In re Darvocet Darvon and Propoxyphene Products Liability Litigation, 062714 FED6, 12-5840
| Opinion Judge | SUHRHEINRICH, Circuit Judge. |
| Party Name | In re: Darvocet, Darvon, and Propoxyphene Products Liability Litigation. v. Teva Pharmaceuticals, USA, Inc., et al., Defendants-Appellees. Yanise Germain, et al., Plaintiffs-Appellants, |
| Attorney | Louis M. Bograd, CENTER FOR CONSTITUTIONAL LITIGATION, P.C., Washington, D.C., for Appellants. Jay P. Lefkowitz, KIRKLAND & ELLIS LLP, Washington, D.C., for Generic Appellees. Henninger S. Bullock, MAYER BROWN LLP, New York, New York, for Brand Appellees. Louis M. Bograd, CENTER FOR CONSTITUTIONA... |
| Judge Panel | Before: SUHRHEINRICH, ROGERS, and SUTTON, Circuit Judges. |
| Case Date | June 27, 2014 |
| Court | United States Courts of Appeals, U.S. Court of Appeals — Sixth Circuit |
Argued: May 7, 2014
Appeal from the United States District Court for the Eastern District of Kentucky at Covington. No: 2:11-md-226—Danny C. Reeves, District Judge.
ARGUED:
ON BRIEF:
OPINION
These appeals arise from a multidistrict litigation action consolidating sixty-eight claims against both generic and brand-name manufacturers for personal injuries related to the use of the drug propoxyphene (brand-name Darvocet or Darvon). Each plaintiff in this appeal (collectively "Plaintiffs") ingested the generic form of the drug (with one exception), and each plaintiff alleges that the manufacturers and sellers of the generic form ("Generic Manufacturers") continued marketing propoxyphene products after they knew or should have known the risks of the drugs exceeded their benefits. Most of the plaintiffs also seek to hold one or more of the manufacturers and sellers of the brand form ("Brand Manufacturers") liable for injuries, alleging that they made misrepresentations about propoxyphene, which led Plaintiffs' physicians to prescribe the generic equivalent of propoxyphene to Plaintiffs. The district court granted the various defendants' motions to dismiss or for judgment on the pleadings and entered final judgment in each case. We affirm the district court entirely, except for its holding regarding the claims in Dickerson, which we reverse and remand for further proceedings.
I. Background
A. Statutory and Regulatory Background
Under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., drug manufacturers must gain approval from the United States Food and Drug Administration ("FDA") before marketing any drug in interstate commerce. § 355(a). A manufacturer seeking approval to market a new drug must submit a New Drug Application ("NDA"), including "full reports of [all clinical] investigations, " § 355(b)(1)(A), relevant nonclinical studies, and "any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source." 21 C.F.R. §§ 314.50(d)(2) and (5)(iv) (2014). An NDA must also include "the labeling proposed to be used for such drug, " 21 U.S.C. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i) and "a discussion of why the [drug's] benefits exceed the risks under the conditions stated in the labeling, " 21 C.F.R. §§ 314.50(d)(5)(viii); 314.50. The FDA may approve an NDA only if it determines that the drug is "safe for use" under "the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." 21 U.S.C. § 355(d). In deeming a drug safe, the FDA makes a judgment that the drug's "expected therapeutic gain justifies the risk entailed by its use." United States v. Rutherford, 442 U.S. 544, 555 (1979).
Originally, the same rules applied to all drugs, including generic drugs, which are designed to be copies of a previously approved "reference listed drug" ("RLD"). Because the process of submitting an NDA is onerous, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the "Hatch-Waxman Act, " to "'make available more low cost generic drugs by establishing a generic drug approval procedure.'" PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2574 (2011) (citing H.R. Rep. No. 98-857, pt. 1, p. 14 (1984)). Under the Hatch-Waxman Act, a generic drug may be approved by an abbreviated new drug application ("ANDA") showing that the drug is equivalent to its RLD and that "the [safety and efficacy] labeling proposed . . . is the same as the labeling approved for the [brand-name] drug." 21 U.S.C. § 355(j)(2)(A)(v).
As a drug is used more widely under diverse conditions, new information regarding the risks and benefits of the drug may become available. All NDA (brand) and ANDA (generic) holders must monitor and review post-marketing adverse drug experience information, from all sources, and comply with FDA post-marketing report requirements. See §§ 355(j)(2)(A)(v); § 355(j)(4)(G); 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7). If significant new adverse information comes to light, the FDA may withdraw approval of the drug, 21 U.S.C. § 355(e), or advise the manufacturer to remove the product from the market. Br. of U.S. as Amicus Curiae Supporting Petitioner ("FDA Br."), Mutual Pharm. Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013) (No. 12-142), 2013 WL 314460, at *5 (U.S. Jan 22, 2013). In other situations, new information changing the risk/benefit profile of the drug may be addressed through labeling changes. Id.
The FDA has created procedures by which manufacturers can make changes to a drug's approved labeling or other changes to an approved application. Drug manufacturers may submit either "Prior Approval Supplements, " which require FDA approval before the proposed change may be implemented, or "Changes Being Effected" ("CBE") Supplements, under which the proposed change may be implemented before the FDA has acted on the supplemental application. 21 C.F.R. § 314.70(b), (c). While most changes to a drug's approved labeling must be requested through a Prior Approval Supplement, manufacturers may "add or strengthen a contraindication, warning, precaution, or adverse reaction" through a CBE supplement. See §§ 314.70(b)(1)(i), § 314.70(c)(6)(iii)(A).
Under current regulations, brand-name and generic manufacturers have different labeling responsibilities, even though both are authorized to use the label supplement procedures. 21 C.F.R. § 314.97. Generic manufacturers are subject to the requirement that their labeling match that of the RLD, Mensing, 131 S.Ct. at 2575, and may invoke the CBE process only "to match an updated brand-name label or to follow the FDA's instructions." Id. As a result, while a brand-name manufacturer is responsible for the accuracy and adequacy of its label, see, e.g., 21 U.S.C. §§ 355(b)(1), (d), a generic manufacturer is responsible for ensuring that its warning label is the same as the brand-name's. See, e.g., §§ 355(j)(2)(A)(v); § 355(j)(4)(G); 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7). This is commonly known as the "duty of sameness."
B. Regulatory History of Propoxyphene
In 1957, the FDA approved propoxyphene for the treatment of mild to moderate pain, under the trade name Darvon, patented and manufactured by Eli Lilly and Company ("Lilly"). In 1972, Lilly obtained FDA approval to market a second product combining propoxyphene with acetaminophen, under the trade name Darvocet. Following passage of the Hatch-Waxman Act in 1984, several companies obtained approval to market generic versions of both Darvon and Darvocet. Lilly sold its NDAs for Darvon and Darvocet to NeoSan in 2002, which in turn sold them to Xanodyne in 2005.
Complaints about perceived risks associated with propoxyphene began in 1978 with a citizen petition by the Health Research Group, and have continued over the ensuing decades, including various clinical and non-clinical studies, post-marketing adverse event data, and the decision of the United Kingdom to withdraw propoxyphene from the market. In 2006, the Health Research Group again petitioned for withdrawal of the drug and presented to two FDA advisory committees. Those committees recommended withdrawing propoxyphene from the market, but the FDA did not follow the advisory committee's...
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