Month: November 2007

Timeline: The Rise and Fall of Vioxx

Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.

Five years after Vioxx’s launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide. A timeline of Vioxx’s rise and fall:

November 1998: Merck asks the Food and Drug Administration (FDA) for approval of Vioxx, having tested the drug on 5,400 subjects in eight studies.

January 1999: Merck launches the Vioxx Gastrointestinal Outcomes Research study (VIGOR). With more than 8,000 participants, it is the largest study ever done of the drug. Half take Vioxx and the other half take naproxen. The clinical trial is designed to see whether Vioxx is safer for the digestive system than naproxen, an older painkiller.

May 1999: The FDA approves Vioxx, making the drug available by prescription in the United States.

October 1999: First meeting of the VIGOR study’s data and safety monitoring board (DSMB). Study results as of Oct. 1, 1999, show that Vioxx patients have fewer ulcers and less gastrointestinal bleeding than patients taking naproxen. It looks as if the study will be a success for Merck.

November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel’s November meeting note that “while the trends are disconcerting, the numbers of events are small.” The panel votes to continue the study and to meet again in a month.

December 1999: The safety panel holds its last meeting. It’s told that as of Dec. 1, 1999, the risk of serious heart problems and death among Vioxx patients is twice as high as in the naproxen group.

Merck Agrees to Settle Vioxx Suits for $4.85 Billion

Three years after withdrawing its pain medication Vioxx from the market, Merck has agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking the drug, according to two lawyers with direct knowledge of the matter.

The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.

The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.

Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.

The agreement could still collapse, though lawyers with knowledge of the deal said that was unlikely. The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal.

Plaintiffs will receive different settlement payments depending on the severity of their injuries and the length of time they took Vioxx.

Merck Agrees to Pay $4.85 Billion in Vioxx Claims

Three years after withdrawing its pain medication Vioxx from the market, Merck announced today that it will pay $4.85 billion to settle 27,000 lawsuits by people who contend they or their family members suffered injury or died after taking the drug.

The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.

The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.

Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.

Plaintiffs will receive different settlement payments depending on the severity of their injuries and the length of time they took Vioxx. The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal.

Based on the fact that the 27,000 suits cover about 47,000 sets of plaintiffs, the average plaintiff will receive just more than $100,000 before legal fees and expenses, which usually swallow 30 percent to 50 percent of payments to plaintiffs. Plaintiffs who do not want to accept the settlement can pursue their own claims, but with so many of the top trial lawyers in the United States agreeing to the deal, they may have difficulty doing so.

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