Garcia v. Wyeth-Ayerst Laboratories

• Decision Date: 07 October 2004
• Docket Number: No. 03-1712.,03-1712.
• Parties: Julia GARCIA, Plaintiff-Appellant, v. WYETH-AYERST LABORATORIES, Defendant-Appellee.
• Court: U.S. Court of Appeals — Sixth Circuit

385 F.3d 961

Julia GARCIA, Plaintiff-Appellant, v. WYETH-AYERST LABORATORIES, Defendant-Appellee.

No. 03-1712.

United States Court of Appeals, Sixth Circuit.

Argued: August 5, 2004.

Decided and Filed: October 7, 2004.

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Appeal from the United States District Court for the Eastern District of Michigan, David M. Lawson, J.

John J. Schutza (argued), Richard B. Worsham (briefed), Worsham & Victor, Southfield, MI, for Appellant.

Shana J. Long (argued and briefed), Michael L. Koon (briefed), Shook, Hardy & Bacon, Kansas City, MO, Scott L. Gorland (briefed), Pepper Hamilton, Detroit, MI, for Appellee.

Before: KENNEDY, SUTTON, and COOK, Circuit Judges.

KENNEDY, Circuit Judge.

Plaintiff Julia Garcia appeals the district court order granting summary judgment to Defendant Wyeth-Ayerst Laboratories in this drug product liability case on the basis of a statutory immunity provided in Mich. Comp. Laws § 600.2946(5). Plaintiff argues that the district court erred in failing to declare the statute unconstitutional on the grounds that (1) it has been impliedly preempted by the federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq., in violation of the Supremacy Clause, (2) it has interfered with her fundamental right of access to the courts and her Seventh Amendment right to a jury trial, and (3) it violated the Due Process Clause by depriving her of the right to use a traditional common law tort remedy as a means of seeking redress for her injuries. Finding no error in the district court's decision, we affirm.

BACKGROUND

In September of 1997, Plaintiff was treated for persistent pain in her neck and shoulders by her physician. To alleviate her pain, her physician gave her multiple prescriptions for Duract, a non-steroidal, anti-inflammatory prescription medication manufactured by Defendant. The medication had been approved for use earlier that year by the United States Food and Drug Administration ("FDA"). The medication, however, caused liver failure and Plaintiff was required to undergo a liver transplant in 1998 to save her life. Plaintiff sued Defendant for making and selling an unsafe drug, and she seeks compensation for her injury, reimbursement for past medical expenses, and future medical expenses including a likely additional liver transplant. Defendant has since voluntarily withdrawn the drug from the market. The district court granted Defendant's motion for summary judgment and dismissed the case on the basis of Michigan's products liability statute that immunizes drug manufacturers from liability under certain conditions. The present appeal followed.

ANALYSIS

Michigan law governs this diversity action. Westfield Ins. Co. v. Tech Dry, Inc., 336 F.3d 503, 506 (6th Cir.2003). The State of Michigan has adopted a drug products liability statute that immunizes drug manufacturers from liability from damages in suits contending that their drug was defective or unreasonably dangerous "if the drug was approved for safety and efficacy by [the FDA], and the drug and labeling were in compliance with [the FDA's] approval at the time the drug left the control of the manufacturer or seller." Mich. Comp. Laws § 600.2946(5). The immunity is subject to two exceptions: (1) if the manufacturer intentionally withheld or misrepresented material information concerning the drug that it is required to be submitted under the Food and Drug Cosmetics Act and the drug would not have been approved, or the FDA would have withdrawn approval if the information was accurately submitted to the FDA, or if the manufacturer bribed an FDA official or employee to secure the drug's approval, Mich. Comp. Laws § 600.2946(5)(a) & (b); and (2) if the offending drug was sold after the FDA withdrew approval or ordered the drug removed from the market, id.

In prior unrelated litigation, the Michigan Court of Appeals had held that this statute was repugnant to the Michigan Constitution because it impermissibly delegated legislative authority to the FDA as the final arbiter of drug safety in Michigan. Taylor v. Gate Pharms., 248 Mich.App. 472, 639 N.W.2d 45 (2001). The Michigan Supreme Court overturned that ruling holding that:

MCL 600.2946(5) is a statute that refers to factual conclusions of independent significance, i.e., the FDA conclusion regarding the safety and efficacy of a drug, that once made causes, at the Michigan Legislature's direction, Michigan courts to find as a matter of law that the manufacturer or seller acted with due care.

