Pharmaceutical Litigation Update

In September, pharmaceutical giant Merck & Co. halted worldwide sales of its arthritis drug Vioxx because a recent clinical trial found an increased risk of heart attack and other cardiovascular complications. The risk was found in patients taking Vioxx at a 25 mg. dose, particularly those who had taken the drug for longer than 18 months.

The trial was stopped after Merck discovered participants had double the risk of a heart attack, compared to other participants taking placebos.

Red flags since 1999

“At Slack & Davis, we were not surprised by this news. Our firm has monitored Vioxx ever since the FDA sent a warning letter to Merck in 1999 calling the firm’s promotional materials ‘false and misleading.’ And in 2002, the Food and Drug Administration (FDA) directed Merck to warn healthcare professionals about the safety of its medication,” said Michael L. Slack, managing partner.

“About two million people worldwide were taking Vioxx at the time of the recall, and a total of 84 million have taken it since it came on the market in 1999,” said Donna Bowen, partner.

According to the Wall Street Journal, a study led by an FDA safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug’s withdrawal. The number is in comparison to how many similar incidents would have occurred had the same patients taken a competitor drug.

“In other media reports, scientists in the United States and Great Britain are calling for a fresh look at Celebrex and other medications similar to Vioxx, such as Bextra.

In the New England Journal of Medicine, a cardiologist’s study suggested problems might extend to the entire class of medications,” Bowen said.

“As a result, our firm is also reviewing claims related to the drugs Celebrex and Bextra,” she added.

Winning track record

“Our firm’s strategy and timing have been pivotal in drug cases where others pursuing similar claims did not enjoy such advantageous results. For example, our firm obtained substantial recoveries for clients in cases involving the cholesterol-lowering drug Baycol and diet drugs like Fen Phen,” said Mike Davis, partner.

“Our experience with drug lawsuits has proven that handling claims individually produces far superior results than class-action litigation,” Slack said.

Vioxx, Celebrex and Bextra Claims

Information is likely to change concerning the adverse heath effects and risk from Vioxx use, as well as other Cox-2 class drugs like Celebrex and Bextra. We will update our Web site at www.slackdavis.com with more information.

As of mid-October 2004, injuries or death claims involving Vioxx, Celebrex and Bextra would likely be based on the following criteria:

• Documented use of Vioxx, Celebrex or Bextra for any period of time and
• Significant adverse event(s) after taking the medication, including heart attack, transient ischemic attack (TIA), stroke, peripheral thrombosis, or new diagnosis of hypertension.

SPECIAL NOTE: In death claims, an autopsy is helpful in proving causation.