On January 11, 2013, the Alabama Supreme Court issued
an opinion in Weeks v. Wyeth, a
matter pending in the Middle District of Alabama. Wyeth filed an application for
rehearing. On August 15, 2014, the
Supreme Court overruled the rehearing application but substituted a new
opinion. In other words, the January 11,
2013 “outcome” remained unchanged.
The
Middle District posed 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 opinion written by Justice Bolin, the Supreme Court answered in
the affirmative. This “outcome” is
contrary to similar rulings in other jurisdictions.
Weeks’s
treating physician wrote a prescription for Reglan but did not specify that the
pharmacist must fill the prescription with “brand-name” Reglan. As permitted by a state statute and
encouraged by medical insurers, Weeks’s pharmacist provided him with a generic
version of Reglan, which Weeks ingested.
Chief
Justice Moore, who was not on the Court on January 11, 2013, wrote a dissent in
which he advocated that the Court should not have accepted the invitation to
answer the posed certify question because there was an insignificantly
developed factual record.
Wyeth’s
position appeared to be that Weeks was seeking to prosecute AEMLD claims in a
situation where he was injured after taking a drug which was not manufactured
by Wyeth. Justice Bolin wrote that, as
to Wyeth, Weeks was not prosecuting any AEMLD claim, predicated on the
prescribed drug being defectively.
Instead, Weeks’s theory was that Wyeth’s fraudulent conduct lead to
Reglan being prescribed in the manner that it was.
Justice
Bolin noted (a) that, like many states, the Alabama Legislature enacted a law
which allowed pharmacists to substitute a generic version of a prescribed
“brand name” drug unless the physician mandates that the prescription be filled
with the “brand name” manufacturer’s drug and (b) that health insurers and
others prefer filling prescriptions with generics and there are economic
reasons why a patient may be willing to accept a generic over a brand
name. Justice Bolin also outlined the FDA
rules and regulations which prevent generic manufacturers from providing
information and warnings different from those approved for dissemination by the
brand-name manufacturer. In other words,
the brand-name maker, and not the generic company, controls the information
upon which physicians rely in choosing to prescribe the subject drug.
The
opinion expressly stated that the Court was not ruling on the ultimate merits
of the case. The Court merely found that
Weeks could pursue this theory despite having not ingested Wyeth’s product. [This may explain Chief Justice Moore’s
dissent because there were no facts developed as to whether the prescribing
physician relied on Wyeth-supplied information in deciding to prescribe Reglan
in the manner in which he did.]
This
opinion appears to promote the notion that brand-name drug manufacturers should
be held legally accountable if they made misrepresentations or omissions which
resulted in physicians “mis-prescribing” a drug. Brand-name manufacturers know that, when a
physician prescribes a drug by its brand name, the prescription may be filled
with a generic version and that physicians may rely on the information which
can only come from the brand-name manufacturer because the generic manufacturer
typically cannot provide any differing information.
