Gaeta v. Perrigo Pharmaceuticals Co.

• Decision Date: 24 January 2011
• Docket Number: No. 09–15001.,09–15001.
• Citation: 630 F.3d 1225
• Parties: Margarita GAETA, as guardian ad litem for A.G., a minor child; Augustine Gaeta, Plaintiffs–Appellants,v.PERRIGO PHARMACEUTICALS COMPANY; BASF Corporation, Defendants–Appellees.
• Court: U.S. Court of Appeals — Ninth Circuit

630 F.3d 1225

11 Cal. Daily Op. Serv. 987

2011 Daily Journal D.A.R. 1269

Margarita GAETA, as guardian ad litem for A.G., a minor child; Augustine Gaeta, Plaintiffs–Appellants,

v.PERRIGO PHARMACEUTICALS COMPANY; BASF Corporation, Defendants–Appellees.

No. 09–15001.

United States Court of Appeals, Ninth Circuit.

Argued and Submitted Oct. 6, 2010.Filed Jan. 24, 2011.

Brian D. Witzer and Rowena J. Dizon of Law Offices of Brian D. Witzer, Inc., West Hollywood, CA, for the plaintiffs-appellants.

Michael F. Healy and Kelly S. Day of Sedgwick, Detert, Moran & Arnold LLP, San Francisco, CA, for the defendants-appellees.Appeal from the United States District Court for the Northern District of California, James Ware, District Judge, Presiding. D.C. No. 5:05–cv–04115–JW.Before: DAVID R. THOMPSON, FERDINAND F. FERNANDEZ and BARRY G. SILVERMAN, Circuit Judges.

OPINION

THOMPSON, Senior Circuit Judge:

Plaintiffs-appellants Margaret Gaeta, as guardian ad litem for A.G., a minor child, and Augustine Gaeta (collectively, “the Gaetas”) appeal the district court's grant of summary judgment in favor of Perrigo Pharmaceutical Company. The district court determined that the Gaetas' state law failure-to-warn claims against Perrigo, a manufacturer of a generic version of ibuprofen, were preempted under federal law. Subsequently, the Supreme Court decided Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), and determined that state law failure-to-warn claims against brand name manufacturers were not preempted by federal law. The district court, however, denied the Gaetas' motion for reconsideration, concluding that Levine does not govern whether federal law preempts similar claims against generic manufacturers.

Since then, two Courts of Appeals and all of the district courts to consider the issue have held otherwise, using the rationale underlying Levine to find that federal law does not preempt state law failure-to-warn claims against generic manufacturers, provided there is no “clear evidence” that the FDA would not have approved the proposed stronger warning. We agree and hold that the district court erred in applying federal preemption. Accordingly, we reverse and remand.

I

On June 3, 2004, A.G. had two benign moles removed in a surgical procedure. During the procedure, A.G. received Halothane, an anesthetic known to be “hepatotoxic”—that is, to cause liver failure in certain circumstances. After the surgery, A.G. was discharged with a prescription for ibuprofen and instructions to take one 400mg tablet once every six hours as needed for pain. Instead, A.G.'s parents purchased Perrigo's generic over-the-counter (“OTC”) ibuprofen at 200mg per tablet. For the next four days, A.G. took 400mg of the generic ibuprofen every six to eight hours.

On June 11, 2004, A.G. developed a fever and was seen by his pediatrician, who prescribed prescription-strength ibuprofen (400mg). However, A.G.'s condition continued to worsen, and on June 13, 2004, he was referred to the emergency room with a diagnosis of septic shock, dehydration, and liver failure. He was later transferred to Stanford University Hospital for a liver transplant, which took place on June 15, 2004. A.G. also developed other complications, and he eventually required amputation of necrotic tissue on his fingers and toes.

The Gaetas filed suit against Perrigo and several other manufacturers of generic ibuprofen, alleging defective design, defective marketing, breach of express and implied warranty, negligence and gross negligence, and deceit by concealment.¹ Prevalent in all of the Gaetas' claims is the allegation that the generic manufacturers failed to warn prescribing physicians and consumers of the increased risk of acute liver injury and renal (i.e., kidney) failure when ibuprofen is taken concurrently with other drugs known to be hepatotoxic.

Perrigo moved for summary judgment on preemption grounds, arguing that the Gaetas' state law failure-to-warn claims conflicted with FDA regulations relating to the labeling and marketing of generic drugs. The district court agreed, and concluded that the Gaetas' claims were preempted because a generic manufacturer could not comply with the heightened state law warning requirements without running afoul of the FDA regulations requiring generic drug labels to conform to the approved labeling for brand name drugs. The district court granted summary judgment in favor of Perrigo, and the Gaetas appealed.

