The spouse of a woman who allegedly died as a result of using a Fentanyl pain patch has filed suit in state court against the companies involved in the manufacture, design and sale of the product.

Philadelphia attorney Rosemary Pinto, of the firm Feldman & Pinto, filed the mass tort claim Jan. 3 at the Philadelphia Court of Common Pleas on behalf of Jose Campuzano of San Leandro, Calif.

Campuzano is suing on behalf of his late wife, Charlene Manzo.

The defendants named in the lawsuit are Harrisburg, Pa.-based Mylan Inc. and Mylan Pharmaceuticals Inc., and Vermont-based Mylan Technologies Inc.

The complaint alleges that Manzo died on Jan. 9, 2010, shortly after receiving a prescription from her doctor for 100 mcg and 75 mcg Fentanyl patches.

Manzo had been prescribed the patches for the control of pain.

“Decedent never abused the Patch or used them inappropriately,” the lawsuit states. “Decedent received a lethal blood concentration of fentanyl – which caused her to die of a fentanyl overdose – while using the [Mylan] Patches as prescribed. The [Mylan] Patches were defective in that they exposed Decedent to an excessive and deadly amount of fentanyl.  As a result of using the [Mylan] Patches, Decedent received an overdose of fentanyl.”

The suit states that a toxicology test after Manzo’s death determined that her body had a blood-fentanyl concentration of 20 ng/ML, which is in the reported lethal range for the drug.

This was more than four times greater than the 4.2 ng/ML mean maximal fentanyl concentration that a “properly functioning” 100 mcg Mylan fentanyl patch and 75 mcg Mylan fentanyl patch are designed to deliver when used together, the suit claims.

“Decedent’s tragic and premature death was proximately caused by the Defendants’ defective product, the Patch, and the defendants’ negligence, gross negligence, recklessness and wanton conduct in connection with the Patch,” the lawsuit states. “The above described defects in the product were well known to each of the defendants on and prior to January 2010. Despite such knowledge, the defendants failed to act, to properly warn or to protect Decedent and other Patch users from deadly harm.”

The lawsuit claims that due to the lucrative nature of the Fentanyl patch, the manufacturers had a financial incentive to “suppress, misrepresent and/or conceal any potential dangers or risks associated with the Patches.”

The suit claims that the manufacturers knew the Fentanyl patch posed dangers, but did not disclose this information to federal regulators, prescribing medical professionals or the public.

“The Defendants, in wanton, reckless, grossly negligent and indefensible disregard of the public safety – and that of Decedent – failed to adequately and appropriately warn of the true and, known to the Defendants, deadly risk posed by the Patch,” the lawsuit states.

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

For each of the counts listed in the complaint, the plaintiff seeks compensatory and punitive damages in excess of $50,000, wrongful death and survival damages and other court costs.

A jury trial has been demanded.

The complaint states that the filing was done at the Philadelphia Court of Common Pleas because the defendants regularly do business “on a continuous and systemic basis” in Pennsylvania and Philadelphia County, specifically.

The case number is 120100086.

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