A month ago, the US pharma giant Merck withdrew its best-selling drug rofecoxib (sold under the brand name Vioxx) after tests proved that it doubled the chances of heart attacks, and perhaps strokes. Many US buyers of the drug plan to become millionaires by suing Merck. Can Indians do the same?
In the US, lawyers mount class action suits on behalf of many sufferers, charging no fees but taking a share of any compensation awarded. Such suits against tobacco companies have won huge compensation for lawyers and smokers alike. Smokers have received millions, lawyers billions.
One website estimates that Merck may have to pay $5 billion, so users could get $2.5 million each. Vioxx may have killed over a lakh people, so relatives of those killed by heart attacks can sue too. Those Indians who imported Vioxx or purchased it while abroad can sign up with US lawyers advertising on the internet. An internet search through Goggle yields a plethora of entries from lawyers. One says that lawyers are paying $200 (Rs 9,000) to people just to sign up!
It goes on to say, “You will receive a document showing how an average person can benefit from this once-in-lifetime opportunity to become a millionaire. There are still places you can buy Vioxx after the recall, you can find them online. Merck is still 100 per cent responsible for any side-effect. The purchase is risk-free, as Merck has to pay you every penny you spend on Vioxx, including tax and shipping.”
Now, the biggest awards go to people who are crippled by disease, or dying. If you have used a dangerous drug and not suffered, your prospects are dimmer. But in recent times, litigants have managed to get compensation even without having contracted a fatal disease or suffered major impairment.
Few Indians would have imported Vioxx. Most would have purchased a locally-made version, manufactured by a dozen top companies (notably Ranbaxy, Unichem, Torrent and Lupin) under their own brand names.
Until the recent ban, the drug was widely used by arthritis patients and others needing anti-inflammatory pain-killers. For decades, such patients have used inexpensive drugs like ibuprofen.
But this drug causes bleeding in the stomach/intestines in some users. So drug companies developed a new class of drugs, cox-2 inhibitors, which cause no bleeding. One of these is rofecoxib. Ironically, other cox-2 inhibitors have not so far proved dangerous.
Rofecoxib in India had annual sales estimated at Rs 135 crore, so the number of users must have run into millions. Can they too sue? They have two options. One is to sue the Indian drug companies, the second to sue Merck. Few in India will try the first route.
Litigation here takes decades, and India does not have a tradition of class action suits. Still, if such a tradition is to ever develop, this could be a promising starting point.
What about suing Merck? The multinational will be outraged at the very thought. In its view, Indian companies have pirated its patent rights on Vioxx. However, patent laws of the US do not apply to India, and Indian companies have acted within Indian (and international) law in devising their know-how to make rofecoxib.
The question remains, can users of Indian versions of rofecoxib sue Merck?
Only the courts can give a final answer. But I suspect that Merck may not be out of reach of Indian litigants.
Accusations are beginning to fly that the company suppressed inconvenient facts from the Food and Drugs Administration (FDA) of the US. Merck denies this. If inquiries show that Merck deliberately misled the FDA, the company could face criminal prosecution apart from private law-suits.
Indian drug companies decided to reverse-engineer rofecoxib and produce it after the FDA certified it for use, and Indian authorities followed suit. The decision of the Indian authorities and Indian drug companies was based on data given by Merck to the FDA. Without question, Merck would have known that FDA approval in the US would lead drug authorities in other countries to approve it, and drug companies in India to produce it. So, lawyers could make the case that Indian users have also suffered from Merck’s sins, if indeed these sins are proved.
Much will depend on what transpires from the latest inquiry into Merck’s affairs. Merck says it never hid relevant data. But some media reports say suspicious e-mails have been found in Merck’s offices.
I urge users to get together to sue either Merck or the Indian drug companies. For too long, companies have got away with substandard and dangerous products, taking advantage of the impossibility of quick justice from Indian courts. I believe we need to develop class action suits along US lines, so that large groups of sufferers can seek remedies without paying high upfront fees to lawyers. The financial bonanza at the end of the process should induce lawyers to run the risks and legal marathon involved. It may even spur them to co-operate in legal reforms to shorten judicial delays.