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___________________________________ Michigan Supreme Court Lansing, Michigan 48909

Chie f Justice Justices Maura D. Corrigan Michael F. Cavanagh Elizabeth A. Weaver Marilyn Kelly Clifford W. Taylor Robert P. Young, Jr. 

# Opinion
Stephen J. Markman FILED MARCH 26, 2003

TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v No. 120624 SMITHKLINE BEECHAM CORPORATION, Defendant-Appellant. TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v Nos. 120637-120640 GATE PHARMACEUTICALS, Defendant-Appellant.
JUDITH H. ROBARDS and KENNETH W. ROBARDS, Plaintiffs-Appellees,
v No. 120641 GATE PHARMACEUTICALS, Defendant-Appellant.____________________________________

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___________________________________ TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v Nos. 120642-120645 MEDEVA PHARMACEUTICALS, INC., Defendant-Appellant.
JUDITH H. ROBARDS and KENNETH W. ROBARDS, Plaintiffs-Appellees,
v No. 120646 MEDEVA PHARMACEUTICALS, INC., Defendant-Appellant. TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v No. 120653 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 No. 120654 A.H. ROBINS COMPANY, INC., WYETH-AYERST LABORATORIES COMPANY, and AMERICAN HOME PRODUCTS CORPORATION, Defendants-Appellants. 2___________________________________ BEFORE THE ENTIRE BENCH TAYLOR, J. We granted leave to appeal in these consolidated products liability cases to consider the Court of Appeals holding that MCL 600.2946(5) is unconstitutional because it constitutes an improper delegation of legislative au thority. As will be explain ed, we reverse the judgment of the Court of Appeals bec ause , correctly understood, the statute is a legitimate
exerc ise of legislative authority. A delegation of legislative pow er d oes 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 Tay lor and Lee Anne Rintz filed a products liability lawsu it in the Wayne Circuit Court against Gate Pharmaceuticals and other manufacturers and distributors of certainprescription diet drugs, 1 seeking damages for injuries resulting from use of the drugs. A similar lawsuit was filed inthe Washtenaw Circuit Court by Judith and Kenneth Robards. Ineach lawsuit , t he defendants filed a motion arguing that they were entitled to summary disposition on the basis of MCL

1 The primary drugs at issue are dexfenfluramine (commonly kno wnas Redux) and fenfluramine and phentermine (common ly referred to as fen-phen when taken together). 3600.2946(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 opposedthe motions for summary disposition, asserting that the statute was an unconstitutional delegation of legislative power. The Wayne Circuit Court entered anorder denying defendants’ motion for summary disposition, ruling that the statute was a n unconstitutional delegation of legislative power. In contrast, the Washte naw 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 MCL 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 produ cts li ability action in Michigan. 3 We subsequently granted leave to appeal to defendants. 4

2 It is unconteste d th at the FDA approved the challenged drugs and their labeling before the drugs left the control of any defendant.
3 248 Mich App 472; 639 NW2d 45 (2001).
4 466 Mich 889 (2002). 4II This Court reviews de novo a trial court’s ruling on a motionfor summary disposition. Veenstra v Washtenaw Country Club , 466 Mich 155, 159; 645 NW2d 643 (2002). The constitutionality of a statute is also reviewed de novo as a questionof law. Mc Douga ll v Schanz , 461 Mich 15, 23; 597 NW2d148 (1999). Statutes are presumed to be constitutional, and courts have a duty to construe a statute as constitutional unless its unconstitutionality is clearly appar ent. Id . at 24. 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 NW2d 208 (1997). III Before it was amended in 1995, MCL 600.2946(5) provided that evidence showing compliance with governmental or industry standards was admissible in a product s li ability action in determining if the standard of car e had been met. Owens v Allis-Chalmers Corp , 414 Mich 413, 422; 326 NW2d 372 (1982). The 1995 amendment of the statute went one step further and provided that compliance with federal governmental standards (establishedby the FDA) is conclusive on the issue of due care for drugs. MCL 600.2946(5) provides: 5Ina product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or sell er is not liable, if the drug was approved for safety and efficacy by the United States food and drug administratio n, 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 UnitedStates food and drug administration to remove the drug from the market or to withdraw its approval. This subse ction 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 misre pres ents to the United States food and drug administrationinformation 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 wouldhave withdraw n appr oval for the drug if the information were accurately submitted. (b) Makes anillegal payment to an official or employee of the United States food and drug administrationfor the purpose of securing or maintaining approval of the drug. Pursuant to this statute, unless the fraud exception in subsectiona or the bribery exception containedin subsection bapplies (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
6time 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 v este d in a Congress of the United States . . . ." US 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 p owe rs of government are divided into three branches: legislative, executive and judicial. No person exer cis ing powers of one branchshall exe rcis e powers properly belonging to another branchexcep t 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 US 649, 692; 12 S Ct 495; 36 L Ed 294 (1892) , in wh ich the United States Supreme Court explained that "the integrity and maintenance of the system of

