GSK Cannot Dodge Defective Drug Lawsuit Brought by Insurers

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

GSK Sued by 41 Insurers over Allegedly Defective Drugs

Pharmaceutical company GlaxoSmithKline (GSK) is unable to avoid a lawsuit filed on behalf of 41 insurance companies, a Pennsylvania judge ruled. The lawsuit focuses on allegedly defective drugs produced by a manufacturer in Puerto Rice who no longer exists. The insurers sued GSK under the Racketeer Influenced and Corrupt Organizations (RICO) Act. The companies cited a recent Third Circuit Court of Appeals decision in filing the lawsuit against GSK. The judge found that insurers were economically injured by buying allegedly adulterated medications.

Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a lawsuit.

The Third Circuit ruling involved GSK’s diabetes drug Avandia. U.S. District Judge Juan Sanchez referred to the ruling, stating “Under In re: Avandia, an insurer’s overpayment for a drug due to the manufacturer’s deceptive market practices is a concrete economic injury,” he said. “Plaintiffs have sufficiently pleaded an analogous injury here.”

The lawsuit was filed against GSK in 2013. The 41 insurers allege that the pharmaceutical company caused the companies to pay billions of dollars by falsely marketing drugs from Puerto Rico. Additionally, the suit claims that GSK failed to address problems when presented and instead chose to obscure the issues.

GSK tried to have the case dismissed, but plaintiffs referred to the Avandia case. The appeals court had ruled that third-parties had established RICO standing by alleging that they suffered economic damage. In that ruling, the court found that GSK caused a drug to be overpriced through fraudulent conduct. In response, GSK argued that the two cases were different. With the Avandia ruling, the allegations focused on misrepresenting the safety of the drug. With the current lawsuit, plaintiff allegations focus on violations at the manufacturing facility. Judge Sanchez responded that “Although plaintiffs here do not allege the same ‘excess price’ and ‘quantity effect’ theories put forth by the In re: Avandia plaintiffs, they do put forth a theory, with supporting facts, that includes elements of both theories: GSK’s nondisclosure rendered the at-issue drugs worthless, and physicians would have not prescribed the at-issue drugs at all had GSK not concealed the … violations because plaintiffs would not have placed the drugs on their formularies,”

GSK Faced Litigation, Government Settlements for Avandia Heart Attack Risks

GSK has faced substantial litigation over Avandia, which raised safety concerns after it was linked to cardiovascular risks. The drug was pulled from the European market in 2010. Use of Avandia has been heavily restricted in the United States. In 2007, the U.S. Food and Drug Administration (FDA) added a black box warning that disclosed a risk of heart attacks with Avandia. The label was revised after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increased risk of cardiovascular disease.

The FDA placed strong limitations on sales of Avandia in 2010, finding that the drug’s risks outweighed its benefits.

In 2013, GSK agreed to settle Avandia lawsuits brought by eight U.S. states. The company resolved the litigation for $229 million.

GSK was also involved in a massive health care fraud settlement in 2012, agreeing to pay $3 billion to resolve allegations with Avandia, Zofran and other medications. The settlement was the largest health care fraud settlement in U.S. history at the time. GSK was accused of marketing the drugs off-label, paying illegal kickbacks to healthcare professionals and failing to report safety data. According to the Department of Justice press release, the federal government alleged that “between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.”

Filing a Personal Injury Lawsuit

Parker Waichman is a national personal injury law firm that represents clients in drug and medical device lawsuits. Our goal is to ensure patient safety and hold manufacturers liable in situations where they failed to warn patients and physicians about the risks associated with a drug or medical device. Misrepresenting the safety of a medical product puts patients at risk. If you or someone you know suffered a drug or medical device injury and want to learn more about filing a personal injury lawsuit, contact our firm today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).