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The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.

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A final judgment of $49 million was entered on April 12, 2007 on behalf of the firm's client 800 Adept Inc. in a patent infringement lawsuit over technology used to route toll-free phone calls.

   
In addition to the $49 million award, the court also invalidated all the defendants' asserted claims related to nine different patents.  800 Adept was also was represented by the Orlando, Fla.-based Intellectual Property law firm of Allen, Dyer, Doppelt, Milbrath & Gilchrist, P.A.
    
The judgment included a permanent injunction preventing defendants Murex Securities Ltd of the Isle of Man, and Vienna, Va.-based affiliates Murex Licensing Corp. and Targus Information Corp. from using 800 Adept's technology to provide similar services. The judgment also upheld a jury finding of willful infringement of two of 800 Adept's U.S. patents (numbers 5,805,689 and Re: 36,111). The jury verdict was issued Oct. 30, 2006, following a six-week trial in the U.S. District Court for the Middle District of Florida.

On August 29, 2008 the U.S. Court of Appeals for the Federal Circuit overturned the final judgment and the U.S. Supreme Court denied certiorari.

During a two week trial in May, The Maher Law Firm partner Steven Maher along with co-counsel, Daniel Cotter, presented the tragic case of 10-year-old Joey Minotti who died in a group home after being given a lethal dose of methadone. The Firm's Of Counsel lawyer, John Jones was also co-counsel on the case.

One of five children in the Minotti family of Deland, Florida, Joey was born with Downs’ Syndrome and was autistic. When he began to express his frustrations with self-injurious behavior, his parents temporarily placed him in an Orlando, Florida group home with the hope that he would be taught less destructive behaviors and return home. While at the group home, Joey began to see Dr. Joseph Keeley, a developmental pediatrician who practices with a Florida Hospital physician group.

Dr. Keeley prescribed methadone to treat him, “a drug more potent than morphine,” says Mr. Maher. A local pharmacy filled the prescription; however, it was dispensed with instructions to give ten times the dose prescribed by the physician due, in part to the physician’s use of trailing zero.

A staff member of the group home administered the lethal dose of methadone to Joey without parental consent. When the night aide found Joey not breathing, she failed to call 911 for several hours and instead left several messages for her supervisor. All the defendants strongly disputed their negligence.

The jury found that the doctor who prescribed the methadone, the pharmacy that filled the prescription and the group home that administered the drug were all negligent and awarded the Minottis $10 million dollars for their pain and suffering. The family entered into confidential settlements with the pharmacy and group home prior to trial. After the trial, there was extensive media coverage of the verdict. Joey’s father, Robert Minotti, told reporters that he and the rest of his family finally felt closure. He said: “Joey’s life was so valuable. He taught me things that I wouldn’t have learned if I hadn’t had a child with disabilities.”