On June 5th, 2017, the U.S. Supreme Court issued its opinion in Kokesh v. Securities and Exchange Commission. The Court unanimously reversed the Tenth Circuit’s decision below, and ruled that a five-year statute of limitations for the enforcement of “any civil fine, penalty, or forfeiture” …
Last week, the Texas Department of Criminal Justice (“TDCJ”) filed an Amended Complaint in a case initially filed against FDA in January 2017 in the U.S. District Court for the Southern District of Texas. TDCJ initially challenged FDA’s delay in determining the admissibility, into domestic …
We last updated readers on the Decosters’ criminal case in January, when the Decosters timely petitioned the Supreme Court for review of the Eighth Circuit decision upholding their three-month prison sentences under the FDC Act. Last week, the government responded to that petition. As reported in …
Since the Supreme Court’s decision in United Health Services v. United States ex rel. Escobar, we have seen a narrowing of situations in which courts will find liability under the False Claims Act (“FCA”). A district court in Pennsylvania provided yet another example of this …
On March 22, 2017, the jury rendered its verdict in the case of the United States v. Cadden, in the U.S. District Court for the District of Massachusetts (jury verdict form available here). The defendant, Barry J. Cadden, was the part owner and head pharmacist at …
Some lawyers old enough to remember carbon paper may also remember, in their archaic law school teaching, the “eggshell plaintiff” rule, accurately described as “a maxim that a tort defendant takes his victim as he finds him.” Also referred to as the “eggshell skull rule,” …
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a …
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 is often said that companies have an absolute right to petition the government to take or not take action without fearing exposure to an antitrust suit. This “right” is thought to be based on a series of Supreme Court decisions that are collectively commonly referred …
Loyal readers know that we at the FDALawBlog have been closely following a significant Park Doctrine case wending its way through the courts, involving father and son Austin (“Jack”) and Peter DeCoster, former executives of Quality Egg, LLC. In an earlier blog posting, we stated …
After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the …
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 …
Your friendly neighborhood bloggers were tempted to headline this post with a Buzzfeed worthy headline such as “When FDA pointed out THIS ONE THING, industry was SHOCKED!” or “FDA issues flood of letters – 25% of 2016 output in a single day. What happened next …
Last month, FDA announced the publication of a revised version of the Draft Quality Metrics Guidance that it had published back in July of 2015. We had blogged about the original Draft Guidance at that time (see prior posting here). Below we provide a brief …
