What Alternatives to Vioxx are Available?

An independent healthcare analyst, Herman Shah of HKS & Co. in Warren, New Jersey, notes that Vioxx (and other drugs in the class) have not proven to be the breakthrough cure-all for pain they are advertised to be. In fact, Shah says physicians prefer ibuprofen for pain relief to Vioxx and Celebrex combined.

The cost of the over-the-counter medication is 10 to 15 times less than that of the prescription drugs. Vioxx is one of a class of anti-inflammatory drugs strenuously marketed as being more effective, with fewer side effects than other, older drugs (including such over-the-counter medications as ibuprofen). Do your research before spending more money than is necessary.

How many people have suffered from the side effects of Vioxx?

FDA safety officer David Graham and others estimate that Merck's signature arthritis drug, Vioxx, has caused as many as 140,000 heart attacks and strokes and killed as many as 55,000 people since being approved by the FDA in 1999. Documents made public on May 5, 2005 by the House Government Reform Committee constitute the strongest evidence yet that Merck executives were aware of the dangers of the drug and took aggressive steps to conceal them, endangering countless lives.

What is the statute of limitations for Vioxx lawsuits?

Before 2004, most state laws required victims in such cases to file their lawsuit within two years after suffering their injury. But for some users of Vioxx the statute of limitations ran out before the drugs were found to cause heart disease. Now, a new bill is being introduced to the Senate which would change the deadline for filing lawsuits to two years after the cause of an injury is discovered. For Vioxx users, that would be Sept. 30, 2004, the date that it was removed from the market.

What instructions were given to Merck's salespeople for discussing Vioxx with doctors?

According to a May 6, 2005 report in the Los Angeles Times, a Merck company bulletin from 2001 ordered the sales force to steer clear of discussing a scientific meeting convened by the Food and Drug Administration to evaluate Vioxx safety. "DO NOT INITIATE DISCUSSIONS," it said in a prominent warning. In other internal missives, concerns about heart risks were termed "obstacles." A sales campaign to overcome the safety concerns was called "Project Offense." Another was dubbed "Project XXceleration"--a play on the spelling of the drug.

How did Merck first repond to early data regarding fatal side effects of Vioxx?

Many recent Vioxx lawsuits bring to light questions as to when Merck was first made aware that fatal side effects were associated with Vioxx, and whether the company failed to inform public health authorities of these side effects, in a timely manner. Additionally, Merck extensively marketed Vioxx as highly safe and effective, while minimizing its risks compared to other drugs on the market.

How has Merck responded to charges of coverup in the case of Vioxx?

Merck Vice President Dennis Erb has defended the company's handling of Vioxx, noting that it promptly released details of studies that first raised the possibility of heart damage and followed up by performing the study that ultimately doomed the drug. "We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option," he said. "My own father was a regular user of Vioxx until we voluntarily withdrew it from the market."

Examining the FDA's Approval of Vioxx

Critic Dr. David Graham has argued that the FDA needs two separate arms; one to evaluate the benefits of using a drug and how safe it is before it is made available to the public and another to independently evaluate drug safety once it's out there. He also said that the FDA's focus is tied too closely to serving the pharmaceutical industry instead of serving the public. "Right now 80 percent of FDA resources are focused on reviewing and approving new drugs for the market," Graham said at a recent conference. "At least 50 percent should be focused on making sure they're safe once they're out there", he said.

How should I prepare for a Vioxx lawsuit?

Do some research of your own on Vioxx before consulting with a lawyer. This will help you spot the lawyers that have done their homework. A Vioxx lawyer will be well versed on the legal factors surrounding the Vioxx situation, and can therefore better advise those looking to seek compensation for harm caused by this drug. By seeking advice from a Vioxx lawyer at the earliest opportunity, you can speed up the legal process and improve your chances of a successful lawsuit.

What role has the FDA approval process played in the Vioxx problems?

The director for Science and Medicine at the Office of Drug Safety, David Graham, delivered a scathing assessment of FDA drug approval policy. He blamed the 55,000 or more Vioxx deaths on the FDA's decision in 1999 to approve Merck & Co.'s sale of the drug, despite data that suggested the arthritis medication was linked to increased risks of heart attack and stroke. "Unless the FDA establishes an independent division to monitor the safety of drugs once they're on the market, Graham said, more Vioxx-like disasters are likely."

What are the supposed advantages of COX 2 inhibitors like Vioxx?

Vioxx was a medicine created and marketed by Merck. Vioxx was prescribed as a medicine that could treat pain due to osteoarthritis, menstruation caused pain in women and acute pain in adults. It belonged to a class of drugs known as COX-2 inhibitors. COX-2 inhibitors were thought to be much more effective in treating pain and inflammation without the gastrointestinal side effects such as stomach ulcers and bleeding. These types of problems were thought to be much more prevalent in users of other NSAIDs such as ibuprofen and naproxen. Before it was taken off the market, Vioxx was one of the most popular anti-inflammatory drugs in the world. It is estimated that 84 million people worldwide have used the drug, including 20 million in the United States.

Under what circumstances might Vioxx return to the market?

In spite of the shakeup at Merck over the dangerous side effects of Vioxx--including the recent resignation of their CEO--there is talk of bringing Vioxx back on the marketplace. Because many people say Vioxx offered relief that other drugs didn't, the FDA's scientific advisers in February of 2005 narrowly voted that Vioxx might be able to come back onto the market under certain conditions, such as restricting its use to patients with severe pain or loading it with strong warnings about the heart risk.

What are the criteria for Vioxx-related side effects that could bring compensation?

If you or your family members have taken Vioxx for any length of time, the following information will be of importance to you. Injury or death claims involving Vioxx would likely be based on the following criteria: Documented use of Vioxx for any length of time and significant adverse events after taking the medication, including heart attack, transient ischemic attack (TIA), stroke, peripheral thrombosis, or new diagnosis of hypertension. If you have any questions, you should contact a qualified Vioxx lawyer.