Vioxx Lawsuit Attorneys and Lawyers

Vioxx, or rofecoxib, the non-steroidal anti-inflammatory drug (NSAID) prescribed for the treatment of arthritis and other acute pain, has been withdrawn from the market by its manufacturer.

According to a news release from the company, the decision was based on recent data from a study that suggests long-term use of Vioxx 25-mg may increase the "...relative risk for confirmed cardiovascular events, such as heart attach and stroke..."*

The manufacturer advises patients taking Vioxx to consult with their physician to discuss discontinuing use of Vioxx and the possibility of alternative treatments. And if you or someone you know was prescribed Vioxx and experienced any of the following, we would like to help: Heart attack, Stroke, Other serious blood, kidney, or cardiovascular problem.

What Is Vioxx?
Vioxx was developed in 1999 by Merck Pharmaceuticals as one of the first of a new class of painkillers. Vioxx is a member of a class of drugs called COX-2 selective nonsteroidal anti-inflammatory drugs, or NSAIDs. These painkillers were developed to be more effective at stopping pain without irritating the stomach.

Vioxx works by blocking the COX-2 enzyme that is thought to contribute to inflammation. It specifically does NOT block the COX-1 enzyme, which protects the stomach lining from acids, making it easier to digest.

Why Is VIOXX dangerous?

The reason Vioxx causes heart attacks and stokes isn't certain, but COX-2 inhibitors suppress a protein responsible for the health of blood vessels and could promote clotting as a result. The COX-1 enzyme encourages blood clotting while the COX-2 enzyme inhibits clotting. Drugs like Vioxx that block COX-2 enzymes and allow COX-1 enzymes may increase blood clotting, an excess of which can lead to coronary events like heart attacks and strokes.

However, long before Merck pulled Vioxx from the market, studies led researchers to question the cardiovascular safety of Vioxx and other COX-2 inhibitors such as Celebrex. A study published in the Medical Journal showed that Vioxx might also cause kidney damage.

In addition to kidney failure, researchers are concerned about increased risk of heart attacks and strokes. In February, the FDA's arthritis drug advisory committee analyzed COX-2 inhibitors' cardiovascular risks. Merck presented a study to support is contention that Vioxx is safer on the gastrointestinal tract than other NSAIDs. Although the study found that Vioxx reduced the incidence of ulcers and other gastrointestinal problems by about half that of the over-the-counter NSAID Aleve, the study showed that people taking Vioxx had four times the risk of a heart attack.

Why should Merck be held liable for injuries caused by Vioxx?

The popular and heavily advertised arthritis drug Vioxx has been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes. On August 25, 2004, a study financed by the FDA found that people taking the recommended dose of Vioxx were at three times the risk of heart attack and sudden death compared to persons taking other non-steroidal painkillers such as ibuprofen. The U.S. Food and Drug Administration released another study in November 2004 that said Vioxx may have contributed to an additional 27,785 heart attacks or deaths from 1999 to 2003.

On September 29, 2004, Merck and Co., Inc. announced that it was withdrawing its arthritis drug Vioxx worldwide following indications after a colon cancer study confirmed long-standing concerns that the drug raises the risk of heart attack and stroke. Merck's decision to withdraw Vioxx from the market came after the Data Safety Monitoring Board overseeing a long-term study of the drug recommended that the study be halted immediately because of a dramatic increased risk of serious cardiovascular events in the study participants.

The fact that Vioxx probably increased the risk of heart attacks and strokes was known for three years, but Merck downplayed it and did not undertake studies to settle the matter. The risk was confirmed only by chance in a clinical trial for another purpose.

In 2000, the VIGOR (Vioxx Gastrointestinal Outcomes Research) study was published. This study was designed to examine the effects of Vioxx on gastrointestinal side effects such as ulcers and bleeding. The study showed that patients taking Vioxx had a highly statistically significant five fold increase in heart attacks. This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension.

