By Terry Baynes
(Reuters) - A federal appeals court on Wednesday offered a
glimmer of hope to plaintiffs' lawyers seeking to hold generic
drugmakers liable for injuries allegedly caused by copycat
The 6th U.S. Circuit Court of Appeals in Cincinnati revived
a lawsuit by Eleanor Fulgenzi, a woman who claimed generic drug
company PLIVA Inc failed to warn her of the risks of developing
a neurological movement disorder after using its gastric reflux
drug for an extended period of time.
The ruling is significant because plaintiffs like Fulgenzi
making "failure-to-warn" claims against generic makers have made
little headway in the wake of the 2011 U.S. Supreme Court ruling
PLIVA v. Mensing. In that case, the high court found that
consumers could not bring failure-to-warn claims against
generics under state law because federal law requires that the
labels on generic drugs must match the labels on their
However, during the course of the Mensing litigation, it
emerged that PLIVA had failed to update the label on its gastric
reflux drug, metoclopromide, to bring it in line with the brand
version, Reglan, made by Schwarz Pharma.
The Food and Drug Administration approved Reglan in 1980,
and generics began producing copycat versions five years later.
The initial warning label on the drug read: "Therapy longer than
12 weeks has not been evaluated and cannot be recommended."
Over time, evidence mounted suggesting that long-term use of
the drug could cause tardive dyskinesia, a neurological disorder
affecting the lower face. In 2004, the FDA approved a label
change proposed by the brand drugmaker stating in bold type:
"Therapy should not exceed 12 weeks in duration." PLIVA did not
update the label for its generic version and did not communicate
the change to any physicians, according to the court's opinion.
In 2009, the FDA ordered a black-box warning for the drug,
saying that treatment for more than 12 weeks should be avoided
in all but rare cases.
In her lawsuit, filed in 2009, Fulgenzi argued that because
she took the drug between 2004 and 2007, when PLIVA's warning
label was out-of-date, the generic drugmaker should be liable
for her neurological injuries allegedly caused by the drug.
PLIVA responded that Fulgenzi was attempting to bring a
failure-to-warn claim against a generic drugmaker, which was
barred by the Supreme Court's Mensing decision. The company also
argued that her suit was an attempt to enforce a federal
labeling requirement, a power reserved to the FDA.
The district court in Akron, Ohio, agreed with PLIVA that
the Mensing ruling knocked out Fulgenzi's claims and dismissed
the case, but a three-judge panel of the 6th Circuit disagreed
on Wednesday, reviving the suit.
The panel found Fulgenzi's case was different from the
Mensing case, where the plaintiff had taken the generic drug
when its label conformed to the brand drugmaker's label. In
Mensing, it would have been impossible for the generic company
to provide a stronger warning while following federal law, which
required the generic to have the same label as the brand. In
Fulgenzi's case, PLIVA's obligation to provide an adequate
warning under state law was in line with its duty under federal
law to adopt the brand drugmaker's stronger warning, the panel
"In our case, not only could PLIVA have independently
updated its labeling to match that of the branded manufacturer
... it had a federal duty to do so," Judge Danny Boggs wrote for
the unanimous panel.
The court also rejected PLIVA's argument that Fulgenzi's
suit was barred because she was attempting to enforce the
federal law that requires the labels to match.
"The federal duty of sameness is not 'a critical element' in
Fulgenzi's case. Her suit instead relies upon the adequacy of
the warnings and the causation of her injuries," Boggs wrote.
While allowing the lawsuit to proceed, the court did note
that Fulgenzi will face significant hurdles in winning her case.
She will have to prove that PLIVA should have adopted the brand
drugmaker's updated warning in 2004; that, if it had, doctors
would likely not have prescribed her the drug; and that the drug
caused her injury.
Teva Pharmaceuticals, which owns Croatia-based PLIVA,
declined to comment on the ruling. PLIVA's lawyer, Jeffrey Peck
at Ulmer & Berne, also declined to comment.
Plaintiffs around the country have attempted to bring
similar "failure-to-update" claims against PLIVA after Mensing
wiped out traditional failure-to-warn claims. The 6th Circuit is
the first federal court of appeals to issue a precedential
opinion on whether such cases can proceed.
In an unpublished per curiam opinion issued in February,
Morris v. PLIVA, the 5th Circuit reached the opposite
conclusion, finding that another plaintiff's failure-to-update
claims over generic Reglan were pre-empted by Mensing.
The 6th Circuit's ruling is not likely to have a
far-reaching effect because most generic manufacturers update
their drug labels, said James Beck, a lawyer at Reed Smith who
defends pharmaceutical companies in personal injury and product
Lawyers for Fulgenzi and plaintiffs in similar cases,
however, said there is evidence of failure to update. They
pointed to a study published in 2012 in the journal
Pharmacoepidemiology and Drug Safety, which found that around 80
percent of generic manufacturers had labels that differed from
"This is not an obscure problem. It's a common problem,"
said Fulgenzi's lawyer, Louis Bograd.
The case is Fulgenzi v. PLIVA Inc, 6th U.S. Circuit Court of
Appeals, No. 12-3504.
For Fulgenzi: Louis Bograd of the Center for Constitutional
Litigation and Richard Schulte of Behnke, Martin & Schulte.
For PLIVA: Jeffrey Peck, Linda Maichl and Joseph Thomas of
Ulmer & Berne.
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