Last week a New Hampshire woman who suffered grievous side effects when she took a generic pain reliever manufactured by Mutual Pharmaceutical filed her merits brief at the U.S. Supreme Court, in a case that will determine whether the Food and Drug Administration's regulation of generic drugs pre-empts state-law design defect claims against manufacturers. Karen Bartlett's lawyers at Kellogg, Huber, Hansen, Todd, Evans & Figel argue that design defect claims, unlike failure-to-warn claims, do not depend on the FDA-approved labels generics are required to carry under the Hatch-Waxman Act. That fact, they contend, distinguishes Bartlett's case (and the underlying 1st Circuit Court of Appeals ruling Mutual is challenging) from the reasoning the Supreme Court applied in its 2011 decision in Pliva v. Mensing, which held that generics are not liable for failing to warn of dangerous side effects because they are required to carry the same labels approved by the FDA for brand-name versions of their products.

Bartlett's brief, which also urged the justices to disregard the U.S. government's changing position on pre-emption for drugmakers, said that the Supreme Court really should consider congressional intent - as the court itself acknowledged when it ruled that FDA regulation doesn't pre-empt state-law product liability suits against brand-name drugmakers in the 2009 case Wyeth v. Levine. Congress was certainly aware of state-court product liability litigation when it passed the Hatch-Waxman Act in 1984, just as it was previously aware of such litigation when it originally enacted the Food, Drug and Cosmetic Act establishing the FDA's regulation of pharmaceuticals. Neither law, Bartlett's brief said, includes a provision expressly stating that those product liability claims are pre-empted by federal regulation. Quoting from the Supreme Court's Levine decision, the brief argues that the absence of pre-emption clauses in Hatch-Waxman and the FDCA is "powerful evidence" that Congress didn't intend FDA regulation to pre-empt common law claims.

Here's even more powerful evidence of Congress's intent: a newly filed amicus brief filed by Senator Tom Harkin (D-Iowa) and Representative Henry Waxman (D-California, and, yes, the Waxman of Hatch-Waxman) in support of Bartlett. Harkin and Waxman, who are represented by Allison Zieve of the Public Citizen Litigation Group, say lawmakers' intentions couldn't be clearer. If Congress wanted federal regulation to preclude personal injury suits, it would have said so. It's no accident that Congress did not, according to the brief.

"The notion that FDA regulation broadly pre-empts design-defect claims against prescription drug manufacturers finds no support in the text or purpose of the FDCA, runs counter to the ... provision addressing product liability law and ignores more than 75 years of history in which damages suits and federal drug approval have co-existed," the brief said. "Congress is well aware of its authority to pre-empt state damages actions, and with respect to prescription drugs, as with (over-the-counter) drugs, it has not done so. Moreover, in recent years, following litigation addressing whether federal regulation pre-empts state-law claims regarding injuries caused by drugs, both chambers of Congress have considered pre-emption of state-law claims concerning drugs. Yet Congress has taken no action to change the historical framework through which state law controls whether injured patients have a tort remedy."

Zieve of Public Citizen told me that Waxman's office reached out to her group after the Justice Department filed its brief in support of pre-emption of design defect claims against generics. Public Citizen, which has actively opposed pre-emption of personal injury litigation against generics, wasn't planning to enter the fray in the Mutual case, Zieve said, but the public interest group and Waxman agreed that the government's filing seemed to escalate the case's risk for consumers. Waxman recruited Harkin to join the brief; Public Citizen would have tried to bring in more members of Congress if there had been more time, Zieve told me. (I asked if she reached out to Orin Hatch, the Utah Republican who co-sponsored the Hatch-Waxman Act. She said she didn't because she didn't think he'd join her side.)

The point of the Harkin-Waxman filing, Zieve said, is to remind the Supreme Court that pre-emption is a policy issue, as the justices themselves have previously held. "Even if it's only on behalf of two members, it reminds the court that this is a decision Congress should be making," she said.

I should note that Waxman's involvement in the case is no guarantee that the justices will agree with his interpretation of the act that bears his name. Waxman filed an amicus brief in the Pliva case, arguing that the labeling requirements in the Hatch-Waxman Act should not pre-empt state-law failure-to-warn claims. The Supreme Court felt differently.

(This post has been corrected. An earlier version incorrectly reported that Public Citizen, and not Waxman, recruited Harkin.)

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