Last month, the Supreme Court of Alabama issued a suprising opinion related to generic drug manufacturers' warnings. In Wyeth,
Inc. v. Weeks, ___ So. 3d ___, 2013 WL 135753 (Ala. Jan. 11, 2013), Weeks
alleged that he suffered injuries as a result of his long-term use of the
prescription drug metoclopramide, which is the generic form of the brand-name
drug Reglan. It was undisputed that
Weeks ingested the generic form of the drug.
In this opinion, the Alabama Supreme Court addressed the following
certified question:
Under
Alabama law, may a drug company be held liable for fraud or misrepresentation
(by misstatement or omission), based on statements it made in connection with
the manufacture or distribution of a brand-name drug, by a plaintiff claiming
physical injury from a generic drug manufactured and distributed by a different
company?
In
an 8 to 1 decision, the Alabama Supreme Court answered:
…
Under Alabama law, a brand-name drug
company may be held liable for fraud or misrepresentation (by misstatement or
omission, based on statements it made in connection with the manufacture of a
brand-name prescription drug, by a plaintiff claiming physical injury caused by
a generic drug manufactured by a different company. Unlike other consumer products, prescription
drugs are highly regulated by the FDA.
Before a prescription drug may be sold to a consumer, a physician or
other qualified health-care provider must write a prescription. The United States Supreme Court in Wyeth v. Levine recognized that Congress
did not preempt common-law tort suits, and it appears that the FDA
traditionally regarded state law as a complementary form of drug
regulation. The FDA has limited
resources to monitor the 11,000 drugs on the market, and manufacturers have
superior access to information about their drugs, especially in the
postmarketing phase as new risks emerge; state-law tort suits uncover unknown
drug hazards and provide incentives for drug manufacturers to disclose safety
risks promptly and serve a distinct compensatory function that may motivate
injured persons to come forward with information. Wyeth
v. Levine, 555 U.S. at 578-79.
FDA
regulations provide that a generic-drug manufacturer’s labeling for a
prescription drug must be exactly the same as the brand-name-drug
manufacturer’s labeling. The Supreme
Court in PLIVA held that it would
have been impossible for the generic-drug manufacturers to change their warning
labels without violating the federal requirement that the warning on the
brand-name version, preempting failure-to-warn claims against generic
manufacturers.
In
the context of inadequate warnings by the brand-name manufacturer placed on a prescription
drug manufactured by a generic-drug manufacturer, it is not fundamentally
unfair to hold the brand-name manufacturer liable for warnings on a product it
did not produce because the manufacturing process is irrelevant to
misrepresentation theories based, not on manufacturing defects in the product
itself, but on information and warning deficiencies, when those alleged
misrepresentations were drafted by the brand-name manufacturer and merely
repeated by the generic manufacturer.
This
opinion includes discussions of (a) Alabama’s Pharmacy Act which permits a
pharmacist to select in place of a brand-name drug a less expensive generic
version and insurance plans’ promoting of using generics; (b) FDA’s
regulations; (c) prior conflicting opinions on this question; and (d) the
learned-intermediary doctrine. As to the
last item, the Alabama Supreme Court observed that Weeks “must show that the
manufacturer failed to warn the physician of a risk not otherwise known to the
physician and that the failure to warn was the actual and proximate cause of
the patient’s injury,” that is, “but for the false representation made in the
warning, the prescribing physician would not have prescribed the medication to
his patent.”
