Failure To Warn Claims:
The Two-Front War Against the
Manufacturers Of Prescription Drugs
Stephen J. Imbriglia
Newark
New York
Trenton
Philadelphia
Wilmington
Pliva, Inc. v. Mensing:
Whether federal law preempts state law causes of action
based on a claim that a generic drug approved by the
Food and Drug Administration was inadequately labeled.
Wyeth v. Levine, 129 S. Ct. 118 (2009)
Federal law does not preempt state tort claims against
brand-name manufacturers for failure to warn.
State-law failure-to-warn suits posed no obstacles to
federal objectives under FDCA. Also, Congress did not
enact an express preemption provision despite its
awareness of the prevalence of state tort litigation.
Federal regulations provide a mechanism for the
company to change its label and seek FDA approval
later.
Mensing:
Do generic manufacturers have the same opportunities
and requirements to effect labeling changes through the
FDA as brand-name manufacturers?
Do state-law failure-to-warn cases pose an obstacle to
federal objectives under the Hatch-Waxman
Amendments to the FDCA?
U.S. Constitution, Article VI, Clause 2
“This Constitution, and the Laws of the United States
which shall be made in Pursuance thereof…or which
shall be made, under the authority of the United States,
shall be the supreme Law of the Land; and the Judges in
every State shall be bound thereby, any…Law of any
State to the Contrary notwithstanding.”
Federal Preemption
A. Express
B. Implied
1. Field Preemption
2. Conflict Preemption
a. Impossibility Preemption
b. Obstacle Preemption
Mensing
Gladys Mensing, Julie Demahy were prescribed generic
form of Reglan, metaclopramide, for gastric disorders.
Both took the drug for approximately four years before
developing tardive dyskinesia, a serious neurological
disorder.
Mensing, Demahy bring state-law products liability
claims for failure to warm.
Allegation: Despite mounting evidence that long-term
use carried a risk of tardive dyskinesia far greater than
indicated on the label, no metoclopramide manufacturer
changed the labeling to enhance the warning.
FDA Action
On February 26, 2009, FDA ordered manufacturers of
Reglan and metaclopramide to add “black box” warning
advising of increased risk of tardive dyskinesia from
long-term metaclopramide use.
Circuit Court Decisions
Fifth, Eighth Circuits: Claims against generics not
preempted.
Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009)
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010)
Generic Manufacturers Argue:
1. Generic Manufacturers cannot unilaterally add safety
information to labeling. For a generic drug to be
approved, the manufacturer must show that the
proposed labeling is “the same” as that for the listed
drug. FDA regulations provide for revocation of prior
approval, if once on the market, a generic drug’s
labeling is no longer consistent with that for the listed
drug.
2. Generic manufacturers, unlike brand-name
manufacturers, cannot issue letters to prescribing
doctors with supplemental information.
Respondents Argue:
1. Congress did not intend to preempt state-law tort
claims. There is no express preemption in HatchWaxman Amendments.
2. Generic manufacturers have ways to comply with both
federal and state law, for example, the PAS process, in
which a generic manufacturer submits an application to
FDA for a change to ANDA, and the CBE process, in
which a generic company may petition for increased
label warnings.
Justice Scalia
The Second Front
Liability for another company’s product? Plaintiffs
contend that brand-name companies can be held liable
for products of generics.
Arguing that claims against brand companies are not
product-liability claims, but classic claims for fraud and
misrepresentation, plaintiffs contend that defendants
knew that prescriptions would be filled with generic
products; knew that consumers would be harmed; and
took no steps to inform the medical community of earlier
misrepresentations about metoclopramide.
Conte v. Wyeth, 168 Cal. App. 4th 89 (2008):
Brand drug manufacturer owes a duty to use due care
when providing product warnings, and this duty extends
not only to consumers of its products but to consumers
of generic products.
Conte “foreseeability analysis”:
Because it is foreseeable that a prescription written in
reliance on a brand manufacturer’s product information
would be filled with a generic product, there is a duty
running from the brand manufacturer to the consumer of
the generic product.
That the brand manufacturer did not manufacture or sell
the metoclopramide Conte ingested does not relieve the
company of “its general duty to use due care in
disseminating product information to those it knows or
should know are likely to be harmed as a result of their
physician’s reliance on that information.”
The Prevailing View
Conte is distinctly minority view.
See Foster v. American Home Products Corp., 29 F.3d
165 (4th Cir. 1994): (1) plaintiffs’ claims an attempt to
evade product liability law; (2) nothing in federal
regulatory scheme imposes liability on brand
manufacturer for competitor’s generic product; and (3)
brand manufacturer has no duty to consumers of other
companies’ products.
Foster has been frequently followed. See, e.g.,
Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616 (E.D.
Texas 2010).
Concluding Points
Opportunities for implied preemption defense in failureto-warn cases appear to be narrowing. Without an
explicit agency decision, establishing preemption will be
difficult.
Plaintiffs are attempting to expand failure-to-warn liability
beyond manufacturers and sellers. By focusing on the
concept of duty, and dispelling the notion that
foreseeability equates with duty, product manufacturers
and sellers will prevail.