7government ordained by the Constitution" precludes Congress from delegating its legislative power to either the executive branchor 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 separationof powers principle, and the nondelegation doctrine inparticular, do not prevent Congress [ or our Legislature] from ob taining the assistance of the coordinate Branches.” Mistretta v United States , 488 US 361, 371; 109 S Ct 647; 102 L Ed 2d 714 (1989). 7

5 The nondelegation doctrine forbids the delegation of legislative powers, not only to t he executive or judicial branches, but also to non-Michigan governmental agencies or to private individ ual s or associations. Coffman v State Bd of Examiners in Optometry , 331 Mich 582, 587-588; 50 N W2d 32 2 (1951).
6 As we stated in People v Turmon , 417 Mich 638, 649; 340 NW2d620 (1983): “As a threshold matter, we recognize that some legislative powers are simply not delegable. Though not specifically mandated by any constitutional provision, this prohibitionarises from the basic structur e of t he government.”
7 See Detroit v Detroit Police Officers Ass’n , 408 M ic h 410, 458, n 29; 294 NW2d 68 (1980) (Opinion by Williams, J.): Perhaps the most concise description of the delegationdoctrine was enunciated in the seminal case of Locke's Appeal , 72 Pa 491, 498-499 (1873): “The legislature cannot delegate its power to make a law; but it ca n make a law to delegate a power to determine some fact o r state of things uponwhich the law makes, or intends t o m ake, its ownaction depend. To deny this would be to stop (continued...) 8The first category of nondelegation case law involves an assertionthat the Congress or a state legislature improperly delegated its legislative power to a federal agency or state agency, respectively.
Inthe federal courts these improper delegation challenges to the p ower of federal regulatory agencies have beenuniformly unsuccessful since the advent of large
r eg ulatory agencies in the 1930s. 8 A recent case, which is
re presentative of the manner in which the federal judi ciar y has handled these challenges, is Whitman v American Trucking Ass’ns , 531 US 457, 465; 121 S Ct 903; 149 L Ed 2d 1 (2001), inwhichthe United States Supreme Court considered a statute that directed the Environmental Protection Agency to set primary air quality standards “which are requisite to protect the public health” with “an adequate margin of safety.” It was argued that this delegation was too vague. It was held, however, that this direction to the EPA was not an improper delegationof legislative authority t o the agency because there was within the delegation “intelligible principle.”

7 (...continued) the wheels of government.”
8 The United States Supreme Court has not used the nondelegation doctrine to invalidate a federal statute since the New Deal period. See ALA Schechter Poultry Corpv United States , 295 US 495, 537-542; 55 S Ct 837; 79 L Ed 1570 (1935); Panama Refining Co v Ryan , 293 US 388, 420-430; 55 S Ct 241; 79 L Ed 446 (1935). 9InMichigan, this Court has considered sim ilar claims regarding statutes where the claims included an allegation of improperly de legating the Legislature’s power to a Michigan agency, and we have rejected the claims on a basis similar to the federally developed rationale. 9 The second category of cases in which there are challenges concerning the delegation of legislative authority i nv olves situations where the Congress, or the Legislature, enacts a statute that might be described as a referral statute, 10 in which, depending on a factual development that is outs ide the control of the legislative body, certain consequences will ensue.
Anexample of a permissible federal referral statute was the 1810 United States statute in which Congr ess au thorized the President to bar trade with France or Great Britain if one
o f those countries had revoked its decree authorizing the

