Another Court Rules Against Preemption in Generic Drug Case; Cornyn Preemption Amendment Would Shield Generic Manufacturers from Liability

By Kurt R. Karst –      

Last week, the U.S. District Court for the District of New Hampshire ruled in a 67-page opinion that various state law tort claims brought against generic drug manufacturer Mutual Pharmaceutical Company, Inc. (“Mutual”) are not preempted by Title I of the Hatch-Waxman Amendments to the FDC Act.  The decision is the latest in a string of cases in which court have ruled that state law tort claims alleging the defective labeling of generic drugs are not preempted by the FDC Act (see e.g., Stacel v. Teva Pharms., USA, 620 F. Supp. 2d 899 (N.D. Ill. 2009), Kellogg v. Wyeth, 612 F. Supp. 2d 421 (D. Vt. 2008), Schrock v. Wyeth, Inc., 601 F. Supp. 2d 1262 (W.D. Okla. 2009), and Demahy v. Wyeth, Inc., 586 F. Supp. 2d 642 (E.D. La. 2008)).  The generic drug preemption question is also the subject of appeals in the 5th (Demahy v. Wyeth, Inc., No. 08-31204 (5th Cir. Dec. 16, 2008)), 6th (Morris v. Wyeth, Inc., No. 09-5509 (6th Cir. Apr. 27, 2009)), and 8th (Mensing v. Wyeth, Inc., No. 08-3850 (8th Cir. Dec. 10, 2008)) Circuit Courts, and is a topic of intense debate on Capitol Hill. 

In Bartlett v. Mutual Pharma. Co., plaintiffs Karen L. and Gregory S. Bartlett claim that Mrs. Bartlett suffered serious injuries after taking the non-steroidal anti-inflammatory drug Sulindac Tablets, which is marketed by Mutual under an Abbreviated New Drug Application ("ANDA") FDA approved in 1991 (ANDA No. 72-051).  (Mutual’s product is an AB-rated version of Merck’s CLINORIL (sulindac) Tablets, which FDA approved in September 1978 under NDA No. 17-911.)  Specifically, the Bartletts claim that after taking Mutual’s Sulindac Tablets in December 2004, Mrs. Bartlett was diagnosed with Stevens-Johnson syndrome progressing to toxic epidermal necrolysis (a serious and potentially fatal condition), and allege that Mutual “had an ongoing duty to conduct postmarketing safety surveillance for any reports of serious adverse events associated with Sulindac including any such report in the medical literature,” and that had Mutual done so, the company would have discovered information compelling the company “to warn physicians about the dangers” of its drug product with respect to Stevens-Johnson syndrome and toxic epidermal necrolysis.  The Bartletts assert several state law tort claims, including strict product liability (failure to warn and design defect), breach of implied warranty, breach of express warranty, fraud, negligence, and gross negligence.

Mutual filed a Motion for Judgment on the Pleadings arguing that Title I of the Hatch-Waxman Amendments, which, among other things, amended the FDC Act to create the generic drug approval procedures at § 505(j), and various FDA regulations implicitly preempt the Bartletts’ state law claims.  Specifically, the Bartletts argue that:

having obtained FDA approval for their generic version of Sulindac under the ANDA procedure envisioned by Hatch-Waxman, they could not change Sulindac’s design, or the warnings included in the drug’s labeling, without running afoul of federal law (impossibility pre-emption).  They further argue that, even if the FDA could approve such a change, it could come only after “substantial expense to obtain the scientific substantiation necessary to support [it],” frustrating Hatch-Waxman’s goal to “increase the availability of low-cost generic drugs” by opening the ANDA process to them (frustration-of-purpose pre-emption).

