Merck & Co., ordered last month to pay $253 million to a Vioxx user’s widow, will argue in a second trial that opens today that its painkiller did not cause the heart attack of an ex-Marine.
Jury selection begins in Atlantic City, New Jersey, where Frederick Humeston claims in court papers that Merck ignored cardiovascular risks of Vioxx before pulling the drug from the market last September. Humeston, 60, had a heart attack in 2001 after taking Vioxx for a knee he injured in the Vietnam War.
Merck, the No. 3 U.S. drugmaker, argues that Humeston’s age, weight, hypertension and inactivity caused his heart attack, not Vioxx, court papers show. Merck, which faces almost 5,000 Vioxx suits, must win this second trial, say lawyers and analysts who predict that several early losses could force billions of dollars in settlements.
"If Merck gets to be 0-4 or 0-5 in these cases, the settlement value of these claims is going to go through the roof,” said attorney Charles Parker of Locke, Liddell & Sapp in Houston.
Parker sued Wyeth over heart and lung problems tied to its fen-phen diet drug combination. Wyeth lost the first five fen- phen cases that went to trial and set aside $21 billion for thousands of other cases. Bayer, which faces suits claiming its Baycol drug caused a muscle-weakening disease, won a key early trial and paid out $1.13 billion to resolve nearly 3,000 cases.
Merck enters the Humeston case after Texas jurors ordered it to pay $253 million to the widow of Robert Ernst, who died after eight months of Vioxx use. The award, which included $229 million in punitive damages, is expected to be lowered to $26 million because of a Texas cap on awards aimed at punishing companies.
Merck, based in Whitehouse Station, New Jersey, withdrew Vioxx after a company study showed that 18 months of daily use doubled the risk of heart attack and stroke. Merck shares have dropped 35 percent since the withdrawal of Vioxx, which reaped $2.5 billion in annual sales.
The Humeston case is one of nearly 2,500 pending before state Superior Court Judge Carol Higbee. Humeston’s lawyers seek to prove that Merck defectively designed Vioxx and failed to warn consumers about its dangers before and after the drug won U.S. Food and Drug Administration approval in 1999. Merck claims it fully tested Vioxx and gave its results to the FDA.
"It’s about marketing over science,” said Humeston’s attorney Christopher Seeger of Seeger Weiss in New York. "We’re going to show that the company knew all about the risks before they sold the drug. We’re going to force them to defend the case on the science.”
Humeston, a postal worker from Boise, Idaho, won two Purple Hearts in Vietnam, where he served for four years. Shrapnel injured his left knee in 1966, court records show. Humeston’s pain intensified in recent years, and he got little relief from several medications. In May 2001, his doctor prescribed Vioxx, and he took two pills, records show.
In July 2001, his doctor’s nurse practitioner gave him free samples and a new prescription for an injury to his right knee, records show. After getting a second prescription, he had a heart attack on Sept. 18, 2001. He left the hospital two days later.
Records show that Humeston, who is 6-feet 1-inch, weighed 231 pounds at the time of the heart attack and had gained 31 pounds since 1988. Humeston claims that he had been an active hiker before the heart attack and that he remains fatigued.
Merck points to several pre-existing conditions before plaque in an artery ruptured, causing a clot to form and blocking blood flow to Humeston’s heart.
"Like an unfortunately large number of Americans, Mr. Humeston had several risk factors including his age, gender, obesity, sedentary lifestyle, borderline hypertension, cholesterol, and stress,” Merck said in court papers.
"It will be very interesting to see how Mr. Seeger unfolds the evidence, if there is any, on how Mr. Humeston’s heart attack occurred,” said C. Anthony Butler, a Lehman Brothers analyst. Butler estimates Merck’s Vioxx liability at between $5 billion and $10 billion. Other analysts say it’s as high as $50 billion.
Merck attorneys say they intend to do a better job of explaining damaging internal documents than they did in the Ernst case, particularly about the marketing of Vioxx. Jurors said afterwards that they wanted to send a message to Merck.
“We continue to learn as we go along and will continue to make modifications in our presentation,” Merck General Counsel Kenneth Frazier told reporters during a teleconference Sept. 9.
The case is Humeston et al v Merck & Co., L-02272-03, Superior Court, Atlantic City, New Jersey.