Garcia v. Wyeth-Ayerst Laboratories

• Decision Date: 19 May 2003
• Docket Number: No. 01-10002-BC.,01-10002-BC.
• Parties: Julia GARCIA, Plaintiff, v. WYETH-AYERST LABORATORIES, Defendant.
• Court: U.S. District Court — Eastern District of Michigan

265 F.Supp.2d 825

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

No. 01-10002-BC.

United States District Court, E.D. Michigan, Northern Division.

May 19, 2003.

COPYRIGHT MATERIAL OMITTED

Richard B. Worsham, Worsham, Victor, Southfield, MI, for plaintiff.

Scott L. Gorland, Michelle M. Lund, Pepper Hamilton, Detroit, MI, for defendant.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT AND DENYING PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT

LAWSON, District Judge.

Before the Court are cross-motions for summary judgment by the parties in this drug products liability case, together with the magistrate judge's Report and Recommendation and the parties' objections to it. For reasons explained in detail below, the Court will reject the magistrate judge's Report and Recommendation, grant the defendant's motion for summary judgment, and dismiss the case.

I.

Julia Garcia, the plaintiff, was thirty-nine years old in September 1997 when she was treating with Dr. Alexander Iwanow for persistent pain in her neck and shoulders. To alleviate her pain, Dr. Iwanow gave her a prescription for Duract, a non-steroidal, anti-inflammatory medication manufactured by the defendant, Wyeth-Ayerst Laboratories, which had been approved for use earlier that year by the United States Food and Drug Administration (FDA). The drug destroyed Julia Garcia's liver; she was required to undergo a liver transplant in 1998 to save her life. Ms. Garcia has sued Wyeth for making and selling an unsafe drug, and she seeks compensation for her injury, including past and future medical expenses, which likely will involve another liver transplant. Wyeth has since voluntarily withdrawn the drug from the market.

Michigan law governs this diversity action. Michigan has a drug products liability statute that immunizes drug manufacturers from liability for damages in suits contending that their drug was defective or unreasonably dangerous "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 manufacturer or seller." Mich. Comp. Laws § 600.2946(5). However, the immunity does not attach if the manufacturer intentionally withholds from or misrepresents material information to the FDA, or bribes an FDA official or employee in order to secure approval of the drug. See id., § 600.2946(5)(a) & (b). Likewise, the immunity statute does not apply if the offending drug was sold after the FDA withdrew approval or ordered the drug removed from the market. See id., § 600.2946(5).

The Michigan Court of Appeals held that this statute was repugnant to the Michigan constitution in the case of Taylor v. Gate Pharmaceuticals, 248 MichApp. 472, 639 N.W.2d 45 (2001), because the statute impermissibly delegated legislative authority to the FDA as the final arbiter of drug safety in Michigan. However, the state supreme court overturned that ruling and held 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. See Taylor v. Smithkline Beecham Corp., ___ Mich. ___, ___, 658 N.W.2d 127,134 (2003).

In this case, Wyeth has moved for summary judgment, claiming the protection of the statute's immunity provision. The plaintiff has moved for partial summary judgment seeking a declaration that the statute is unconstitutional. The state supreme court's determination upholding the statute's constitutionality was made solely on the basis of Michigan's constitution. Since diversity jurisdiction is the source of this Court's authority to adjudicate the dispute, under the rule of Erie R.R. v Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938), state law, as determined by the state's highest court, furnishes the substantive rules for decision. See also Garden City Osteopathic Hosp. v. HBE Corp., 55 F.3d 1126, 1130 (6th Cir.1995); Angelotta v. American Broad, Corp., 820 F.2d 806, 807 (6th Cir.1987). However, the plaintiff claims that the statute violates the federal constitution, a determination that is not influenced by the state court holdings. See Barden Detroit Casino, L.L.C. v. City of Detroit, 230 F.3d 848 (6th Cir.2000) (affirming dismissal of a challenge to a Michigan statute on federal constitutional grounds).

