Jon Campisi Jun. 9, 2011, 4:53pm

The widower of a New York woman who allegedly died as a result of using a fentanyl patch is suing the product’s manufacturers.

Attorney Rosemary Pinto, of the Philadelphia firm Feldman & Pinto, filed the product liability lawsuit June 6 at the Philadelphia Court of Common Pleas on behalf of New York resident Steven Shemelia, the husband of the deceased Patricia Shemelia.

The three defendants named in the lawsuit are Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc.

The first two defendants are based in Harrisburg, Pa., while the third is located in Vermont.

According to the complaint, which awaits mass tort status, Patricia Shemelia was prescribed the fentanyl patch by doctors in September 2009. A month later, she was dead of an apparent overdose of the potent opioid fentanyl, which the suit describes as a painkiller at least “80 times more potent than morphine.”

Fentanyl is classified as a Schedule II controlled substance by the FDA, the lawsuit states, and is only available by prescription and is generally given for the treatment of chronic pain.

The complaint states that an excess amount of fentanyl was delivered into Patricia Shemelia’s bloodstream as a result of using patches that contained deadly doses of the drug.

The lawsuit accuses the defendants of negligence in not being aware that numerous patients have received lethal doses of fentanyl while using the patches as prescribed.

The suit claims that the companies involved with the manufacture and distribution of the drug should have known that many families of patients who have died while using the Mylan Fentanyl Patch have filed wrongful death lawsuits against the companies alleging that patients have died because of a lethal fentanyl blood concentration.

The lawsuit also claims that the defendants should have received information from the FDA’s adverse event reporting system indicating that patients have received lethal fentanyl levels from the patch, and that they should have received information from the World Health Organization noting the same.

According to the complaint, Patricia Shemelia’s blood fentanyl concentration at the time of her death was reported in the lethal range, since it was 17 times higher than the mean maximal fentanyl concentration that a properly functioning 100 mcg and 25 mcg fentanyl patch is designed to deliver when used together.

The lawsuit also contains counts of strict products liability, breach of implied warranties, breach of express warranties and wrongful death.

The plaintiff demands judgment against the defendants jointly and severally in an amount in excess of $50,000 in compensatory and punitive damages, plus related costs, in each of the five counts listed in the suit.

The non-jury matter is awaiting case management listing.

The case number is 110600140.

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