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.

___________________________________ 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

The primary drugs at issue are dexfenfluramine (commonly known as Redux) and fenfluramine and phentermine (commonly referred to as fen-phen when taken together).

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

It is uncontested that the FDA approved the challenged drugs and their labeling before the drugs left the control of any defendant.

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

466 Mich 889 (2002).

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:

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, USC 301 to 321, 331 to 343-2, 344 to 346a, 347, 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

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

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

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).

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.”

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...)

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.”

(...continued) the wheels of government.”

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).

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

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).

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).

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

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.

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.

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

MCL 290.603 provides that basic units of weight and measure “as published by the national bureau of standards” govern transactions in Michigan.

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

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

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

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.”

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

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.

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,

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

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.

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.

Aff’d 396 Mich 660; 242 NW2d 749 (1976).

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

The only basis for the dissent’s position is Dearborn Independent where the doctrine was misunderstood also and accordingly has today been overruled.

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.

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

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,

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

Judge Marianne O. Battani.

Judges William B. Murphy and Kathleen Jansen, Judge Jeffrey G. Collins not participating, 248 Mich App 472; 639 NW2d 45 (2001).

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

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.

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).

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

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?

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

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

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