To support its position, Mutual points to the “same labeling” requirement in the FDC Act and in FDA’s regulations applicable to generic drug applicants seeking approval of a duplicate of a brand-name drug (arguing that the company could not have changed its  labeling to add or strengthen a warning absent a change by Merck), and FDA’s Changes Being Effected (“CBE”) regulations (which the company argues apply only to NDA-approved drug products).  In particular, Mutual points to a statement FDA included in a footnote in the preamble to the Agency’s proposed CBE regulations (and elsewhere) that “CBE changes are not available for generic drugs approved under an [ANDA].  To the contrary, a generic drug manufacturer is required to conform to the approved labeling for the listed drug.” 

In denying Mutual’s motion, the court, relying on the Supreme Court’s preemption decisions in Wyeth v. Levine and Medtronic, Inc. v. Lohr (and the often quoted statement from the Court that in preemption cases “in which Congress has legislated . . . in a field which the States have traditionally occupied,’ we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.)” ruled that neither the Hatch-Waxman Amendments nor FDA’s regulations explicitly or implicitly preempt the Bartletts’ state law claims.  According to the court:

To fit their claimed predicament into this framework, the defendants would need to show a federal law saying “You may not change your label” to conflict with the state law underlying the Bartletts’ failure-to-warn claims, i.e., “You must change your label.” So the defendants’ assertion that the FDCA does not say one way or the other whether they can change their label is insufficient. [(underline in original)]

It is also incorrect, because . . . the [FDA Modernization Act] allows, “[w]ith respect to a drug for which there is in effect an approved application under section 355 . . . , a change from the manufacturing process approved pursuant to such application.” 21 U.S.C. § 356a(a)(1).  Both NDAs and ANDAs, of course, are approved under section 355. . . . 

Because 21 U.S.C. § 356a expressly authorizes a manufacturer’s changes to an application approved under § 355 of the Act – whether under subsection (b), as in the case of an NDA, or under subsection (j), as in the case of an ANDA – the defendants are incorrect that nothing in the Act permits a manufacturer to change its label post-approval.

And with respect to FDA’s ANDA and CBE regulations, the court stated that:

The FDA’s footnote-bound position that “CBE changes are not available for generic drugs approved under an [ANDA] under 21 U.S.C. § 355(j)” is not persuasive . . . .  First, the footnote did not so much as acknowledge 21 C.F.R. § 314.97 [concerning supplements to approved ANDAs].  Second, while the footnote did cite § 314.150(b)(10), that rule, as already discussed at length, provides only that the FDA may attempt to withdraw its approval of an ANDA if “the labeling for the drug product that is the subject of the [ANDA] is no longer consistent with that for the listed drug”; it says nothing at all about CBE changes, and cannot be read to prevent them in light of the other provisions of the ANDA rules.  Third, while the footnote also cited certain of the agency’s comments in promulgating the ANDA regulations, those comments, as also already discussed at length, do not support excluding generic manufacturers from the CBE process.  Based on these deficiencies, this court joins with those others that have refused to adopt the view set forth in the FDA’s footnote.

As if to provide a perfect transition for us to report on what is happening on Capitol Hill, the district court concluded its opinion noting that it cannot grant Mutual’s motion finding preemption absent “a clear expression of intent” from Congress.  And in fact, Congress is working on providing that “clear expression of intent.” 

Sen. John Cornyn (R-TX) recently filed an amendment to both the Senate Finance Committee’s health reform bill and in the Judiciary Committee to Sen. Herb Kohl's (D-WI) “reverse payment” (S. 369) bill that would preempt tort suits against generic drug makers.  Specifically, Sen. Cornyn’s amendment would amend the law to state:

Notwithstanding any other provision of State or Federal law, a person who manufacturers a generic drug approved under an abbreviated new drug application shall not be liable because the label did not warn against an adverse reaction, unless the Food and Drug Administration required a change to the label to provide such warnings and the manufacturer failed to comply with such requirement, or the manufacturer failed to provide to the Food and Drug Administration health and safety information otherwise required to be provided under regulations issued by the Secretary for Health and Human Services regarding such drug.