Garcia v. Wyeth-Ayerst ( 2004 )

RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
File Name: 04a0346p.06
UNITED STATES COURTS OF APPEALS
FOR THE SIXTH CIRCUIT
_________________
JULIA GARCIA , X
Plaintiff-Appellant, -
-
- No. 03-1712
v. -
>
,
WYETH-AYERST LABORATORIES, -
Defendant-Appellee. -
N
Appeal from the United States District Court
for the Eastern District of Michigan at Bay City.
No. 01-10002—David M. Lawson, District Judge.
Argued: August 5, 2004
Decided and Filed: October 7, 2004
Before: KENNEDY, SUTTON, and COOK, Circuit Judges.
_________________
COUNSEL
ARGUED: John J. Schutza, WORSHAM & VICTOR, Southfield, Michigan, for Appellant. Shana J. Long,
SHOOK, HARDY & BACON, Kansas city, Missouri, for Appellee. ON BRIEF: Richard B. Worsham,
WORSHAM & VICTOR, Southfield, Michigan, for Appellant. Shana J. Long, Michael L. Koon, SHOOK,
HARDY & BACON, Kansas city, Missouri, Scott L. Gorland, PEPPER HAMILTON, Detroit, Michigan,
for Appellee.
_________________
OPINION
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KENNEDY, Circuit Judge. Plaintiff Julia Garcia appeals the district court order granting summary
judgment to Defendant Wyeth-Ayerst Laboratories in this drug product liability case on the basis of a
statutory immunity provided in MICH. COMP. LAWS § 600.2946(5). Plaintiff argues that the district court
erred in failing to declare the statute unconstitutional on the grounds that (1) it has been impliedly preempted
by the federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq., in violation of the Supremacy
Clause, (2) it has interfered with her fundamental right of access to the courts and her Seventh Amendment
right to a jury trial, and (3) it violated the Due Process Clause by depriving her of the right to use a
traditional common law tort remedy as a means of seeking redress for her injuries. Finding no error in the
district court’s decision, we affirm.
1
No. 03-1712 Garcia v. Wyeth-Ayerst Laboratories Page 2
BACKGROUND
In September of 1997, Plaintiff was treated for persistent pain in her neck and shoulders by her
physician. To alleviate her pain, her physician gave her multiple prescriptions for Duract, a non-steroidal,
anti-inflammatory prescription medication manufactured by Defendant. The medication had been approved
for use earlier that year by the United States Food and Drug Administration (“FDA”). The medication,
however, caused liver failure and Plaintiff was required to undergo a liver transplant in 1998 to save her life.
Plaintiff sued Defendant for making and selling an unsafe drug, and she seeks compensation for her injury,
reimbursement for past medical expenses, and future medical expenses including a likely additional liver
transplant. Defendant has since voluntarily withdrawn the drug from the market. The district court granted
Defendant’s motion for summary judgment and dismissed the case on the basis of Michigan’s products
liability statute that immunizes drug manufacturers from liability under certain conditions. The present
appeal followed.
ANALYSIS
Michigan law governs this diversity action. Westfield Ins. Co. v. Tech Dry, Inc., 336 F.3d 503, 506
(6th Cir. 2003). The State of Michigan has adopted a drug products liability statute that immunizes drug
manufacturers from liability from damages in suits contending that their drug was defective or unreasonably
dangerous “if the drug was approved for safety and efficacy by [the FDA], and the drug and labeling were
in compliance with [the FDA’s] approval at the time the drug left the control of the manufacturer or seller.”
MICH. COMP . LAWS § 600.2946(5). The immunity is subject to two exceptions: (1) if the manufacturer
intentionally withheld or misrepresented material information concerning the drug that it is required to be
submitted under the Food and Drug Cosmetics Act and the drug would not have been approved, or the FDA
would have withdrawn approval if the information was accurately submitted to the FDA, or if the
manufacturer bribed an FDA official or employee to secure the drug’s approval, MICH . COMP. LAWS
§ 600.2946(5)(a) & (b); and (2) if the offending drug was sold after the FDA withdrew approval or ordered
the drug removed from the market, id.
In prior unrelated litigation, the Michigan Court of Appeals had held that this statute was repugnant
to the Michigan Constitution because it impermissibly delegated legislative authority to the FDA as the final
arbiter of drug safety in Michigan. Taylor v. Gate Pharms., 639 N.W.2d 45 (Mich. Ct. App. 2001). The
Michigan Supreme Court overturned that ruling holding that:
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.
Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 134 (Mich. 2003). It concluded that the statute’s
linking of dangerousness to the FDA’s complex and detailed approval process is nothing more than an
incorporation of common standards, such as weights and measures or the time of day, which are also
determined by federal agencies. According to the Michigan Supreme Court, therefore, the statute is valid
under the Michigan Constitution. Plaintiff in this case, however, challenges the applicable statute under the
federal constitution. As the district court properly noted, a federal court evaluating the statute’s validity
under the federal constitution is not bound by a state court’s evaluation of the same statute under the state
constitution. Garcia v. Wyeth-Ayerst Labs., No. 01-10002-BC, slip op. at 3 (E.D. Mich. May 19, 2003)
(citing Barden Detroit Casino, L.L.C. v. City of Detroit, 230 F.3d 848 (6th Cir. 2000)). Before the district
court, Plaintiff argued that the Michigan statute is unconstitutional because (1) it had been impliedly
preempted by the FDCA and therefore runs afoul of the Supremacy Clause, (2) it interferes with Plaintiff’s
fundamental right of access to the courts and her Seventh Amendment right to a jury trial, and (3) it violates
the Due Process Clause by depriving her of the right to use a traditional common law tort remedy as a means
No. 03-1712 Garcia v. Wyeth-Ayerst Laboratories Page 3
of seeking redress for her injuries.1 For the reasons stated below, we agree with the district court that
Plaintiff’s arguments are without merit.
A. Implied Preemption
Plaintiff argued before the district court that Section 600.2946(5) conflicts with and is impliedly
preempted by federal law because it requires one to prove fraud on the FDA as part of her cause of action
against Defendant. She cannot prove fraud on the FDA because such claims are preempted by federal law
and, thus, cannot bring herself within the exceptions. The district court agreed with Plaintiff that the fraud-
on-the-FDA exception to the general statutory immunity was preempted by federal law but held that it could
sever the offending exception and uphold the general statutory immunity in light of an explicit severability
provision in MICH. COMP. LAWS § 8.5.
In general, a federal law may preempt a state law in any of the following three scenarios. First, a
federal statute may expressly preempt the state law. Gibson v. Am. Bankers Ins. Co., 289 F.3d 943, 948 (6th
Cir. 2002). Second, a federal law may impliedly preempt a state law. Id. at 948-49. Third, preemption
results from an actual conflict between a federal and a state law. Id. at 949. Since neither express
preemption nor an actual conflict is present in this case, we are concerned solely with the question of implied
preemption. As this Court has explained:
Implied preemption occurs if a scheme of federal regulation is so pervasive as to make
reasonable the inference that Congress left no room for the States to supplement it, if the Act
of Congress touches a field in which the federal interest is so dominant that the federal
system will be assumed to preclude enforcement of state laws on the same subject, or if the
goals sought to be obtained and the obligation imposed reveal a purpose to preclude state
authority.
Id. (citations omitted). As the district court properly noted, in “analyzing implied preemption, a court must
begin with the assumption that a state law is valid and should be reluctant to resort to the Supremacy
Clause.” Garcia v. Wyeth-Ayerst Labs., No. 01-10002-BC, slip op. at 7 (E.D. Mich. May 19, 2003)
(citations omitted).
The United States Supreme Court has expressly considered the question of a state common law
fraud-on-the-FDA tort claim and found that it was impliedly preempted by the FDCA and the Medical
Device Act (“MDA”), 21 U.S.C. §§ 360e(b)(1)(A) & (B). Buckman Co. v. Pls.’ Legal Comm., 531 U.S.
341, 350 (2001) (explaining that “[s]tate-law fraud-on-the-FDA claims inevitably conflict with the FDA’s
responsibility to police fraud consistently with the Agency’s judgment and objectives.”) This case, however,
presents a somewhat different legal regime from the one invalidated in Buckman. The Michigan legislature
has provided a general immunity for drug manufacturers with a specific exception for circumstances
involving, inter alia, fraud on the FDA2 rather than a specific cause of action for fraud on the FDA. This
1
On motion for summary judgment, the district court held that Plaintiff had submitted no evidence supporting its claims of
bribery or misrepresentation to the FDA, nor any evidence that the withdrawal of Duract was precipitated by the FDA or based
on any provable misconduct by Defendant. Plaintiff has not appealed that determination. Therefore, Plaintiff can only succeed
in this action if we find that the two exceptions are unconstitutional and that the offending exceptions cannot be severed from the
general immu nity provision, thereby invalidating the general immunity provision and stripping Defendant of its statutory
protection.
