Desiano v. Warner-Lambert & Co.

467 F.3d 85, 2006 U.S. App. LEXIS 25108, 2006 WL 2846454
CourtCourt of Appeals for the Second Circuit
DecidedOctober 5, 2006
DocketDocket Nos. 05-1705-cv(L), 05-1743-cv(CON), 05-1745-cv(CON)
StatusPublished
Cited by143 cases

This text of 467 F.3d 85 (Desiano v. Warner-Lambert & Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Second Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Desiano v. Warner-Lambert & Co., 467 F.3d 85, 2006 U.S. App. LEXIS 25108, 2006 WL 2846454 (2d Cir. 2006).

Opinion

CALABRESI, Circuit Judge:

It has long fallen within the province of states to safeguard the health and safety of their citizens. See Medtronic v. Lohr, 518 U.S. 470, 475, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Consonant with the “historic primacy of state regulation” of these matters, see Medtronic, 518 U.S. at 485, 116 S.Ct. 2240, the power of states to govern in this field is considerable and undisputed. See Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756, 105 S.Ct. 2380, 85 L.Ed.2d 728 (1985) (“The States traditionally have had great latitude under their police powers to legislate as ‘to the protection of the lives, limbs, health, comfort, and quiet of all persons.’ ”) (quoting Slaughter-House Cases, 83 U.S. 36, 16 Wall. 36, 62, 21 L.Ed. 394 (1873); Thorpe v. Rutland & Burlington R. Co., 27 Vt. 140, 149 (1854)). Historically, common law liability has formed the bedrock of state regulation, and common law tort claims have been described as “a critical component of the States’ traditional ability to protect the health and safety of their citizens.” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 544, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (Blackmun, J., concurring in part and dissenting in part). In recent years, some states, in exercising their traditional authority with respect to the pharmaceutical industry, have narrowed common law liability in order to insulate drug companies from burdensome litigation. See generally David G. Owen, Special Defenses in Modern Products Liability Law, 70 Mo. L.Rev. 1, 22-23 (2005). The case before us concerns a supposed conflict between federal law and the products liability regime of one such state.

In 1995, the State of Michigan enacted legislation immunizing drugmakers from products liability claims so long as the [87]*87Food and Drug Administration (“FDA”) approved the pharmaceutical product at issue. See Mich. Comp. Laws § 600.2946(5) (hereinafter “M.C.L. § 2946(5)”). Michigan’s immunity scheme contains an exception that preserves liability if the pharmaceutical company withheld or misrepresented information that would have altered the FDA’s decision to approve the drug. In 2001, in a case dealing with different legal rules and a different jurisdiction, the Supreme Court held that state “fraud-on-the-FDA” claims were impliedly preempted by federal law. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). The question presented by this appeal is whether, under the rationale of Buckman, federal law also preempts traditional common law claims that survive a state’s legislative narrowing of common law liability through a fraud exception to that statutory limitation. For the reasons below, we conclude that federal law does not preempt these state claims. We therefore vacate the District Court’s grant of judgment on the pleadings and remand the case for further proceedings consistent with this opinion.

BACKGROUND

A. Michigan’s Immunity Statute

Prior to its amendment in 1995, Michigan’s products liability statute provided that “evidence showing compliance with governmental or industry standards was admissible in a products liability action in determining if the standard of care had been met.” Taylor v. Smithkline Beecham Corp., 468 Mich. 1, 658 N.W.2d 127, 130 (2003). In describing the pre-amendment law, the Supreme Court of Michigan emphasized the limits on the probative value of this sort of evidence of compliance:

We note that our Legislature has recently enacted a statute which provides that industrial and governmental standards are admissible in products liability actions [citing earlier version of M.C.L. § 600.2946]. The statute does not provide that such standards are conclusive. [We affirm the position] that compliance with governmental and industrial standards is admissible as evidence but is not conclusive as to whether the defendant was negligent or the product was defective.

Owens v. Allis-Chalmers Corp., 414 Mich. 413, 326 N.W.2d 372, 375-76 (1982).

In 1995, Michigan’s legislature amended the law in order to confer immunity upon drugmakers in product liability suits where the FDA had approved the drug in question. See Taylor, 658 N.W.2d at 130 (“The 1995 amendment of the statute ... provided that compliance with federal governmental standards (established by the FDA) is conclusive on the issue of due care for drugs.”). The relevant provision states:

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, 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.

M.C.L. § 2946(5). In addition to several qualifications not relevant to the case before us,1 the immunity provision contains an important exception:

[88]*88This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(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 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.

M.C.L. § 2946(5)(a) (internal citations omitted). Hence, under these provisions, so long as a drug company did not withhold or misrepresent information that would have affected the FDA’s approval of a putatively harmful drug, the company can successfully defend itself against products liability litigation by establishing that its product received the FDA’s approval and complied with the FDA’s labeling and substantive requirements.

B. Procedural History

Appellants in this case are all Michigan residents alleging injuries caused by Rezu-lin, a drug marketed and sold by Appellees for the treatment of Type-2 diabetes. The FDA originally approved Rezulin in 1997. After adverse liver-related effects were documented in patients taking Rezulin, Appellees agreed to a series of label changes, which were authorized by the FDA on four occasions between November 1997 and June 1999. In March 2000, apparently at the FDA’s request, see Desiano v. Warner-Lambert Co., 326 F.3d 339

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Bluebook (online)
467 F.3d 85, 2006 U.S. App. LEXIS 25108, 2006 WL 2846454, Counsel Stack Legal Research, https://law.counselstack.com/opinion/desiano-v-warner-lambert-co-ca2-2006.