The Court has twice referred the motions to the magistrate judge for a Report and Recommendation on the plaintiffs motion challenging the constitutionality of the statute on federal constitutional grounds. Both times, the magistrate judge made reports and recommendations based on Michigan state law and failed to address the plaintiffs issues under federal law. The magistrate judge initially recommended that the plaintiffs motion be held in abeyance and the case be stayed pending the certification of a question to the Michigan Supreme Court on the constitutionality of the statute under the state constitution. This Court rejected the Report and Recommendation and instructed the magistrate judge to promptly proceed to decide the federal issues, and to notify the Michigan Attorney General in accordance with 28 U.S.C. § 2403(b) that the state statute was challenged under the United States Constitution. On July 2, 2002, the magistrate judge issued a second report on the plaintiffs motion recommending the motion be granted based on the premise that the Michigan Court of Appeals had held the statute unconstitutional, once again under state law. Both recommendations were made without the benefit of the state supreme court's latest decision upholding the statute under state constitutional law in Taylor, and neither report addressed the federal issues. The second report, premised upon the state intermediate appellate court decision, will be rejected.

The Court proceeds now to a de novo review of the motions for summary judgment, focusing on the issues raised by the parties, particularly the plaintiffs contention that the statute violates the Constitution and laws of the United States.

II.

The plaintiff argues that Mich. Comp. Laws § 600.2946(5) is unconstitutional because it has been impliedly preempted by the federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq., and therefore runs afoul of the Supremacy Clause; it interferes with the plaintiffs fundamental right of access to the courts and her Seventh Amendment right to a jury trial; and 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.

A.

As an initial matter, the Court turns to a claim in the complaint that the statute is inapplicable to the defendant. The plaintiff alleged in her complaint that Wyeth intentionally misrepresented material information and made illegal payments to the FDA during the drug approval process. Compl. ¶¶ 14-17. If that is true, the defendant cannot claim protection from the statute's immunity from liability according to the statute's own terms. However, the defendant contends that the plaintiff has not come forward with any evidence supporting these allegations.

A motion for summary judgment under Federal Rule Civil Procedure 56 presumes the absence of a genuine issue of material fact for trial. The Court must view the evidence and draw all reasonable inferences in favor of the non-moving party, and determine "whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251-52, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). When the "record taken as a whole could not lead a rational trier of fact to find for the nonmoving party," there is no genuine issue of material fact. Simmons-Harris v. Zelman, 234 F.3d 945, 951 (6th Cir.2000).

The party bringing the summary judgment motion has the initial burden of informing the district court of the basis for its motion and identifying portions of the record which demonstrate the absence of a genuine dispute over material facts. Mt. Lebanon Pers. Care Home, Inc. v. Hoover Universal, Inc., 276 F.3d 845, 848 (6th Cir.2002). The party opposing the motion then may not "rely on the hope that the trier of fact will disbelieve the movant's denial of a disputed fact" but must make an affirmative showing with proper evidence in order to defeat the motion. Street v. J.C. Bradford & Co., 886 F.2d 1472, 1479 (6th Cir.1989). A party opposing a motion for summary judgment must designate specific facts in affidavits, depositions, or other factual material showing "evidence on which the jury could reasonably find for the plaintiff." Anderson, 477 U.S. at 252, 106 S.Ct. 2505. If the nonmoving party, after sufficient opportunity for discovery, is unable to meet his or her burden of proof, summary judgment is clearly proper. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

The party who bears the burden of proof must present a jury question as to each element of the claim. Davis v. McCourt, 226 F.3d 506, 511 (6th Cir.2000). Failure to prove an essential element of a claim renders all other facts immaterial for summary judgment purposes. Elvis Presley Enters., Inc. v. Elmsly Yours, Inc., 936 F.2d 889, 895 (6th Cir.1991).

The plaintiff has not offered any evidence supporting its claims of bribery and misrepresentation. In fact, it appears that those claims have been abandoned. Although Duract was withdrawn from the market, the plaintiff has not offered any evidence that this action was precipitated by the FDA or based on any provable misconduct by Wyeth. Moreover, there is no factual dispute that Duract was approved by the FDA before it was prescribed to Julia...