Healthy Skepticism Library item: 5497

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Publication type: news

Johnson L.
Merck: Obesity Caused Woman's Heart Attack
Associated Press 2006 Jul 11
http://biz.yahoo.com/ap/060711/vioxx_trial.html?.v=14

Full text: AP Merck: Obesity Caused Woman’s Heart Attack Tuesday July 11, 5:33 pm ET By Linda A. Johnson, AP Business Writer Merck Lawyers Tell Jurors That Obesity Is to Blame for Woman’s Heart Attack, Not Use of Vioxx

ATLANTIC CITY, N.J. (AP) — Severely clogged arteries, obesity and other factors caused a 68-year-old grandmother’s heart attack — not her use of Vioxx, lawyers for the drug’s maker told jurors during closing arguments Tuesday in New Jersey’s latest case over the withdrawn painkiller.

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While plaintiff Elaine Doherty of Lawrenceville had lost 100 pounds and taken steps to control her blood pressure, cholesterol level, diabetes and other risk factors, that couldn’t prevent her January 2004 heart attack, Merck & Co. attorney Diane Sullivan told the jury.

“For somebody like Mrs. Doherty, it’s not whether you’re going to have a heart attack, it’s when,” she said. “It would be hard to find somebody with more risk factors for a heart attack.”

At its peak, Vioxx was a $2.5 billion-a-year blockbuster for Whitehouse Station-based Merck, which withdrew Vioxx from the market on Sept. 30, 2004, saying research showed it doubled risk of heart attack and stroke after 18 months’ use. Data released since then indicate the risk started much sooner and persisted after people stopped taking Vioxx, numerous doctors say.

Doherty’s lawyers have alleged Merck downplayed the risks of Vioxx to doctors and to patients. Jurors will vote on whether Merck failed to warn either group before they can consider whether Merck is to blame for Doherty’s heart attack and should have to pay damages.

Tuesday was the Atlantic County Superior Court jury’s first time in the courtroom in 12 days, mainly due to a shutdown of New Jersey state government during a budget impasse. Three of the original jurors dropped out over the break, leaving seven to deliberate. The trial began June 5.

Sullivan argued that tests taken the day of Doherty’s heart attack showed her blood was thin and not likely to clot. Plaintiffs lawyers and many doctors have said Vioxx triggered heart attacks by causing blood clots. But Doherty lawyer Jim Pettit later told the jury that his client was given clot-busting drugs at the hospital.

Sullivan said Doherty underwent bypass surgery shortly after having a mild heart attack because four of five heart arteries were at least 90 percent blocked. She said the heart attack was so mild the plaintiff took six trips, three overseas, last year. Sullivan also pointed to inconsistencies in statements of the plaintiff’s expert cardiologist, Dr. John MacGregor, and other witnesses.

Repeatedly invoking Merck’s reputation for thorough research, she said the company sent doctors letters about the drug’s cardiac risks once they were known. And she said because Merck didn’t discuss benefits of Vioxx in consumer ads, it wasn’t required to state its risks.

Pettit said Merck had an obligation to do so, given its ubiquitous ads with “America’s sweetheart,” ice skater Dorothy Hamill, pitching Vioxx on TV and in magazines, and that Doherty’s doctor wouldn’t have prescribed Vioxx if he knew that for a diabetic, taking Vioxx increased heart attack risk sixfold.

He said Merck in recent years has put marketing before science and ran a huge campaign to “neutralize” doctors who raised safety concerns about Vioxx by complaining to their bosses and other methods. He reviewed numerous internal Merck documents shown during the trial that indicated Merck executives knew of the drug’s cardiac risks soon after Vioxx was launched in 1999 and worried about how to maintain sales.

He said Merck hid Vioxx risks from regulators by dumping “a forest of paper” about the drug on the U.S. Food and Drug Administration and successfully campaigned to get the FDA, in 2002, to note the drug’s heart risks in the precautions section of the Vioxx package insert — not in the more-prominent warnings section. Immediately after that, Pettit said, Merck canceled a planned study of the drug’s heart safety.

“Do you think they made $2 billion to $2.5 billion a year (on Vioxx sales) by being transparent, by telling doctors everything they knew?” Pettit asked jurors.

He said Sullivan unfairly maligned his witnesses — an FDA scientist and a highly regarded cardiologist — because they have raised alarms over Vioxx and testified for plaintiffs. Pettit told jurors they need only find Vioxx contributed to Doherty’s heart attack, not that it was the main cause.

Merck now faces more than 13,000 Vioxx-related lawsuits and has vowed to fight them one by one. It has lost three trials so far, with juries awarding multimillion-dollar verdicts in each. The company plans to appeal those losses.

The New Jersey trial is the seventh over Vioxx; an eighth trial is under way in Los Angeles.

The jury is to begin deliberating Wednesday morning after receiving instructions from Superior Court Judge Carol Higbee.

http://www.merck.com