Vioxx lawyers were immediately contacted following the announcement of the Vioxx recall.

Both the FDA and Merck & Co. have been under heavy criticism following the Vioxx recall for allowing Vioxx to remain on the market for so many years before claiming they were aware of the potentially deadly effects. About 20 million Americans have used Vioxx, and the Vioxx lawyers representing potential cases are alleging the cardiovascular events suffered by their clients were the result of Merck failing to provide complete safety information and not acknowledging earlier warnings that the drug was linked to serious effects. Vioxx lawyers and regulators are also pointing fingers at the FDA, whose job it is to protect consumers from unsafe drugs before they are allowed onto the market as well as once it is on the market.

For the last several years, Vioxx safety concerns have caused sales of the blockbuster drug to even out. With worldwide sales still totaling $2.5 billion in 2003, Vioxx’s multi- billion share of the arthritis and pain relief market has created many questions for patients that Vioxx lawyers are trying to address. Many people were unaware that many researchers have been cautioning against the use of Vioxx and that Public Citizen consumer group included Vioxx on its Best Pills, Worst Pills list in 2001 warning users of a possible link to heart attacks and strokes.

Patients are becoming more and more cautious of the information they receive from the drug industry that has been spending an increasing amount of money on advertising. Even as the FDA required Merck to make a labeling change warning of the possible link to heart attacks and strokes in April 2002, Merck was spending over $100 million a year in direct-to-consumer advertising. Vioxx lawyers claim Merck continued to minimize unfavorable findings that continued to surface over the years up until a month before Vioxx was removed from the market.

An FDA researcher, Dr. David Graham, concluded high doses of  Vioxx should not be prescribed or used because a study found it tripled risks of heart attacks and sudden cardiac death when compared to patients on a rival medication Celebrex. Merck issued an August 26, 2004 press release refuting Graham’s study saying, “Merck stands behind the efficacy, overall safety and cardiovascular safety of Vioxx.” Currently, the investigative arm of Congress, the Government Accountability Office, is investigating the FDA’s handling of  Vioxx and of Graham’s report, which was met with resistance, according to Graham. Vioxx lawyers point out that it is not the first time the FDA has been accused of silencing internal staffers finding links between drugs and adverse effects.

Merck has been questioned as to why earlier safety measures were not taken when study results indicated a possible risk of cardiovascular events might be linked to Vioxx years earlier. Vioxx lawyers are expected to argue that Merck’s earlier 2000 study results found a significantly higher risk of cardiovascular problems in Vioxx users when compared to naproxen and that Merck then failed to study Vioxx’s effects when compared to a placebo. When asked why the company did not take recall measures in 2000 after Merck’s initial study, the company president claimed adequate conclusions could not be drawn since the study did not include comparisons to a placebo.

Cases involving drugs causing side effects can be extremely difficult to prove. Going up against powerful drug companies and having to prove without a doubt that the drug was responsible for the alleged health effect can be challenging.

The Vioxx recall was controversial with accusations that the drug company Merck & Co. could have pulled the drug years be fore after its own study indicated risk of heart attack and stroke. Merck has defended its actions regarding their blockbuster drug Vioxx. Vioxx attorneys were immediately contacted following the removal announcement for side effects now believed to have been the result of taking the drug. An estimated 20 million people in the U.S. alone have used Vioxx. A Vioxx attorney who is experienced in matters like drug recalls understands the complexity of the se cases and has access to the many resources the drug industry is able to retain and must be met with powerful evidence and testimony.

Vioxx attorneys have seized an FDA warning letter dated September 17, 2001 that was sent to Merck Chief Executive Raymond Gilmartin. The Vioxx lawsuits that ensue may focus on the 2001 FDA warning, according to some predictions. Included in the warning letter is the agency saying Merck engaged in “a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular finding that were observed.” The letter was sent after Merck completed its VIGOR study, which it started in January 1999 and made preliminary results available in March 2000.

The Vioxx attorneys arguing cases are expected to use the VIGOR study results and Merck’s reaction to them. The test was designed to see if Vioxx causes fewer gastrointestinal problems than naproxen, a drug that belongs to the same class of drugs as ibuprofen and aspirin. Upon Vioxx approval, the FDA still required Vioxx labeling to include the same digestive warning s that it requires on naproxen , despite claims that Vioxx was associated to a lower risk of the side effect. While VIGOR did show Vioxx had fewer gastrointestinal problems than naproxen, the unexpected discovery was that a person taking Vioxx had a higher risk of heart attack and stroke than someone taking naproxen.

Even though coronary artery blockage is one of the leading killers in the U.S., Vioxx attorneys are sure to argue Merck’s attempts to downplay what the VIGOR study revealed. Merck indicated in a March 2000 press release that the VIGOR study showed there were significantly fewer heart attack and strokes observed in naproxen patients, which the company attributed to naproxen’s ability to protect against them instead of Vioxx’s ability to cause them. The FDA letter seized by Vioxx attorneys accuses Merck of minimizing unfavorable findings , and the agency ordered the company to send doctors a letter in September 2001 “to correct false or misleading impressions and information” the company had made.

In April 2002, the FDA followed its own advisory panel’s recommendations, requiring Merck to implement a Vioxx labeling change warning of the possible link to heart attacks and strokes. Following the Vioxx recall, the Merck president Peter Kim was asked why a Vioxx recall was not made after the VIGOR study four and a half years prior to the actual recall, and Kim claimed the VIGOR study did not allow Merck to make a decision because a placebo was not used. The latest 3-year Merck-sponsored study was cut short after 18 months using a placebo , when the company could no longer deny potentially deadly effects were being risked by taking Vioxx.

