Defective Drugs Comments Off on Generic Drug Maker Pleads Guilty, Agrees to Pay $500 Million in Fines
Ranbaxy, an India-based generic drug manufacturer, has pleaded guilty to federal drug safety violations and has agreed to pay $500 million in fines to resolve claims that it sold substandard drugs, The New York Times reports.
The article states that the company also made false statements to the U.S. Food and Drug Administration (FDA) regarding its manufacturing practices at two factories in India. This is the largest settlement in U.S. history, which involves safety violations by a generic drug manufacturer.
Several Safety Violations
Since last year, Ranbaxy has been operating under a “consent decree” with the FDA, after the agency identified a number of manufacturing lapses at plants in India and one in the United States. As part of the settlement, Ranbaxy pleaded guilty to three felony counts of violating the federal drug safety law and four of making false statements to the FDA. Company officials also admitted that they failed to conduct proper safety and quality tests of several drugs manufactured in their plants including gabapentin, which treats epilepsy and nerve pain and the antibiotic ciprofloxacin.
In the case of gabapentin, although the company knew between June and August of 2007 that certain batches were contaminated, it waited until October 2007 to issue a recall, which eventually included more than 73 million pills. In addition, prosecutors said the company’s workers did not properly ensure that certain batches of the drugs remained effective throughout their estimated shelf life.
It is appalling that the manufacturers of these generic medications were so brazen in terms of giving false information or lying to the FDA. It is reassuring that the government went after this manufacturer and held them accountable. It is unclear how many patients may have been affected by these defective drugs. At question is the epilepsy drug, which may have been contaminated. In addition, there were also other drugs that lost their effectiveness before their estimated shelf life.
Anyone who has suffered adverse effects as the result of taking these or other defective drugs would be well advised to contact an experienced California product liability attorney who will hold the negligent corporations accountable. Drug companies have formidable legal defense teams on their side looking out for their best interests. Victims and their families need a committed lawyer on their side who will fight hard for their rights and ensure that they receive fair and full compensation for their significant losses.