Taylor v. Smithkline Beecham Corp.

• Decision Date: 26 March 2003
• Docket Number: Docket No. 120653-120654,Docket No. Calendar,Docket No. 120642-120646,Docket No. 120637-120641,Docket No. 120624,Docket No. 7-10.
• Citation: 468 Mich. 1,658 N.W.2d 127
• Parties: Tamara TAYLOR and Lee Anne Rintz, Plaintiffs-Appellees, v. SMITHKLINE BEECHAM CORPORATION, Defendant-Appellant. Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. Gate Pharmaceuticals, Defendant-Appellant. Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. Gate Pharmaceuticals, Defendant-Appellant. Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. Medeva Pharmaceuticals, Inc., Defendant-Appellant. Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. Medeva Pharmaceuticals, Inc., Defendant-Appellant. Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. A.H. Robins Company, Inc., Wyeth-Ayerst Laboratories Company, and American Home Products Corporation, Defendants-Appellants, Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. A.H. Robins Company, Inc., Wyeth-Ayerst Laboratories Company, and American Home Products Corporation, Defendants-Appellants.
• Court: Michigan Supreme Court

658 N.W.2d 127

468 Mich. 1

Tamara TAYLOR and Lee Anne Rintz, Plaintiffs-Appellees, v. SMITHKLINE BEECHAM CORPORATION, Defendant-Appellant.

Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. Gate Pharmaceuticals, Defendant-Appellant.

Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. Gate Pharmaceuticals, Defendant-Appellant.

Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. Medeva Pharmaceuticals, Inc., Defendant-Appellant.

Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. Medeva Pharmaceuticals, Inc., Defendant-Appellant.

Tamara Taylor and Lee Anne Rintz, Plaintiffs-Appellees, v. A.H. Robins Company, Inc., Wyeth-Ayerst Laboratories Company, and American Home Products Corporation, Defendants-Appellants, Judith H. Robards and Kenneth W. Robards, Plaintiffs-Appellees, v. A.H. Robins Company, Inc., Wyeth-Ayerst Laboratories Company, and American Home Products Corporation, Defendants-Appellants.

Docket Nos. 120624, 120637-120641, 120642-120646, 120653-120654, (Calendar Nos. 7-10).

Supreme Court of Michigan.

Argued December 10, 2002.

Decided March 26, 2003.

Charfoos & Christensen, P.C., (by David R. Parker, Samuel L. Simpson, and J. Douglas Peters), Detroit, MI, for Tamara Taylor, Lee Anne Rintz, Judith H. Robards, and Kenneth W. Robards.

Buesser, Black, Graham, & Buesser, P.C., (by Ronald F. Graham), Bloomfield Hills, MI, and Goodwin & Procter, LLP, New York, NY, for Gate Pharmaceuticals, Inc.

Kitch Drutchas Wagner DeNardis & Valitutti (by Thomas J. Foley and Susan Healy Zitterman), Detroit, MI, for Smith-Kline Beacham Corporation.

Plunkett & Cooney, P.C. (by Robert G. Kamenec), Bloomfield Hills, MI, McDermott, Will & Emery (by Peter L. Resnik, Cathy McNeil Stein, and Kevin E. Young), Chicago, IL, and Bingham McCutchen, LLP (by Peter C. Neger), New York, NY, for Medeva Pharmaceuticals, Inc.

Honigman Miller Schwartz & Cohn (by Ronald S. Longhofer and Andrew Doctoroff), Detroit, MI, Secrest, Wardle, Lynch, Hampton, Truex & Morley (by John Mitchell and Michael L. Updike), Farmington Hills, MI, and Arnold & Porter (by Donald O. Beers, Darryl W. Jackson, and Michael C. Augustini), Washington, DC, for A.H. Robins Company, Incorporated, Wyeth Ayerst Laboratories Company, and American Home Products Corporation.

Kelley Cawthorne (by Dennis O. Cawthorne), Lansing, MI, Covington & Burling (by Bruce N. Kuhlik and David H. Remes), and Russel A. Bantham and Marjorie E. Powell, Washington, DC, for Pharmaceutical Research and Manufacturers of America.

Clark Hill PLC (by James E. Brenner and Paul C. Smith), Detroit, MI, (Hugh F. Young, Jr., of counsel), Reston, VA, for The Product Liability Advisory Council, Inc.

Howard & Howard Attorneys, P.C., (by Mary C. Dirkes), Bloomfield Hills, MI, for The Michigan Manufacturers Association.

TAYLOR, J.