9 In Turmon , supra at 641-642, the Cour t cons idered a challenge to a statute that authorized the Board of Pharmacy to classify controlled substances within legislatively establishedschedules. This Court, on the basis that the statute provided the agency wi th “sufficient standards” and safeguards, rejected the claim that an improper delegation of authority had oc curr ed. However, the delegation must have standards or principles. If there are none, the delegation is improper because the Legislature’s powers have beenimproperly given to the agency. Blue Cross & Blue Shield of Michigan v Governor , 422 Mich 1, 53-55; 367 NW2d 1 (1985).
10 What we describe as a referral statute should not be confu sed with a reference statute, which is a statute th at incorporates by reference a separate statute. Pleasant Ridge v Governor , 382 Mich 225, 246-247; 165 NW2d 625 (1969). 10seizure of American ships and the other country did not follow suit within three months. When the statute was challenged as
animproper delegation of legislative power, the United States Supreme Court held that thi s was not a delegation of legislative power because the statute only called on the President to determine if a fact, revocation of the dec ree, had taken place. If so, the President was authorized by the Congress to act. Cargo of the Brig Aurora v United States , 11 US (7 Cranch) 382, 388-389; 3 L Ed 378 (1813). Michigan’s referral statutes are apparently so uncontroversial as to be rar ely challenged. This is not surprising whenone considers that, for example, any statutory reference to time, weight, age, gender, birth, death, or even pr int size for legal documents 11 is an exercise o f th e Legislature referring to findings made by someone other than itself. As is apparent in the ca se of time 1 2 this would be

11 For example, pursuant to MCL 168.544c(1), nominating petitions must be “ 8-1⁄2 inch es by 14 inches in size” and the words “nominating petition” must be pri nte d in 24-point boldface type. “We, the undersigned” must be printed in 8 point type. “Warning” and the language in the warning must be printed in 12-point boldface type . See also MCL 445.953(1)(m), which requires that certain rental pur chase agreements contain a notice in type not smaller than 12-poi nt type or in legible print with letters not smaller than 1/8 inch.
12 Representative of this type of statute are MCL 168.720 and 168.721, which provide that the polls shall be open on election day from 7:00 a.m. until 8:00 p.m. Eastern Standard Time. 11the Naval Observatory and when it comes to weights, it would be the National Bureau of Stand ards . 13 Regarding birth and death, it would be the governmental agencies collecting vital statist ic s; and, in the case of print size, standards established by consensus in th e printing industry. The Legislature can , of c ourse, do such things without fear of running afoul of the nondelegation doctri ne because these public or private agency fact findings a re considered to be findings of independent significan ce. That is, there is no improper delegation where th e agen cy or outside body making the finding (such as when it is, say, 7:00 a.m., or when a personwas born, or what weight equals a pound, and so forth) is doing it for purposes independent of the particular statute to which it makes reference. The independently significant standard was described well recently by the New Mexico Supreme Court in Madrid v St Joseph Hosp , 122 NM 524, 531; 928 P2d 250 (1996), in which that court stated: [W]here a private organization's standards have significance independent of a legislative enactment, they may be incorporated into a statutory scheme withou t violating constitutional restrictions on delegation of legislative powers. A private entity's standards cannot be construed as a deliberate law-making act when their development of

13 MC L 29 0.603 provides that basic units of weight and measure “as published by the national bu reau of standards” govern transactions in Michigan.
12the standards is guided by objectives unrelated to the statute in which they function. This concept was also recognized in Lucas v Maine Comm of Pharmacy , 472 A2d 904, 911 (1984), in which the Maine Supreme Court held that legislative incorporation of a decision by a private entity does n ot v iolate the nondelegation doctrine where the decisio n has aspects of significance beyond the legislature’s reliance on it. The independently significant standard has also been discussed by administrative law scholars. Professor Kenneth C. Davis in 1 Administrative Law (2d ed), § 3.12, p 196, has
ex plainedit as follows: “statutes whose operation depe nd s uponprivate action which is taken for purposes which are independent of the statute.” Here in Michigan, Thomas M. Cooley Law School Dean Don LeDuc, in his treatise on Michigan Administrative Law, § 2.25, p 71, has succinctly warned of its limitations and described its operation as follows: “Care must be exercised in distinguishing betweenstatutes which delegate the authority to make the s tandar ds to private parties and th ose wh ich refer to outside standards as the measuring device.” We deal here with the latter ty pe of statute. 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

