2L student, Laura Anne Taylor, Fellow for the Center of Law and Biomedical Sciences
The Supreme Court heard oral arguments on Tuesday, March 19 in Mutual Pharmaceutical Co. v. Bartlett, one of a series of cases this term the outcome of which could have a significant impact on public health. Plaintiff Karen Bartlett suffered a horrific rare side effect[LF1] , a severe reaction known as Stevens-Johnson syndrome and related toxic epidermal necrolysis (“SJS/TEN”), after taking a generic painkiller manufactured by Defendant Mutual Pharmaceutical Company (“Mutual”).[1] Bartlett sued Mutual in New Hampshire state court under a design defect product liability theory, alleging Mutual was liable for her injuries for manufacturing an “unreasonably dangerous” product.[2] A jury awarded Bartlett over $21 million in damages, and the 1st Circuit upheld the award.[3] A transcript of the Supreme Court oral arguments is available here.
Two recent Supreme Court cases inform the potential outcome of the case. In 2009, the Supreme Court held in Wyeth v. Levine that pharmaceutical manufacturers could be held liable for inadequate warning labels (“failure to warn” claims) because the federal regulatory scheme governing pharmaceutical approvals neither expressly nor implicitly pre-empts state tort law.[4] In 2011, the Supreme Court narrowed Wyeth’s reach by holding in PLIVA v. Mensing that generic pharmaceutical manufacturers could not be held liable in failure to warn suits because such manufacturers have essentially no control over what warnings labels say;[5] they are required under federal law to duplicate the warning label approved for the corresponding name-brand product.
Counsel for Mutual argued that PLIVA should govern because “there is no principle[LF2] [LT3] [sic] basis for treating design defect claims any differently from failure to warn claims.”[6] Bartlett’s counsel countered by arguing that Bartlett’s claim is distinguishable from PLIVA: in PLIVA, an impossibility conflict arose when state tort law attempted to impose liability on a generic pharmaceutical manufacturer for failing to alter its warning label despite its inability to do so under federal law. Counsel argued that in Bartlett’s case, in contrast, New Hampshire law does not impose any duty on Mutual prohibited by federal law, but merely imposes “a duty to pay compensation if [the] unreasonably dangerous product harms a patient,”[7] with no resulting impossibility conflict[LF4] [LT5] . Justice Kagan seemed skeptical of Bartlett’s bright-line distinction between failure to warn and design defect claims, recognizing that the adequacy of the warning label is an element of a design defect claim under New Hampshire law,[8] which could bring the instant case under PLIVA’s precedent. However, Chief Justice Roberts challenged Mutual’s impossibility claim by positing that the Federal and state laws do not impose different (or conflicting) duties on the manufacturer,[9] which suggests Bartlett’s case might be distinguishable from PLIVA.
Regardless of the outcome of the case, the holding is likely to impact two important (and related) public health concerns. First, the availability of safe, low-cost generic drugs is an important public health concern. Widespread access to such products can potentially help achieve or maintain favorable population health outcomes with lower overall healthcare costs. However, if Bartlett’s jury award is upheld, generic pharmaceutical manufacturers may be overly cautious when deciding which brand-name products to produce as generics, if those products have rare but serious side effects. Alternatively, if Mutual avoids liability, generic pharmaceutical manufacturers can continue to produce low-cost versions of expensive brand-name drugs without the risk of jury damages (though arguably also without adequate checks to ensure product safety).
Second, a related public health interest exists in ensuring that pharmaceutical products are safe for public use. Substantial jury awards against pharmaceutical manufacturers can act as a deterrent against production of pharmaceutical products whose dangers outweigh their health benefits, ideally resulting in safer pharmaceutical products overall. If Bartlett’s jury award is upheld, all pharmaceutical manufacturers, brand-name and generic, will be further incentivized to take all potentially “unreasonably dangerous” products off the market. However, if the award is struck down, generic pharmaceutical manufacturers will have little incentive to halt production and marketing of products with potentially “unreasonably dangerous” side effects.
A decision from the Court is expected this summer.
[1] Katie Thomas, Justices to Take Up Case on Generic Drug Makers’ Liability, The N.Y. Times (Mar. 4, 2013), http://www.nytimes.com/2013/03/05/business/justices-to-take-up-case-on-generic-drug-makers-liability.html.
[2] http://www.supremecourt.gov/oral_arguments/argument_transcripts/12-142.pdf [hereinafter Transcript].
[3] See Bartlett v. Mutual Pharmaceutical Co., 760 F. Supp. 2d 220 (D.N.H. 2011); Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012).
[4] See Wyeth v. Levine, 555 U.S. 555, 581 (2009).
[5] PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2572 (2011).
[6] Transcript at 3, lines 19–21.
[7] Transcript at 46, lines 7–9.
[8] Transcript at 30, lines 18–30.
[9] Transcript at 20, lines 8–23.