                                                                       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