13the Michigan Legislature’s direction, Michigan courts to find
as a matter of law that the manufacturer or seller acted with due care. The FDA decision is, in Dean LeDuc’s formulation, simply a “measuring device.” V The Court of App eal s in its handling of this matter concluded that MCL 600.2946(5) is an unconstitutional delegationof legislative powe r b ecause it believed the statute placed “the FDA in the position of final arbiter with respect to whether a particular drug may form the basis of a pr oducts liability action in Michigan.” 248 Mich App 483 . Yet, this statut e o nly establishes that a determination of independent significance, here the FDA finding that a drug is safe and effective, will be the measure in Michigan of whether the duty of reasonable care has been met by a drug manufacturer or seller in a tort case. While the Court of Appeals recognized that the Legislature can alter the commonlaw duty of reasonable care in a drug products liability tort case, the panel and the dissent in this Court contend that MCL 600.2946(5) went beyond this and gave the FDA the authority to “make, alter, amend, and repeal laws.” 248 Mich App 478. This is incorre ct. T he FDA does not decide who may bring a products liabil ity action in Michigan; rather, the FDA, for i ts own reasons that are independent of Michigan tort law, simply ma kes a factual finding regarding the safety and
14efficacy of drugs. It is the Michigan Legislature that has determined the legal consequences that flow from that finding. The Legislature’s action in doing so is no different from the Legislature’s referring to weights and measures or even dates and times, which are, as discussed above, all findings of independent significance by bodies deemed by the Legislature to be expert. By using such independent determinations as a referent, the Legislature is not delegating how that fact will be used, just as the Congress in 1810 was not delegating the makin g of rules to France or Great Britain in Cargo of the Brig Aurora, supra . The Court of Appeals acknowledged the independently significant standard, but placed anunjustified limitation on it. The panel correctly stated that, “[a]ssimilation of standards adopted for a purpose separate from the incorporating legislation, and having independent significance, presents no problem,” but added a condition, whi ch w as “if the standards are established and essentially unchanging.” 248 MichApp 485 (emphasis added). There is no soundlegal basis for this limitation. 14 Whether the Legislature’s adoption of the actions of an external body as
a cause for statutory legal consequence s i s a delegation of

14 Inthe words of Locke's Appeal , supra , the Legislature canmake a law delegating its “power to determine some fact or state of things upon which the law makes, or intends to make, its own action depend.” 15legislative authority cannot rationally d epend on a court’s perceptionof the relative pe rmane nce of the actions adopted. 15 The Court of Appeals, in buttressing its holding, relied
onlanguage in Coffman v State Bd of Examiners in Optometry , 331 Mich 582; 50 NW2d 3 22 (1951), to the effect that the Legisla tur e could not require an applicant for a license to practice optometry to have graduated from an optometry school
or college that recei ved a certain rating by the international association of boards of examiners in
o ptomet ry. This language was dicta because the actual holding in Coffmanwas that the applicant was not entitled to mandamus. As dicta, it is in no sense binding authority. The Court of App eals also cited Colony Town Club v MichiganUnemployment Compensation Comm , 301 Mich 107; 3 NW2d 28 (1942). This case merely rejecteda party’s argument that
a decision by the federal government interpreting a federal statute was binding on a subs tantially similar Michigan

15 Moreover, any change issue is irrelevant here becaus e under MCL 600.2946(5) the bar the statute establishes applies only to drugs approved by the FDA at the time the drug leaves the control of the manufacturer or seller. The bar does not apply to a drug sold after the effective date of an order from the FDA to remove the drug from the market or to withdraw its approval. Thus, the FDA’s conclusion in effect when a manufacturer or seller distributes a drug is unchanging with regardto that batch of drugs. The Court of Appeals inc orrectly concluded that the FDA determinations were no t constant. The dissent’s assertion that FDA decisions are not “essentially unchanging”, post at 7, is incorrect. 16sta tute. In contrast with the argument rejected in Co lon y To wnClub , the statute at issue here, MCL 600.2946(5), neither purports to giv e the FDA the final say in the interpretationof a state statute nor provides that a Michigancourt in applying Michigan law is bound by an interpretationmade by a federal agency in interpreting a substantially similar provisionof federal law. Colony Town Club is thus inapposite.

