By Elizabeth Dilts
(Reuters) - In a setback for plaintiffs seeking to bring a
class action against the maker of a generic form of Lipitor
found to contain tiny glass particles, a New Jersey federal
judge has ruled that Ranbaxy Pharmaceuticals does not have to
broaden its voluntary retail-only recall of the anti-cholesterol
In an unusual move, the plaintiffs, five people who took the
tainted drug and said they experienced minor irritations like
diarrhea and upset stomach, had sought emergency relief from
U.S. District Court in Trenton to compel Ranbaxy to broaden the
recall to include consumers. The plaintiffs also sought
reimbursement for consumers who bought the drugs, whether they
ingested them or not.
But Judge Peter Sheridan ruled on Tuesday that the Food and
Drug Administration, which is overseeing the voluntary recall,
has primary jurisdiction in the matter and should be permitted
to complete its oversight of Ranbaxy's recall before other
measures are taken.
Ranbaxy initiated the voluntary retail-only recall of
approximately 480,000 bottles Nov. 9 after glass particles were
discovered in Atorvastatin.
The FDA on Nov. 29 announced the possibility of harm from
the pills appeared low, but worried consumers might want to
consult their doctors. The next day the agency amended its
statement and said that consumers should continue taking the
cholesterol drug unless their doctor said otherwise, and that it
had so far received no reports of injury, according to FDA
Barry Gainey of Gainey & McKenna, a lawyer for the
plaintiffs, said the conflicting messages left consumers with a
choice between taking possibly adulterated pills or not taking
the medication at all. He said the plaintiffs sought to expand
the voluntary recall to include consumers because it was the
most expedient way "to get the product out of the public's
Product liability lawyers said the maneuver was unusual
because under the Federal Drug and Cosmetics Act, only the Food
and Drug Administration, not private parties, has the right to
require a recall.
A company which initiates a voluntary recall can be sued for
doing it negligently, but in the Ranbaxy case, that would be
extremely hard to prove since the FDA is monitoring the recall,
said James Beck, a product liability litigator with Reed and
"It's not surprising that the court rejected (the
plaintiff's request for injunction)," said Beck.
Kurt Karst, a lawyer who provides regulatory counseling to
pharmaceutical manufacturers and writes Hyman, Phelps and
McNamara's FDA law blog, said he couldn't remember any cases
when a consumer won a request for broader recall because judges
perceived that to be an attempt to privately enforce the Federal
Drug and Cosmetics Act.
Plaintiffs' lawyer Gainey called Sheridan's ruling
"unfortunate for the public."
A lawyer for Ranbaxy, Kirkland & Ellis partner Jay
Lefkowitz, said his client was satisfied with the ruling.
The case is Francis Fenwick v. Ranbaxy Pharmaceuticals, Inc,
U.S. District Court of New Jersey, No. 12-7354.
For Francis Fenwick: Barry Gainey of Gainey & McKenna
For Ranbaxy Pharmaceuticals, Inc: Jay Lefkowitz, Matthew
Dexter and Steven Menashi of Kirkland & Ellis; Allyn Lite,
Michael Patunas and Mayra Tarantino of Lite Depalma Greenberg.
For Express Scripts: Husch Blackwell.
Follow us on Twitter @ReutersLegal | Like us on Facebook