Title: TAMARA TAYLOR V GATE PHARMACEUTICALS

State: michigan

Issuer: Michigan Supreme Court

Document:

____________________________________________________________________________________________ 
____________________________________________________________________________________________________________________________ 
___________________________________ 
___________________________________ 
___________________________________ 
Michigan Supreme Court 
Lansing, Michigan 48909 
Chie f Justice 
Justices 
Maura D. Corrigan 
Michael F. Cavanagh 
Elizabeth A. Weaver 
Marilyn Kelly 
Clifford W. Taylor 
Robert P. Young, Jr. 
Opinion 
Stephen J. Markman 
FILED MARCH 26, 2003  
TAMARA TAYLOR and LEE ANNE RINTZ,  
Plaintiffs-Appellees,  
v 
No. 120624  
SMITHKLINE BEECHAM CORPORATION,  
Defendant-Appellant.  
TAMARA TAYLOR and LEE ANNE RINTZ,  
Plaintiffs-Appellees,  
v 
Nos. 120637-120640  
GATE PHARMACEUTICALS,  
Defendant-Appellant.  
JUDITH H. ROBARDS and KENNETH W.  
ROBARDS,  
Plaintiffs-Appellees,  
v  
No. 120641  
GATE PHARMACEUTICALS,  
Defendant-Appellant.  
____________________________________ 
___________________________________ 
___________________________________ 
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 “8-½ 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.  
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 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  
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 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  
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