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Glimmer of hope in US drug fine

Washington, Aug. 20: A Texas jury’s decision yesterday to award $253 million in a single lawsuit alleging negligence in the death of a man taking the once-popular painkiller Vioxx has brightened the possibility that Indians who have used the medicine’s local version ' Rofecoxib ' could obtain legal relief for damages.

The verdict, which grabbed American TV and print headlines yesterday and today, will be a precedent in 4,200 lawsuits that are already in US courts holding Merck, the manufacturer of Vioxx, responsible for heart attack or stroke among thousands of the 20 million people who had used the drug by the time of its recall in September last year.

Merck, which is to appeal yesterday’s decision, saw its stocks tumble 7.73 per cent on Wall Street following the jury’s stunning verdict.

The pharmaceutical industry here estimates that Rofecoxib had annual sales in India of Rs 1,350 million and was used by hundreds of thousands of arthritis patients and others suffering from inflammatory pain.

Until its ban on October 12, 2004, Rofecoxib was made in India by Ranbaxy, Unichem, Torrent, Lupin and 26 other pharmaceutical firms.

The possibility that Indian patients ' even Indian companies which pirated Merck’s US patent rights and manufactured Rofecoxib ' could sue Merck under the American justice system stems from allegations that Merck deliberately misled the US Food and Drug Adminis- tration (FDA) into allowing Vioxx to be in drugstores in the US.

The New York Times reported as early as 2000 that Merck overruled one of its scientists after he suggested that a 73-year-old female patient had probably died of a heart attack.

She had participated in a clinical trial for Vioxx before it was put on the market.

In e-mail exchanges between Dr Edward M. Scolnick, Merck’s senior scientist and Dr Alise S. Reicin, vice-president for clinical research, Reicin repeatedly advised Scolnick to change his views about the death “so that we don’t raise concerns”.

In later reports to the FDA and in a paper published in 2003, Merck described the cause of this death as “unknown”.

And when Vioxx was finally withdrawn from drugstores, the company said it had learned that the medicine posed a risk of heart attack and stroke only recently.

If it is established that Merck knowingly misled the FDA, the company will be open to criminal prosecution, paving the way for Indian companies and patients to join class action suits in the US demanding billions of dollars, which are in the pipeline.

Meanwhile, it is expected that any final settlement in yesterday’s verdict will be reduced from the $253 million awarded by the jury.

Texas law has a cap on punitive awards to twice the economic damage of $450,000, in this instance, and up to another $750,000. However, there is no financial limit for loss of companionship or mental anguish.

Yesterday’s verdict involved Carol Ernst, a widow who alleged that her husband, Robert Ernst, 59, died of a heart attack in 2001 after being prescribed Vioxx.

Until he started taking the prescription, Robert had no heart problems and was even running in marathons.

Merck has so far set aside only $675 million to help cover legal costs, but the Texas verdict may only be the tip of an iceberg that may overwhelm the New Jersey-based pharmaceutical giant.

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