Because generic prescription drugs are so much less expensive than name-brand drugs, they are often chosen by money-conscious consumers. In fact, some insurance companies refuse to pay for name-brand drugs when a generic version is available, essentially forcing their customers to use the generic. Generic drugs are supposed to be the same as their name-brand counterparts in every important respect—but as a pharmaceutical liability lawyer, I believe they have very important legal differences. And according to Bloomberg News and the AP, generics from manufacturer Ranbaxy Laboratories differed in a very important area: the company has admitted to selling impure drugs and lying to the U.S. Food and Drug Administration about it. Now, Ranbaxy has agreed to pay $500 million in criminal and civil penalties to the federal government, all 50 states and the District of Columbia. The settlement will end a years-long investigation into Ranbaxy by federal authorities.
The wrongdoing by Ranbaxy—which it admitted to in the criminal settlement but not the civil whistle-blower lawsuit—goes back many years. The federal government alleged that Ranbaxy sold several kinds of generic drugs with unspecified purity problems. No one has come forth with allegations that the tainted drugs harmed them, but Ranbaxy also admitted to intentionally continuing to sell one drug that failed a purity test. It also delayed a recall of a drug that it knew would not last as long as its expected shelf life. Regarding drug purity tests, Ranbaxy admitted to improperly storing its samples before testing, doing tests well after it told the FDA they had been done and not sticking to the testing schedule laid out by law, then lying to the FDA about it. In November, a Ranbaxy subsidiary stopped sales of generic Lipitor because shards of glass were found in the drug.
A federal investigation into some of these problems led the FDA in 2008 to ban imports of 30 Ranbaxy drugs from Indian factories. In 2011, it agreed to improve its procedures and undergo extra oversight of manufacturing processes. In 2012, it agreed to stop making drugs for the U.S. market at two plants with suspect manufacturing processes. And this week, a court unsealed a whistle-blower lawsuit filed in 2007 by former executive Dinesh Thakur of New Jersey. Thakur published a statement this week saying he took his concerns to his supervisors originally, but when they did nothing, he went to federal authorities. The $500 million Ranbaxy agreed to pay includes $350 million to settle the lawsuit, which claims Ranbaxy knowingly defrauded federally funded health care programs. The other $150 million is to pay criminal fines and forfeitures.
As a dangerous drug attorney, I’m pleased to see such a large payment for such serious wrongdoing. It may just be good luck, or poor communication, that there are no known cases of people injured by Ranbaxy’s sloppy quality control procedures and deceit. Adulterated drugs have serious consequences; an impurity can sicken people who may be taking medicines because they already feel unwell. And an overdose or underdose, both of which can be caused by sloppy manufacturing, actually threatens the lives of people who rely on the drug to be correctly manufactured. As a defective drug lawyer, I want drug safety fines to be so expensive that it more than negates any extra profits made by breaking the law.
If you or someone you love suffered an illness or injury from taking a medication that was supposed to help, contact Carey, Danis & Lowe today to discuss your rights and your options. You can send us a message online or call 1-877-678-3400.
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