The False Claims Act is a piece of legislation specifically concerning qui tam law. “Qui tam” means “as well as” and refers to citizens who bring matters to court concerning harm done to the government as well as to themselves. This is different from a whistleblower, who acts on behalf of a private entity, though the verbiage is often confused. Qui tam law in the United States began in 1863 when a defense contractor was brought to trial for defrauding the government during the Civil War.
Frequently, in modern times, the False Claims Act is used to protect the government from abuse from the healthcare industry. One well-known case was brought against Pfizer, Inc. and one of its subsidiaries, Pharmacia & Upjohn Company Inc. in concern of the manufacturing and distribution of an anti-inflammatory drug called Bextra. Bextra was being distributed actively to patients by the time qui tam law caught up to Pfizer, as the testing processes had shown potential safety concerns and was rejected by the FDA. Pfizer, attempting to say that the safety concerns were only found in some of the dosages and applications and not those marketed to patients and doctors, ended up having to pay $2.3 billion in damages for their violations. Part of the money Pfizer had to pay was $1.195 billion in a criminal fine, the largest ever of its kind imposed in the United States.
Many see the False Claims Act as merely a money-making scheme for the United States federal government. In reality, the False Claims Act is a kind of pledge of responsibility from the United States government to its people. It’s stating that entities of any kind cannot make false claims of any kind — while these days, most do occur in health care, it does cover all industries and all entities equally in terms of false claims — to the United States government and expect to get away with it if they are caught doing so. There was a notion for a little while that some businesses were “too big to fail” in the early 2000s in this country. Businesses may, in some cases, be too big to fail, but they are not too big to be prosecuted to the fullest extent of the law, such as in the case with Pfizer’s subsidiary and the Bextra drug.
An anti-inflammatory sounds like a pretty innocuous substance, and certainly, the case could be made that the government was just out for Pfizer’s blood. But if you consider the particulars of the case, and the particulars of the drug’s potential side effects, the case looks a lot different.
A major trial of Bextra showed significant increases in the risk of heart attacks in patients undergoing heart bypass surgery. And frankly, the cross-section of patients who may be taking an anti-inflammatory drug for arthritis and patients who may be short-listed for vascular surgery is pretty substantial. You’re talking about a lot of people who may be affected, possibly even killed, because of this effect that Pfizer tried to dodge having to deal with by saying it was only in certain doses and people with certain issues.
Further confusion exists when people are assumed to be “whistleblowers” in qui tam cases. Qui tam law specifically refers to the American government; whistleblowers are people who identify irresponsible, illegal and/or malicious practices within a private corporation. It’s similar, no doubt, but qui tam bears with it the weight of the United States government, and generally whistleblower cases don’t have that kind of power, even if they are working for an extremely large corporation. Still, qui tam remains pertinent only when discussing bringing a case concerning defrauding the United States government. The largest corporations in the country do not fall under the same laws.
If you have any questions about qui tam law or need advice on a qui tam matter, Tate-Bywater is here to help. We’ve worked with many qui tam cases over the years and our friendly and helpful attorneys are more than happy to assist you in whatever your concerns may be. Contact your local Virginia lawyers at Tate-Bywater, Attorneys at Law, for all of your legal needs. We look forward to working with you.