2
The statute p rovid es, in relev ant part:
(5) In a product liability action against a manufacturer or a 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 lab eling 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 se ller....This
subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the
No. 03-1712 Garcia v. Wyeth-Ayerst Laboratories Page 4
difference, however, is immaterial in light of Buckman. As the district court properly found, “Buckman
teaches that state tort remedies requiring proof of fraud committed against the FDA are foreclosed since
federal law preempts such claims.” Garcia v. Wyeth-Ayerst Labs., No. 01-10002-BC, slip op. at 8 (E.D.
Mich. May 19, 2003).
Having concluded that M.C.L. § 600.2946(5)(a) and (b) were unconstitutional, the district court had
to consider what effect that conclusion had on the rest of M.C.L. § 600.2946(5). It is unclear whether the
district court concluded that the offending subsections can simply be severed from the rest of the section,
giving drug manufacturers a full immunity from state-law lawsuits in the State of Michigan as long as they
complied with the FDA’s requirements and the drug had been approved by the FDA, or whether it concluded
that in view of the preemption “the exceptions can only be triggered by a finding by the FDA that a drug
manufacturer committed fraud or bribed an FDA official in order to obtain approval of a drug.” Appellee’s
Br. at 18.
It is one thing, however, to say that Buckman applies to the exemptions contained in Michigan
Compiled Laws § 600.2946(5); it is quite another to say that Buckman preempts these exemptions in all of
their applications. Doubtless, Buckman prohibits a plaintiff from invoking the exceptions on the basis of
state court findings of fraud on the FDA. Such a state court proceeding would raise the same inter-branch-
meddling concerns that animated Buckman. But the same concerns do not arise when the FDA itself
determines that a fraud has been committed on the agency during the regulatory-approval process. Cf.
Buckman, 531 U.S. at 351 (“[F]raud-on-the-FDA claims would also cause applicants to fear that their
disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient
in state court.”). Thus, in this setting, it makes abundant sense to allow a State that chooses to incorporate
a federal standard into its law of torts to allow that standard to apply when the federal agency itself
determines that fraud marred the regulatory-approval process. In the final analysis, the exemptions are
invalid as applied in some settings (e.g., when a plaintiff asks a state court to find bribery or fraud on the
FDA) but not in others (e.g. claims based on federal findings of bribery or fraud on the FDA).
Having concluded that Michigan Compiled Laws § 600.2946(5)(a)&(b) are unconstitutional in some
settings – including plaintiff’s own suit (as she alleged bribery and fraud on the FDA but did not offer any
federal findings) – we now face the issue urged upon us by the plaintiff: Does the preemption of these
exemptions in some settings requires us to invalidate § 600.2946(5) in its entirety? We do not think so.
The Michigan Legislature has provided a general severability clause that applies to all its enactments.
The clause provides:
In the construction of the statutes of this state the following rules shall be observed unless
such construction would be inconsistent with the manifest intent of the legislature, that is to
say: If any portion of an act or the application thereof to any person or circumstances shall
be found to be invalid by a court, such invalidity shall not affect the remaining portions or
applications of the act which can be given effect without the invalid portion or application
. . ., and to this end acts are declared to be severable.
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 . . ., and the drug
would have not 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 p urpose
of securing or maintaining approval of the drug.
M ICH . C O M P . L AWS § 600.29 46(5).
No. 03-1712 Garcia v. Wyeth-Ayerst Laboratories Page 5
Mich. Comp. Laws § 8.5. See also Maki v. East Tawas, 188 N.W.2d 593, 596 (Mich. 1971) (upholding the
remainder of the enacted law because it is “otherwise complete in itself and capable of being carried out
without reference to the unconstitutional” section). The question, accordingly, is whether the Michigan
Legislature would have preferred the situation where drug manufacturers would enjoy immunity in the
absence of a federal finding of bribery or fraud on the FDA, or the situation urged by the Plaintiff where drug
manufacturers would enjoy no immunity at all. As we explained on an earlier occasion, the law remaining
after an invalid portion of the law is severed will be enforced independently “unless the invalid provisions
are deemed so essential, and are so interwoven with others, that it cannot be presumed that the legislature
intended the statute to operate otherwise than as a whole.” Moore v. Fowinkle, 512 F.2d 629, 632 (6th Cir.
