The Herald, Sharon, Pa.

July 22, 2013

Federal court gets man’s lawsuit

By Joe Pinchot
Herald Staff Writer

HERMITAGE — A local man’s suit against a drug maker filed in Mercer County Common Pleas Court has been transferred twice and ended up in Louisiana federal court.

James E. McBride, 339 S. Buhl Farm Drive, Hermitage, filed suit Feb. 1 against Takeda Pharmaceuticals Co. and Takeda Pharmaceuticals USA, the makers of a diabetes treatment drug called Actos.

Takeda had the suit moved to U.S. District Court, Pittsburgh, while federal court officials have transferred it to the Western District Court of Louisiana to be heard with more than 300 similar suits.

Actos is a blood-sugar control drug prescribed for patients with Type 2 diabetes.

McBride said he was prescribed the drug on June 29, 2006, and his dosage was upped the following September to the highest amount available.

In April 2006, he was diagnosed with bladder cancer, which recurred in October 2007 and June 2010. He was treated with drugs and/or surgery.

McBride alleges his bouts with bladder cancer were caused by Actos, and he charged Takeda with one count of negligence and two counts of defective manufacturing.

Takeda answered the suit denying that Actos causes bladder cancer and is “safe and effective when prescribed and used in accordance with its FDA approved labeling.”

The FDA said in 2011 that patients who use Actos for more than one year may have an increased risk of bladder cancer, a reference made by Takeda on its website under the “warning and precautions” concerning use of the drug.

The company listed 55 defenses to the suit, including that McBride had pre-existing conditions; he improperly used the drug; the benefits of Actos outweigh the risks; any problems with safety of the drug were unavoidable; McBride suffered an “idiosyncratic reaction”; and that there was “no practical or technically feasible alternative design or formulation that would have prevented the harm alleged by McBride without substantially impairing the usefulness” of Actos.

India, France and Germany have banned the drug, while the FDA has taken no such steps.

Takeda reportedly is facing more than 1,500 suits over use of Actos.