Manufacturers of drugs and medical devices are responsible for ensuring that their goods are safe and that possible dangers are disclosed. However, manufacturer negligence and greed with a flawed FDA approval process exposes millions of people to the risk of catastrophic, debilitating injuries, sometimes resulting in death.
People whose medications or medical devices have been harmed resort to the legal system for assistance. The avandia lawsuits are one of the most significant defective drug lawsuits witnessed. Avandia was reported to have caused severe heart and bone complications in its patients and even proved fatal in some cases.
Avandia- History, Uses, and Risks
In 1999, the US FDA approved rosiglitazone for treating Type II diabetes to make patients more responsive to insulin. Following year, in 2000, EMA too approved the drug. However, it required two post marketing reports confirming the drug’s long-term side effects on chronic heart failures and cardiovascular effects.
By 2006, annual sales peaked at around $2.5 billion. But, in 2007, the drug was linked to an elevated risk of a heart attack. Due to this, the annual sales amounted to only $9.5 million in 2012, and then the drug’s patent lapsed. Though the drug has been substantiated to high risk of heart failure, it is still available on the market. Alternatively, the European Medicines Agency (EMA) advised that the medicine be terminated in September 2010 since the benefits no longer outweighed the hazards. As a result, it was withdrawn from the United Kingdom, Spain, and India markets. In addition, in 2011, it was removed from the market in New Zealand and South Africa.
Uses & Risks
Avandia is the trade name given to the drug rosiglitazone and marketed by pharmaceutical giant GlaxoSmithKline (GSK). The drug is used as an antidiabetic drug for Type II diabetes. Avandia posed significant health risks surrounding multiple organs.
- Heart failure
Fluid retention was one of the critical safety concerns. Furthermore, when rosiglitazone was combined with insulin, the risk of congestive heart failure increased. As a result, there were contraindications in Europe for usage in heart failure and when combined with insulin.
- Heart Attacks
According to a meta-analysis published in May 2007, rosiglitazone use showed an increased risk of up to 1.4-times of a heart attack. Furthermore, the analysis depicted an increase in the risk of death from all cardiovascular illnesses. In a total of 42 experiments,27 of them were previously unpublished. This showed that GSK deliberately tried to cover up the fatal risks of Avandia.
- Bone fractures
According to GSK, female diabetics taking rosiglitazone had higher upper arm, hand, and foot fractures than those taking other drugs for the same illness.
There were more complications than Avandia caused in the patients, namely, stroke, hypoglycemia, eye damage, hepatotoxicity, weight gain, and even death.
Lawsuits and Settlements
The first of avandia lawsuits were filed in May 2007, and it was a class-action lawsuit. Celenio Cruz-Santana, a Puerto Rican, launched the class-action case against GSK. A judicial panel reassigned the case to Pennsylvania, along with other federal lawsuits involving Avandia.
A black box warning for Avandia was published in 2007, warning patients and medical professionals about the drug’s health hazards.
By March 2010, 13,000 lawsuits had been lodged, according to UBS analysts. Santa Clara County, and California, were among those suing, claiming to have spent $2 million for rosiglitazone at its public hospital between 1999 and 2007. Eventually, it sought triple damages. GSK secured settlement agreements in some of the complaints against the business in May 2010, agreeing to pay $60 million to settle 700 lawsuits. In addition, GSK made settlement agreements to close another 10,000 complaints against them in July 2010, agreeing to pay $460 million to resolve these cases.
GlaxoSmithKline decided to plead guilty and pay a $3 billion fine in 2012, in part for suppressing the results of two studies on the cardiovascular safety of Avandia conducted between 2001 and 2007. The settlement results from claims made by four GSK workers, including a former senior marketing development manager and a regional vice president. They tipped off the government about a variety of unlawful conduct between the late 1990s and the mid-2000s.
The most significant settlement in healthcare fraud
GSK was sued by 38 state attorney generals over its marketing of Avandia. They claimed that GSK misrepresented Avandia as a cholesterol-lowering drug and positioned it as having cardiovascular advantages. In reality, it aggravated the cardiovascular risks.
In July 2013, GSK agreed to pay a $229 million settlement to Louisiana, Kentucky, Mississippi, Maryland, South Carolina, New Mexico, West Virginia, and Utah.
GSK never agreed to admit any responsibility for the false marketing or gruesome side effects of the drug. Instead, it claimed to have agreed to settlements only to avoid lengthy trials that hamper the sales and trials of new medicines.
Many other medical insurance companies sued GSK as they paid for their clients’ medical costs who took Avandia. For example, Humana Medical Plans claimed to sue for recovery of healthcare costs they paid as benefits. The federal Medicare Secondary Payer Act allowed private insurers to recover these costs.
After settling thousands of avandia lawsuits, GSK suffered huge sales losses. As a result, Avandia was pulled off the shelves of pharmacies in 2011. The drug was prescribed only if no other treatment worked and also under a particular government program. In 2013, GSK ended its multi-year trial, also known as RECORD. The prosecution reported having found no adverse effects on the heart, and FDA lifted off the restrictions on Avandia.
Avandia claimed to use an alternative treatment methodology where it didn’t introduce additional insulin in the body but instead altered its reaction to already present insulin and utilize that. This caused the body to react differently in other functionalities damaging the organs and proving fatal in specific scenarios.
If a person or close one suffers from adverse effects of Avandia, it is advised to contact a defective drug attorney. Before jumping to any conclusion, it is advisable to evaluate if the claim is viable for Avandia’s settlement or not.