In 2001 Merck ordered no trial , did no tests on Vioxx's cardiovascular safety, and spent 100 million to promote the drug including that press release issued May 22 2001 entitled "Merck reconfirms favorable cardiovascular safety of vioxx" In 2001, the FDA sent to Merck Chief Executive Raymond Gilmartin a warning letter. In the eight-page letter, the FDA says Merck engaged "in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" in a clinical trial comparing Vioxx to naproxen , a less-expensive painkiller . "Your promotional campaign discounts the fact" that in the trial , "patients on Vioxx were observed to have a four to five-fold increase" in heart attacks , compared with patients on naproxen , the letter said.

The FDA letter also criticized Merck for suggesting to physicians that the reason patients taking Vioxx had a higher incidence of heart attacks in the study was that naproxen has heart benefits. Merck has maintained that the reason it didn't know earlier of a link between Vioxx and heart attacks is because naproxen is "heart protective." But the FDA's letter says, "You fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties," (the clinical term for causing blood clots that could lead to heart attacks . )

The letter said the press release titled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx " was "simply incomprehensible," given the rate of heart attacks and "serious cardiovascular events compared to naproxen ."

Emails unearthed by the Wall Street Journal confirm Merck executives knew about the cardiovascular risks as early as 2000.

A new analysis published online by the British journal The Lancet pooled results from 29 studies of Vioxx and found that people who took it had more than double the risk of heart attack than those given dummy pills or other painkillers.

Legal action against the drug's manufacturer, Merck, is going forward. Serious questions about when Merck was first aware that potentially dangerous side effects were associated with Vioxx, and whether it failed to timely inform public health authorities of these side effects are being investigated. Additionally, we will argue that Merck's heavy marketing campaign may have resulted in over prescription of the drug and led many people to use it without understanding its dangers.

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Merck profits signal a rebound
The drugmaker said sales were key to overcoming Vioxx losses.

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• October 23, 2007 |

Merck & Co. Inc. is coming back.
Two years ago, the company was reeling from its failed pain reliever, Vioxx, and from the impending loss of one of its most profitable drugs. Analysts were openly skeptical about the company's prospects.

But yesterday, Merck reported a 62 percent rise in net income for the third quarter, fueled by a doubling of vaccine sales.

Merck, whose vaccine operations are based in West Point, Montgomery County, made more money in part because it cut marketing and administrative costs 18 percent and increased revenue 12 percent.

Driving sales were Merck's heavily marketed drugs, including its top seller, the asthma and allergy medication Singulair, and more recent additions, including the human papillomavirus vaccine Gardasil.

So far, the market has responded, driving up Merck's share price 20 percent over the last year.

Merck's return to glory is far from assured. Like its competitors, the third-largest U.S. drugmaker faces patent expirations on key products in the next few years. And the company's quarterly results improved in part because executives chose to reserve less money for Vioxx lawsuits than in the quarter a year earlier.

Merck must still contend with 26,600 lawsuits involving Vioxx, which the company pulled from the market three years ago for safety reasons.

Vioxx "is still the biggest risk," said Michael Levesque, a credit analyst and senior vice president with Moody's Investors Service.

Still, Levesque added, "they have executed on their pipelines in the last several years in a way that sets them apart from many of their peers."

The company cited the third quarter, which ended Sept. 30, as part of a trend. "The momentum that Merck began to build last year continues, as proven by the strong performance in this last quarter," chief executive officer Richard T. Clark said in a conference call with Wall Street analysts.

Sales for the quarter were $6.1 billion, up from $5.4 billion in 2006. Net income increased to $1.5 billion from $941 million. And earnings per diluted share rose to 70 cents from 43 cents.

Merck's biggest seller, Singulair, which goes off patent in 2012, saw its sales rise 17 percent to $1 billion in the quarter.

The antihypertension drugs, Cozaar and Hyzaar, reached $814 million, or about even with last year. Those patents expire in April 2010.

Another big seller, Fosamax for bone loss, chalked up $725 million in sales, representing a 6 percent drop. It goes off patent in February.

Total vaccine sales were a bright spot, rising from $555 million a year earlier to $1.2 billion. Leading the firm's vaccine sector was Gardasil, the new vaccine against the human papillomavirus, which can cause cervical cancer and genital warts. The drug accounted for $418 million for the quarter and is expected to have one of the largest markets in history for a vaccine.

