A Court has ordered AbbVie to payout £105 million after they were found to have misrepresented the risks of its testosterone drug known as AndroGel, which lead to one user suffering a heart attack.
A lawyer who helped represent the victim said that the verdict was not just a victory for his client, but served as a warning to companies who put profits above consumer health. He noted that “the large punitive award really reflects that jury’s decision.”
The victim’s case is one of the several cases to ‘test the waters’ to see how the courts will react to similar claims, notably in terms of the range of damages, payout sums, and how to move forward with such legal proceedings. Many more claimants are expected to bring their claims against the pharmaceutical drug company now this verdict has been reached. There may be a wave of potential claimants pursuing actions in the near future.
AbbVie say they will appeal the verdict on the basis that their AdroGel product reportedly complies with regulatory standards.
In this case, the claimant reportedly used AndroGel for around two months in 2010 before suffering a heart attack. Manufacturer of the highly successful testosterone drug contested that, at 56, the claimant’s heart attack was triggered by other factors like obesity and high blood pressure.
They also denied making any misrepresentation as to the safety of using AndroGel. Supplied in boxes of individual dose packets, neither the box nor the packets reportedly carry warnings about heart attacks or heart disease.
Not the first case to settle
Back in July, another case against AbbVie for its AndroGel saw an outcome of £112 million being awarded in punitive damages, but nothing was awarded in compensation to the claimant because they couldn’t prove their heart attack was linked.
AndroGel has been massively successful in dominating the market for testosterone treatments. Last year they reportedly made over £500 million in sales alone.
Will more cases where compensation is awarded to users emerge?
What do experts say?
Cardiologist, Steven Nissen, warns that hormone replacement drugs can have powerful effects; not just in the sexual organs.
The chair of cardiovascular medicine at Cleveland Clinic reminded that hormone replacement drugs used by women to prevent heart disease can in fact cause heart attacks, strokes and breast cancer.
In 2014, an advisory committee was set up by regulators to specifically look at the impact testosterone drugs had on the heart and the cardiovascular system. This was prompted by a study that revealed taking testosterone could double the risk of heart attacks for men over 65, and triple the risks for younger men who had histories of heart disease.
According to the study, 5.3 million prescriptions for testosterone were made in 2011, yet only half of these men were diagnosed with hypogonadism (diminished sexual functions). A quarter hadn;t even had their testosterone levels tested, apparently.
With so many men opting to take testosterone perhaps without needing it, Steven Nissen says it’s a “gigantic experiment, and I’m extremely concerned.”
The committee made a recommendation to AbbVie to add a warning on AndroGel’s packaging about the potential adverse risks of heart attacks.
On the product’s dedicated website, there is an Important Safety Information banner for AndroGel at the bottom of the page. Along with the long list of warnings, it reads in bold “Possible increased risk of heart attack or stroke.”