LAW REVIEW WYETH’S “GERD” DRUG DISCLAIMER RESULTS IN LAWSUIT
The drug manufacturer Wyeth produces the name-brand drug Reglan used to
treat gastroesophageal reflux disease, also known as GERD, a condition I myself
suffer. I also suffer high cholesterol and for that I take…oh forget it. Other less
known manufacturers make generic versions of Reglan, which is actually
metoclopramide. This ‘case of first impression’ arose concerning generic
For four years Plaintiff Elizabeth Conte took a generic prescription drug
equivalent to Reglan. Conte developed a debilitating and incurable neurological
disorder, which she attributed to taking the generic version of Reglan.
Conte sued Wyeth claiming the company knew of a widespread tendency
among physicians to mis-prescribe Reglan and generic metoclopramide for long
periods of time even though the medication is only approved for 12 months of
use—because the drug’s labeling substantially understates the risks of serious
side effects from extended use. I.e. Conte claimed Wyeth disseminated
misleading and/or incomplete warnings about Reglan’s side effects.
Wyeth defended Conte’s suit alleging that her prescribing physician did
not rely upon the Reglan warnings and product labeling, and a name-brand
pharmaceutical manufacturer owes no duty to individuals who take only generic
The trial court ruled in favor of Wyeth. Conte appealed.
Conte alleged a name-brand manufacturer that disseminates information
about its product owes a duty of care to ensure the information’s accuracy to any
doctor who prescribes the drug and relies on the information even if the patient
ends up taking the name-brand product’s generic equivalent. Amazingly, no
court had ever looked at this issue in California before Conte’s suit.
Just as interesting, under California law Wyeth's duty to warn of risks
associated with its products runs to the physician, not the patient, so if someone
is injured by a drug and claims lack of adequate disclosure of the potential
dangers, it's not what they read about the drug that matters, it’s what their
prescribing physician reads. Wow. So it is immaterial if I buy a prescribed drug
relying on misleading labeling by the manufacturer. That does not seem right.
One of the leading cases in this area is Motus v. Phizer. Phizer makes the
antidepressant Zoloft. Motus, like my younger brother, committed suicide a week
or so after his physician prescribed an antidepressant—in his case Zoloft. My
brother was given Effexor, also manufactured by Wyeth—prescribed to him by a
general practitioner without any warning of the drug’s known and well
documented tendency to lead to an increased risk of suicidal behavior.
Victor Modus’s widow sued Phizer but lost because Victor’s prescribing
physician had not read the package insert or the Physician’s Desk Reference
information on Zoloft until after Victor died. Again, that makes no sense.
Under the Hatch-Waxman Amendments, a generic manufacturer is not
required to submit evidence of the drug’s safety, but instead need only certify that
the generic product is the equivalent of the name-brand drug and that the
labeling and the warning for the generic drug is the same as the name brand.
The Court of Appeal concluded that Conte’s physician was familiar with
the Reglan warnings, and just because Wyeth did not manufacture or sell the
generic version of its Reglan did not relieve the company from its obligation to
disseminate accurate product warning labels. The Court wrote: “Wyeth owes a
duty of due care to those people it should reasonably foresee are likely to ingest
metoclopramide in either the name-brand or the generic version when it is
prescribed by their physicians in reliance on Wyeth’s representations (for the
Wyeth's product representations regarding Reglan may be relied upon by
consumers of its generic equivalent as long as the prescribing physician is
familiar with the product labeling and relied upon the representations before the
I would not be surprised if this case is appealed to the California Supreme
Jim Porter is an attorney with Porter Simon, with offices in Truckee, South Lake Tahoe, Incline Village and Reno and a licensed California Real Estate Broker. He was the Governor's appointee to the Bipartisan McPherson Commission on political ethics and the California Fair Political Practices Commission. He may be reached at [email protected] or at the firm’s web
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