The Supreme Court subsequently decided Levine, 555 U.S. 555, 129 S.Ct. 1187. In light of Levine, the Gaetas obtained a limited remand from this court to allow the district court to consider a post-judgment motion for reconsideration. The district court, however, denied the motion for reconsideration, concluding that the Court's holding in Levine that the FDA regulations do not preempt state tort law claims for inadequate labeling against brand name manufacturers does not govern whether the FDA regulations preempt similar claims against generic manufacturers.

II

We review de novo an order granting summary judgment. Lopez v. Smith, 203 F.3d 1122, 1131 (9th Cir.2000) (en banc). We must determine “whether, viewing the evidence in the light most favorable to the nonmoving party, there are any genuine issues of material fact and whether the district court correctly applied the relevant substantive law.” Id. (citation omitted).

III

This appeal presents an issue of first impression for our court. We must determine what effect, if any, the Supreme Court's decision in Levine has on the question whether applicable FDA regulations preempt state tort law claims for inadequate labeling against generic—as opposed to brand name—manufacturers. In resolving this question, we consider a brief history of federal drug regulation and labeling.

A. The FDA's Regulation of Drugs

In the 1930's, Congress became “increasingly concerned about unsafe drugs and fraudulent marketing,” Levine, 129 S.Ct. at 1195, and enacted the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 21 U.S.C. § 301 et seq. The FDCA required every manufacturer to submit a new drug application (“NDA”), including reports of investigations and specimens of proposed labeling, to the FDA before any new drug could be marketed and sold to the public. 21 U.S.C. § 355(b). In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Levine, 129 S.Ct. at 1195. These amendments, which are still in effect, require the manufacturer to demonstrate that its drug is “safe” and “effective” before the drug can be distributed. Id.; see also 21 U.S.C. § 355(b). Once the drug covered by the NDA is approved for safety and effectiveness, that drug—also referred to as the “listed drug”—may be sold to consumers under the NDA holder's brand name.

A less demanding approval process applies to manufacturers seeking to market generic drugs. In 1984, Congress passed the Hatch–Waxman Amendments to the FDCA, which provided that once a brand name drug's NDA is approved and the drug is officially listed by the FDA, any manufacturer may seek permission to market a generic version of that drug by submitting an abbreviated NDA (“ANDA”). See Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98–417, 98 Stat. 1585 (1984). Under the Hatch–Waxman Amendments, generic manufacturers need not repeat the clinical work of their brand name counterparts, but rather must establish that except for enumerated differences irrelevant here, their drug is the “same as” the brand name drug that has already been approved by the FDA as to active ingredients, route of administration, dosage form, strength, and conditions of recommended use specified on the label. 21 U.S.C. § 355(j)(2)(A). By avoiding unnecessary duplication of previously-performed clinical trials, Congress sought to accelerate the availability of low-cost drugs, thereby resulting in significant cost savings to the American public.²

ANDA applicants must also show that the labeling proposed for a new generic drug is the “same as” the labeling approved for the listed drug. 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G). At any time after a new generic drug is approved, the FDA reserves the right to withdraw approval if it determines that the generic drug's labeling is “no longer consistent” with that of the listed drug. 21 C.F.R. § 314.150(b)(10). Moreover, the FDCA prohibits all manufacturers from distributing a “misbranded” drug, 21 U.S.C. § 331(a)-(b), including a drug whose “labeling is false or misleading in any particular.” See 21 U.S.C. § 352(a). The FDA has enforcement mechanisms to ensure that drugs with misleading labels are taken off the market. See 21 U.S.C. §§ 333, 355(e).

B. The Supreme Court's Decision in Wyeth v. Levine

In Levine, the plaintiff, Diana Levine, brought suit against a drug manufacturer, Wyeth, when she developed gangrene after receiving an IV-push injection of Phenergan, Wyeth's brand name for an antihistamine used to treat nausea. 129 S.Ct. at 1191. Levine asserted state tort law claims against Wyeth alleging that Phenergan's labeling was defective because, although it warned of the danger of gangrene and amputation following inadvertent intra-arterial injection, the label failed to warn against the use of the IV-push method for administering the drug, which posed a higher risk than the IV-drip method. Id. at 1191–92.

The Supreme Court upheld the trial court's refusal to overturn on preemption grounds the jury's verdict in favor of Levine. Id. at 1204.

Wyeth contended it would have been impossible for it to comply with the state-law duty to modify Phenergan's labeling without violating federal law. Id. at 1196. The Court rejected this argument, concluding that because FDA regulations permit drug manufacturers to make certain changes to their labels without prior FDA approval, Wyeth could have met its state-law obligation to provide additional warnings without violating FDA...