Vioxx Lawsuit Help

Vioxx Heart Attack

Vioxx heart attack and stroke links have been made practically since Vioxx was first FDA approved, escalating in recent years. The Vioxx safety concerns were evident in the lagging sales Merck & Co. experienced, though the blockbuster drug still reached sales of $2.5 billion in 2003 alone. For years, researchers have been warning about the Vioxx heart attack and stroke connection, but until the September 30, 2004 recall, Merck continued to argue they were unaware of significant risks.

In January 1999, Merck started the VIGOR test , and its preliminary results were available in March 2000. The test was designed to see if Vioxx, part of the COX-2 inhibitors class, had less gastrointestinal problems than another pain reliever naproxen, part of the nonsteroidal anti-inflammatory drug class that includes ibuprofen and aspirin. The study did show Vioxx was easier on the digestive tract than naproxen but this study unexpectedly found heart attack and stroke risks associated with Vioxx as well, which Merck described as being “of concern to us.”

Merck described the Vioxx heart attack and stroke findings in its preliminary March 2000 results as showing “a difference in the cardiovascular event rate” when compared to naproxen , but was quick to prevent a negative light from being cast. Merck continued to argue for the remainder of Vioxx’s stay on the market that it wasn’t that Vioxx heart attack and stroke problems were not present, but naproxen protected against cardiovascular events and Vioxx could not be fairly compared to naproxen. The company did mention in the March 2000 press release that the naproxen heart-protecting effect had not been observed in any previous clinical studies.

When Merck was questioned after the Vioxx recall, Peter Kim, president of Merck Research Laboratories, said “it was not possible” to conclude if increased Vioxx heart attack problems were present because a placebo was not used. Kim was then asked why Merck did not use a placebo in the VIGOR trial instead of naproxen, and he responded that it was designed to test patients with painful rheumatoid arthritis and using sugar pills for a long time would have been “medically difficult.”

In September 2001, the FDA sent a n eight-page warning letter to Merck Chief Executive Raymond Gilmartin which included criticism of the company’s suggestions to physicians that the reason for higher incidence of Vioxx heart attacks in the study was that naproxen has heart benefits. In the letter, the FDA said, “You fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence.” Attorneys have seized the FDA letter, and the allegations the agency makes against Merck for minimizing potential Vioxx heart attack risks may end up being an important factor as cases begin to go to trial.

In addition, the FDA letter said a press release titled “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx” was “simply incomprehensible” considering the rate of Vioxx heart attacks suffered compared to naproxen. While it is unknown how many Vioxx heart attacks and strokes have been suffered, two million Americans were taking Vioxx when it was pulled and Merck has said approximately 20 million people in the U.S. have used the drug. The Vioxx recall was issued after Merck halted a three-year study that found heart attack and stroke events were twice as likely to occur in patients taking Vioxx than in those taking a placebo when using the drug for at least 18 months.

For more information on Vioxx heart attacks, please contact us to confer with an attorney.

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