Lawyers meeting on Tuesday to discuss Vioxx litigation say pending lawsuits will show that Merck & Co. Inc. (MRK.N) was aware of the arthritis drug’s risks before it was taken off the market.
The litigation conference was held a day after Merck said it had received a subpoena from the U.S. Justice Department and that the Securities and Exchange Commission had started an informal inquiry concerning Vioxx.
“We are finding out that Merck knew what was going on. They excluded people who were at risk of heart attack from their studies,” said Andy Birchfield, an attorney handling Vioxx litigation for the Birmingham, Alabama firm of Beasley, Allen, Crow, Methvin, Portis & Miles.
That firm’s J. Paul Sizemore told the meeting that the 16th edition of Merck’s drug manual mentioned a risk of blood clots from thromboxane, a hormone-like substance produced when the COX-2 enzyme is blocked, but the notation was absent from the 17th edition. Vioxx blocks inflammation and pain by inhibiting production of COX-2.
The company maintains it acted responsibly.
“Merck believes it has strong and meritorious defenses and will continue to vigorously defend itself against allegations brought in any lawsuit,” Merck said in a statement.
Merck, based in Whitehouse Station, New Jersey, voluntarily recalled Vioxx on Sept. 30 after a clinical study showed an increased risk of heart attack and stroke in patients who took the drug for more than 18 months.
The company said that as of Oct. 31 it has been served or is aware that it has been named as a defendant in about 375 Vioxx-related suits, including suits representing about 1,000 plaintiff groups.
Birchfield said he represents the family of a 38-year-old woman who died of a heart attack after taking Vioxx for about a month. “There are a number of cases where you have young people with no confounding risks who died of heart attack,” he said.
Whether one of these cases will be first to go to trial remains to be seen. One of Birchfield’s cases in Birmingham federal court was scheduled for trial, but several cases there are now being combined and it will likely be delayed.
Thomas Moore, an attorney with Drinker Biddle & Reath, said Merck should aggressively litigate marginal claims, but it may make sense to analyze the data and see if there is a subset of claims that should be settled.
BAYER, WYETH HAVE BEEN DOWN THIS ROAD
In 2001, Bayer AG (BAYG.DE) pulled cholesterol drug Baycol off the market after it was linked to severe muscle weakness. In 1997. Wyeth (WYE.N) recalled diet drug fen-phen, which was tied to heart-valve damage and a deadly lung condition.
The Baycol recall has cost Bayer more than $1 billion so far, while Wyeth has taken more than $16 billion in charges to pay for fen-phen claims and legal expenses.
Moore said Baycol was a good model for resolving litigation because “they sequestered the marginal claims,” while fen-phen has generated the type of widespread litigation plaintiffs’ attorneys are anticipating with Vioxx.
Worldwide sales of Vioxx were $2.55 billion in 2003. Merck has said the drug has been taken by 20 million Americans.
Several lawyers said it was too soon to tell whether Merck could withstand the potential payout.
CIBC World Markets analyst Mara Goldstein detailed in a recent report a “worst case scenario” in which 50,000 individuals would walk away with $250,000 each.
Some plaintiffs’ attorneys put the number of Vioxx-related claims as high as 200,000.