In a landmark judgement last week a US jury in Texas ordered Merck & Co to pay US $230 million as compensation to the widow of a patient died of heart failure after a period of taking Vioxx. Merck voluntarily withdrew the multi billon dollar drug brand containing rofecoxib from the world markets for its adverse drug reactions in September last. Adverse drug reaction of rofecoxib was just not the only reason for Merck to withdraw its US $2.5 billion brand from the market. The company could have continued the sale of Vioxx by adding label warnings especially when there was no direction from the US FDA against marketing the drug.
The company has been facing a bunch of consumer suits filed in various courts in the US from a large number of patients or their relatives and are facing huge payment liabilities. Merck had found in clinical studies last year that the molecule posed an increased risk of cardiovascular events on patients who were on use of the drug for more than 18 months. Therefore what actually prompted Merck to withdraw Vioxx was the string of lawsuits against the company. An Oklahoma lawsuit on September 30 had already charged Merck for misleading patients about the safety of the drug. The suit alleged Vioxx raised the risk of heart attack, blood clots and other cardiovascular events, which could lead to injuries and death. Now, the prospects of meeting huge payments as compensation to patients in many cases could be a real threat to the very existence of the company. Such payouts could easily wipe out much more than what it earned from the product during the last five years of marketing the product. Consumer suits against Merck is probably the third prominent litigation in the US against pharmaceutical companies in recent years. The first suit was against Pfizer for its off label promotion of Neurontin in May last year and the second was against GSK in June for concealing negative information about Paxil, its antidepressant drug. What is becoming evident from these frequent litigations is that pharmaceutical companies cannot anymore get away with their lax attitude towards drug safety and consumer health.
Rofecoxib was approved for marketing in India on June 26, 2000 and had a market size of Rs 91 crore. Drug Controller General of India has already ordered withdrawal of the drug from the Indian market soon after the Merck’s decision. A recent media report from Delhi, however, said that rofecoxib formulations are still circulating in the Delhi market. Now, the extent of physical disabilities or deaths the drug might have caused to the patients in India may not be known as the country’s pharmacovigilance body is still to be functional. Merck and Indian companies could escape from obligations of compensation liabilities because of this and also on account of the fact that Indian judiciary normally does not award heavy penalties to pharma companies for marketing harmful drugs. One of the significant features of any chemical based drug is its inherent toxicity and consequent adverse reactions. Regulatory authorities are, therefore, expected to assess these negative aspects of any drug before and after marketing approvals are given. Extensive and genuine clinical trials are, possibly, the only way of ensuring the safety and efficacy of a drug. But, even after the scrutiny of toxicity studies and clinical trial reports, regulatory authorities could clear a potentially harmful drug for marketing. The role of an informed and strong judicial system is therefore critical to grant justice to the patients, who are usually at the mercy of medical profession and powerful pharmaceutical industry.