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In May 1999 a revolutionary new drug was introduced to the US market – a drug that could act as a non-steroidal anti-inflammatory drug without putting the patient through the gastric discomfort usually associates with other NSAIDs. What was this new drug? It was the new cox-2 inhibitor manufactured by Merck, and marketed as Vioxx. Along with Celebrex, another cox-2 inhibitor that was approved at the same time, Vioxx gained huge popularity in a short space of time, and within five years has netted Merck a massive eight billion dollars in profits.
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Vioxx was welcomed by medical professionals all over the world, because it could do something that traditional non-steroidal anti-inflammatory drugs could not do – it could isolate and inhibit the cox-2 enzymes produced by the body, whereas other NSAIDs inhibited both the cox-1 and cox-2 enzymes thus making the cox-1 enzyme – which protects the lining of the stomach – ineffective.
From May 1999, when Vioxx was approved by the Food and Drugs Administration (FDA) is was widely prescribed for a number of ailments. It was commonly used for the treatment of osteoarthritis. However, it was also prescribed for adult pain management and in the treatment of menstrual cramps. Tests had not yet been performed into the effects of Vioxx on under eighteens, and therefore this medication was restricted for adult use only.
Just over five years later, it all went wrong for Vioxx and its manufacturer, Merck. After a number of recent studies, results were produced that indicated that, although Vioxx was able to provide the benefits of a traditional non-steroid anti-inflammatory drug without the gastric discomfort, it appeared to come at a very high price. The test results indicated that vioxx could in fact dramatically increase the risk of heart attacks and strokes in patients.
On 30 th September 2004, Merck announced that it was recalling all stocks of Vioxx from the US market in light of these findings. With the help of the FDA in coordinating the recall, Merck began the task of removing Vioxx from the shelves and retrieving stocks of Vioxx that were already in circulation. This was done on an entirely voluntary basis, which appeared to stand Merck in good stead. However, at around the same time a couple of journals made allegations that Merck had known about the potential risks associated with Vioxx all along, and rather than do something about it had continued to market the drug letting professionals and patients go on believing that it was a safe, reliable drug.
The journals in question claimed to have proof that Merck knew about the dangers of Vioxx, in the form of documentation and internal e-mails. The share prices of Merck had already fallen after the recall, but following these allegations the share prices plummeted. Merck denied these claims, but doubts had already been raised in too many minds by this time. The FDA’s approval of the drug was also under scrutiny, and the FDA did go on to make a statement to announce more stringent measures for future drug approval.
Many lawyers are already preparing themselves for the expected influx in Vioxx lawsuits, and some have even started legal action against Merck on behalf of clients that were taking this medication. Should the claims against Merck be proven correct, then the likelihood is that much of the eight billion in profits made by the manufacturer will be lost in paying a string of successful lawsuits.