Conte vs. Wyeth, INC
Court of Appeal, First
District, Division 3
Decided: November 7, 2008
Plaintiff Elizabeth Conte developed a serious and
irreversible neurological condition. She alleges her condition is due to her
long-term consumption of a generic prescription drug, and that the warnings
provided by the manufacturers of the drug failed to adequately warn of known
dangers resulting from its long-term use.
The trial court granted summary judgment in favor of all the
manufacturers. Judgment was entered in favor of Wyeth, Inc. (Wyeth), the
name-brand manufacturer of the drug, on two grounds: (1) Conte could not show
that she or her physician relied upon warnings or product labeling disseminated
by Wyeth; and (2) a name-brand pharmaceutical manufacturer owes no duty to
individuals who take only generic versions of its product. The court granted
summary judgment in favor of three generic manufacturers on grounds of federal
preemption and Conte's lack of reliance on their warnings or product labeling.
We hold that the common law duty to use due care owed by a
name-brand prescription drug manufacturer when providing product warnings
extends not only to consumers of its own product, but also to those whose
doctors foreseeably rely on the name-brand manufacturer's product information
when prescribing a medication, even if the prescription is filled with the
generic version of the prescribed drug. We further conclude that Conte has
shown there is a material factual dispute as to whether her doctor relied on
Wyeth's product information, but that she is unable to show he relied on any
information supplied by the generic manufacturer defendants.
Accordingly, we reverse the judgment in favor of Wyeth and
affirm the summary judgment in favor of each of the three generic
manufacturers. In light of our disposition of this appeal, it is unnecessary
for us to reach the generic defendants' further contention that federal law
preempts state tort claims based upon allegedly inadequate drug labeling.
The
defendants in these consolidated appeals manufacture and market metoclopramide,
which Conte's physician prescribed in its generic and name brand form, Reglan,
to treat her gastro esophageal reflux disease. Wyeth manufactures and markets
Reglan. Defendants Pure Pac Pharmaceutical Company (Pure Pac), Teva
Pharmaceutical USA, Inc. (Teva), and Pliva, Inc. (Pliva) manufacture generic
versions of metoclopramide.
Conte
developed tardive dyskinesia, a debilitating and incurable neurological
disorder. She alleges she developed her condition as a result of taking
metoclopramide for almost four years between August 2000 and April 2004. It is
undisputed that Conte took only the generic version of the medication, not
Reglan. She claims that defendants knew or should have known of a widespread
tendency among physicians to misprescribe Reglan and generic metoclopramide for
periods of 12 months or longer, even though the medication is only approved for
12 weeks of use, because the drugs labeling substantially understates the risks
of serious side-effects from extended use.
Her
complaint, after various pretrial amendments, asserts claims for fraud, fraud
by concealment and negligent misrepresentation 1 against Wyeth; negligence, strict products
liability, negligence per se, and breach of express and implied warranties
against the generic manufacturers; and medical negligence against her doctor,
Robert Elsen, M.D. The crux of Conte's claims against all of the drug company
defendants is that she was injuriously overexposed to metoclopramide due to
their dissemination of false, misleading and/or incomplete warnings about the
drug's side effects.
Purepac
successfully moved for summary judgment on the ground that Conte's claims
against it are preempted by the federal Food, Drug and Cosmetic Act (FDCA) (21
U.S.C. § 301 et seq.) and its implementing regulations.
Pliva and
Teva subsequently filed a joint motion for summary judgment on the same basis.
While the Pliva/Teva motion was pending, Wyeth moved separately for summary
judgment arguing its product information had no causal relationship to Conte's
injuries and it owed her no duty of care. Unlike the generic manufacturers, it
did not assert that Conte's claims were preempted by federal law. Pliva (but
not Purepac or Teva) joined in Wyeth's motion asserting a lack of causation, and
argued Conte could not prove any alleged inadequacies in its own labeling 2 caused
her injuries because neither she nor her doctor relied on it.
The court
granted Wyeth's motion on both grounds. The court found that neither Conte nor
her doctor relied on drug information provided by Wyeth, and that as a
name-brand manufacturer; Wyeth owes no duty of care to the users of generic
versions of its name-brand drug. The court subsequently granted the Pliva/Teva
summary judgment motion on the ground that Conte's state tort claims were
preempted by federal law.
Conte timely
appealed the judgments in favor of each company. We granted her unopposed
motion to consolidate the appeals for purposes of briefing, oral argument, and
decision.
Similar to Pliva vs. Mensing, it is said that generic brand
drugs are not at fault for the injury that happens to the patient, but rather
it is the name brand’s liability. The court decided that "those whose doctors foreseeably rely
on the name-brand manufacturer's product information when prescribing a
medication, even if the prescription is filled with the generic version of the
prescribed drug." Thus making name brands to be held accountable since generic brands are
using the same ingredients and warnings as the name brands. In this specific
case, because the court found it foreseeable that physician would prescribe a
generic version in reliance on Wyeth’s representations about Raglan
the court allowed the negligence claims against Wyeth.
