“We don’t know any drug right now with this number of deaths associated with it,” one plaintiffs’ attorney who has represented Vioxx victims told Bloomberg.com.

According to this weekend’s Bloomberg report, the fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes.  The fund will  also pay “an unspecified number” of claims on behalf of Vioxx users whose deaths didn’t meet the criteria for payments related to the drug’s use.

Families of heart attack victims who died will get an average payment of about $374,000, Bloomberg said. Some will get as little as $5,000 and others more than $1.5 million, depending on the  user’s age, how long they took the drug and whether they had health risks such as obesity or hypertension.

According to Bloomberg, the law firm administering the $4.85 billion settlement fund says $1.4 billion will be paid to heart attack claimants. The firm will pay most of the balance of the $4 billion fund to more than 20,000 claimants after Sept. 30. Stroke claimants have received $69.8 million of the $850 million so far. Claimants’ lawyers will be paid as much as $1.55 billion of the settlement fund, Bloomberg said.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion.   However, the painkiller  was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn’t properly warn doctors and patients of the drug’s risks.   To settle most of those suits, Merck established the $4.85 billion fund in November 2007. The settlement does not require that Merck make any admission of causation or fault.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck’s recalled Vioxx.  Such medications are linked to an increased risk of blood clots, heart attacks and strokes. In 2004, the Food and Drug Administration’s (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Last November, Merck announced a $4.85 billion settlement with the thousands of people who had filed Vioxx injury lawsuits.  Under the terms of the settlement, Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. Partial settlement payments started going out to some Vioxx plaintiffs last month.

Pfizer withdrew Bextra from the market in 2005, and  Celebrex is the only COX-2 inhibitor still on the market in the United States. Celebrex carries the FDA’s strictest “black-box” warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes.

Pfizer said it hopes to finalize the settlement by the end of the year.  A spokesperson for the company said that Pfizer would also like to include many of the remaining personal injury lawsuits the settlement.  The company will fight those not settled with court motions or at trial.

According to The New York Times, $760 million of the Bextra and Celebrex settlement would go to settle roughly 7,000  personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

This latest Vioxx study involved  followed people who had participated in the international APPROVe trial, which compared Vioxx to placebo over 3 years in an attempt to see whether the drug could cut the recurrence of cancerous colon polyps. The trial was stopped early in 2004 because of the increased risk for heart attacks and stroke. Nearly 2600 people participated in the APPROVe trial, and the authors of the Lancet study said they were able to contact about 84 percent of them.

According to the study, former Vioxx users still had a 79 percent increased risk of heart attack, stroke or death compared with those who had received placebo.  Individual patients faced double  the risk of heart attack or stroke in the year after stopping the drug. The increased risk of dying was 31 percent compared with those who had taken placebo, the researchers noted.

Co-author of the study, Dr. Robert Bresalier, told the Washington Post that it is probable that all non-aspirin NSAIDs – such as Celebrex, ibuprofen and naproxen – can  also increase the risk of cardiovascular problems.  “Similar data has been evident for some of the other cox-2 inhibitors,” Bresalier said. “In fact, it seems to be a class effect for most if not all NSAIDs.”

For that reasone, patients with pre-existing cardiac problems should avoid long-term use of these drugs.  However, the risk is small when NSAIDS are taken for short periods of time for intermittent pain relief.

This is not the first time Vioxx trials run by Merck have raised serious ethical questions. In April, it was learned that Merck concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. According to articles that appeared in the April issue of the “Journal of the American Medical Association”, an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed.

Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.

The report on the Advantage study was compiled by researchers working as paid consultant for lawyers who were suing Merck for Vioxx injuries. The Advantage study supposedly compared the gastrointestinal effects of Vioxx to naproxen when given to patients already taking aspirin. The Merck marketing executives who were in charge of the study were nominated for the company’s “Best Physician Program Award.” According to the award memo, the executives were nominated because the physicians who participated in the study prescribed Vioxx much more often than other doctors.

The original Advantage study was published in the Annals of Internal Medicine in 2003. A later analysis found several patients suffered cardiovascular complications that weren’t reported in the original trial. That omission makes the study even more disturbing.

