Tamara Taylor v. Gate Pharmaceuticals ( 2003 )


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  •                                                                        Michigan Supreme Court
    Lansing, Michigan 48909
    ____________________________________________________________________________________________
    Chie f Justice                   Justices
    Maura D. Corrigan                Michael F. Cavanagh
    Opinion
    Elizabeth A. Weaver
    Marilyn Kelly
    Clifford W. Taylor
    Robert P. Young, Jr.
    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.
    ___________________________________
    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 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 MCL
    1
    The primary drugs at issue are dexfenfluramine (commonly
    known as Redux) and fenfluramine and phentermine (commonly
    referred to as fen-phen when taken together).
    3
    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     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
    products     liability action in Michigan.3                  We subsequently
    granted leave to appeal to defendants.4
    2
    It is uncontested that 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).
    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    NW2d   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
    NW2d 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
    .     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 products liability action in
    determining if the standard of care 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
    (established by the FDA) is conclusive on the issue of due
    care for drugs.
    MCL 600.2946(5) provides:
    5
    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
    6
    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 . . . ." 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 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 US 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
    7
    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 nondelegation doctrine
    in particular, do not prevent Congress [or our Legislature]
    from obtaining 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 the executive or judicial
    branches, but also to non-Michigan governmental agencies or to
    private individuals or associations. Coffman v State Bd of
    Examiners in Optometry, 
    331 Mich 582
    , 587-588; 50 NW2d 322
    (1951).
    6
    As we stated in People v Turmon, 
    417 Mich 638
    , 649; 340
    NW2d 620 (1983): “As a threshold matter, we recognize that
    some legislative powers are simply not delegable. Though not
    specifically mandated by any constitutional provision, this
    prohibition arises from the basic structure of the
    government.”
    7
    See Detroit v Detroit Police Officers Ass’n, 
    408 Mich 410
    , 458, n 29; 294 NW2d 68 (1980) (Opinion by Williams, J.):
    Perhaps the most concise description of the
    delegation doctrine 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 can make a law to delegate a
    power to determine some fact or state of things
    upon which the law makes, or intends to make, its
    own action depend. To deny this would be to stop
    (continued...)
    8
    The first category of nondelegation case law involves an
    assertion that the Congress or a state legislature improperly
    delegated its legislative power to a federal agency or state
    agency, respectively.
    In     the   federal   courts        these     improper     delegation
    challenges to the power of federal regulatory agencies have
    been       uniformly   unsuccessful        since    the   advent   of   large
    regulatory agencies in the 1930s.8                 A recent case, which is
    representative of the manner in which the federal judiciary
    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),
    in which the 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
    delegation of legislative authority to 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 Corp v 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).
    9
    In Michigan, this Court has considered similar claims
    regarding statutes where the claims included an allegation of
    improperly delegating 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
    involves 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   outside the control of the legislative body, certain
    consequences will ensue.
    An example of a permissible federal referral statute was
    the 1810 United States statute in which Congress authorized
    the President to bar trade with France or Great Britain if one
    of those countries had revoked its decree authorizing the
    9
    In Turmon, supra at 641-642, the Court considered a
    challenge to a statute that authorized the Board of Pharmacy
    to classify controlled substances within legislatively
    established schedules.    This Court, on the basis that the
    statute provided the agency with “sufficient standards” and
    safeguards, rejected the claim that an improper delegation of
    authority had occurred. However, the delegation must have
    standards or principles. If there are none, the delegation is
    improper because the Legislature’s powers have been improperly
    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
    confused with a reference statute, which is a statute that
    incorporates by reference a separate statute. Pleasant Ridge
    v Governor, 
    382 Mich 225
    , 246-247; 165 NW2d 625 (1969).
