Drugs

Courts Narrowing Liability Under False Claims Act

Attorneys Rachel Hunt and JP Ellison (Hyman, Phelps & McNamara) cite a Pennsylvania federal court decision as further proof that courts have been narrowing situations in which they will find liability under the False Claims Act (FCA) due to a Supreme Court decision in United Health Services v. United States ex rel Escobar. Writing in their firm’s FDA Law Blog, they say the Pennsylvania decision dismissed a case by whistleblowers attempting to enforce a regulatory scheme via the FCA.

Two whistleblowers alleged that Dr. Reddy’s Labs manufactured and pharmacists dispensed prescription drugs that did not comply with federal laws requiring child resistant packaging. Although the plaintiffs brought a total of 34 claims, the attorneys write, the court focused on the four concerning FCA violations and found that they failed to plead sufficient facts to allege violations of that act.

“This case represents another example of how Escobar has changed the landscape of FCA analysis in narrowing the instances where a court will impose liability,” the post concludes. “This case also signals an important shift to deference towards regulatory agencies in an effort to minimize situations in which companies experience regulatory consequences and then find themselves involved in litigation over the same conduct.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome