Source: https://www.fdalawblog.net/2009/10/another-court-rules-against-preemption-in-generic-drug-case-cornyn-preemption-amendment-would-shield/
Timestamp: 2019-04-26 11:57:32+00:00

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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.
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).
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.
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.
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.

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