SAN FRANCISCO – The California Supreme Court will decide a
case that attorneys hope will once-and-for-all put an end to courts allowing
brand-name drug manufacturers to be held liable for injuries resulting from use
of their products’ generic counterparts.
A June Minnesota district court drug manufacturer liability
ruling shed light on the issue of innovator liability, which the California
Supreme Court has agreed to consider after a state appeals court ruled that a
similar case can move forward.
Steven J. Boranian of Reed Smith LLP said innovator
liability was rejected in the Gillette v.
Boehringer Ingelheim Pharm. Inc., case decided by the U.S. District Court
for the District of Minnesota. Boranian said this ruling followed what almost
every other court has decided on the innovator liability issue.
“That was the correct result,” Boranian told the Northern California Record.
However, innovator liability has been allowed in some other
cases, including Conte v. Wyeth, a
2008 ruling in which a California appeals court went against the tide and ruled
that brand-name manufacturers can be liable for injuries allegedly caused by
Under traditional tort law, a product’s seller or
manufacturer can be liable to a product user when a product defect causes an
injury. However, Boranian said innovator liability is a departure from that core
Normally, when a person uses a branded drug and experiences
an injury that he or she attributes to the drug, Boranian said he or she can
sue the brand name manufacturer, also known as the “innovator.” When a person
uses a generic version of the drug and experiences an injury that he or she
attributes to the drug, he or she can sue the generic manufacturer.
Boranian said innovator liability comes into play when
someone uses a generic drug, but then sues the branded manufacturer, not the
generic manufacturer. In that case, the innovator could be potentially liable
for a product that he or she did not make and did not sell.
“That is contrary to well-established product liability
law,” Boranian said.
In the case to be considered by the California Supreme
Court, TH v. Novartis, the California court of appeal ruled that an innovator liability lawsuit can move forward.
Boranian said the California Supreme Court now has the
opportunity to overrule the Conte and
TH opinions and hold unequivocally
that California law does not allow innovator liability.
“Innovator liability is not innovative,” Boranian said. “It
has been roundly rejected outside California with very few exceptions, and it
should be rejected here, too.”
decision, in which innovator liability was rejected, is tied to a Mirapex
multi-district litigation. Although the case was decided by the Minnesota
district court, the litigation falls under the Indiana Products Liability Act.
The plaintiff in Gillette alleged that she gambled
compulsively because she was taking Mirapex. However, pharmacy records revealed
that the gambling issue did not occur until after the plaintiff’s subscription
was changed to the generic version of Mirapex from the brand-name drug.
However, the plaintiff only sued Mirapex, not the manufacturer of the generic