UPDATE: Merck, Schering To Pay $41.5 Million To Settle Lawsuits
05 Agosto 2009 - 5:00PM
Dow Jones News
Merck & Co. (MRK) and Schering-Plough Corp. (SGP) have
agreed to pay $41.5 million to settle lawsuits accusing the
companies of marketing their cholesterol drugs misleadingly and
failing to disclose the results of a negative clinical study in a
timely manner.
It's the second legal settlement in as many months related to
the jointly marketed drugs, Vytorin and Zetia, but it doesn't
resolve all of the outstanding litigation. A U.S. Department of
Justice investigation is still pending, as are lawsuits alleging
securities-law violations.
Merck has agreed to acquire Schering-Plough in a deal expected
to close by the end of the year. Shareholders of both companies are
scheduled to vote on the deal Friday.
The latest settlement resolves more than 140 lawsuits pending in
U.S. District Court for the District of New Jersey that were
seeking class-action status to represent consumers and insurers who
purchased, used or paid money towards the purchase Vytorin or
Zetia. Some suits alleged the drugs caused personal injuries, or
sought a court order that the companies pay for medical monitoring
of users of the drugs.
Vytorin is a single-pill combination of two drugs: Zetia and
simvastatin. In early 2008, Merck and Schering-Plough released a
study, titled "Enhance," which showed that Vytorin was no better
than simvastatin alone at mitigating thickening of the arteries,
despite producing a greater drop in bad cholesterol levels.
The study cast doubt on the drugs' efficacy and triggered a drop
in sales of both drugs, while a subsequent study raised new safety
concerns about the drugs. Merck and Schering-Plough have defended
the drugs' efficacy and safety.
In addition, Merck and Schering waited nearly two years after
Enhance was completed to release the results, which led to
accusations that the companies purposely delayed the release
because they knew the study was negative and would hurt sales. The
companies have said data-quality problems with the study required
repeated analyses, and that top company officials didn't know the
results until shortly before they were released.
Merck and Schering didn't admit any misconduct or liability in
the latest settlement. The settlement with proposed class-action
suits requires court approval. A separate portion of the settlement
doesn't require court approval.
Last month, the companies agreed to pay $5.4 million and comply
with certain rules to settle a probe by 35 U.S. states and the
District of Columbia into whether their handling of the Enhance
study violated consumer-protection laws.
While Vytorin has presented a legal headache for Merck and
Schering-Plough, the amounts paid so far pale in comparison to the
nearly $5 billion Merck had to fork over to settle personal-injury
and other litigation surrounding its former pain drug Vioxx.
Still, more and bigger Vytorin settlements could be in the
works. In September 2008, Merck received a letter from the Justice
Department saying it was investigating whether the companies'
promotion of Vytorin caused false claims to be submitted to federal
health-care programs; the companies are cooperating with the probe.
The companies also have received letters from Congressional
committees seeking information about their handling of the Enhance
trial.
Merck's shares fell 16 cents to $29.68 in recent trading;
Schering shares were off 12 cents at $26.34.
The two companies have also faced separate lawsuits over their
pending $47 billion merger, which remains on track to close during
the fourth quarter.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com
(Kerry Grace Benn contributed to this article.)