US drug company defends Vioxx lawsuit in TTBy Andre Bagoo Sunday, July 19 2009
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Pearl Ena Skinner Thomas...died after taking Vioxx....
MERCK and Company Inc, one of the largest pharmaceutical companies in the world, is fighting a lawsuit in the local courts brought against it by the family of a Trinidadian woman who died after taking its once popular drug Vioxx.
On Monday, the company filed a defence of a negligence lawsuit brought against it by the family of the late Pearl Ena Skinner Thomas in the Port-of-Spain High Court, where the matter is currently before Justice Maureen Rajnauth-Lee. Merck is fighting the case alongside the local distributor of the drug, Oscar Francois Ltd.
Thomas, 76, died of a heart attack in 2005 at the San Fernando General Hospital, after being prescribed Vioxx by two separate doctors between the period 2000 to 2004 in order to treat her rheumatoid arthritis.
Thomas’ family argues that she displayed symptoms similar to those suffered by participants in Merck studies which had shown the harmful side effects of the drug which led to the company pulling it from the shelves in September 2004. They allege that Merck concealed the results of its 2000 study, called VIGOR, which first unearthed evidence of the drug’s harmful side effects. Those side effects included increased risks of cardiac arrest, diventicular disease and bleeding.
“In the latter part of 2004, the deceased became progressively ill…losing weight, having diarrhoea, vomiting, passing blood, culminating with a heart attack on February 28, 2005,” the statement of case filed in February this year by attorneys acting on behalf of the Thomas family states.
“The defendants at all material times knew of the harmful effects of Vioxx years prior to its withdrawal from the market and it suppressed the harmful effects of the drug while it continued to aggressively market the drug without properly disclosing the information found in a study commissioned by the first defendant and known as VIGOR.
“At all material times it was well known to the first defendant (Merck) that the use of the drug Vioxx had several side effects. However, it negligently and/or recklessly concealed this information even though the VIGOR study which was commissioned by the first defendant revealed the adverse effects of the use of the drug and yet it never provided adequate warning to users of the drug.”
But in its 22-page defence, obtained by Sunday Newsday, Merck’s attorneys JD Sellier and Company deny the claims of the Thomas family.
“The defendants aver that Merck…sought and received approval from the Food and Drug Division of the Ministry of Health to market the prescription medicine Vioxx in Trinidad and Tobago and that at all material times Vioxx was safe for use for its indicated uses,” the defence lodged by attorney Kimberly Molligan on Monday reads.
The company further argues that the VIGOR study compared the performance of Vioxx with a drug called naproxen and not a placebo, making the interpretation of the results of the study difficult. “The cardiovascular data from VIGOR were difficult to interpret for a variety of reasons and were not a sufficient basis to form the belief that Vioxx causes thrombotic cardiovascular events…The naproxen group suffered significantly fewer confirmed thrombotic cardiovascular events than the Vioxx group.
“VIGOR compared Vioxx to naproxen rather than placebo. In the absence of a placebo control, one cannot tell from VIGOR alone if Vioxx increased the risk or if naproxen decreased the risk of thrombotic cardiovascular events.”
As a result, Merck argues, it “examined data from two large ongoing placebo-controlled trials which were examining a hypothesised benefit of Vioxx…The data strongly suggested that Vioxx did not increase the risk of thrombotic cardiovascular events.”
Merck’s submissions come in the face of findings by The Lancet, the world’s most prestigious medical journal, which in 2004 published an article which concluded that the drug should have been withdrawn far earlier than 2004 given clear evidence that, “the cardioprotective effect of naproxen was small…and could not have explained the findings of the VIGOR trial.”
“Our findings indicate that (Vioxx) should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarise the accumulating evidence need to be clarified,” the report in The Lancet concluded.
Thomas’ family is seeking damages, which could amount to millions, for breach of warranty as to safety as well as exemplary damages. To date there have been similar cases brought against Merck in countries around the world from Australia to the United States.
About 50,000 people have sued Merck claiming that they or their family members have suffered medical problems such as heart attacks or strokes after taking Vioxx. In 2005, Merck was found liable in the first case that went to trial in the US and the plaintiff was awarded US$253.4 million in damages; however, the judgment was subsequently reduced to $20 million and then, upon appeal, the verdict was reversed in 2008.
In November 2007, Merck proposed to pay US$4.85 billion to settle most of the pending Vioxx lawsuits.
On May 20, 2008, Merck was found liable for using deceptive marketing tactics to promote Vioxx and 30 states will split the $58 million settlement.
Earlier this year Merck came to another settlement in relation to another of its drugs, Vytorin. Officials launched a probe following the lengthy delay of negative results from a clinical trial of Vytorin. Though the trial ended in May 2006, a partial reporting of negative results did not occur until January 2008 and complete results were not published until the following April. Officials alleged that prior to release of study results, Vytorin had been heavily promoted in direct-to-consumer advertisements. Merck agreed to set aside US$5.4million to settle claims.
