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In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
The Second Circuit issued an opinion tackling the interplay between an attorney's ethical obligation to maintain client confidences and the ability to act as a "whistleblower" to report unlawful conduct to the government. The...more
States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more
The United States Supreme Court recently indicated its potential interest in hearing arguments in a key False Claims Act (FCA) case that would address a circuit split over the important issue of the level of specificity of...more
Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more
In 1949, the Washington Legislature enacted what has become known as the “anti-rebate statute,” codified as RCW Chapter 19.68. Rep. Eileen Cody recently asked the state Attorney General (AG)’s Office whether this statute...more
The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and...more
President Obama has declared that electronic medical records will “reduce error rates, reduce our long-term cost of health care and create jobs.” “Obama’s Prime Time Press Briefing,” N.Y. Times, Feb. 9, 2009. Congress has...more
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