On Sept. 24, 2008, plaintiffs’ decedent Rose Ann Brayton, 54, was found dead. At the time of her death, she was wearing a 75 microgram/hour Mylan Fentanyl Transdermal System®, an FDA-approved drug patch indicated for the treatment of persistent moderate to severe chronic pain. The Mylan Fentanyl Transdermal System is a generic patch for the brand name patch Duragesic. It operates by delivering fentanyl, an opioid analgesic, through the skin. Brayton’s family claimed that the fentanyl transdermal system was defective and that such defects caused Brayton’s death. Brayton’s husband, Whitney Brayton, and adult daughters, Jenea Brayton and Joline Brayton, sued the designer, manufacturer and distributor of the fentanyl transdermal system, Mylan Inc., Mylan Pharmaceuticals Inc. and Mylan Technologies Inc. Brayton’s family alleged that the defendants defectively designed, manufactured and marketed the product. They also alleged that the defendants negligent misrepresented the product and that the defendants’ actions constituted a breach of warranty. Plaintiffs’ counsel contended that the Rose Ann Brayton’s patch was defective because it malfunctioned and delivered a fatal dose of fentanyl. They asserted that this fatal dose was caused by either a design defect, due to the Mylan patch lacking a rate control membrane like with the brand name patch Duragesic, or due to a manufacturing defect, which caused it to deliver too much fentanyl. Plaintiffs’ counsel also asserted that the patch lacked adequate warnings and instructions. They contended that the Mylan defendants exercised substantial control over the content of the warnings and/or instructions, but failed to provide warnings of the product’s dangers or instructions on how to safely use the product, and/or failed to provide adequate warnings and/or instructions. In addition, plaintiffs’ counsel contended that the Mylan defendants failed to provide information to the Food and Drug Administration. Defense counsel asserted that the Mylan patch did not need a rate control membrane because it has chemical rate control. They also asserted that the plaintiffs had no evidence of any manufacturing defect. They further asserted that that the Mylan companies had no right or ability to change the warnings or instructions since their product was a generic drug. Defense counsel contended that the Mylan Fentanyl Transdermal System had FDA-approved labeling which stated: “Hypoventilation (Respiratory Depression): serious or life-threatening hypoventilation may occur at any time during the use of fentanyl transdermal system especially during the initial 24 to 72 hours following initiation of therapy and following increases in dose.” Counsel also asserted that the plaintiffs had no evidence that Brayton’s prescribing physician read and relied upon the labeling for the Mylan Fentanyl Transdermal System. Defense counsel further contended that while the Mylan Fentanyl Transdermal System was distributed with an FDA-approved medication guide that was provided to all patients, there was no evidence that Brayton relied upon Mylan publications in using the product., Rose Ann Brayton was found dead on Sept. 24, 2008. One the plaintiffs’ physicians opined that the decedent’s death was the result of “one of the potential mechanisms of fentanyl patch malfunction.” Brayton was 54. She was survived by a husband and two adult daughters. Brayton’s family sought recovery of wrongful death damages, including the loss of love, affection, society, companionship, support, right of support, expectation of future support, counseling, solace and moral support. They also sought recovery of damages for funeral, burial, and memorial expenses.