Even short-term use of the painkiller Vioxx can double the risk of heart attack, a medical statistics expert testified Thursday in a product liability trial, a finding that manufacturer Merck & Co. misrepresented.
Testifying on behalf of a postal worker suing Merck, University of Washington biostatistician Richard Kronmal said patients who took the now-withdrawn painkiller in company-sponsored tests suffered serious side effects to blood vessels almost immediately.
“It clearly is a drug that has severe effects on the vascular system,” Kronmal said.
But he acknowledged on cross-examination that neither outside scientists who reviewed safety data on the drug nor the U.S. Food and Drug Administration shared his view, and that he had never seen the medical records of Frederick “Mike” Humeston.
Humeston, 60, of Boise, Idaho, is suing Merck, claiming his Sept. 18, 2001 heart attack was caused by Vioxx. His lawyers have told jurors Merck knew of the drug’s risks and failed to warn consumers.
Merck, based in Whitehouse Station, contends Humeston’s heart attack was because of health problems and that, as a Vioxx user for only two months, he wouldn’t have been among those at risk. Merck has said Vioxx only increased cardiac risks after 18 months of use and that it properly disclosed those risks.
The drug, pulled off the market by Merck a year ago, had been a blockbuster, with an estimated 20 million people using it. Many were arthritis sufferers dissatisfied with other prescription pain relievers because they caused stomach pain or bleeding.
In June 2000, Merck released results of a study that found Vioxx users suffered five times as many heart attacks as users of naproxen, an older painkiller. Merck said that was because naproxen protected the heart, not because Vioxx was dangerous.
The Food and Drug Administration rebuked Merck for making that assertion without proof, and Humeston’s lawyers have hammered at that point.
Kronmal’s testimony came as the trial—which is being closely watched because of a $253 million liability verdict against Merck last month in Texas—entered its second week.
Merck has yet to begin presenting its side of the case to the seven-woman three-man jury.
Merck faces more than 5,000 lawsuits over Vioxx, nearly half of which have been filed in New Jersey. All 2,475 New Jersey cases have been consolidated under Higbee.
Merck plans to appeal the Texas verdict, which will be reduced to about $26 million because of Texas law capping punitive damages.
The company’s shares fell 20 cents to close at $27.60 in trading on the New York Stock Exchange. Shares are down more than $1.50 since the trial started.