The Department of Justice announced on July 24, 2017, that Celgene agreed, without admitting liability, to pay a total of $280 million to settle a qui tam case relating to two of its drug products, Thalomid® and Revlimid®. The qui tam complaint filed in the …
Courts continue to wrangle over last year’s Supreme Court decision in United Health Services v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), and as reported here and here, there appeared to be an emerging trend of courts narrowing the types of False …
Dr. Scott Gottlieb was sworn in as FDA’s 23rd Commissioner on May 11, 2017. There has been a lot of speculation about what policies he will prioritize for the Agency during his tenure. A review of his background shows he has been an advocate for …
Although the First Amendment has been more often discussed in the context of drug and medical device promotion, the Eleventh Circuit recently evaluated whether claims for a food also deserve similar constitutional scrutiny. In Ocheesee Creamery LLC v. Putnam, the Eleventh Circuit considered whether the …
It has been 40 years since Steve Perry changed the lyrics to the iconic song Lights to refer to San Francisco rather than Los Angeles. As it turns out, litigants looking to gain easy access to otherwise confidential agency documents may want to make the …
Without pomp or circumstance, Congressman Morgan Griffith (R-VA) introduced a bill on March 27, 2017, that would expand the communications pharmaceutical and medical device companies can have with doctors about their products. The bill, titled the Medical Product Communications Act of 2017, seeks to clarify …
One and a half years since FDA first proposed changes, two months since the final rule was published, one month after objections threatening an Administrative Procedure Act challenge, and one day before the rules would have taken effect, FDA announced on Monday that it would …
FDA recently released a report summarizing its enforcement activities for FY 2016 (October 1, 2015 to September 30, 2016). It shows, among other things, that the number of warning letters from the Center for Drug Evaluation and Research doubled (76 in FY 2015 to 151 …
It has become almost commonplace to see a weekly announcement of a False Claims Act settlement by a major pharmaceutical or medical device manufacturer. Perhaps that is why last month’s settlement by Baxter Healthcare Corporation flew under the radar of the FCA bar. Or perhaps …
It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address …
Just before the holidays, the First Circuit gave the defense bar a gift by applying a stringent standard to reject a fraud-on-FDA claim under the federal False Claims Act (FCA). This case effectively serves as the death knell for the fraudulent inducement theory in the …
By Anne K. Walsh & John R. Fleder – DOJ Deputy Attorney General Sally Q. Yates spoke last week before the New York City Bar Association White Collar Crime Institute to provide an update on the DOJ policy she announced in September 2015, about which we …
By Anne K. Walsh & John R. Fleder – As we reported in September, DOJ’s Deputy Attorney General Sally Quillian Yates released a seven-page memorandum announcing DOJ’s reinforced efforts to bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to …
By Anne K. Walsh & John R. Fleder – It has been just over a month since the Department of Justice, via the “Yates Memorandum,” reemphasized its commitment to pursue individuals when dealing with corporate misconduct, reported here. Ever since then, FDA-regulated industry has been awaiting …
By Anne K. Walsh & John R. Fleder – The government has long repeated the mantra that it will hold individuals personally liable for the activities of their corporate employer. In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set …
