2011 Case Law to follow FDA LAW
Priority to
RA Case
Professionals
1 Smith v. Bayer Corp.
2 PLIVA, Inc. v. Mensing
3 Matrixx Initiatives, Inc. v.
Siracusano
4 Bruesewitz v. Wyeth
5 Sorrell v. IMS Health Inc.
Summary
Several consumers filed a lawsuit in federal court, seeking
permission to proceed as a class action against a drug maker.
After the federal court denied class status, other consumers –
individuals who would have been members of the class but
were not the same people who filed the federal law suit –
attempted to file a separate class action in state court. The
question is whether the federal court had authority to prohibit
the state lawsuit.
Issue: Whether the Eighth Circuit abrogated the Hatch-
Waxman Amendments by allowing state tort liability for
failure to warn in direct contravention of the Act’s
requirement that a generic drug’s labeling be the same as the
labeling approved by the Food and Drug Administration for
the listed (or branded) drug.
Issue: Whether a plaintiff can state a claim under § 10(b) of
the Securities Exchange Act and SEC Rule 10b-5 based on a
pharmaceutical company’s nondisclosure of “adverse event”
reports even though the reports are not alleged to be
statistically significant.
Plain English Issue: Does a drug company violate federal
securities laws by failing to disclose reports of patients having
adverse reactions to its drugs when the number of incidents
was not statistically significant?
Holding: The National Childhood Vaccine Injury Act, which
created a no-fault program to provide compensation for
vaccine-related injuries, preempts all design-defect claims
against vaccine manufacturers by individuals seeking
compensation for injury or death.
Judgment: AFFIRMED, 6-2, in an opinion by Justice
Antonin Scalia on February 22, 2011. Justice Breyer filed a
concurring opinion. Justice Sotomayor filed a dissenting
opinion, which was joined by Justice Ginsburg. Justice Kagan
took no part in the consideration or decision of these cases.
Issue: Whether a law that restricts access to information in
nonpublic prescription drug records and affords prescribers
the right to consent before their identifying information in
prescription drug records is sold or used in marketing violates
the First Amendment.
Plain English Issue: Pharmacies collect data regarding what
drugs doctors prescribe to their patients, and make that data
publicly available (with patient identifying information
redacted) for various uses. Does the First Amendment permit a
state to prohibit drug manufacturers from using that data to
market drugs to doctors?