With so much whining from the pharmaceutical and medical device industries over the onerous process of Federal Drug Administration (FDA) approval for a new treatment or technology, one would assume that the safety of the products in question is beyond reproach. After all, it’s a bit untenable to argue for reduced consumer protections on products that are harming consumers.
Yet that’s exactly the argument industry lobbyists continue to defend. In reality, Big Pharma has paid billions in settlements directly related to fraudulent claims and injuries caused by their products — quantifying in stark terms just how dangerous some of these medical advents can be without meaningful oversight.
Below are five stories of tragic victims and brave whistleblowers whose sacrifices have made us all a little bit safer.
When it was first released, transvaginal mesh looked like a promising treatment option for pelvic organ prolapse in women, but it quickly became one of the most controversial and litigious medical implants in history. Patients suffered from a host of severe issues, including urinary dysfunction, loss of sexual function and severe pain. Some 70,000 lawsuits against a slew of companies including Bard and Boston Scientific are currently in progress, with firms like Mostyn Law charging the way. Though it’s unclear yet how much settlement money mesh lawsuits will eventually account for, a single defendant — American Medical Systems — last year set aside $1.6 billion to settle various claims against it. Meanwhile, Johnson & Johnson has already paid out $120 million in transvaginal mesh settlements and State Attorney Generals in California, Washington and Kentucky recently filed lawsuits against the company as well.
In the largest pharmaceutical settlement to date, British drugmaker GlaxoSmithKline paid out $1 billion in criminal penalties and an additional $2 billion in civil damages in cases related to a variety of prescription medications including Wellbutrin, Advair, Avandia and several others. The allegations against the company included failing to disclose vital safety data to federal regulators, promoting unapproved, off-label uses, and paying physicians kickback money to encourage prescriptions.
In 2008 alone, sales for Actos, a diabetes drug, totaled more than $2.4 billion, and that’s incidentally exactly the amount Takeda was forced to pay in 2015 to settle allegations that Actos caused bladder cancer. Even though the number only represented a year of sales, the Japanese pharmaceutical firm’s settlement is still one of the largest tort awards in medical history.
In 2009, Pfizer paid out $2.3 billion to settle one of the most expensive pharmaceutical lawsuits in history. In charges pertaining chiefly to its Bextra painkiller, the company settled with six whistleblowers, along with 49 states. In one of the most egregious examples off-label marketing, the company promoted the drug as an alternative to morphine in treating post-operative pain following knee surgery. The drug wasn’t approved for post-surgery pain management of any kind.
In another eye-opening settlement, Abbott Labs in 2012 agreed to pay $1.5 billion to resolve criminal and civil charges stemming from its promotion of Depakote for the treatment of schizophrenia and dementia — uses that the medication was not approved for. The company reportedly trained its sales reps to target elderly patients in nursing homes, as well as paid out illegal kickbacks to doctors.
We all want new medical products and medications, but as science advances we have to make sure that these new products aren’t being pushed out just to increase profits for Big Pharma with more problems for consumers.