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In late 2010, the FDA approved the drug called Pradaxa (dabigatran); manufactured by Boehringer Ingelheim. Pradaxa is a blood thinner and is supposed to be prescribed to patients who suffer from the cardiac disorder atrial fibrillation. Atrial Fibrillation is the most common form of abnormal heart rhythm.  Patients who suffer […]

In 2010, the U.S. Food & Drug Administration approved Pradaxa (Dabigatran Etexilate).  Pradaxa acts as a blood “thinner” and is promoted to reduce the risk of stroke and blood clots in people with atrial fibrillation. Atrial fibrillation, affecting over two million Americans, occurs when the heart does not beat properly […]

Pradaxa (dabigatran etexilate mesylate), a new oral anticoagulant, achieved Food & Drug Administration (“FDA”) approval on October 19, 2010. One notable advantage of using Pradaxa to replace Warfarin to prevent clot formation is the elimination of INR testing in patients taking Pradaxa. INR is the acronym for International Normalized Ratio, which is used to monitor the effectiveness of anticoagulant such as warfarin.

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 […]

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 […]

Spoliation of evidence has been defined by the courts as “the destruction or significant alteration of evidence, or the failure to preserve property for another’s use as evidence in pending or reasonably foreseeable litigation.” The concept behind this word defies one of the basic tenants in our legal system – […]

Boehringer Ingelheim, a German drug company and maker of the blood thinner Pradaxa, must pay the federal government $95 million in compensation for defrauding Medicare. The government charged that Boehringer Ingelheim promoted their drug “off label” meaning for uses they had not received regulatory approval by the U.S. Food and […]

Have you ever wondered how risky and dangerous drugs make it to market under the watchful eye of the U.S. Food and Drug Administration, charged with the responsibility of making sure they are safe and effective before they are released? The Journal of the American Medical Association tackles that question […]

The Top Ten of anything usually designates the ‘best’ but not in this case. An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 […]

It’s little known and rarely applied but the Park doctrine does allow the U.S. government to file a misdemeanor criminal charge against corporate officials even if they didn’t intend to violate any law. The law is based on the conviction of a Mr. John Park, who owned Acme Markets, a […]