Doctors Concerned over Generic Drug Safety

Doctors Concerned over Generic Drug Safety | Pintas & Mullins Law Firm

It may be surprising, but 40% of all prescription and over-the-counter drugs in the U.S. are manufactured in India. Recently, after years of recalls, shut downs and federal investigations, doctors have begun voicing concerns over the quality of these products. Our team of dangerous drug lawyers takes a closer look at these Indian manufacturers and what is at risk.

The FDA recently banned three Indian drug manufacturers from importing products into the U.S. entirely: Ranbaxy Labs, Wockhardt Ltd, and Sun Pharmaceutical Industries. The agency cited a multitude of reasons for shutting them out, ranging from sanitation issues to data and record manipulation. These types of problems are not limited to Indian manufacturers, of course, but the sheer amount of drugs imported from India is what is causing concern.

Generic drugs, which are exact copies of brand-names like Lipitor or Adderall, account for about 85% of all drugs prescribed in the U.S. These drugs are made by companies throughout the world, and most are imported into the country from Canada. Some doctors are concerned less with drugs specifically made in India and more so with generic drugs in general.

Dr. Joel Zonszein, for example, recently told Reuters that many of his patients reported their medications smelled of dead fish upon opening; a situation that was further worsened because he was unaware of what company made those drugs. American physicians have no control over which generic drugs a patient receives – it is up to the individual pharmacy.

In light of these recent recalls, the FDA plans to tighten rules on how generic drugs from India are regulated. Generic drugs are a hot topic in American industry and courts, not least of all because of their immense and widespread use.

Can Generic Companies be Sued if a Patient is Injured?

We recently reported on a decision in Illinois, where a federal judge ruled that a Big Pharma company could be held liable for a patient’s injuries even though he was prescribed a generic version of its drug. The medication at issue, Paxil, is manufactured by GlaxoSmithKline, who was named a defendant in a lawsuit after a man committed suicide from taking the drug.

As stated, under federal law, generic companies like Ranbaxy Labs are required to replicate brand name drugs exactly – down to the warnings on bottles and package inserts. Because of this requirement, the issue of who is liable when a patient is injured or killed by a pharmaceutical is hotly contested.

The U.S. Supreme Court recently ruled in Mutual Pharmaceutical v. Bartlett that generic companies may not be sued for producing an unreasonably dangerous drug and failing to warn about its dangers on labels. This Illinois ruling is different because the plaintiff was attempting to hold the brand name manufacturer liable for negligence and failing to warn patients about a drug’s serious risks.

The judge agreed that the man’s suicide was directly connected to his generic Paxil prescription, and that Glaxo owed a duty to its patients to warn about the risk of suicide. Since generics are required to have the exact same warnings as brand names, it was in fact Glaxo who held responsibility for failing to warn. 

Back to the issue of the Indian generic drug industry, Ranbaxy recently agreed to pay about $500 million in a federal settlement. The company also pleaded guilty to seven counts of selling adulterated drugs, intent to defraud consumers, failure to report defects, and knowingly making false statements to regulators.

Dangerous drug attorneys at Pintas & Mullins Law Firm will continue to report on generic and brand name drug liability as more news comes out. It is important to remember that any patient who was seriously injured or by a pharmaceutical or over-the-counter drug may be able to receive compensation for their injuries. We provide free, no-obligation legal consultations to injured patients nationwide, so contact us today.