    10
    seizure of American ships and the other country did not follow
    suit within three months.            When the statute was challenged as
    an improper delegation of legislative power, the United States
    Supreme     Court      held   that   this    was    not    a   delegation    of
    legislative power because the statute only called on the
    President to determine if a fact, revocation of the decree,
    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 rarely challenged.                      This is not
    surprising when one considers that, for example, any statutory
    reference to time, weight, age, gender, birth, death, or even
    print     size   for    legal   documents11    is    an    exercise   of    the
    Legislature referring to findings made by someone other than
    itself.     As is apparent in the case of time12                this would be
    11
    For example, pursuant to MCL 168.544c(1), nominating
    petitions must be “8-½ inches by 14 inches in size” and the
    words “nominating petition” must be printed 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 purchase agreements contain a notice in type not
    smaller than 12-point 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.
    11
    the Naval Observatory and when it comes to weights, it would
    be the National Bureau of Standards.13 Regarding birth and
    death, it would be the governmental agencies collecting vital
    statistics;   and,   in   the   case   of   print   size,   standards
    established by consensus in        the printing industry.         The
    Legislature can, of course, do such things without fear of
    running afoul of the nondelegation doctrine because these
    public or private agency fact findings are considered to be
    findings of independent significance.         That is, there is no
    improper delegation where the agency or outside body making
    the finding (such as when it is, say, 7:00 a.m., or when a
    person was 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 without 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
    MCL 290.603 provides that basic units of weight and
    measure “as published by the national bureau of standards”
    govern transactions in Michigan.
    12
    the 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 not violate the nondelegation doctrine
    where the decision 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
    explained it as follows: “statutes whose operation depends
    upon private 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 between statutes which delegate
    the authority to make the standards to private parties and
    those   which refer to outside standards as the measuring
    device.”
    We deal here with the latter type 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
    13
    the 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 Appeals in its handling of this matter
    concluded    that      MCL    600.2946(5)     is    an     unconstitutional
    delegation   of       legislative    power   because       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
    products liability action in Michigan.”                   
    248 Mich App 483
    .
    Yet, this statute only 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 common­
    law 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 incorrect.           The FDA does not decide who may bring a
    products liability action in Michigan; rather, the FDA, for
    its own reasons that are independent of Michigan tort law,
    simply makes      a    factual finding regarding the safety and
    14
    efficacy 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
    making 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 an unjustified 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,
    which was “if the standards are established and essentially
    unchanging.”        
    248 Mich App 485
     (emphasis added).           There is no
    sound       legal   basis   for    this      limitation.14      Whether   the
    Legislature’s adoption of the actions of an external body as
    a cause for statutory legal consequences is a delegation of
    14
    In the words of Locke's Appeal, supra, the Legislature
    can make 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.”
    15
    legislative authority cannot rationally depend on a court’s
    perception     of   the   relative         permanence     of     the   actions
    adopted.15
    The Court of Appeals, in buttressing its holding, relied
    on language in Coffman v State Bd of Examiners in Optometry,
    
    331 Mich 582
    ; 50 NW2d 322 (1951), to the effect that the
    Legislature could not require an applicant for a license to
    practice optometry to have graduated from an optometry school
    or   college     that     received        a    certain        rating   by   the
    international       association      of       boards     of     examiners   in
    optometry.      This language        was dicta because the actual
    holding in Coffman was that the applicant was not entitled to
    mandamus.     As dicta, it is in no sense binding authority.
    The Court of Appeals also cited Colony Town Club v
    Michigan Unemployment Compensation Comm, 
    301 Mich 107
    ; 3 NW2d
    28 (1942).     This case merely rejected a party’s argument that
    a decision by the federal government interpreting a federal
    statute was binding on a          substantially similar Michigan
    15
    Moreover, any change issue is irrelevant here because
    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
    regard to that batch of drugs.         The Court of Appeals
    incorrectly concluded that the FDA determinations were not
    constant. The dissent’s assertion that FDA decisions are not
    “essentially unchanging”, post at 7, is incorrect.
