Drugs

Lawyer Urges Whistleblower Case Discovery Stay

Attorney Stephen Wood (Chuhak & Tecson) says a stay of discovery should be mandatory to weed out frivolous False Claims Act cases before defendants have to bear the cost of discovery. Writing in a Washington Legal Foundation Legal Backgrounder, Wood says that the small percentage of whistleblower cases that succeed if the government declines to intervene suggests that perhaps 70% or more lacked merit from the outset. “These numbers strongly suggest that the promise of a windfall leads relators to bring many unmeritorious claims,” he says. Wood speculates that the cost of frivolous false claims cases runs into the hundreds of millions of dollars annually, adding significantly to a company’s cost of doing business with the federal government.

Congress is unlikely to address the problem, he writes, since in recent years lawmakers have increased incentives and lowered procedural hurdles for whistleblowers. But the lack of congressional action wouldn’t prevent the courts from policing the law’s abuses and removing baseless claims from their dockets, he maintains.

Automatically staying discovery until after disposition of any motions challenging the sufficiency of a whistleblower suit under the federal rules of civil procedure would (1) reduce expenditures in many cases that evidence reveals are unlikely to survive the pleadings stage and (2) promote the False Claims Act’s objective of encouraging insiders to come forward with proof of fraud that can inform the government’s intervention decision, Wood says. Also, he concludes, discovery is not necessary to safeguard the government’s interests in non-intervened cases because existing law provides the government with ample tools to protect its own interests without the need for assistance from the court.

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