaintiff to provide him with the Medication Guide that would have made clear that his physician was prescribing the drug off-label and that it had various risks. (If we were talking about the risk of these cases, we might talk about how little apparent connection there seems to be between the information gap alleged with each brief prescription and the remote injuries.) Amiodarone was originally approved as a “special needs” drug to be used as “a last resort,” and has a regulatory history with a fair amount of back-and-forth on discouraging (and not encouraging) physicians from prescribing it as first or second line therapy. Plaintiffs apparently did not contend that the Medication Guide hid the ball on the drug’s indication or risks.
Way back in 2007 we said this: “We really don’t see the purpose in a separate cause of action for breach of implied warranty in a case involving a prescription medical product. Warranty claims are for ham sandwiches and lawn chairs, where the term “merchantable” has some coherent meaning. . . . Except in unusual situations, where there’s physical contamination or a counterfeit product, an implied warranty of merchantability makes no sense and adds nothing except a different statute of limitations.” We still feel the same way. Fortunately, so do a lot of courts.
In some states breach of implied warranty claims have been merged with other warning-based theories of liability (like in New Jersey where all products claims other than breach of express warranty have been subsumed under the Products Liability Act). In states where a breach of implied warranty claim remains as an independent cause of action, some courts have ruled that such claims are not allowed in the context of prescription drugs and devices. The reasons vary but most often include application of the learned intermediary doctrine (see post here) or the unavoidably unsafe product doctrine.
And while at a quick glance, Alabama appears to be one of the states that generally doesn’t recognize a cause of action for breach of implied warranty of merchantability for inherently dangerous products – the law on the issue has become muddled over time. So, in Collins v. Novartis Pharma. Corp., slip op., No. 2:08-cv-438-MHT-PWG (M.D. Ala. Jan. 14, 2015), the court tried to sort it all out.
Continue Reading Risks Don’t Make Drugs Un-Merchantable in Alabama