FDA Policy/General

Massive Judgment Against Ethicon Upheld

A California state appeals court has upheld almost all of a massive $344 million civil penalty judgment against Johnson & Johnson’s Ethicon unit awarded in a bench trial for circulating misleading instructions about its transvaginal pelvic mesh products. Legal Newsline reports the appeals court only struck $42 million in penalties for oral marketing communications, saying there was no evidence of what Ethicon employees and agents said in any oral communications. However, Ethicon is left with a $302,037,500 bill to pay in the civil penalties the court upheld.

Legal Newsline says the Washington Legal Foundation said the penalty is larger than all other reported California awards combined. It also maintained that Ethicon’s statements accurately described the results of scientific studies as the company urged healthcare providers to prescribe its mesh products.

In 2008 FDA warned of complications experienced by women who were prescribed the product to help with stress urinary incontinence and pelvic organ prolapse. Thousands of personal injury lawsuits have been filed alleging pain, urinary problems, and bowel, bladder, and blood vessel perforation.

The case involved company communications including instructions for use, marketing to California doctors, and marketing to California patients. The trial court ruled that the communications violated state unfair competition and advertising laws and said Ethicon’s behavior over 17 years was “grave” and “egregious.” The judge said he believed the $344 million judgment was fair, given that it represented less than 1% of J&J’s net worth. The appeals court mostly backed the trial judge’s reasoning, Legal Newsline says, noting the trial court “prepared a 23-page violations appendix cataloging the precise manner by which each and every written or online marketing communication was likely to deceive doctors.”

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

Read more

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