Last month, an Indian drug maker that specializes in producing knock-off versions of brand-name medications removed all its antiretroviral drugs from the World Health Organization's list of approved pharmaceuticals. Ranbaxy Laboratories withdrew its medications used to treat AIDS patients as part of the so-called "triple cocktail" after the World Health Organization (WHO) concluded that the tests used by the company to prove the safety and effectiveness of the drugs "were unreliable or poorly documented," according to the Washington Post. The action came just months after the WHO similarly "de-listed" three other Ranbaxy anti-AIDS medications along with two antiretroviral drugs made by Cipla Ltd., another Indian pharmaceutical maker.
Here in the United States, such official regulatory rebukes would, no doubt, start a race to courthouses by plaintiff's lawyers across the country, each in search of a big and easy payday — the latest example coming at the end of September, when the painkiller Vioxx was taken off the market. However, the antiretroviral drugs removed from the WHO's list of "prequalified" medicines aren't being used in America and, in fact, were never approved for use by the U.S. Food and Drug Administration. Instead, the now-withdrawn medications are being used to treat millions of AIDS patients in the developing world, and especially Africa. Nevertheless, just because the Atlantic Ocean separates our courts from the patients who are taking these dubious drugs doesn't mean the lawsuits cannot or will not be brought here.
So who exactly will the patients sue?
The answer to that question is the same one the plaintiff's lawyers have been giving for a long time: Sue everyone you can, starting with the richest. And, based on this simple principle, it is clear that there are some who can be sued and others that can't.
First, those who cannot be sued. Although many, if not most, of the now-discredited anti-AIDS medications are being purchased with money given as foreign aid by national governments (including the United States) and recognized international bodies (such as the United Nations, including the WHO), their sovereign immunity prevents them from being held liable, even if they are partially responsible for the use of the faulty medications. Thus, despite the fact that these governments certainly constitute the deepest pockets of all — at worst, they can borrow or print as much money as they need — they will not be left to pay any verdict if and when victims sue for being given drugs the WHO cannot now qualify as safe or effective for AIDS treatment.
Second, those who can be sued. The now-withdrawn anti-AIDS medications are being distributed in Africa and throughout the developing world by a number of non-governmental organizations (NGOs), including Doctors Without Borders, the Salvation Army and others. These groups face the very real possibility of being sued successfully because, unlike national governments or recognized international bodies, NGOs — even non-profit humanitarian organizations — are not entitled to sovereign immunity to escape liability. Moreover, since many of these groups have headquarters or offices located in the United States, they could be proper defendants and subject to lawsuits brought in U.S. courts. Indeed, NGOs, like Doctors Without Borders and the Salvation Army, are particularly attractive defendants because of their large operating budgets — which to plaintiff's lawyers means there is ample money to be had for damages.
Beyond the NGOs that are distributing the now-unapproved antiretroviral medications, certain American doctors could be held liable in a medical malpractice or product liability tort case brought by an injured AIDS patient who was prescribed unsafe or ineffective drugs. This is particularly worrisome with respect to organizations like Doctors Without Borders, which touts itself as an group that sends volunteer physicians to foreign countries to assist patients in need. Specifically, despite the volunteer status and good intentions of doctors who choose to help patients in the developing world, presumably, the legal reality that doctors can be sued when they prescribe unsafe or ineffective drugs does not depend upon whether the patient pays the bill. As a result, if an American doctor dispenses unapproved medication to any patient, even one treated while on a humanitarian mission, the doctor could be subject to a lawsuit if and when the patient is injured. Additionally, since the defendant's residence is nearly always a proper place to file a lawsuit, the doors of the U.S. courts would be open whenever the treating physician was an American.
None of this is to say that these lawsuits should be filed — after all, such a tactic would surely paralyze and undermine global efforts to fight the AIDS epidemic. Nevertheless, our eyes should be wide open to the liability created by the use of unapproved and possibly unsafe medications. There is absolutely no reason such drugs should be given to AIDS-afflicted patients in the developing world on the off-chance that they might work. There are numerous tested and approved antiretroviral drugs that have been pronounced safe and effective by U.S., EU and Japanese regulatory bodies, not to mention the WHO. The use of these medications would eliminate the possibility of mass lawsuits and costly liability if the world community would only ensure their use.
Then there would never be a question about who to sue.December 9, 2004