According to the authors of the Vioxx Advantage report, using seeding trials to market drugs is not an unusual practice. But such a trial is a “moral offense,” the authors wrote, because there is no way for people outside of the drug company to know the study’s true intent.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits.

The conduct of Merck and the Food & Drug Administration (FDA)  had already come under a great deal of scrutiny because of the Vioxx debacle. In 2004, an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Now, it seems that Merck was less than forthcoming about two studies involving Vioxx and Alzheimer’s Disease patients. According to an analysis of court documents uncovered in the course of Vioxx injury lawsuits, Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed.

Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.

The JAMA reports show the extent to which drug companies are able to manipulate clinical trial data. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. In fact, the only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices. This is not the first time drug makers have been accused of withholding vital safety information about their medications. Recent litigation involving the Ortho Evra birth control patch has revealed documents that indicate Johnson & Johnson hid information on Ortho Evra’s blood clot risk from the FDA. And the recent scandal surrounding tainted heparin has proven that the FDA is ill-equipped to police the safety of even the most routine medicines.

Senator Charles Grassley (R-Iowa), a long-time critic of both the drug industry and the FDA, said in an emailed statement to Bloomberg.com that the revelations about the ghostwritten Vioxx articles reveal the lengths to which a drug maker might to bury information that might hurt sales. “Revealing this kind of activity is very important in building pressure on the FDA to regulate, not accommodate drug makers,” Grassley said.

Jerry Parker, Managing Partner at Parker Waichman Alonso LLP, a law firm that has represented thousands of people injured by defective drugs, says he couldn’t agree more. “Vioxx is just more reason – if we needed it after Ortho Evra – that the civil justice system plays an important role in policing the pharmaceutical and medical device companies,” Parker said. “It is the role that the FDA was supposed to play but is unable to.”

Scandals like the one involving Ortho Evra, taken together with today’s Vioxx revelations, raise serious questions about attempts by the pharmaceutical and medical industries to convince courts that FDA approval of drugs preempts drug injury lawsuits in state courts. With pharmaceutical and medical device makers going to great lengths to manipulate and withhold results of clinical trials, and the FDA seemingly unable to adequately oversee safety, litigation is often the only way abuses such as Merck’s are ever made known. Unfortunately, the US Supreme Court has already extended a lawsuit shield to device makers, and this fall it will hear a second pre-emption case involving the drug maker Wyeth. Many legal experts expect the court to rule in favor of drug companies.

Vioxx was pulled off the market in 2004, after it was linked to an increase of risk suddden cardiac deaths, and thousands of oroduct liability lawsuits. In November 2007, Merck announced a proposed $4.85 billion settlement with thousands of Vioxx plaintiffs, and by a January 2008 deadline, 95 percent of those eligible had registered for the settlement.

But today’s reports of a grand jury Vioxx investigation mean that Merck’s Vioxx problems are far from over. According to The Wall Street Journal, on February 2007, Merck disclosed in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company’s research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes. Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.

One lawyer representing Vioxx patients told the Journal that the possibility of a grand jury indictment would give Merck added incentive to resolve Vioxx personal injury suits. However, this lawyer also said that potential of an indictment probably won’t change too many people’s minds about whether to enter the proposed settlement.

The federal government has gone after other drug makers for promoting off-label uses of drugs. According to the Wall Street Journal, Justice Department probes into drug marketing have resulted in settlements of $875 million with TAP Pharmaceuticals in 2001 and $355 million with AstraZeneca in 2003. Eli Lilly & Co. is negotiating with federal investigators regarding its marketing of antipsychotic drug Zyprexa. A report yesterday indicated that Eli Lilly could pay a fine in excess of $1 billion to settle those charges.

According to a Food & Drug Administration (FDA) study, it is estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

According to the Associated Press, the Florida lawyers representing these plaintiffs say they had an agreement to set up an “amicable, working relationship” with the plaintiffs’ steering committee “for the mutual benefit of their clients,” and had submitted a list of clients who had not yet filed suit. However, they said, they weren’t informed that a settlement was close, and therefore could not get their clients’ situation considered.

But many lawyers involved in the Vioxx settlement oppose the petition, fearing that adding more plaintiffs to the Vioxx settlement would lessen the awards each eligible participant would receive. However, if the situation is not resolved, Vioxx patients who did not file suit against Merck by the November 9 deadline could still bring their own lawsuits. But that means Merck’s Vioxx troubles – which the $4.85 billion settlement was supposed to resolve – would be far from over.

