Defective Drugs

Janssen Pharmaceuticals’ type 2 diabetes medication is under new scrutiny. This new scrutiny follows confirmation from the Food and Drug Administration (FDA) that use of the drug canagliflozin, sold as Invokana and Invokamet, potentially increases the risk of amputation of the feet or legs. Most of these amputations have involved […]

In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re:  Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, […]

First, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers about the dangerous side effects of a type of antibiotic known as fluoroquinolones. Aneurysms. Arrhythmia. Inflammation and pain to the joints, muscles and tendons. Permanent damage to the central-nervous system. Type 2 diabetes. All from the […]

Miami Beach was the place to be for mass tort lawyers last week, with two drug and medical device conferences as well as a critical hearing before the Judicial Panel on Multidistrict Litigation (also known as the “JPML”). The Judicial Panel, a group of federal judges that meets every two […]

Is Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less. Consumer clarity on how certain products make […]

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency. Researchers compared adverse drug-reaction data for anticonvulsants […]

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses. In the federal case of Amarin Pharma Inc. […]

The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims.  Pfizer, the manufacturer of Viagra, did not oppose this request by the Plaintiffs.  Pfizer’s attorneys also agreed with the Plaintiffs’ suggestion that all of the pending Viagra […]

Serious Side Effects Associated with Popular Antibiotic Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated with the pills sold commercially as Avelox, Cipro and […]