Taylor v. Smithkline Beecham Corp., 468 Mich. 1, 658 N.W.2d 127, 134 (2003). It concluded that the statute's linking of dangerousness to the FDA's complex and detailed approval process is nothing more than an incorporation of common standards, such as weights and measures or the time of day, which are also determined by federal agencies. According to the Michigan Supreme Court, therefore, the statute is valid under the Michigan Constitution. Plaintiff in this case, however, challenges the applicable statute under the federal constitution. As the district court properly noted, a federal court evaluating the statute's validity under the federal constitution is not bound by a state court's evaluation of the same statute under the state constitution. Garcia v. Wyeth-Ayerst Labs., 265 F.Supp.2d 825, 2003 WL 21246424, slip op. at 3 (E.D.Mich. May 19, 2003) (citing Barden Detroit Casino, L.L.C. v. City of Detroit, 230 F.3d 848 (6th Cir.2000)). Before the district court, Plaintiff argued that the Michigan statute is unconstitutional because (1) it had been impliedly preempted by the FDCA and therefore runs afoul of the Supremacy Clause, (2) it interferes with Plaintiff's fundamental right of access to the courts and her Seventh Amendment right to a jury trial, and (3) it violates the Due Process Clause by depriving her of the right to use a traditional common law tort remedy as a means of seeking redress for her injuries.¹ For the reasons stated below, we agree with the district court that Plaintiff's arguments are without merit.

A. Implied Preemption

Plaintiff argued before the district court that Section 600.2946(5) conflicts with and is impliedly preempted by federal law because it requires one to prove fraud on the FDA as part of her cause of action against Defendant. She cannot prove fraud on the FDA because such claims are preempted by federal law and, thus, cannot bring herself within the exceptions. The district court agreed with Plaintiff that the fraud-on-the-FDA exception to the general statutory immunity was preempted by federal law but held that it could sever the offending exception and uphold the general statutory immunity in light of an explicit severability provision in Mich. Comp. Laws § 8.5.

In general, a federal law may preempt a state law in any of the following three scenarios. First, a federal statute may expressly preempt the state law. Gibson v. Am. Bankers Ins. Co., 289 F.3d 943, 948 (6th Cir.2002). Second, a federal law may impliedly preempt a state law. Id. at 948-49. Third, preemption results from an actual conflict between a federal and a state law. Id. at 949. Since neither express preemption nor an actual conflict is present in this case, we are concerned solely with the question of implied preemption. As this Court has explained:

Implied preemption occurs if a scheme of federal regulation is so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it, if the Act of Congress touches a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject, or if the goals sought to be obtained and the obligation imposed reveal a purpose to preclude state authority.

Id. (citations omitted). As the district court properly noted, in "analyzing implied preemption, a court must begin with the assumption that a state law is valid and should be reluctant to resort to the Supremacy Clause." Garcia v. Wyeth-Ayerst Labs., 265 F.Supp.2d 825, 2003 WL 21246424, slip op. at 7 (E.D.Mich. May 19, 2003) (citations omitted).

The United States Supreme Court has expressly considered the question of a state common law fraud-on-the-FDA tort claim and found that it was impliedly preempted by the FDCA and the Medical Device Act ("MDA"), 21 U.S.C. §§ 360e(b)(1)(A) & (B). Buckman Co. v. Pls.' Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (explaining that "[s]tate-law fraud-on-the-FDA claims inevitably conflict with the FDA's responsibility to police fraud consistently with the Agency's judgment and objectives.") This case, however, presents a somewhat different legal regime from the one invalidated in Buckman. The Michigan legislature has provided a general immunity for drug manufacturers with a specific exception for circumstances involving, inter alia, fraud on the FDA² rather than a specific cause of action for fraud on the FDA. This difference, however, is immaterial in light of Buckman. As the district court properly found, "Buckman teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since federal law preempts such claims." Garcia v. Wyeth-Ayerst Labs., 265 F.Supp.2d 825, 2003 WL 21246424, slip op. at 8 (E.D.Mich. May 19, 2003).

Having concluded that M.C.L. § 600.2946(5)(a) and (b) were unconstitutional, the district court had to consider what effect that conclusion had on the rest of M.C.L. § 600.2946(5). It is unclear whether the district court concluded that the offending subsections can simply be severed from the rest of the section, giving drug manufacturers a full immunity from state-law lawsuits in the State of Michigan as long as they complied with the FDA's requirements and the drug had been approved by the FDA, or whether it concluded that in view of the preemption "the exceptions can only be triggered by a finding by the FDA that a drug manufacturer...