Articles Posted in Generic Meds

In an unexpected ruling, the Seventh Circuit Court of Appeals has denied GlaxoSmithKline PLC’s motion to dismiss a drug defect lawsuit blaming the pharmaceutical company for a man’s suicide. The wrongful death case, filed by the widow of Stewart Dolin, contends that it was the six paroxetine tablets, which he took as prescribed, that prompted him to kill himself in 2010. Paroxetine is a generic version of Paxil.

Dolin’s widow, Wendy Dolin, claims that the warning on the generic Paxil’s bottle was inadequate because it failed to caution that there was an increased suicide risk for adults. She believes that her husband experienced the serious side effect called Akathisia, which has been linked to certain Selective Serotonin Reuptake Inhibitors that are prescribed for anxiety and depression. The resulting inner agitation and restlessness can be so intense that some experts have said that a person might wish to end his/her life.

Under the law, generic drug makers are not allowed to change the labeling designated by the makers of brand name drugs. They must use the same exact wording on their products’ labels. This can make it tough for a consumer to file a drug injury case against the manufacturer.

Dinesh Thakur, a former employee of Ranbaxy, will receive $48.6 million for his role as the lead whistleblower in the case against the India-based generic-drug company. The company pleaded guilty to seven counts of “selling adultered drugs with the intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government.” Ranbaxy paid a total $500 million in criminal penalties.

Thakur began his work at Ranbaxy in early 2004 after he was recruited from the brand-name pharmaceutical company Bristol-Myers Squibb (BMY) based out of New Jersey. As the new director of project information and management, he learned Ranbaxy was in trouble in August 2004, during a meeting with his boss Dr. Rajinder Kumar, Ranbaxy’s head of research and development. Kumar disclosed to Thakur that during an inspection of Vitma Laboratories (a clinical testing lab Ranbaxy hired to test its antiretroviral-ARV-AIDS medication) the World Health Organization (WHO) had discovered that Vitma had fabricated test results. Kumar also disclosed to Thakur that the fabricated test results were not limited to the ARVs Ranbaxy had been producing; rather inventing false data and covering up original test data had been a common practice throughout the company for years.

After the initial allegations from the Vitma incident, Thakur assigned project managers to compare the data Ranbaxy had about its other various drugs with data collected by regulators. Thakur also met with a company official where he was informed that the basic company culture was to manipulate data to achieve the results it wanted in order to have the drugs approved and put on the global market. The company regularly forged, backdated and lied to regulators about its operating and manufacturing procedures. Ranbaxy’s scientists also made it known to Thankur that it frequently substituted ingredients in medications for less expensive, low quality ingredients in order to manage production costs, as well as manipulated testing parameters by substituting brand-name drugs for their own drugs in order to accomplish better testing results. Some drugs made by Ranbaxy had never been tested, and the company essentially put millions of patients at risk.
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Ranbaxy USA Inc., the American subsidiary of Ranbaxy Laboratories Limited, an Indian generic pharmaceutical maker, has agreed to pay $500 million to settle fines related to claims that it made false statements to the FDA about its manufacturing practices abroad and sold substandard medications and pay penalties. The US Justice Department, which announced the terms of this resolution, said that Ranbaxy also pleaded guilty to criminal charges involving federal drug safety violations.

Former Ranbaxy Director (and Global Head, Research & Portfolio Management) Dinesh S. Thankur, who filed the whistleblower lawsuit, is the one who brought forward the allegations that the company violated Good Manufacturing and Laboratory Practices, leading to the making of subpar drugs and the falsification of drug information. He also contends that Ranbaxy submitted false claims for a number of adulterated drugs to government healthcare programs for payment, as well as turned in false information when no tests were conducted while falsifying data about backdating tests.

Thankur alleges that the generic drug manufacturer committed Medicare/Medicaid fraud and pharmaceutical fraud. He said that he was forced to notify healthcare authorities about the violations after his former employer didn’t act when he alerted them to the problems.

The US Supreme Court has just heard arguments in Mutual Pharmaceutical Co. v. Bartlett, a dangerous drug lawsuit involving a woman who was awarded $21 million verdict for serious injuries she sustained after taking the generic version of the drug Clinoril. The plaintiff, Karen L. Bartlett, developed Stevens-Johnson Syndrome and Toxic Epidermal Necrolosis.

The two life-threatening conditions had caused her outer skin to burn off. Not only was at least 60% Bartlett’s body left as an open wound following the skin loss but she also now legally blind. Now, the justices are trying to decide whether generic drug manufacturers can be sued in state court for design defects-especially when the generic version is an exact copy of its brand-name counterpart that the federal government had already approved.

At issue is whether the Supreme Court should reinforce its 2011 ruling that protected generic drug manufacturers from state products liability claims accusing them of not warning about possibly dangerous side effects. In a 5-4 vote, the court had agreed with the defendants that they had no alternative but to use the exact same drug labels as the ones used by the brand drug makers. Following Bartlett’s verdict, which was upheld by 1st US Circuit Court of Appeals on the grounds that the plaintiff had pushed a different legal theory (concentrating on the danger of the drug and not whether or not the warning was accurate) and that even if the defendant could not have used a different warning label for Sulindac, it could have chosen to not manufacture the drug, the drug industry contended that the Supreme Court’s 2011 ruling had been disregarded.

This week, Supreme Court Justice Elana Kagan noted that the Federal Food, Drug, and Cosmetic Act doesn’t give drug manufacturers grounds to expect protection from traditional product defect cases filed under state law. Meantime, Chief Justice Roberts questioned the argument that Mutual couldn’t have complied with both federal and state law. A ruling is expected in June.

Drug Injury Lawsuits
Drug manufacturers are tasked with making sure that they medications that they sell are safe for consumers. In addition to warning of potential dangers, risks, and side effects, they also must design a drug in such a way that such dangers are minimized and with benefits that far surpass any risks.

Unfortunately, there are still pharmaceutical companies that will rush to get a product out there or keep it in the marketplace in order to make a profit-and it is the patients that suffer.

Patients’ Generic-Drug Lawsuits Questioned by High Court, Bloomberg, March 19, 2013

Mutual Pharmaceutical Co. v. Bartlett (PDF)

More Blog Posts:

Azithromycin Gets Tougher FDA Warning About Deadly Heart Rhythm Risk
, Drug Injury Lawyers Blog, March 16, 2013

Fungal Meningitis Outbreak Update: Framingham, Massachusetts-Based Compound Pharmaceutical Company Now a Defendant in Dozens of Federal Drug Injury Lawsuits, Boston Injury Lawyer Blog, December 13, 2012
Jury Orders Merck to Pay $285,000 Fosamax Injury Verdict, Drug Injury Lawyers Blog, February 26, 2013 Continue reading

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