U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects.
Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No
Compare that to the Indian Law System
Madras High Court in India allowed a stay on immediate withdrawal of drugs banned due to Severe Side Effects. The pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries successfully managers to convince the legal system to set aside the safety of patients & to get a reversal of the ban for a short period. DCGI has a long way to go before effective PV can be enforced in India. The systems failed in France very recently even with the strong arm run EU PV policy in place,
The French Regulatory system was rocked recently in its disability to handle PV issues in proper maner. A report from the Inspection Generale des Affaires de Santé (IGAS). Mediator a lipopenic drug (a drug to lower fat levels in the blood) was discovered to have appetite suppressant qualities and was heavily over-prescribed by doctors whose patients wished to lose a little weight. Controversially, the drug stayed on the market despite a succession of warnings over its side-effects, which include heart valve disease and pulmonary hypertension. It is thought that as many as 2,000 people may have died from the severe Adverse Drug Reactions (ADR) incurred by their use of the drug. However, already in 1997 the drug was banned in the US and in Switzerland ; with France following suit 12 years later. The European Medicines Agency warned in 2002 of the risks associated with the medicine, however the warnings went unheeded.