The Court of Appeals also cited Dearborn Independent, Inc v Dearborn , 331 Mich 447; 49 NW2d 370 (1951). In Dearborn , the Court considered a statute that provide d th at
a newspaper was qualified to publishlegal notices if it was admittedby the United States Post Office for transmission of second-class mail. The Court held t he statute in violation of the nondelegation doctrine because it “unlawfully attempts to delegate to the Unite d St ates post-office department the determinationof the qualifications of a newspaper to publish legal not ices.” Id . at 454. The Court was concerned that the statute made the validity of publication of legal notices dependent onthe future as well as present regulations of the UnitedStates Post Office. Id . To the extent that the post office’s decisionwhether to approve a newspaper for secondclass mail is an act of independent signi ficanc e, which it appears to us to be, Dearborn Independent is inconsistent withthe independently significant stan dard. It was, thus, 17incorrectly decided i n lig ht of the law’s subsequent development in this area and is overruled. 16 The Court of Appeals also cited Radecki v Director of Worker’s Disability Compen sati on , 208 Mich App 19; 526 NW2d 611 (1994). In Radecki , the Court considered a state statute that incorporated by reference a federal statute. The Court
sa id that state statutes may incorporate existing federal statutes, but not future legislation. Id . at 23. Utilizing its “no change” argument, the Court of Appeals characterized MCL 600.2946(5) as an impermissible “reference statute” that incorporates future s ta ndards promulgated by the FDA. 248 MichApp 483. We disagree. First, MCL 600.2946(5) is not a “reference statute” as that phrase is used, which is to mean incorporationinto Michigan l aw of a standard from a different jurisdiction as a r ul e of law to be applied in Michigancourts. Rather, it provid es that certain legal consequences flow from factual determinations made by the FDA andis not a delegation. Accordingly, Radecki, whatever its merits as law, is not relevant to a consideration of whether MCL 600.2946(5) is an improper dele gation of legislative

16 We also no te t hat in this case there is no concern regarding future regulations issued by a federal governmental agency. As noted above, the determination whether a particular drug had been approved by the FDA when the drug left the m anufacturer or seller is constant with regard to that batch of the drug. Although there certainly will be new drugs approved by the FDA in the future, the key question pursuant to MCL 600.2946(5) is whether the drug was approved when sold. 18power. Finally, to deal with the last of the Michigan cases on whichthe Court of Appeals relied, our analysis is consistent with Michigan Baptist Homes & Dev Co v Ann Arbor , 55 Mich App 725; 223 NW2d 324 (1974). 17 In Baptist Homes , a state statute granteda property tax exemption to nonprofit corporations th at had obtained financing under § 202 of the Nat iona l Housing Act (12 USC 1701q). Th e plaintiff argued that the Le gislature had made the state tax exemption dependent u po n actionby the Secretary of Housing and Urban Development and that limiting the state statute in this manner was invalid because it was an unconstitutional del ega tion of power to a federal official to decide who gets the exemption. The Court of Appeals correctly rejected this argument, explaining that the federal official does not make a determination of who shall receive the s tate exemption. This is because the federal official merely determines which nonp ro fit corporations are eligible to receive federal financing pursuant to the federal act. This is to be understo od, in DeanLeDuc’s useful characterization, a s an example of the “measuring stick.” In our case, also, because the FDA decisionis only the measure, i .e., t he enabling fact, MCL 600.2946(5) is not an unl awfu l delegation of legislative authority.

17 Aff’d 396 Mich 660; 242 NW2d 749 (1976). 19VI The dissent misunderstands the independently significant standard. 18 What is central to grasping this doctrine is that if the fact or finding to which the Legis la ture refers has significance independent of a legislative enactment, because the agency or outside body making the finding is doing it for purposes independent from the particular statute that refers to it, then there is no delegation. Whether the fa ct or finding of independent significance changes thereafter is irrelevant to the question whether there has been an improper delegation. 19

VII Insum, MCL 600.2946(5) de le gates nothing to the FDA; rather, it uses independently significant decisions of the FDA as a measuring device to set the st andard of care for manufacturers and sellers of prescriptiondrugs in Michigan. It represents a legislative determination as a matter of law

