Vioxx user was a heart attack waiting to happen

In the on-going court battle facing drug company Merck over it’s blockbuster painkiller Vioxx, a lawyer for Merck has said one of the plaintiffs was more or less a heart attack waiting to happen regardless of Vioxx.

It seems 68-year-old New Jersey woman Elaine Doherty had previous health problems, led a sedentary life, was obese, suffered from diabetes, high blood pressure, elevated cholesterol and had a family history of heart disease.

These factors say the lawyers were the cause of her heart attack in January 2004 and not their painkiller drug Vioxx, and it would be hard to find somebody with more risk factors for a heart attack.

Merck’s lawyer Diane Sullivan made the comments at the conclusion of the third Vioxx trial to be heard in Merck’s home state of New Jersey.

Sullivan also said Doherty underwent bypass surgery shortly after having a mild heart attack because four of five heart arteries were at least 90 percent blocked but the heart attack was so mild the plaintiff took six trips, three overseas, last year.

Sullivan also illustrated inconsistencies in statements of the plaintiff’s expert cardiologist, Dr. John MacGregor, and other witnesses and repeatedly reminded the court of Merck’s reputation for thorough research, saying the company alerted doctors about the drug’s cardiac risks as soon as they were known.

According to Doherty’s lawyer James Pettit his client had lost 100 pounds, had lower blood pressure and her cholesterol levels had fallen and that it was only after she took Vioxx that she had a heart attack.

Lawyers for the plaintiffs’ are accusing Merck of putting profits before safety because it needed a blockbuster drug to replace other drugs whose patents were about to expire.

Vioxx annual sales exceeded $2.5 billion during its five years on the market but Merck was forced to withdraw the drug after it was shown to double the risk of heart attack among those taking it for more than 18 months.

Pettit has argued that science had been superceded by commerce, and research and development had been abandoned in favour of marketing.

As many as 11,500 lawsuits have now been filed in the United States against Merck by former Vioxx users who say the drug caused their heart attacks or strokes.

The Doherty case is the seventh contested in court by Merck, which has said it will fight each one by one; a decision is expected to be reached this week.

The company informed doctors, regulators and medical journals in 2000 after a study showed a far higher risk of heart attacks among patients taking Vioxx than those taking the standard painkiller naproxen.

Merck in agreement with the U.S. Food and Drug Administration decided that the information about Vioxx risks should be published in the precautions section of the drug’s label.

Pettit says Merck had an obligation to openly discuss possible risks associated with Vioxx and that Doherty’s doctor would not have prescribed Vioxx if he knew that for a diabetic, taking Vioxx increased heart attack risk sixfold.

Merck has already won three of the six cases that have so far been to court; in April another court awarded $13.5 million to John McDarby, 77, after finding that Vioxx contributed to his heart attack and Merck failed to warn of the drug’s risks, but the same jury concluded that Vioxx did not cause the heart attack of Thomas Cona, 60, whose suit was heard at the same time.

Provided by ArmMed Media
Revision date: June 20, 2011
Last revised: by Sebastian Scheller, MD, ScD