Drugs

Patients Harmed by Levaquin Sue Hamburg and Husband

Six patients claiming they were harmed by Johnson & Johnson’s Levaquin have filed a federal lawsuit in Washington, DC District Court against the company, former FDA commissioner Margaret Hamburg and her husband Peter Brown, alleging violations of the Racketeering and Corrupt Organizations Act, the Lanham Act, and a variety of common law torts.

According to attorney Larry Klayman, founder of Judicial Watch and Freedom Watch, while Hamburg was leading the agency, “her husband profited enormously from as much as half a billion dollars in Johnson & Johnson stock held by Renaissance Technologies, where Brown is co-CEO. Levaquin is a drug intended to treat a range of infections, including routine sinus, skin and urinary tract infections.

The complaint alleges that Hamburg, Brown and others at Renaissance Technologies “conspired with Johnson & Johnson and other defendants to suppress information about Levaquin’s harmful effects... To reveal it would have not only harmed Johnson & Johnson's profits, but invite significant lawsuits, driving Johnson & Johnson stock price downward, thereby financially harming Dr. Hamburg, her husband and Renaissance Technologies’ profits.”

Attorneys for Hamburg have reportedly called Klayman’s allegations “patently false, reckless and offensive... There is no factual or legal basis for his lawsuit, and we are confident the court will dismiss his claims in their entirety.”

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