18 The only basis for the dissent’s position is Dearborn Independent where t he doc trine was misunderstood also and accordingly has today been overruled.
19 Although, in response to the arguments advancedby the Court of Appeals and the dissent, we have established in this opinionthat FDA findings regarding a drug do not in fact change as far as MC L 600.2946(5) is concerned, we emphasize that we a re no t required to do so in determining whether a legislative act has made a delegation of legislative authority inviolation of the Constitution. Stability of a fact or fin ding is not an element of the independently significant standard analysis. 20of when a manufacturer or seller of a pre sc ription drug has acted sufficiently re ason ably, solely for the purpose of defining the limits of a cognizable products liability claim under Michigan law. Accordingly, we reverse the judgment of the Court of Appeals that the statute constitutes an improper delegation of legislative power. Clifford W. Taylor Maura D. Corrigan Michael F. Cavanagh Robert P. Young, Jr. Stephen J. Markman WEAVER, J. I concur in the result only. Elizabeth A. Weaver

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___________________________________ S T A T E O F M I C H I G A N SUPREME COURT

TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v No. 120624 SMITHKLINE BEECHAM CORPORATION, Defendant-Appellant. TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v Nos. 120637-120640 GATE PHARMACEUTICALS, Defendant-Appellant.
JUDITH H. ROBARDS and KENNETH W. ROBARDS, Plaintiffs-Appellees,
v No. 120641 GATE PHARMACEUTICALS, Defendant-Appellant. TAMARA TAYLOR and LEE ANNE RINTZ,___________________________________

___________________________________

___________________________________ Plaintiffs-Appellees,
v Nos. 120642-120645 MEDEVA PHARMACEUTICALS, INC., Defendant-Appellant.
JUDITH H. ROBARDS and KENNETH W. ROBARDS, Plaintiffs-Appellees,
v No. 120646 MEDEVA PHARMACEUTICALS, INC., Defendant-Appellant. TAMARA TAYLOR and LEE ANNE RINTZ, Plaintiffs-Appellees,
v No. 120653 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 No. 120654 A.H. ROBINS COMPANY, INC., WYETH-AYERST LABORATORIES COMPANY, and AMERICAN HOME PRODUCTS CORPORATION, 2___________________________________ Defendants-Appellants. KELLY, J. ( dissenting ). I agree with the rulings of the Wayne Circuit Court 1 and the Court of Appeals 2 holding that MCL 600.2946(5) represents
anunconstitutional delegation of the Legislature's power. The majority reverses these rulings by adopting, with little discussion, the "independently significant standard" doctrine, while restricting the limitation that our lower courts and our precedent have placed onlegislative delegations. In keeping withthe wisdom of our lower courts' ruling s and our precedent, I would affirm the decisio ns b y holding MCL 600.2946(5) unconstitutional. I The majority focuses on the independence of the Food and Drug Administration(FDA). In so doing, it loses sight of the
s ignifi cant fact that the standards used by the FDA change from time to time. Whenthe Legislature adopts the determinations of a foreignbody, it implicitly determines that the body's choice

1 Judge Marianne O. Battani.
2 Judg es W illiam B. Murphy and Kathleen Jansen, Judge Je ffr ey G. Collins not participating, 248 Mich App 472; 639 NW2d 45 (2001). 3is sufficiently reliable to be conclusive. When the foreign b ody al ters the standards by which it makes its determinations, it undermines the stability of the Legislature's choice. The foreign body becomes the only authority that approves the changed standards as well as the
one that applies them. At that point, it steps into the shoes of the Legislature, making a policy choice for the people of Michigan. Its decision no longer represents the Legislature's intent. A statute that e nables a f oreign body to make a policy determination not embraced by the Legislature perpetrates an unconstitutional delegation of the Legislature's power. The analysis I have set forthis the basis for the Court of Appeal s ho lding: an unconstitutional delegation occurs whena st atute references fact-finding that is based on standards that are not "established and essentially unchanging." 248 Mich App 472, 485; 639 NW2d 45 (2001). Contrary to the asser tion of the majority, the Court of Appeals did not invent this limitation. Rather, it drew it directly from this Court's holding in Dearborn Independe nt , Inc v Dearborn , 331 Mich 447; 49 NW2d 370 (1951). In Dearborn , we examined a statute that prescrib ed qualifications a newspaper must satisfy in order to publish
4legal notices. One qualification was that the newspaper "sh all have been admitted by the United States post-offic e department for transmission as mail matter of the second class . . . ." Id. at 454. The Court held that this reference to post office determinations depended on "future as well as present regulations . . . ." Id . Because the postal authority could and might at any time revise the standards for second-class mail, the statute allowed the authority to step into the shoes of the Legislature. Thus, it constituted an unlawful delegation of legislative power. 3 Conversely, if the qualifications for second-class mail had been unchanging, the law would have been constitutional. The standard would have had independent significance and its content would have been known to the legislators who adopted it. The Court of Appeals prope rly interpreted the Dearborn holding as requiring both "established and essentially unchanging" standards. 248 Mich 485. The present situation closely parallels that in Dearborn .