1975).3
We find that Plaintiff has failed to persuade us that the district court erred as a matter of law, and that
given a choice between immunity absent a finding of bribery or fraud by the Federal Government and no
immunity, the Michigan Legislature would prefer the former option. First, it appears that the Michigan
legislature was concerned that unlimited liability for drug manufacturers would threaten the financial
viability of many enterprises and could add substantially to the cost and unavailability of many drugs. See
generally State Fiscal Agency, Revised Bill Analysis, S.B. 344 & H.B. 4508 (Mich. 1996). Second, and
most importantly, severing the preemption exemptions will not give license to drug manufacturers to use
bribery or fraud as a means of obtaining FDA approval, then rely on that approval as a shield from products
liability: it will merely place responsibility for prosecuting bribery or fraud on the FDA in the hands of the
Federal Government rather than state courts.
B. Access to Courts and the Right to a Jury Trial
Plaintiff also argues that her rights to have access to courts and a jury trial have been violated by her
complete inability to obtain relief for her injury. We find it unnecessary to add anything to the thoughtful
analysis provided by the district court on this question:
Although a right-of-access case can be established when a person can prove that a
state’s judicial process does not provide an adequate procedure to remedy an alleged wrong,
see Glover v. Johnson, 75 F.3d 264, 268 (6th Cir. 1996) (“Access to the courts . . .
encompasses all the means a defendant . . . might require to get a fair hearing from the
judiciary on all charges brought against him or grievances alleged by him.”) (citing Gilmore
v. Lynch, 319 F. Supp. 105, 110 (N.D. Cal. 1970), aff’d sub nom. Younger v. Gilmore, 404
U.S. 15 (1971), such claims are generally recognized for civil litigants only in the context of
spoliation of evidence or interference with filing a lawsuit. See [Swekel v. City of River
Rouge, 119 F.3d 1259, 1263-64 (6th Cir. 1997)]. A cognizable claim can be made out “only
by showing that the defendants’ actions foreclosed [a potential litigant] from filing suit in
state court or rendered ineffective any state court remedy [the litigant] previously may have
had.” Ibid. The argument that a state statute stiffens the standard of proof of a common law
claim does not implicate this right.
In this case, the plaintiff does not allege that she was unable to gain access to court
to litigate her claim. Rather, she contends in essence that Section 600.2946(5) requires too
much, and that the immunity it grants to drug manufacturers is too broad. These allegations
do not constitute a claim of denial of access to the courts.
3
W here possible, the Supreme Court “interp rets congressional enactm ents to avoid raising serious constitutional questions,”
Cheek v. United States, 498 U.S. 192 (1991) (citations omitted). The Michigan courts adhere to a similar principle. “A legislative
enactment can be held to be facially invalid only if there are no factual circumstances under which the provision could be
constitutionally implemented.” Gera v. M axw ell, et al., 456 M ich. 704 (1998) (citing United States v. Salerno, 481 U.S. 731,
739 (1987) n.15, Pigorsh v. Fahner, 386 Mich. 508 (1972) at 509 (we are bound, if possible, to construe statutes as to give them
validity and a reasonable interpretation)).
No. 03-1712 Garcia v. Wyeth-Ayerst Laboratories Page 6
Garcia v. Wyeth-Ayerst Labs., No. 01-10002-BC, slip op. at 19-20 (E.D. Mich. May 19, 2003). Plaintiff has
failed to set forth any legally binding precedent that would warrant a reversal of the district court’s opinion
in this respect.
C. Due Process
Plaintiff finally challenges the district court’s finding that the abolition of her cause of action does
not violate the Due Process Clause. Plaintiff’s argument is without merit. As this Court has previously
stated,
Legislatures do not violate federal due process rights by creating statutes of repose that
prevent causes of action from accruing. A litigant has no vested property right in a cause of
action until it accrues. The United States Supreme Court has held that due process does not
prohibit the abolition of causes of action[. Those] cases have clearly established that a
person has no property, no vested interest, in any rule of the common law [,and that t]he
“Constitution does not forbid the creation of new rights, or the abolition of old ones
recognized by the common law, to attain a permissible legislative object” despite the fact that
otherwise settled expectations may be upset thereby.
Hartford Fire Ins. Co. v. Lawrence, Dykes, Goodenberger, Bower & Clancy, 740 F.2d 1362, 1367 (6th Cir.
1984) (citations omitted). The only question for us to consider is whether Section 600.2946(5) rationally
furthers a legitimate state objective. On that point, we agree with the district court’s finding that “the
Michigan legislature acted within its authority when it granted immunity from liability to drug sellers and
manufacturers who market their products after obtaining approval from the FDA.” Garcia v. Wyeth-Ayerst
Labs., No. 01-10002-BC, slip op. at 14 (E.D. Mich. May 19, 2003).
CONCLUSION
For the reasons stated above, we affirm the district court’s order granting summary judgment in favor
of Defendant.