Rotateq, the vaccine against rotavirus that launched in February 2006, had sales of $171 million in the third quarter. BothChildren's Hospital of Philadelphia and the nearby Wistar Institute helped develop the vaccine and receive royalties.

Eight Merck drugs have been approved by the FDA in the last two years, including six novel compounds, such as Januvia, Gardasil and the new HIV drug Isentress.

Isentress, which won approval this month, is a first-in-class treatment for HIV patients whose infections have become resistant to other drugs.

The medication could gain more than half the sales in its projected $1 billion class by 2016, said analyst Sylvia Eash of Decision Resources, a privately held firm in Waltham, Mass., that analyzes drugs for pharmaceutical and biotech firms.

On the Vioxx front, Merck put aside an additional $70 million for its legal defense, a big drop from the $598 million it reserved in last year's third quarter. The difference helped cut marketing and administrative expenses in this year's third quarter, the company said.

Merck spent $160 million on the suits in the third quarter alone. It has not put aside any money to pay verdicts, a company spokeswoman confirmed.

The company's scorecard, as of yesterday, showed 11 victories and five losses.

The five losses carry judgments totaling $102.5 million, though the company is appealing each case and has yet to pay any money.

Marc Grossman, a Long Island lawyer who is representing about 350 Vioxx plaintiffs, said Merck was "playing this denial game" and "creating the perception that their Vioxx strategy is working . . . when in fact the litigation is just beginning."

Daniel Hoffman, a pharmaceutical analyst based in Glenmore, Chester County, praised management for starting to turn around the company, but said the Vioxx cases remained a concern. "They're not out of the woods by any stretch of the imagination," he said.

Merck's stock rose $1.53, or 2.9 percent, to close at $54.64.

Merck denial game
Vioxx inside Press Release

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• October 23, 2007 | Marc Grossman, Esq.

"Once again Merck is playing the denial game for its own benefit. They did it when they denied Vioxx was dangerous for as long as they could get away with it. Now, they are doing it by denying their true financial liability exposure to artificially prevent their stock from falling.
They have created a ruse to pull the wool over their investor's eyes and all of Wall Street by creating and sustaining the erroneous perception that their Vioxx defense strategy is working.

Their setting aside a total pool of $720 million for DEFENSE and nothing for liability is completely ignoring the history of this litigation."

ON BACKGROUND: On just the first 16 trials, juries told Merck to pay victims over $100 million. (It would have been much higher, were it not for state limits and judge's reductions.) This winning strategy translates to an average payout of well over $6 million per case on 32,000 cases, resulting in exposure in the billions of dollars.

If these are the projections when Merck is doing well, I can't wait to see what happens when more juries get to hear what Merck did. Their setting aside only 70 million today is only another step in their ploy to convince analysts and shareholders that their defense costs will be decreasing. This couldn't be further from the truth as this litigation has barely begun.

Stock holders should be outraged by a strategy where Merck has spent a billion dollars defending a handful of cases, and where the company has failed to accurately project for actual damages that juries have awarded to plaintiffs.

There are more than 20 trials scheduled in the next six months alone.
Consolidated trials of 8-10 plaintiffs will begin in NJ this February.
Soon Merck's appeals and delays will be exhausted and they will have to start writing checks, and they haven't set aside a single penny to cover these debts.

At the same time, the company's expenses are building up as they will have to defend on far more fronts. Just last month the New York State attorney general and New York City jointly sued Merck for $100 million.
Last week, Erie County (NY) filed suit as well. (As a reminder, there are 3,142 counties in the United States.)

The longer this litigation goes on, the more skeletons we will find in Merck's closet. Just recently, attorney Eric Weinberg was granted a mediation to review FDA documents provided by Merck - documents which the FDA basically stonewalled on - which shed light on the role of two FDA officials who as it turns out, also worked for Merck. The more time plaintiff's attorneys have to gather information and the more truth that is exposed, the more liability Merck is going to have. This handful of cases is just the tip of the iceberg.