1 british institute of international and comparative law september 25, 2008 joseph k. hetrick

1

British Institute of International and Comparative Law

September 25, 2008

Joseph K. Hetrick

2

Federal Preemption of State Law

• “Implied Conflict Preemption”

– The federal laws of the United States preempt, or supersede, the laws of the states in three situations, one being “implied conflict preemption”

– “Implied conflict preemption” means state law cannot create liability for acts mandated by federal law, i.e., a party cannot be liable under state law for following federal law

– Analogous to European Union Directives

• European Union Member States’ laws cannot be at odds with Directives of the European Union

3

The FDA Final Rule and Preamble

• Issued January 24, 2006

• New rule mandating new content and format of labeling for, among other things, prescription drugs sold in the United States

• Effective June 30, 2006

4


• The Preamble to the Final Rule addresses federal conflict preemption

• FDA stance is very clear:

– “FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.” 71 Fed. Reg. 3,934 (2006)

5


• FDA reasons for conflict preemption:

– FDA is expert U.S. agency charged with ensuring that drugs are safe and effective

– State courts should not decide on a case-by-case basis whether individual warnings, including those rejected by FDA, should have been included on a label

– “Overwarning” just as dangerous as “underwarning”

6


• FDA reasons for conflict preemption (continued):

– FDA regulations are both “ceiling” and “floor”

– adding unapproved language to label may make manufacturer liable in government enforcement action for making label “false or misleading”

– (See generally 71 Fed. Reg. 3,933-36 (2006))

7

Colacicco v. Apotex, Inc., et al.

• Colacicco v. Apotex, Inc., et al., filed in federal court alleging state claims, E.D. Pa. Civ. A. No. 05-5500, Oct. 21, 2005

• Plaintiff suing both generic and pioneer drug manufacturer on behalf of his wife’s estate under state law

• Plaintiff’s wife committed suicide while on the generic form of Paxil® in October 2003

• Plaintiff claimed, among other things, that manufacturers failed to warn of risk of increased suicidal behavior

8


• Pioneer manufacturer argued that the Decedent did not ingest its product, so it could not be liable

• Both generic and pioneer manufacturer argued that federal law prevented them from warning the Decedent

– Modifying the label without FDA permission would expose them to liability for misbranding

– Therefore, federal labeling law “preempted” Plaintiff’s state law claims

9


• The FDA weighs in

• After lengthy briefing, the Court invites the FDA to file an amicus brief on the “novel” preemptions issues

10


• The FDA’s tantalizing brief:

– FDA notes that it already considered Paxil’s® safety and efficacy and did not find, at the time, a warning concerning adult suicidal behavior was warranted. Br. at 6-11.

– Any such warning would have been “deemed ‘misleading’ and, thus, a violation of federal law.” Br. at 15.

11


• The Court’s ultimate ruling…

• The Court agrees with the manufacturers and the FDA:

– Rules that pioneer manufacturer cannot be liable for ingestion of generic version of its product. Op. at 1.

– “a name brand drug manufacturer does not owe a legal duty to consumers of a generic equivalent of its drug.” Op. at 36.

12


• The Court also agrees with the points raised in the FDA’s amicus brief:

– The Court noted that the FDA’s position was consistent with the view taken in two prior FDA amicus briefs in other failure-to-warn cases. See Op. at 16.

– It was “appropriate to afford deference to the FDA’s position” that any label change would have “constituted misbranding” and would have been “contrary to the [then available] scientific evidence…” Op. at 17.

13


• The Court also recognized the statements in the Preamble

– The Court deferred to the FDA’s clear statement of policy in the Preamble: “the FDA’s position that it is merely clarifying its “longstanding views on preemption,” 71 Fed. Reg. at 3934….” Op. at 28.

– “[I]t is not the function of this Court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA’s about these medical issues.” Op. at 21.

14


-The Court also recognized that the adequacy of warnings is a matter for legislation, not ad hoc judicial intervention:

“this is not a case about individual rights or Constitutional interpretation, in which judges have obligations to protect civil liberties, but is essentially a case about economics — whether a drug company should be at risk for damages because of the death of a woman taking its drugs. When Congress established the elaborate system of legislation for the introduction of new drugs, and authorized a federal agency to implement and police its operation, the resolution of claims arising out of alleged shortcomings in drug instructions and labeling should be as allowed by Congress. Congress has not provided for such claims, and the FDA has taken the position that plaintiff’s claims based on state law are inconsistent with its statutory-administrative regimen.” Op. at 31.

15

The Appeal

• Colacicco was recently affirmed by the United States Court of Appeals for the Third Circuit, in a very strong decision.

• A petition for review has been filed before the United States Supreme Court.

• Thus, it is possible that the Colacicco case may be heard along with the Wyeth by the Supreme Court.

16

What is the current state of preemption law?

• The United States Supreme Court in February, 2008 decided Riegel v. Medtronic, Inc., a medical device case

• The Court held that traditional product liability claims against manufactures of medical devices are preempted by the express provisions of the Medical Device Act

17

Pharmaceuticals

• The US Supreme Court has not yet spoken definitively on this issue, but the most recent decision, Warner-Lambert v. Kent resulted in a stalemate

– This case really presents a case of statutory construction, not pure pre-emption

– At least 3 pharmaceutical cases are briefed and ready for decision

18

Preemption Beyond Health Care

• Automobiles — do existing status for seatbelts, glass, etc. preempt tort claims?

• Railways statutes — attempts are being made to pre-empt asbestos claims.

• Tobacco — does the Cigarette Labeling Act pre-empt “light” cigarette suits?

• Insurance — do flood insurance regulations pre-empt “bad faith” claims?

• Employment — are discrimination claims pre-empted by the Labor Management Relations Act?

1 british institute of international and comparative law september 25, 2008 joseph k. hetrick

Documents