Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of …
The U.S. Food and Drug Administration, in two complaints (here and here) filed last week in federal court, is seeking permanent injunctions to prevent two stem cell clinics from marketing stem cell products without FDA approval. Specifically, a permanent injunction is being sought against US Stem …
FDA is continuing the crackdown on the sale of tobacco products to minors (see our post here regarding recent FDA actions). On May 1, 2018, FDA and FTC issued 13 joint warning letters to manufacturers, distributors, and retailers for misleadingly labeling or advertising nicotine-containing e-liquids …
Last week United States ex rel. Campie v. Gilead Sciences Inc. took one step closer to being the first FCA materiality case to be taken up by the Supreme Court since the Court’s seminal decision in Universal Health Services, Inc. v. United States ex rel. …
Last year, the First Circuit reversed the dismissal of a False Claim Act (FCA) case brought against DePuy Orthopaedics, Inc., holding that the district court had wrongly dismissed the relators’ complaint for failing to plead with particularity under Federal Rule of Civil Procedure 9(b) (see …
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 …
Last month, the U.S. Court of Appeals for the Eleventh Circuit affirmed prison sentences for Stewart and Michael Parnell, and Mary Wilkerson, formerly of the Peanut Corporation of America (PCA). If you missed our earlier coverage of this historic case (here and here), PCA was …
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 …
On January 24, 2018, FDA and the Federal Trade Commission (FTC) posted joint warning letters to 11 marketers and distributors of opioid cessation products, alleging that those products were unapproved new drugs that violated the Federal Food, Drug, and Cosmetic Act (FDC Act) and made …
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 …
FDA gave us all a New Year’s present on January 2nd when it announced the Agency’s new Data Dashboard. The Dashboard graphically breaks down data on FDA Inspections, Compliance Actions (warning letters, injunctions, and seizures – more commonly known by industry as “enforcement actions”), Recalls, …
