Marsh v. Genentech, Inc.

• Decision Date: 12 October 2012
• Docket Number: 11–2385,11–2417,Nos. 11–2373,11–2419.,s. 11–2373
• Citation: 693 F.3d 546
• Parties: Vicki MARSH, The Estate of Shay Blair, by personal representative Trisharla Brown, David Tiefenthal, and The Estate of Eddie A. Muniz, by personal representative Sheila Muniz, Plaintiffs–Appellants, v. GENENTECH, INC. and Xoma (U.S.) LLC, Defendants–Appellees.
• Court: U.S. Court of Appeals — Sixth Circuit

693 F.3d 546

Vicki MARSH, The Estate of Shay Blair, by personal representative Trisharla Brown, David Tiefenthal, and The Estate of Eddie A. Muniz, by personal representative Sheila Muniz, Plaintiffs–Appellants,

v.GENENTECH, INC. and Xoma (U.S.) LLC, Defendants–Appellees.

Nos. 11–2373, 11–2385, 11–2417, 11–2419.

United States Court of Appeals,Sixth Circuit.

Argued: July 20, 2012.

Decided and Filed: Sept. 6, 2012.

Rehearing and Rehearing En Banc Denied Oct. 12, 2012.

ARGUED:Alyson Oliver, Kresch Oliver PLLC, Southfield, Michigan, for Appellants. Richmond T. Moore, Williams & Connolly LLP, Washington, D.C., for Appellees. ON BRIEF:Alyson Oliver, Kresch Oliver PLLC, Southfield, Michigan, for Appellants. Richmond T. Moore, Jennifer N. Wimsatt Pusateri, Williams & Connolly LLP, Washington, D.C., for Appellees.

Before: SILER and MOORE, Circuit Judges; VAN TATENHOVE, District Judge.^*

OPINION

KAREN NELSON MOORE, Circuit Judge.

Vicki Marsh, Shay Blair, David Tiefenthal, and the Estate of Eddie Muniz (collectively, “Marsh”), the plaintiffs in these consolidated products-liability actions, brought suit against drug manufacturers Genentech, Inc. and Xoma (U.S.) LLC (collectively, “Genentech”) to recover for injuries allegedly sustained from use of the psoriasis medication Raptiva. The district court granted Genentech's motion to dismiss, holding that Genentech was entitled to immunity under the Michigan Products Liability Act (the Act) and that Marsh's claim that immunity did not apply was preempted by federal law. Because the allegations underlying Marsh's argument that immunity does not apply are essentially the type of claim that Supreme Court and Sixth Circuit precedent holds is preempted, we AFFIRM.

I. BACKGROUND

Genentech designed, manufactured, and sold the psoriasis medication Raptiva, which was approved by the federal Food and Drug Administration (“FDA”) in 2003 and sold in the United States from 2003 until 2009. Raptiva works by suppressing T-cells to prevent them from migrating to the skin and causing psoriasis. Because T-cells help fight infections, however, their suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, in patients treated with Raptiva, Genentech voluntarily removed Raptiva from the market in 2009.

Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung; she attributes these conditions to her use of Raptiva.¹ She brought suit against Genentech in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She contends that, both prior to and after FDA approval of Raptiva, Genentech knew of dangerous side effects that it concealed from the public and did not include in the drug's label. Marsh also alleged that Genentech “intentionally and negligently failed to update statement of contraindications, warnings, precautions, and adverse reactions that Defendant affirmatively knew about” and “intentionally and negligently failed to comply with various but not limited to, 21 CFR 201, 21 CFR 202, 21 CFR 314.80, and 21 CFR 314.81.” R.1 (Marsh Complaint) at ¶¶ 110–111 (Page ID # 27).²

Following a transfer of venue, Genentech moved to dismiss on the grounds that it was immune from suit under the state Act, which provides that drug manufacturers are not liable in products-liability actions if the allegedly dangerous drug and its label were approved by the FDA and were in compliance with the FDA's approval at the time that the drug left the manufacturer's control. SeeMich. Comp. Laws § 600.2946(5). Marsh countered that Genentech was not entitled to immunity because it failed to submit updated safety information to the FDA after Raptiva had gone to market or otherwise comply with various FDA regulations regarding post-marketing reporting, which was a condition of FDA approval.