We granted leave to appeal in these consolidated products liability cases to consider the Court of Appeals holding that M.C.L. § 600.2946(5) is unconstitutional because it constitutes an improper delegation of legislative authority. As will be explained, we reverse the judgment of the Court of Appeals because, correctly understood, the statute is a legitimate exercise of legislative authority. A delegation of legislative power does not occur when a statute merely provides that specific legal consequences under Michigan law will result from an act or determination by a federal agency of a fact that has independent significance.

I

Tamara Taylor and Lee Anne Rintz filed a products liability lawsuit in the Wayne Circuit Court against Gate Pharmaceuticals and other manufacturers and distributors of certain prescription diet drugs,¹ seeking damages for injuries resulting from use of the drugs. A similar lawsuit was filed in the Washtenaw Circuit Court by Judith and Kenneth Robards. In each lawsuit, the defendants filed a motion arguing that they were entitled to summary disposition on the basis of M.C.L. § 600.2946(5), which limits the liability of drug manufacturers and sellers where the drug at issue was approved for safety and efficacy by the United States Food and Drug Administration and labeled in compliance with FDA standards.²

The respective plaintiffs opposed the motions for summary disposition, asserting that the statute was an unconstitutional delegation of legislative power. The Wayne Circuit Court entered an order denying defendants' motion for summary disposition, ruling that the statute was an unconstitutional delegation of legislative power. In contrast, the Washtenaw Circuit Court entered an order granting defendants' summary disposition motion, rejecting the claim that the statute was unconstitutional.

The Court of Appeals granted an application for leave to appeal in each lawsuit and consolidated the appeals. The Court concluded that M.C.L. § 600.2946(5) operates as an unconstitutional delegation of legislative authority because it places the FDA in the position of final arbiter with respect to whether a particular drug may form the basis of a products liability action in Michigan.³ We subsequently granted leave to appeal to defendants.⁴

II

This Court reviews de novo a trial court's ruling on a motion for summary disposition. Veenstra v. Washtenaw Country Club, 466 Mich. 155, 159, 645 N.W.2d 643 (2002). The constitutionality of a statute is also reviewed de novo as a question of law. McDougall v. Schanz, 461 Mich. 15, 23, 597 N.W.2d 148 (1999). Statutes are presumed to be constitutional, and courts have a duty to construe a statute as constitutional unless its unconstitutionality is clearly apparent. Id. at 24, 597 N.W.2d 148. Further, when considering a claim that a statute is unconstitutional, the Court does not inquire into the wisdom of the legislation. Council of Organizations & Others for Ed. About Parochiaid, Inc. v. Governor, 455 Mich. 557, 570, 566 N.W.2d 208 (1997).

III

Before it was amended in 1995, M.C.L. § 600.2946(5) 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. Owens v. Allis-Chalmers Corp., 414 Mich. 413, 422, 326 N.W.2d 372 (1982). The 1995 amendment of the statute went one step further and provided that compliance with federal governmental standards (established by the FDA) is conclusive on the issue of due care for drugs.

MCL 600.2946(5) provides:

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. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This 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, chapter 675, 52 Stat 1040, 21 USC 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.

(b) 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.

Pursuant to this statute, unless the fraud exception in subsection a or the bribery exception contained in subsection b applies (plaintiffs make no such claim here), a manufacturer or seller of a drug that has been approved by the FDA has an absolute defense to a products liability claim if the drug and its labeling were in compliance with the FDA's approval at the time the drug left the control of the manufacturer or seller. Thus, the Legislature has determined that a drug manufacturer or seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently so that no tort liability may lie.

IV

The United States Constitution provides that "[a]ll legislative powers herein granted shall be vested in a Congress of the United States...." U.S. Const, art I, § 1. Similarly, the Michigan Constitution provides that "[t]he legislative power of the State of Michigan is vested in a senate and a house of representatives." Const 1963, art 4, § 1. The Michigan Constitution also provides: "The powers of government are divided into three branches: legislative, executive and judicial. No person exercising powers of one branch shall exercise powers properly belonging to another branch except as expressly provided in this constitution." Const 1963, art 3, § 2.

These constitutional provisions have led to the constitutional discipline that is described as the nondelegation doctrine. A simple statement of this doctrine is found in Field v. Clark, 143 U.S. 649, 692, 12 S.Ct. 495, 36 L.Ed. 294 (1892), in which the United States Supreme Court explained that "the integrity and maintenance of the system of government ordained by the Constitution" precludes Congress from delegating its legislative power to either the executive branch or the judicial branch.⁵ This concept has its roots in the separation of powers principle underlying our tripartite system of government.⁶ Yet, the United States Supreme Court, as well as this Court, has also recognized "that the separation of powers principle, and the...