By John J. Park, Jr., of counsel to the Atlanta office of the law firm Strickland Brockington Lewis LLP who was Deputy Attorney General for the State of Alabama from 1995 to 2006.
In January 2013, the Alabama Supreme Court released its initial decision in Wyeth, Inc. v. Weeks, holding that brand-name drug manufacturers can be held liable for the generic drug maker’s allegedly defective warnings of the dangers associated with use of the brand-name drug.1 A WLF Legal Opinion Letter published the following month noted that the Alabama decision was an outlier; it joined only one California appellate court and a federal district court in Vermont, while more than 70 court decisions, including four from federal courts of appeals, had gone the other way.2
On August 15, 2014, that court doubled down, releasing a substituted opinion that denied rehearing.3 The Court claimed that it was not “plow[ing] new ground” or “creat[ing] a heretofore unknown field of tort law that has been referred to as ‘innovator liability.’”4 Nonetheless, its decision still has the effect of “using a name brand manufacturer’s statements about its own product as a basis for liability for injuries caused by other manufacturers’ products.”5 That is something Alabama has not done before, and its decision remains an outlier.6
On rehearing, Chief Justice Moore and Justice Parker joined Justice Murdock in dissent.7 Chief Justice Moore objected to answering the question at all, and Justice Parker wrote that it was not Alabama’s responsibility to change its “bedrock legal principles.”8
Justice Murdock again criticized the majority’s equation of foreseeability with duty, explaining that foreseeability, standing alone, is not enough. In tort law, we understand that, when a manufacturer puts a product into the marketplace, it stands behind it and answers for its safety. But Ford doesn’t answer for the safety of Chevrolets because the Chevy is not a Ford product. The Weeks majority threatens to make Pfizer answer for the safety of the generic version of Reglan.
The Weeks majority reasoned that federal regulations require the generic maker to use the brand-name manufacturer’s warning. If that warning is defective, the brand-name manufacturer is responsible for its content, even if the injured consumer took only the generic version.
The U.S. Supreme Court held 5-4 in PLIVA, Inc. v. Mensing9that state common-law based claims of failure to warn directed at the makers of generic versions of brand-name products are pre-empted by federal regulatory rules. Put simply, because federal regulations require the generic drug makers to use the same labels that the Food and Drug Administration (FDA) has approved for the corresponding brand-name products, the generic manufacturer can’t change them in response to state law. If it’s impossible to comply with both federal and state rules, the federal rules control.
In PLIVA, the Court recognized that its preemption decisions go in different directions. A state-law based failure-to-warn claim directed at the brand-name manufacturer is not preempted and can go forward, but the same claim against a generic manufacturer of the corresponding product cannot. But, the Court explained that it was up to Congress and the FDA to change the “meaningfully different” federal laws and regulations that apply to brand-name and generic drug manufacturers.
In its June 2013 decision in Mutual Pharmaceutical v. Bartlett,10 the Court expanded the scope of its holding in PLIVA, extending federal preemption to state-law design-defect claims. As with the warning label on the generic product, which must be the same as the one on the corresponding brand-name product, the composition of the generic product must be the same as that of the brand-name drug. Once again, the Court said the problem was one for Congress to resolve: “Suffice to say, the Court would welcome Congress’ ‘explicit’ resolution of the difficult pre-emption questions that arise in the prescription drug context.”
The danger of a decision like Wyeth, Inc. v. Weeks is that courts will subvert the work of Congress and the FDA. Moreover, other courts may follow the ruling or its rationale. The February, 2014 decision in Dolin v. SmithKline Beecham11 is an example of that phenomenon. Acknowledging that “[n]umerous courts” have taken a “dim view” of innovator liability, Judge James B. Zagel nonetheless declined to follow them. Instead, the court allowed common-law negligent design and warning, as well as negligent misrepresentation claims, to proceed against brand-name manufacturer SmithKline, even though the alleged injury resulted from the generic version of Paxil. The court applied Bartlett to dismiss the claims against the generic manufacturer.
As the Supreme Court said in PLIVA and Bartlett, the job is one for Congress and the FDA, not the courts. It may not be an easy one; as the commentators referenced above note,12 the FDA allows generic drugs to have different inert ingredients and release mechanisms that can change the rate and extent of absorption from those of the corresponding brand-name product. Those differences undermine the presumption of sameness.
The generic versions of non-biological complex drugs strain that presumption of sameness even more. Last July, former FDA Deputy Commissioner Scott Gottlieb reported that the FDA’s analysis of the generic versions of non-biological complex drugs is “far trickier than generic versions of the normal, small molecule pill drugs that FDA is accustomed to evaluating.”13 He explained that none of the FDA’s approvals of generic complex drugs “have been smooth affairs;” in some instances, the FDA has sought post-approval testing to make sure that the generic product was safe. If that’s the case, why should the brand-name manufacturer be on the hook for the generic product’s warning label?
If the FDA has trouble determining whether the generic version of a non-biological complex drug is the same and behaves in the same way as the brand-name version, why should we look to a jury to figure it out? The genie needs to go back into the bottle.
- 2013 Ala. LEXIS 2, *59 (Ala. Jan. 17, 2013).
- Victor E. Schwartz, Phil Goldberg & Cary Silverman, Warning: Alabama Court’s Blame-Shifting Pharma Decision Will Have Serious Side Effects, WLF Legal Opinion Letter, Feb. 8, 2013, available at http://www.wlf.org/upload/legalstudies/legalopinionletter/02-08-2013SchwartzGoldbergSilverman_LegalOpinionLetter.pdf.
- Wyeth, Inc. v. Weeks, Case No. 1:10-cv-602 (Ala. Aug. 15, 2014), available at http://freepdfhosting.com/a84f20bf6c.pdf (hereinafter “Weeks II”).
- Id., slip op. at 6, n. 2.
- See Foster v. American Home Products, Inc., 29 F. 3d 165, 170 (4th Cir. 1994).
- As Associate Justice Murdock observed in his dissent, since the Alabama Supreme Court’s original 2013 decision, “another dozen or more decisions on this issue by federal courts around the country, including decisions by four federal courts of appeals, two of them weighing in for the first time” have gone the other way. Weeks II, slip op. at 130 (Murdock, J., dissenting).
- Chief Justice Moore was not on the Court in January 2013, Weeks II, slip op. at 75 (Moore, C.J., dissenting), and Justice Parker was in the majority.
- Weeks II, slip op. at 83 (Parker, J., dissenting).
- 131 S. Ct. 2567 (2011).
- 133 S. Ct. 2466 (2013).
- No. 12 C 6403 (N.D. Ill. Feb. 28, 2014).
- Schwartz, Goldberg & Silverman, supra note 2.
- Scott Gottlieb, “FDA’s Looming Decision on a Generic to TEVA’s Copaxone Reveals Drug Approval Woes,” July 7, 2014, available at http://www.aei.org/article/health/fdas-looming-decision-on-a-generic-to-tevas-copaxone-reveals-drug-approval-woes/.