If the motion to expand the Vioxx settlement is granted, it could have ramifications well beyond Florida. Lawyers for the Florida plaintiffs told the Associated Press that states with even longer statutes of limitations could be affected by a decision if their lawyers had similar agreements with the steering committee. North Dakota residents had six years, Missouri residents had five and Wyoming residents four. According to the Associated Press, Maine residents also have six years to file Vioxx lawsuits, and those in Nebraska and Utah have four.

In New Orleans, the federal judge overseeing the Vioxx settlement dismissed the motion filed Monday. But a lawyer for the Florida plaintiffs said a substitute was being filed, and a hearing was tentatively scheduled Feb. 21.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

In order to be eligible for the settlement, Vioxx claimants will have to enter into a resolution process. Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary.  Under the terms of the Vioxx settlement agreement, Merck has admitted no fault for the defective drug.

But the Vioxx settlement agreement, which was reached by Merck and plaintiffs’ attorneys from several large law firms, is not popular with all Vioxx plaintiff lawyers.  Merck has tried to coerce Vioxx plaintiffs to take the offer by including an “all or nothing” provision in the settlement. According to that provision, before they can take part, lawyers must agree to recommend the deal to all their clients — and withdraw from representing those who do not enter into the settlement.   Some plaintiffs’ attorneys are saying that while the Vioxx settlement is appropriate for some of their clients, it does not serve the interests of all.  .

Already, motions have been filed to strike the “all or nothing” provision from the Vioxx settlement. The Wall Street Journal reported last week that one of these motions, filed by lawyers from Missouri and Illinois, is scheduled for a hearing Jan. 18 before U.S. District Judge Eldon E. Fallon of New Orleans, who is overseeing the settlement. Another motion by lawyers from Kentucky and Indiana hasn’t yet been set for a hearing.

Those Vioxx victims who do not decide to participate in the Merck settlement will still have the option of suing the drug maker on their own, but if the “all or nothing” provision is allowed stand, they might have difficulty finding lawyers to represent them in their fight against Merck.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.  Merck has already spent $1.2 billion fighting Vioxx lawsuits prior to the announcement of the settlement. Merck said it planned to announce the final registration tally at a court hearing on Jan. 18 in New Orleans federal court.

Under the proposed Vioxx settlement, Merck is to set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. According to The Wall Street Journal, plaintiffs who agree to the Merck Vioxx settlement could see payments ranging from $50,000 on the low end to $1.5 million at the top, with an average above $200,000. Those amounts are subject to attorneys’ fees, expenses and liens from government entities like Medicaid and Medicare.

According to The Wall Street Journal, Jan. 15 is the deadline when all plaintiffs with a Vioxx-related case must register — whether or not their injuries would necessarily qualify for the settlement payout. This preliminary step will establish how many cases Merck faces. Those that don’t qualify for the settlement could still go to court. The second big deadline comes Feb. 29, when the estimated 45,000 plaintiffs with heart-attack and stroke cases that qualify for the settlement must enroll.

But the settlement will only take effect if 85 percent of those suing Merck over Vioxx injuries agree to accept it by the last deadline. Merck has tried to coerce Vioxx plaintiffs to take the offer by including an “all or nothing” provision in the settlement. According to that provision, before they can take part, lawyers must agree to recommend the deal to all their clients — and withdraw from representing those who do not enter into the settlement.

Some lawyers say this provision of the Vioxx settlement puts them in a difficult position. They argue that t while the Vioxx settlement is appropriate for some of their clients, it does not serve the interests of all. They also feel that the stipulation prevents them from offering the best independent judgment for each client, and opens them up to future lawsuits from disgruntled clients.

Already, motions have been filed to strike the “all or nothing” provision from the Vioxx settlement. The Wall Street Journal is reporting that one of these motions, filed by lawyers from Missouri and Illinois, is scheduled for a hearing Jan. 18 before U.S. District Judge Eldon E. Fallon of New Orleans, who is overseeing the settlement. Another motion by lawyers from Kentucky and Indiana hasn’t yet been set for a hearing.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Since then, tens of thousands of Vioxx victims have sued Merck.