The district court granted Genentech's motion to dismiss, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers—that the manufacturer had defrauded or bribed the FDA—applied. Citing our decision in Garcia v. Wyeth–Ayerst Laboratories, 385 F.3d 961 (6th Cir.2004), the district court explained that federal law preempts tort claims premised on the Act's exceptions absent a finding by the FDA itself that the manufacturer had committed fraud or bribery. The district court concluded that, because Marsh had not alleged that the FDA had found that Genentech committed fraud, her claim was preempted. The district court subsequently denied Marsh's motion for reconsideration. Marsh timely appealed.

On appeal, Marsh again contends that immunity does not apply because Genentech's failure to submit updated safety information rendered Raptiva non-compliant with the FDA's approval at the time it left Genentech's control. Because her claim is premised on non-compliance rather than the fraud exception, she argues that it is not preempted under Garcia. In addition, she characterizes this suit as the type of state-law tort claim that the Supreme Court held was not preempted in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Finally, Marsh argues that immunity is an affirmative defense and thus that the district court erred by not requiring Genentech to prove Raptiva's compliance with the FDA's approval after Marsh alleged non-compliance in the complaint.

In response, Genentech characterizes failure to submit safety update reports as a species of fraud that falls within the Act's first exception and is thus preempted absent a finding of fraud by the FDA. Alternatively, Genentech argues that Marsh's claim is preempted under Garcia regardless of how it is characterized.

II. JURISDICTION AND STANDARD OF REVIEW

We have jurisdiction over this diversity action pursuant to 28 U.S.C. § 1332. Both parties agree that Michigan law applies. We review the district court's grant of Genentech's motion to dismiss de novo. Brown v. Cassens Transp. Co., 675 F.3d 946, 953 (6th Cir.2012).

III. ANALYSIS

A. Implied Preemption and Michigan Products–Liability Law

Michigan's products-liability regime is statutory. A drug manufacturer or seller is not liable for injuries caused by the use of its products “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller.” Mich. Comp. Laws § 600.2946(5). As a matter of law, “a drug is not defective or unreasonably dangerous” if such criteria are met. Id. Statutory immunity does not apply, however, if the manufacturer or seller:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343–2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

or

(a) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.

Id. The Michigan Supreme Court has described the Act's immunity provision as “an absolute defense to a products liability claim” premised on the determination that “compliance with federal governmental standards (established by the FDA) is conclusive on the issue of due care for drugs.” Taylor v. Smithkline Beecham Corp., 468 Mich. 1, 658 N.W.2d 127, 130–31 (2003).

In Garcia, 385 F.3d at 965–66, we held that federal law impliedly preempts the Act's two exceptions.³ In so holding, we relied on Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), in which the Supreme Court held that the federal Food, Drug, and Cosmetic Act (“FDCA”) impliedly preempts state-law fraud-on-the-FDA claims.⁴

The plaintiffs in Buckman brought suit against a medical-device manufacturer under state law, alleging that the manufacturer had made fraudulent representations to the FDA in the course of the approval process and that, as a result, the device was improperly placed on the market. 531 U.S. at 346–47, 121 S.Ct. 1012. The Court held that such claims are preempted because they interfere with the federal regulatory scheme for the approval of drugs and medical devices, id. at 348–50, 121 S.Ct. 1012, and because they implicate the “inherently federal” issue of “the relationship between a federal agency and the entity it regulates,” id. at 347, 121 S.Ct. 1012. Indeed, because “[p]olicing fraud against federal agencies is hardly ‘a field which the States have traditionally occupied,’ ” the traditional presumption against preemption did not apply. Id. (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947)).

The FDCA sets forth a “comprehensive scheme” of disclosure requirements as part of the approval process. Id. at 348, 121 S.Ct. 1012. Along with these requirements, the FDCA empowers the FDA to investigate and penalize fraud in a manufacturer's disclosures or elsewhere in the approval process. Id. at 348–49, 121 S.Ct. 1012. The Court viewed these provisions of the FDCA as evidence that Congress intended exclusively federal enforcement. Id. at 352, 121 S.Ct. 1012. State-law fraud-on-the-FDA claims would thus “inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives” by allowing state courts to rule on the adequacy of a manufacturer's disclosures. Id. at 350, 121 S.Ct....