17 articles in this category
Problems with Avandia continue to haunt GSK. Previously, GSK has settled thousands of claims over Avandia while claiming there is nothing wrong with the onetime diabetes wonder drug. And now confronted with allegations brought by the State of Utah the drug giant defrauded the state’s Medicaid program through allegedly false and misleading marketing of Avandia, […]
This week, Johnson & Johnson etched its name in the history books of another big pharma company that has been fined over billions of dollars due to a drug manufacturer practices of improper marketing and failure to warn. Johnson & Johnson pled guilty to claims stemming from allegations that the giant pharmaceutical company knowingly marketed […]
On June 5-6, 2013, the FDA will convene an advisory committee meeting on Avandia, a drug which was removed in most countries in 2010 and placed under severe restrictions in the US. Avandia, a project of GSK (GlaxoSmithkline), was the subject of extreme medical controversy and massive litigation in both the MDL and in State […]
Faced with multiple criminal investigations into illegal practices, on November 3, 2011, the British drug company GlaxoSmithKline said that it had agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs, including Avandia. Company whisteblowers alleged that GSK improperly paid Doctors and manipulated medical […]
A recent Bloomberg article discusses a new threat from taking Avandia: “People taking the drugs have a 3 to 6 times increased risk of developing diabetic macular edema, a condition in which the retina thickens and swells, according to a study of more than 100,000 people to be presented Sunday at the American Diabetes Association’s […]
Yesterday, the FDA ordered GlaxoSmithKline (GSK) to stop selling diabetes drug Avandia in retail pharmacies starting later this year. Once the best selling diabetes drug in the world with $3 billion in annual revenue, GSK still generated $680 million in Avandia sales last year even after the significant risks of this drug became known. In […]
A Bloomberg article reports that GlaxoSmithKline (GSK) is seeking to settle with 1000 patients who claim to be injured by the diabetes drug Avandia. There are about 5300 cases pending in state courts concerning Avandia, which was pulled from the market in Europe and meant to be used only in limited cases in the United […]
Louisiana Attorney General Buddy Caldwell has filed suit in a Baton Rouge state court against GlaxoSmithKline claiming that it defrauded Louisiana’s Medicaid program out of $36 million in reimbursement payments related to Avandia. AG Caldwell contends that GSK “wrongfully and illegally marketed, priced, sold and promoted the diabetes medication”. Avandia use has been linked to […]
With the advent of globalization and the move of manufacturing plants off shore, many drug manufacturers have taken advantage of lower costs and shipped American jobs overseas. Unfortunately the FDA’s U.S. based inspectors did not follow overseas to ensure the quality of the products manufacture for consumption in the U.S. In the U.S., FDA inspections […]
British drug manufacturer GlaxoSmithKline (GSK), which makes the recalled diabetes drug Avandia, has set aside a $3.4 billion “to pay for United States government investigations and product liability cases over its marketing of” Avandia. Click here to read the entire New York Times article. This set aside is in addition to the $2.36 billion charge […]
“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas…in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach…?” A fascinating article recently discussed the increasingly common practice of performing clinical drug trials outside of the United States for drugs planned to be […]
This week, Honorable Cynthia M. Rufe of the U.S. District Court for the Eastern District of Pennsylvania rejected GlaxoSmithKline’s (GSK) request to exclude three plaintiff experts from testifying about the health risks associated with taking the diabetes drug, Avandia. The national Avandia multidistrict litigation is coordinated in front of Judge Rufe. Multidistrict Litigation (MDL) is […]
A segment on 60 Minutes discussed the story of Cheryl Eckard, who was the global quality assurance manager at GlaxoSmithKline (GSK). Her job was to inspect plants to make sure drugs were manufactured properly and met government standards for purity. In 2002, Ms. Eckard was assigned to GSK’s important Cidra, Puerto Rico, plant where 900 […]
For decades, the Brandi Law Firm has represented victims of defective pharmaceutical drugs and medical devices when their use has been shown to be unreasonably dangerous to users. One similarity in all of these cases it that the adverse affects of these drugs was found after FDA approval through a high incidence of side effects. […]
The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and […]
The FDA announced in September that they are placing severe restrictions on the continuing use and prescription of Avandia. The European Medicines Agency (Europe’s version of the FDA) went even further, banning the advertising, marketing, or sale of Avandia. Under the FDA’s restrictions, a doctor will have to certify that their patient has tried all […]
Studies Show Avandia Increases Risk for Cardiac Problems Type two diabetics with high blood sugar levels are prone to serious health problems, such as hypertension, obesity, stroke, heart attack and heart disease. Avandia (generic name rosiglitazone maleate) has been given to many type two diabetes patients to keep their blood sugar levels below dangerous levels. […]