This is only from the Reed Smith side of the blog
We’ve just received today’s decision by the Supreme Court of Iowa in Huck v. Wyeth, Inc., No 12-0596, slip op. (Iowa July 11, 2014). It’s 48 pages long (with a 1-justice concurrence and a 3-justice dissent). It addresses both generic preemption and innovator drug liability for injuries allegedly caused by ingestion of generic drugs. On the latter it’s a big win for the good guys. The court roundly rejects innovator liability, which it correctly observes would “turn Iowa tort law upside down.” Slip op. at 27. On the other hand, it holds that there is a “narrow” exception to generic drug preemption for failure to update claims,
allowing a variety of theories to slip through that exception to the limited extent that they are based on failure to update allegations. Id. at 18-25. Essentially, Huck adopts the preemption analysis in Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013). Slip op. at 23-24, and allows a variety of theories to escape generic preemption to the extent that they allege failure to update generic warnings to match changes made in the innovator label. Interestingly, Huck never
outright holds that a duty to update claim exists under Iowa law, deciding “only the preemption issue.” Slip op. at 17 n. 7.
The good part is that Huck KOs innovator liability where the plaintiff only took generic drugs. The court (or a majority of it) refuses to do away with product identification in generic drug litigation just because otherwise plaintiffs might be preempted. Slip op. at 27.
[It is] a well-settled requirement of Iowa law [that] the plaintiff must prove injury caused by a product sold or supplied by the defendant. This long-standing
requirement bars [plaintiff’s] recovery from the manufacturers of a brand she never used. Under Iowa law, manufacturers owe duties to those harmed by use of their products. We decline to change Iowa law to impose a new duty on manufacturers to those who never used their products and were instead harmed by use of a competitor’s product.
Id. Huck agreed with the “overwhelming majority of courts” that had rejected innovator liability in generic drug cases. Id. at 28.
The various rationales offered by the plaintiffs were rejected, starting with Hatch-Waxman. “We see no indication Congress intended to alter common law principles of causation to create liability for injuries caused by use of a competitor’s product.” Huck, slip op. at 30. Negligent misrepresentation
(Restatement Second §552) did not avoid the product identification requirement, and in any event “does not apply to sellers of products.” Id. at 31. Fraud is not a way around product identification. “We never held or suggested a fraud claim could be brought by a plaintiff against a manufacturer who owed the plaintiff no duty.” Id. at 33. The Third Restatement, Liability for Physical Harm §7 does not apply “to eliminate the requirement that the plaintiff prove her injuries were caused by a product sold or supplied by the defendant or to impose liability for injuries caused by a competitor’s product.” Id. at 35.
The court rejected the “outlier” decisions, Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, (Cal. App. 2008), and the now reargued Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013). Huck, slip op. at 36-37. The rest of Huck (pp. 39-46) is largely devoted to the many reasons why “[e]conomic and public policy analyses strongly disfavor imposing tort liability on brand manufacturers for harm caused by generic competitors.” Id. at 41.
We are unwilling to make brand manufacturers the de facto insurers for competing generic manufacturers. It may well be foreseeable that competitors
will mimic a product design or label. But, we decline [plaintiff’s] invitation to step onto the slippery slope of imposing a form of innovator liability on
manufacturers for harm caused by a competitor’s product. Where would such liability stop? If a car seat manufacturer recognized as the industry leader designed a popular car seat, could it be sued for injuries sustained by a consumer using a competitor’s seat that copied the design? Why not, under [plaintiff’s] theory, if it is foreseeable others will copy the design?
In sum, we will not contort Iowa’s tort law in order to create liability for brand manufacturers.
Id. at 47.
In sum, we like this part of Huck very, very much.
A big hat tip – and congratulations – to Henninger Bullock of Mayer Brown who both argued Huck and then thought enough of us to send it along.