Merck Vioxx News and Press Releases

February 23, 2005 - Despite an expert panel's recommendation that Vioxx is safe enough to go back on the market, Merck is not expected to get much relief in court, where it faces billions of dollars in liability over the drug's safety problems. In the unfolding drama surrounding Vioxx, the recommendation late last week by an advisory panel to the Food and Drug Administration represented another murky twist, raising new questions even as it tried to answer old ones.

Howard Latin, a professor at Rutgers University School of Law who specializes in product liability, said the latest development may "not be terribly influential either way" when it comes to the litigation facing the Whitehouse Station- based drug maker. "It won't exonerate Merck and it won't implicate Merck," he said. "The biggest effect is Merck could continue to make money, but Vioxx will never be the successful, widely used big-seller it was."

After Merck pulled Vioxx from the market in September because studies showed it increased the risk of heart attacks and strokes, the number of Vioxx-related lawsuits against the drug maker mushroomed. In New Jersey alone, the number of cases grew from about 50 to more than 300. Attorneys going up against Merck viewed the withdrawal as evidence of Vioxx's dangers, but then came last week's recommendation by the expert panel. After nearly three days of hearings, the panel said Vioxx and two other popular pain relief medicines, Celebrex and Bextra, both made by Pfizer, were safe enough to remain on the market.

The panel suggested all three offered consumers benefits despite their risks of causing heart attacks and strokes. In the case of both Vioxx and Bextra, the panel voted by a narrow margin to allow the medicines to remain on the market. There were provisions, though, and the ultimate decision rests with the Food and Drug Administration. The advisory panel said all three drugs should carry new, strongly worded safety warnings. It also recommended the drugs be prescribed to a limited number of patients and no longer be aggressively marketed. "This isn't going to change the plaintiff's strategy significantly," Stephen Sheller, a Philadelphia attorney who represents consumers who used Vioxx, said. "It shouldn't have been marketed without the appropriate information and warning."

Close to 1,000 lawsuits have been filed across the country blaming Merck for problems that occurred because patients were taking Vioxx. Analysts have estimated the legal woes will come at a hefty cost -- anywhere between $4 billion and $30 billion. Law professors, lawyers and Wall Street analysts seemed to agree that although the latest developments may affect public perception -- potentially even a juror's perception -- legally the drug maker's liability rests on what it knew about the drug's risks and when it knew it.

Frank McClellan, a professor at the Beasley School of Law at Temple University in Philadelphia, said Merck's initial decision to withdraw Vioxx was likely a calculated move to limit its liability. Ted Mayer, an attorney for Merck, said it is too early to tell what effect the panel's recommendation will have on the litigation.

Merck has not disclosed whether it will resume sales of Vioxx. But on Friday, the drug maker's shares spiked 13 percent on news of the panel's findings. Yesterday, the stock declined $1.40, or 4 percent, to close at $31.21 a share. "If Merck believes Vioxx has its risks but is not uniquely dangerous, I'm not sure it would really hurt the company to put the drug back on the market," Wayne Eastman, a professor of law and ethics at Rutgers Business School, said. "But if they keep it off the market, I would think from a trial lawyer's point of view, it's because Merck suspects there are more risks," he said.

One Wall Street analyst expects to see little effect on the drug maker's liability over Vioxx. "Even if Vioxx returns, we don't see a change in product liability," Richard Evans, an analyst with Sanford C. Bernstein, said.

Susan Todd can be reached at stodd@starledger.com or (973) 392-4125.

FDA recommends restrictions on use of Celebrex, Bextra

23 Dec 2004 - CBC News - WASHINGTON - Doctors are advised to limit their use of anti-inflammatory drugs linked to a higher risk of heart attack and stroke, U.S. regulators said Thursday.

The U.S. Food and Drug Administration said it was "recommending limited use of COX-2 inhibitors," a class of drugs that were hailed for treating arthritis and inflammation.

COX-2 inhibitors were originally promoted as being easier on the stomach than older drugs called standard nonsteroidal anti-inflammatory drugs or NSAIDs, such as ASA and ibuprofen.

COX-2 inhibitors still on the market include Pfizer's Celebrex and Bextra. Merck and Co. recalled another COX-2 inhibitor, Vioxx, in September after it was associated with an increased risk of heart attacks.

All three drugs "may be associated with an increased risk of serious cardiovascular events [heart attack and stroke] especially when they are used for long periods of time or in very high risk settings [immediately after heart surgery]," the FDA said in a public health advisory.

"Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients."

The regulator said it may be appropriate to use COX-2 inhibitors for patients who:

Have a high risk of gastrointestinal bleeding.
Have a history of intolerance to non-selective NSAIDS.
Are not doing well on non-selective NSAIDs.

The FDA also said it was considering ordering a re-evaluation of trials designed to test the potential of COX-2 inhibitors to prevent cancer.

FROM DEC. 21, 2004: Heart risks prompt U.S. to halt naproxen trial

Such cancer research revealed the heart problems associated with high doses of Vioxx and the non-selective drug Naproxen.

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