Although evidence mounts that Vioxx is harmful, an FDA panel recommends continued use. Then the FDA takes Bextra off the market. Confused?

As many as 55,000 patients may have died from heart attacks and strokes induced by the painkiller Vioxx, according to estimates by officials at the Food and Drug Administration.

Dr. David Graham, associate director for science at the FDA, estimated that the now-withdrawn drug may have caused up to 139,000 heart attacks and strokes. Graham publicly criticized the FDA last November during congressional hearings.

Yet, an FDA advisory panel recommended in February that Vioxx and its sibling Cox-2 inhibitor drugs Celebrex and Bextra should be allowed to be sold to the public. Then in April, Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the FDA and European regulators.

Pfizer said in its press release that the FDA cited a risk of serious, sometimes fatal, skin reactions to Bextra on top of the cardiac risks shared by other similar drugs.

WHO’S ON FIRST?

“It’s clear that safeguards designed to protect Americans from dangerous medications have been eroded by conflicts between the federal bureaucrats who approve new drugs and those who oversee their safety,” said Mike Davis.

“It defies logic that the panel recommended Vioxx remain on the market, especially when that drug seemed to trouble panel members most. The members, some of whom are consultants to drug manufacturers, voted 31-1 in favor of Celebrex, 17-13 for Bextra and 17-15 for Vioxx,” said Donna Bowen.

“Now the FDA has taken Bextra off the market and is requiring all Cox-2 inhibitor drugs to carry black box warnings that users may face an increased risk of cardiovascular side effects,” said Davis.

FDA ON THE HOT SEAT

As a result of recent revelations that the FDA had approved drugs which later proved harmful, the FDA is being investigated by two committees in Congress, examined by the General Accounting Office and evaluated by the Institute of Medicine.

Several lawmakers, including Sens. Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) are preparing legislation that would mandate major reforms for the agency.

The Bush administration has attempted to defuse criticism by appointing a permanent FDA commissioner--a position that has been vacant for a year--and create a new Drug Safety Oversight Board.

“Those actions do not fully address deep-rooted flaws in the FDA, including conflicts of interest, a lack of attention to safety issues and a lack of authority in forcing the drug industry to heed its recommendations. The major problem is, the FDA doesn’t have a mechanism for follow-up when new 4 information reveals problems with approved drugs. For example, it wasn’t the FDA that took Vioxx off the market,” said Davis.

Merck & Co took Vioxx off the market in September 2004 after a study found a higher risk of heart attacks and stroke in volunteers who took the drug compared with those on a placebo.

“Merck should have pulled Vioxx from the market years ago. Data has existed since at least 2000 showing that Vioxx raised the risk of heart attacks,” said Bowen.

LITIGATION UPDATE

Drug industry analysts have differing estimates of Merck’s potential liability in Vioxx cases, but all are huge, ranging from $4 billion to $30 billion, according to the Associated Press.

Vioxx cases in federal court have been consolidated in New Orleans. Judge Eldon Fallon of the U.S. District Court for the Eastern District of Louisiana was assigned to coordinate all pretrial motions and discovery in federal liability cases involving Vioxx.

“In Texas, however, it looks as though we will be able to maintain our cases in state court in Dallas, Harris, Tarrant and Bexar counties,” said Davis.

“This is good news for our Texas clients,” said Bowen. “For clients outside Texas, we may be able to maintain their cases in state court. If we can’t, our understanding is that the MDL judge is very fair-handed, which is positive news as well.”

Slack & Davis is reviewing medical records for numerous clients. “It takes time to do a thorough analysis. Until you review the medical records, you can’t know whether you have a claim. I suspect the merits of most claims will be contingent on each client’s underlying medical condition,” said Bowen.

“In addition to our clients, prescribing physicians somewhat became ‘victims’ as well. Because Merck concealed information about cardiac risks, many doctors unknowingly prescribed Vioxx to people who already had heart problems or greater risk of stroke,” said Davis.

CRITERIA FOR VIOXX CLAIMS

Slack & Davis continues to review claims of persons who have experienced a heart attack or ischemic stroke while taking Vioxx or Bextra. Please call our office to discuss potential claims with our legal nurse consultants.