A recent New York Times article about the drug company GlaxoSmithKline’s agreement to pay a $750 million settlement to the FDA caught my eye, as a defective prescription drugs attorney. The settlement resulted from a whistleblower’s suit concerning problems with contaminated and ineffective products, which she said GlaxoSmithKline chose to ignore. Whistleblowers help protect us all by holding drug companies accountable for making profit-hungry decisions that put innocent people at risk.
Cheryl D. Eckard was a quality manager for GlaxoSmithKline. In that role, she warned senior managers, including top executives, repeatedly about serious problems with their Puerto Rico plant. She recommended recalls of defective products and warned that she would call the Food and Drug Administration. Instead of carrying out the recalls and protecting patients’ health and safety, the company terminated her as a “redundancy” — British for layoff — in 2003. The Puerto Rico plant, which produced $5.5 billion of worth drugs each year, had contaminated air and water, products that were stored in rented vans, intravenous cancer drugs of uncertain sterility, and bottles that incorrectly mixed different types of drugs. FDA inspectors failed to catch all of these problems, and the company did not live up to its promises to fix the ones that the FDA did find. The plant was closed in 2009, seven years after Eckard found the problems.
As a result, GlaxoSmithKline sold tablets of the antidepressant Paxil CR that did not contain the drug’s active ingredient, even after Eckard’s warning. Other defective drugs made in the factory included the ointment Bactroban, the diabetes drug Avandia, the heart drug Coreg, and the acid reflux drug Tagamet. When Eckard notified the FDA and sued under the whistleblower law, the FDA launched a criminal investigation, and armed federal marshals seized nearly $2 billion worth of drugs in 2005. The $750 million settlement includes $150 million to settle criminal charges for knowingly selling adulterated drugs—the first successful case of this kind. It also involves $600 million in civil penalties. Of that $96 million will go to the Eckard for blowing the whistle, under the federal False Claims Act.
As a defective prescription medication attorney, I am glad that Eckard’s whistleblower suit was successful. Her story shows yet again that we cannot rely on the FDA’s inspections to keep us safe, even if the FDA is trying its best. Drug companies will not always correct their mistakes, especially when profits are at stake. That means public safety depends to some extent on drug company employees who have inside knowledge and honest consciences to hold their employers, or former employers, accountable. As the federal prosecutor quoted in the article noted, the public expects drugs to be safe and perform as expected. When drug manufacturers intentionally ignore safety warnings, they undermine public health as well as public confidence in the regulatory system.
After a defective drug makes patients sick, those who were harmed don’t have to rely on the FDA or individual whistleblowers to hold drug makers accountable. Civil as well as criminal laws allow individual patients who were injured, and their families, to hold manufacturers legally liable for their actions. Drug manufacturers are legally required to warn the public if they know about potential negative effects of their products. If they sell dangerous or defective drugs without warning the public, any patient who gets hurt by these drugs can sue the drug manufacturer for the costs and injuries they suffered because of its negligence. This can include damages for medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and immoral to trick patients into taking a dangerous drug by withholding information about it. Companies who do this have to pay the consequences.


The pharmaceutical liability attorneys at Carey, Danis & Lowe help victims of dangerous drugs put their lives back together. We don’t charge an attorney fee unless we recover financial compensation for you. We have handled cases involving many different drugs and are ready to put our experience and knowledge to work for you. Pharmaceutical liability lawsuits are complicated claims that sometimes end up in multi-state class-action litigation. They require experience and knowledge to handle successfully, which is why patients and families should look for attorneys like ours who focus on pharmaceutical liability lawsuits. If you or a loved one have been hurt by a dangerous prescription or over the counter medication, let Carey, Danis & Lowe help you stand up for your rights. For a free consultation, call us toll-free at 1-877-678-3400 or contact us through our website.