After the Vioxx recall announcement, Vioxx attorneys nationwide were contacted. Merck has said it has “strong and meritorious” defenses in the case filed against it, but some analysts predict Vioxx litigation could become very costly for the drugmaker

FDA whistleblower creates more waves regarding Vioxx

Dr. David Graham, an FDA scientist and whistleblower, said he was firmly discouraged from publishing his data questioning the safety of Vioxx, which was recalled last September.

The paper suggested while Vioxx was on the market from 1999 to September 2004, it caused up to 140,000 serious injuries or deaths. A leading international medical journal, The Lancet, was supposed to publish Graham’s paper on November 17, but has just released it online.

Graham called The Lancet asking for the paper to be withdrawn from publication because he said he was pressured and firmly discouraged from releasing data questioning the safety of Vioxx. Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, contacted The Lancet before the originally scheduled publication date questioning Graham’s analysis and the science and integrity of the research process.

Lancet editor Richard Horton said Galson had contacted him by telephone and email to criticize the paper. In an email to Horton, Galson wrote, “Some of the questions involve basic data integrity. (Graham) has declined to address these issues, and we think it’s important that your readers know this.”

When Horton contacted Graham directly, he said resolution to all the concerns, which he considered minor, was quickly reached. He said he discovered Galson had not even contacted Graham to discuss the points raised.

Earlier this month, the FDA said despite its concerns it would publish Graham’s findings on its website. With an upcoming congressional investigation on Vioxx that the FDA must appear, Graham said he believed the agency’s actions were in response to political pressure.

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.

Vioxx lawsuit

Vioxx was supposed to be the ’super aspirin’ that would relieve pain safely.

Instead, Vioxx was recalled because it increased the risk of heart attacks and strokes.

For a Vioxx lawsuit, you will need a law firm with a proven record of success in the Vioxx litigation. Weitz & Luxenberg is the law firm that won the second lawsuit against Merck for a Vioxx heart attack victim in Atlantic City, a jury verdict of $13.5 Million.

An experienced Vioxx lawyer/attorney from Weitz & Luxenberg can help you file a lawsuit to get compensation for your injuries. We’ll worry about the legal deadlines; you focus on feeling better. Our short form below will start the process.

Vioxx Victims

Merck & Co. has estimated 20 million Americans have used its arthritis and pain-relief drug Vioxx during its stay on the market and is unsure how many people worldwide have used the popular drug.

When Merck made the announcement September 30, 2004 that it was removing Vioxx from the shelves, a potentially high number of Vioxx victims were left wondering if adequate steps had been taken to ensure the safety of patients. In recent years, troubling events have left patients leery of the drug industry and wondering if federal regulators are too passive in enforcing safety measures. The Vioxx recall is the latest event to bring focus and criticism on both the drug industry and the FDA, and Vioxx victims are determined to fight back.

Vioxx’s safety appears to never have been fully established, and Vioxx victims wonder how the drug was able to remain on the market for as long as it did. Launched in May 1999, Vioxx is part of a relatively new class of NSAID drugs (like aspirin and ibuprofen) called COX-2 inhibitors. The lure to allowing Vioxx onto the market was not because they were more effective than classic NSAIDs, but because they were less likely to cause bleeding and other digestive tract complications. Now Vioxx victims are wondering if an older NSAID drug would have been just as effective and a much safer treatment option than Vioxx.

The FDA initially required Merck to include the same digestive warning as NSAIDs. When Merck launched a trial comparing Vioxx to a traditional NSAID naproxen in hopes of proving its drug was safer on the digestive tract and should not have to carry the same warning, the trial backfired. The study to prove that Vioxx was associated to fewer digestive tract problems than naproxen was successful, but the study had an unexpected result. It showed that patients taking Vioxx had double the risk of cardiovascular problems compared to those taking naproxen. The Vioxx victims that are alleging cardiovascular events suffered were the result of Vioxx are now questioning Merck’s four and a half year delay from the study results to finally pulling the drug from the market.

After serious Vioxx side effects were discovered, safety warnings were delayed reaching the public because the FDA and manufacturer Merck & Co. had to negotiate what the warning should say.

In response to the Vioxx controversy, the FDA asked Congress on Tuesday for authority to dictate label changes for drugs to end the back and forth with pharmaceutical companies that delayed warnings to Vioxx users about potential risks. The FDA’s deputy director for new drugs told the Senate Committee on Health, Education, Labor and Pensions that the Vioxx safety warning lapse was the result of negotiating ?how the specific language should be worded.?

It can take a very long time to agree on the wording of a safety warning, and with Vioxx, it took more than a year. Merck rejected several FDA proposals and the FDA rejected many of Merck’s.

New Vioxx warnings were added to labels in 2002, but Vioxx was eventually pulled from the market in September 2004 after more research linked the drug to heart attacks and stroke. An FDA advisory panel decided February 18 that COX-2 inhibitors, including Vioxx and Pfizer Inc.’s Celebrex and Bextra, had benefits outweighing the risks of heart attacks and strokes, but suggested the arthritis drugs include strong warnings.

The FDA has been under fire in recent years after a series of safety concerns involving drugs already on the market. Congress is currently considering legislation to tighten rules on how the government keeps track of drugs following FDA approval.

Last month, the Bush administration announced it will set up an independent Drug Safety Oversight Board to monitor FDA approved medicines once they have entered the market and update physicians and patients with surfacing risk and benefit drug information.