Woman says pain patch to blame for son's death

CLARKSBURG -- The mother of a deceased man has filed suit against a major drug manufacturer, alleging her son died after he was exposed to a lethal amount of fentanyl through a prescribed pain patch.

Carlene Locklear, mother of Michael Locklear, says her son received a prescription for a 50 mcg fentanyl patch manufactured by defendant Mylan.

The patch, also known as the matrix patch, contains the drug fentanyl, which is used to relieve pain, according to the federal complaint filed Sept. 27 in U.S. District Court for the Northern District of West Virginia.

Patients apply the patch themselves, and it is supposed to release a certain amount of fentanyl at a certain rate through the patient's skin, the suit states.

However, Carlene Locklear claims the patch released too much fentanyl into her son's body, causing him to die on Sept. 29, 2008. She says Michael Locklear did not improperly use the patch and blames his death on the defective condition of the patch.

"The patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients," the complaint says. "The Mylan Defendants knew or should have known that patients were receiving lethal fentanyl doses from proper use of the Patch because of wrongful death lawsuits filed against them, from the FDA's adverse event reporting system, and adverse event reports from medical examiners and the World Health Organization."

Because of Michael Locklear's death, his family has suffered sorrow, mental anguish and solace and incurred medical and funeral costs, the suit states.

According to the complaint, Mylan failed to warn of risks associated with the patch and could have used a safer design that was technologically feasible at the time the patch was manufactured.

Causes of action include strict product liability, negligence, negligent misrepresentation, breach of implied warranty of fitness, breach of express warranty and breach of implied warranty of merchantability.

Mylan answered Carlene Locklear's complaint, contending that the fentanyl patches it manufactures are free of defects and are safe for use.

"The Mylan Defendants' product, which Plaintiff alleges in the Complaint to be defective, is a medical product that was state of the art and met the standards for safety and suitability known within the medical and scientific community at the time of its design, manufacture and distribution," Mylan's answer says.

Carlene Locklear is seeking unspecified punitive and exemplary damages, actual damages, plus pre- and post-judgment interest, costs and other relief to which she may be entitled.

Mylan would like to see the court dismiss Carlene Locklear's complaint, saying it is not responsible for her son's death.

"Each purported cause of action in the Plaintiff's Complaint is barred because any injury or damage allegedly sustained was the result of an independent, unforeseeable, superseding or intervening cause," the company's answer says.

In fact, if the court does award Carlene Locklear damages, it is in violation of the company's constitutional rights, the company says.

"Any claims for punitive damages are barred by the due process and ex post facto clause of the United States Constitution and the Constitution of the State of West Virginia to the extent Plaintiff seeks to impose penalties and forfeitures on the Mylan Defendants retroactively, for conduct that was not actionable when it occurred," its answer says.

In addition to dismissal of the suit, Mylan seeks costs associated with defending the suit.

Carlene Locklear will be represented by Kathryn R. Bayless of The Bayless Law Firm in Princeton. Michael Heygood, James Craig Orr Jr., Eric D. Pearson and Charles W. Miller of Heygood, Orr, Reyes and Bartolomei in Dallas will serve of counsel.

Mylan will be represented by Clem C. Trischler and Ryan J. King of Pietragallo, Gordon, Alfano, Bosick and Raspanti in Pittsburgh.

U.S. District Court case number: 1:10-cv-164