    16
    statute.    In contrast with the argument rejected in Colony
    Town   Club,   the    statute    at    issue     here,   MCL    600.2946(5),
    neither purports to give              the FDA the final say in the
    interpretation       of   a   state    statute     nor   provides    that    a
    Michigan court in applying Michigan law is bound by an
    interpretation made by a federal agency in interpreting a
    substantially similar provision of 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 provided that
    a newspaper was qualified to publish legal notices if it was
    admitted by the United States Post Office for transmission of
    second-class mail.        The Court held the statute in violation
    of the nondelegation doctrine because it “unlawfully attempts
    to delegate to the United States post-office department the
    determination of the qualifications of a newspaper to publish
    legal notices.”       
    Id. at 454
    .            The Court was concerned that
    the statute made the validity of publication of legal notices
    dependent on the future as well as present regulations of the
    United States Post Office.            
    Id.
         To the extent that the post
    office’s decision whether to approve a newspaper for second­
    class mail is an act of independent significance, which it
    appears to us to be, Dearborn Independent is inconsistent
    with the independently significant standard.                   It was, thus,
    17
    incorrectly     decided    in   light      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 Compensation, 
    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
    said 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 standards promulgated by the FDA.                   
    248 Mich App 483
    .    We disagree.      First, MCL 600.2946(5) is not a
    “reference statute” as that phrase is used, which is to mean
    incorporation    into     Michigan     law      of    a   standard   from   a
    different jurisdiction as a rule of law to be applied in
    Michigan courts.        Rather, it provides that certain legal
    consequences flow from factual determinations made by the FDA
    and is 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 delegation of legislative
    16
    We also note that 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 manufacturer 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.
    18
    power.
    Finally, to deal with the last of the Michigan cases on
    which the 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
    granted a property tax exemption to nonprofit corporations
    that had obtained financing under § 202 of the National
    Housing Act (12 USC 1701q).          The plaintiff argued that the
    Legislature had made the state tax exemption dependent upon
    action by the Secretary of Housing and Urban Development and
    that limiting the state statute in this manner was invalid
    because it was an unconstitutional delegation 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 state exemption.              This is because the
    federal      official    merely      determines     which     nonprofit
    corporations     are    eligible    to    receive   federal   financing
    pursuant to the federal act.          This is to be understood, in
    Dean LeDuc’s useful characterization, as an example of the
    “measuring stick.”         In our case, also, because the FDA
    decision is only the measure, i.e., the enabling fact, MCL
    600.2946(5) is not an unlawful delegation of legislative
    authority.
    17
    Aff’d 
    396 Mich 660
    ; 242 NW2d 749 (1976).
    19
    VI
    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 Legislature 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 fact or
    finding of independent significance changes thereafter is
    irrelevant to the question whether there has been an improper
    delegation.19
    VII
    In sum, MCL 600.2946(5) delegates nothing to the FDA;
    rather, it uses independently significant decisions of the
    FDA as a measuring device to set the standard of care for
    manufacturers and sellers of prescription drugs 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 the doctrine was misunderstood also and
    accordingly has today been overruled.
    19
    Although, in response to the arguments advanced by the
    Court of Appeals and the dissent, we have established in this
    opinion that FDA findings regarding a drug do not in fact
    change as far as MCL 600.2946(5) is concerned, we emphasize
    that we are not required to do so in determining whether a
    legislative act has made a delegation of legislative authority
    in violation of the Constitution.     Stability of a fact or
    finding is not an element of the independently significant
    standard analysis.
    20
    of when a manufacturer or seller of a prescription drug has
    acted sufficiently reasonably, 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
    21
    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 Court1 and
    the Court of Appeals2 holding that MCL 600.2946(5) represents
    an unconstitutional 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 on legislative delegations.                     In keeping
    with       the   wisdom   of    our     lower   courts'     rulings    and   our
    precedent,       I   would     affirm    the    decisions    by   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
    significant fact that the standards used by the FDA change
    from time to time.
