For years, those who consumed generic drugs produced by the pharmaceutical company Ranbaxy unwittingly faced serious injuries and even death, as the drugs were produced in overseas factories that failed to follow federal safety guidelines.
For this and for lying to authorities with the U.S. Food & Drug Administration about these violations, Ranbaxy has pleaded guilty to criminal charges and will pay a record $500 million fine.
Our Asheville drug injury lawyers believe this case was an important one in setting a precedent of accountability for foreign drugmakers. The reality is that the FDA already has a tough time regulating drugmakers based in the U.S. The challenges for overseas are even more numerous. But they made the drugs cheaply, so for a long time, their practices weren’t questioned.
But in reality, the FDA said, these were drugs that had high rates of impurities. They were easily degradable. They would become virtually useless in hot, humid conditions. These were drugs used for conditions such as AIDS, epilespy, nerve pain and bacterial infections.
One example of the lack of caring for human life came amid the testimony provided by Dr. Kathy Spreen, the firm’s executive director of clinical medicine and pharmacovigilance. She stated that in a conference call with a dozen or so of the company’s executives, she raised concerns about the generic AIDS drug’s effectiveness, particularly in Africa, with the hot climate conditions. In response, one executive allegedly said, “Who cares? It’s just a bunch of blacks dying.”
The firm, based in India, has since last year been operating in the U.S. under a consent decree with the FDA, after a number of these violations were confirmed.
In the case of gabapentin, also known as Neurontin, the company has admitted that during the summer of 2007, a number of batches had internally tested positive for unknown impurities and had shelf lives that were unreliable. This was especially troubling considering that gabapentin is used to treat epilepsy, and patients relied on it to be able to complete functions of daily living. Despite knowing of the problems with the batch for months, the company waited until the fall of that year to notify the FDA and initiate a recall. In the end, that recall involved nearly 75 million pills.
When it came to making sure their drugs remained effective for the appropriate shelf life, Ranbaxy executives apparently placed little priority. It would fail to test the quality of the drugs until weeks or sometimes months after it told the FDA that it had.
For all of this, the company pleaded guilty to producing sub-par products and making false statements to the FDA. It will pay $150 million in criminal fines. About $50 million of that goes to a former executive who blew the whistle. The other $350 million made available to settle the existing civil claims brought by the federal government and state governments. It is not to late to file a case now if you believe you have been negatively affected by use of a generic drug produced by Ranbaxy.
If you or someone you love has suffered a drug injury in North Carolina, contact Grimes Teich Anderson LLP. Call 1.800.533.6845.
More Blog Entries:
Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al. Disappointing for North Carolina Drug Injury Sufferers, March 26, 2013, Asheville Drug Injury Lawyer Blog