As one of her final acts before leaving DOJ, Associate Attorney General Rachel Brand announced that DOJ would no longer permit its lawyers to use guidance documents issued by its “client” agencies as a basis for civil enforcement. The “Brand Memo” provides guidance about DOJ’s use …
The saga continues in United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), a False Claims Act case alleging that Gilead concealed information from FDA regarding the contamination of certain drugs, leading to false claims being paid by the …
We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding: This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is …
The Department of Justice recently issued a memo to all attorneys in the Commercial Litigation Branch, Fraud Section, and any Assistant U.S. Attorneys handling False Claims Act (FCA) cases, directing those attorneys to seek dismissal of FCA cases under certain circumstances. While the government’s ability …
In a thorough and thoughtful 23-page opinion, Judge Steven Merryday of the Middle District of Florida dismissed a $350 million judgment against the defendants, owners and operators of specialized nursing facilities. The court detailed the rigorous materiality and scienter requirements for liability under the False …
To prevail on an allegation under the False Claims Act (FCA), a plaintiff must allege that the misrepresentation by defendant was “material to the Government’s payment decision.” Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). The U.S. Supreme …
Hyman, Phelps & McNamara, P.C. is pleased to present this report summarizing leading cases and settlements from 2017 affecting the FDA-regulated industry. Our goal was to provide a concise summary of issues that most impact our clients, many of whom are drug and medical device …
The Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation, and Compliance Conference is just a few weeks away, and spaces are going fast! The two-day conference will be held on December 6-7, 2017, in Washington, D.C. Hear from new government officials, including Rebecca Wood, the …
Earlier this month, the U.S. District Court for the Central District of California dismissed a qui tam complaint filed against Medtronic and its subsidiaries alleging violations of the False Claims Act (FCA). The relator (an LLC named “The Dan Abrams Company LLC” formed by a former …
In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc. Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …
In a settlement noteworthy to any company with a drug subject to a Risk Evaluation and Mitigation Strategy (“REMS”), on September 5, 2017, the U.S. announced a multi-million dollar civil settlement with Novo Nordisk for an alleged violation of REMS requirements for its drug Victoza …
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 …