    When the Legislature adopts the determinations of a
    foreign body, it implicitly determines that the body's choice
    1
    Judge Marianne O. Battani.
    2
    Judges William B. Murphy and Kathleen Jansen, Judge
    Jeffrey G. Collins not participating, 
    248 Mich App 472
    ; 639
    NW2d 45 (2001).
    3
    is sufficiently reliable to be conclusive.                   When the foreign
    body     alters    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 enables a foreign 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 forth is the basis for the Court
    of Appeals holding:           an unconstitutional delegation occurs
    when a statute         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 assertion of the majority, the Court of
    Appeals did not invent this limitation.                    Rather, it drew it
    directly from this Court's holding in Dearborn Independent,
    Inc v Dearborn, 
    331 Mich 447
    ; 49 NW2d 370 (1951).
    In   Dearborn,    we   examined     a    statute      that   prescribed
    qualifications a newspaper must satisfy in order to publish
    4
    legal notices.     One qualification was that the newspaper
    "shall have been admitted by the United States post-office
    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 properly 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
    constitutionally required to construe the statute as
    continuing to refer to the original federal enactment before
    amendment."    Radecki v Director of Bureau of Worker's
    Disability Compensation, 
    208 Mich App 19
    , 23; 526 NW2d 611
    (1994).
    5
    Here, the statute refers to the findings of the FDA, which are
    based     on    changing   standards.        As   a     consequence,      MCL
    600.2946(5) must be held unconstitutional under the logic
    employed by 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
    Dearborn       as   "incorrectly   decided   in   light    of    the    law's
    subsequent development in this area . . . ."4              Ante at 19-20.
    I disagree with this approach and prefer to square the
    "independently        significant    standard"        doctrine   with     our
    precedent by limiting the doctrine as Dearborn would have
    4
    The majority also holds that any change in FDA standards
    is irrelevant because the Legislature restricted the statute's
    application to the time the drug leaves the manufacturer's
    hands. The date the drug was manufactured is not relevant to
    whether 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?
    6
    limited it.        That is, we should hold it constitutionally
    acceptable to adopt by reference independent decisions of a
    foreign body as long as the 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.    Accordingly,       FDA
    determinations are not "essentially unchanging" and a statute
    that incorporates them perpetrates an unlawful delegation.
    The majority rejects this analysis, saying that the
    determination       of     a     statute's     constitutionality         "cannot
    rationally depend on a court's perception of the relative
    permanence of the actions adopted."                     Ante at 17.       To the
    contrary,    I     believe      that   courts     are    able    to    make   that
    assessment    with       great    accuracy.       Courts    can       distinguish
    between static standards and evolving standards. For example,
    the standard by which the Naval Observatory calculates the
    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        basis     for    upholding      an
    unconstitutional statute and discarding the precedents of this
    7
    Court.
    III
    Some    characterize         MCL   600.2946(5)     as   a   tort-reform
    statute       that    adopts    a    foreign     body's    standards       while
    maintaining the consumer's ability to bring suit in the event
    of fraud or bribery.             It is of interest that, after MCL
    600.2946(5) was enacted, the United States Supreme Court
    decided the case of Buckman Co v Plaintiff's Legal Committee,
    
    531 US 341
    ; 
    121 S Ct 1012
    ; 
    148 L Ed 2d 854
     (2001).                         Under
    Buckman and 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 person who claims to have
    been     injured      by   an   FDA-approved       drug    from    suing     the
    manufacturer in a Michigan court.                When read in conjunction
    with the Buckman decision, this simple tort-reform statute
    becomes elevated to a "tort-elimination" statute.
    IV
    In sum, I would affirm the judgments of the Wayne Circuit
    Court    and    the    Court    of    Appeals    holding   MCL     600.2946(5)
    unconstitutional. The majority misconstrues my position. The
    conclusiveness of the FDA's decisions does not undermine the
    8
    statutes's constitutionality.        What undermines it is the fact
    that the FDA's decisions are founded on shifting standards.
    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
    9