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Michigan Supreme Court 

Lansing, Michigan 48909 

Chie f Justice Justices 

Maura D. Corrigan Michael F. Cavanagh 

Elizabeth A. Weaver 

Marilyn Kelly 

Clifford W. Taylor Opinion 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
 

1The 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
 

2It is uncontested that the FDA approved the challenged


drugs and their labeling before the drugs left the control of


any defendant.
 

3248 Mich App 472; 639 NW2d 45 (2001).
 

4466 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
 

5The 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).
 

6As 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.”
 

7See 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.”
 

8The 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
 

9In 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). 


10What 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
 

11For example, pursuant to MCL 168.544c(1), nominating


petitions must be “8-1⁄2 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.
 

12Representative 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
 

13MCL 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 commonlaw duty of reasonable care in a drug products liability tort
 

case, the panel and the dissent in this Court contend that MCL
 

600.2946(5) went beyond this and gave the FDA the authority to
 

“make, alter, amend, and repeal laws.” 248 Mich App 478.
 

This is 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
 

14In 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
 

15Moreover, 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 secondclass 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
 

16We 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.
 

17Aff’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
 

18The only basis for the dissent’s position is Dearborn
 

Independent where the doctrine was misunderstood also and
 

accordingly has today been overruled.
 

19Although, 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
 

1Judge Marianne O. Battani.
 

2Judges 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.
 

3In 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
 

4The 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