Michael A. Swit, Esq.
Vice President, The Weinberg Group Inc.
Top 20 Food & Drug Cases
Wyeth v. Levine
• Facts:
– Diana Levine – musician; migraines; went to
clinic and given Demerol for pain and
Phenergan (promethazine HCl) for nausea –
both first IM and later in day via IV-Push
method
– Gangrene; amputated arm
– Sued health care facility, clinician, and Wyeth;
settled with all but Wyeth
– Core allegation – labeling should have included
a clear warning not to use IV-Push method.
Top 20 Food & Drug Cases
Wyeth v. Levine …
• Trial Court:
– Jury verdict -- $7.4 million
– Jury instructions -- not objected to by Wyeth -- FDA regulations
allow a drug maker to strengthen label warnings without FDA
prior approval
– Rejected motion to dismiss verdict:
• No direct conflict between FDA law and state law claims
because FDA regulations allow strengthened claims
• Record of at least 20 similar amputations going back to the
‘60’s
• Verdict here would not obstruct FDA’s work because FDA
paid only “passing attention” to the issue of IV-Push
• State law plays a compensatory function not present in
federal regulation
Top 20 Food & Drug Cases
Wyeth v. Levine …
• Vermont Supreme Court – affirmed trial court
• Wyeth at Supreme Court – Two issues
– It would have been impossible to meet the state law
duty to change label without violating Federal law.
Impossibility preemption
– Allowing state law claim creates an unacceptable
“obstacle to the accomplishment and execution of
the full purposes and objectives of Congress” by
substituting a lay jury’s opinion for FDA’s expert
judgment on the labeling
Implied Conflict Preemption
Top 20 Food & Drug Cases
Wyeth v. Levine …
• Net result if Wyeth had won: might have
preempted all state tort failure-to-warn
claims due to FDA’s approval of labeling
• USSC: On preemption, two principles
guide:
– Purpose of Congress
– Presumption -- Historic police powers of state were
not to be superseded by federal law unless “was the
clear and manifest purpose of Congress.”
Top 20 Food & Drug Cases
Wyeth v. Levine …
• Impossibility Preemption – would Wyeth
have violated federal law by complying with
state’s expectation of including a warning on
the IV-Push?
• Supreme Court – No. You could have filed a
Changes Being Effected (CBE) supplement
– Rejected a claim that FDA would not have approved a CBE
supplement on basis of nothing in trial record to
substantiate
– Impossibility preemption – a “demanding defense”
Top 20 Food & Drug Cases
Wyeth v. Levine …
• “Obstruct Purposes” Issue
– USSC – all evidence exists that Congress intended for
state law claims to remain. Examples:
• did not create a private right of action in 1938
• never has created express preemption for drugs (contrast
devices)
– USSC – FDA’s 2006 declaration that it preempted
state law on labeling – weight given that conclusion is
a factor of the ”thoroughness, consistency and
persuasiveness” of the agency statement
• USSC – 2006 preamble “does not merit deference”
– Preemption not discussed in 2000 proposal; “inherently suspect
in light of this procedural failure”
– Contradicts Congressional intent and years of FDA stance on
matter
Top 20 Food & Drug Cases
Wyeth v. Levine …
• “Obstruct Purposes” Issue …
– Benefits of state law do not conflict with
FDA’s mission
• Uncover unknown drug hazard
• Provide incentives for manufacturers to disclose
safety risks promptly
• Distinct compensatory function (not present in
fed system)
– In sum, Wyeth did not show that the state
law requirement of greater warning would
frustrate FDA’s purposes
Top 20 Food & Drug Cases
Wyeth v. Levine … The Future?
• Might still claim preemption if you can show you
did all that was possible and FDA would not
allow you to put it on your label
– CBE’s will multiply
– SSRI’s – might prevail on failure to warn
because FDA has reviewed and rejected need
for suicidal warnings
• But – Mason v. SKB – ignored Levine
• No impact on Buckman – that fraud on
FDA claims are preempted
Top 20 Food & Drug Cases
Perez v. Nidek
• Facts:
– Nidek has PMA approval for excimer lasers for
LASIK and PRK for myopia, but not hyperopia
– Plaintiffs – Nidek and doctor defendants
conspired to use lasers for hyperopia uses not
approved in PMAs
– Claims: numerous California state law
violations based on FDA violations
– Filed in U.S. District Ct. for Southern District of
California
Top 20 Food & Drug Cases
Perez v. Nidek
• Federal Question Jurisdiction claimed due
to the alleged FDCA violations.
– COURT: no; the alleged violations clash with
Section 337(a) of FDCA –
• “… all proceedings for the enforcement, or to
restrain violations [of the Act] shall be by and in the
name of the United States.” Courts: no private right
of action under the FDCA
• “When there is no private right of action under a
federal statute such as the FDCA, “the presence of a
claimed violation of the statute as an element of a
state cause of action is insufficiently ‘substantial’ to
confer federal question jurisdiction.”…”
Top 20 Food & Drug Cases
Perez v. Nidek
• Plaintiffs – Preemption Defense
conferred Fed. Question Jurisdiction.
– Court -- rejected
• “… [t]he fact that a defendant might ultimately
prove that a plaintiff’s claims are preempted …
does not established federal jurisdiction.
Caterpillar v. Williams, 482 U.S. 386, 398 (1987).
Preemption gives rise to federal question
jurisdiction only when an area of state law has
been completely preempted by federal law. Id.
At 393.”
Top 20 Food & Drug Cases