Tamara Taylor v. Gate Pharmaceuticals ( 2003 )

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
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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?
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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
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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
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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
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