3 In the analogous context of reference statutes, the Court of Appeals has held that "when a Michigan statute adopts by reference a federal law that is subsequently amended, but the Michigan statute remains unchanged, the courts are constitutionallyrequired to construe the statute as continuing to refer to the original federal enactment before ame nd ment." Radecki v Director of Bureau of Worker's D isabil ity Compensation , 208 Mich App 19, 23; 526 NW2d 611 (1994). 5Here, the statute refers to the findings of the FDA, which are basedon changing standards. As a cons equenc e, MCL 600.2946(5) must be held unconstitutional under the logic employedby the Dearborn Court. Because it is empowered to change the standards by which it approves drugs, the FDA, not the Legislature, determines whether an action for the injuries drugs cause may be sustained in Michigan. That constitutes an exercise of the Legislature's power to act as the lawmaker in Michigan. II No previous Michigan case has adopted the "independently significant standard" doctrine. In embracing it, the majority eradicates the precedent that would limit it, overruling Dearbornas "incorrectly decided in light of the law 's subsequent development in this area . . . ." 4 Ante at 19-20. I dis agr ee with this approach and prefer to square the "independently significant standard" doctrine with our precedent by limiting the doctrine as Dearbo rn would have

4 The majorityalso holds that any change in FDA standards is irrelevant because the Legislature restricted the statute's application to the ti me t he drug leaves the manufacturer's hands. The date the drug was manufactured is not relevant to wh eth er the statute is unconstitutional. The pertinent question is, when the FDA evaluates a drug in the future, does it use the standards that the Legislature knew of and relied on when the act was passed? 6limited it. That is, we sho uld hold it constitutionally acceptable to adopt by reference independent decisi ons of a foreignbody as long as t he foreign body's standards are "established and essentially unchanging." The present statute fails the test. The natures of both science and the drug approval process are of the sort that the FDA's standards must evolve over time. According ly, FDA determinations are not "essentially unchanging" and a statute that incorporates them perpetrates an unlawful delegation. The majority rejects this analysis, saying that the determinationof a statute's constitutionality "cannot rationally depend on a court's perception of the re lative permanence of the actions adopted." Ante at 17. To the contrary, I believe that courts are able to make that assessment wit h great accuracy. Courts can distinguish betweenstatic standards and evolving standards. For example, the standard by which the Naval Observatory calculates th e passage of time reasonably can be expected not to change. Contrast that with the manner in which the FDA determines the safety and efficacy of a drug, an evolving standard. Distrust of the judiciary's ability to distinguish standards is an inappropriate b as is for upholding an unconstitutional statute and discarding the precedents of this

7Court. III Some characterize MCL 600.2946(5) as a tort-reform statute that adopts a foreign body's stan da rds while maintaining the consumer's ability to bring suit in the event of fraud or bribery. It is of interest that, after M CL 600.2946(5) was enacted, the United States Supreme Court decidedthe case of BuckmanCo v Plaintiff's Legal Committee , 531 US 341; 121 S Ct 1012; 148 L Ed 2d 854 (2001). Under Buckmanand its progeny, a plaintiff's allegations of fraud or bribery are preempted by federal law. Only the FDA may determine whether it was defrauded or bribed when it approved a drug. MCL 600.2946(5) precludes a personwho claims to have beeninjured by an F DA-app roved drug from suing the manufacturer in a Michig an court. When read in conjunction wi th t he Buckman decision, this simple tort-reform statute becomes elevated to a "tort-elimination" statute. IV Insum, I would affirm the judgments of the Wayne Circuit Court and the Court of Ap peal s holding MCL 600.2946(5) unconstitutional. The majority misconstrues my position. The conclusiveness of the FDA's decisions does not undermine the
8statutes's constitutionality. What undermines it is the fact that the FDA's decisions are founded on shift ing st andards. It is only when the standards are "established and essentially unchanging" that a statutory reference to the products of the standards should be ruled a constitutional delegation of the legislative power. The holding I advocate would accord with logic and this Court's precedent, while adopting with appropriate restriction the "independently significant standard" doctrine. Marilyn Kelly

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