Oftentimes, people refer to the False Claims Act as “Lincoln’s Law,” for this fraud-fighting law was originally championed by President Abraham Lincoln in 1863. However, the roots of the False Claims Act’s qui tam, or whistleblower, provisions actually date back to Medieval England, when many laws included bounty provisions that rewarded citizens for bringing civil and criminal actions on behalf of the king.
In time, however, powerful industry forces led to the repeal of many British qui tam laws, and by the mid-1900s, they were completely erased from the books. Thus, in the modern-day United Kingdom, whistleblowers are not protected or incentivized by laws akin to the United States False Claims Act.
This legislative disparity has real-world consequences when it comes to fighting alleged pharmaceutical fraud. The most poignant example was recently revealed in the successful False Claims Act qui tam action against generic drugmaker Ranbaxy. In that case, Dinesh Thakur, formerly a senior Ranbaxy executive, filed a False Claims Act qui tam action in the United States, alleging, among other things, that Ranbaxy manufactured drug products in violation of Current Good Manufacturing Practice regulations. This case recovered $500 million for federal and state governments, and it resulted in a criminal plea.
However, the story was much different across the pond in the United Kingdom. There, because the country lacked a qui tam enforcement mechanism, Mr. Thakur was forced to go door to door, voicing his concerns to various government agencies. In fact, according to a recent article, Mr. Thakur repeatedly contacted officials at the UK Medicines and Heath Products Regulatory Authority (MHRA) with concerns about at least 16 drugs the company was supplying or seeking to supply to the National Health Service. Each time, his concerns were supposedly met with cursory responses or silence.
In contrast, according to the above article, the United States Food & Drug Administration launched an investigation a few weeks after it was first contacted by Mr. Thakur. Ultimately, with the assistance of Mr. Thakur and his counsel, the FDA’s investigation led to seven charges against Ranbaxy for selling improperly prepared drugs, failing to report that its drugs did not meet specifications, and providing false information.
Perhaps because of this experience, the United Kingdom House of Commons will dust off its law books and enact a robust qui tam mechanism modeled after the United States False Claims Act.
More information for whistleblowers is located at the Nolan Auerbach & White website.