Fentanyl Patch Lawsuit MDL to be Considered Next Month

At a hearing next month, a panel of federal judges will consider whether to consolidate and centralize all product liability lawsuits involving problems with fentanyl pain patches manufactured by Watson Pharmaceuticals. 

According to an order issued last week by the U.S. Judicial Panel on Multidistrict Litigation, oral arguments are scheduled for July 26 in response to a motion filed to consolidate at least 26 fentanyl patch lawsuits brought against the generic drug maker in U.S. District Courts throughout the country.

Fentanyl is a painkiller that is about 100 times more powerful than morphine. It is commonly delivered through a patch that is worn on the skin, and is supposed to deliver the medication in a regulated manner through a membrane.

All of the clams involve similar allegations that Watson manufactured and sold defective pain patches, which were prone to allowing fentanyl gel to leak directly onto the skin.

Given the potency of the opiate painkiller, if the fentanyl gel comes into direct contact with the skin of individuals administering or wearing the pain patch, it can cause a fentanyl overdose, resulting in serious injury and possibly death.

Originally introduced as the Duragesic pain patch, manufactured by a subsidiary of Johnson & Johnson, the claims against Watson Pharmaceuticals involve individuals who used the drug maker’s generic version of the fentanyl patch.

Since it was developed, the FDA has received hundreds of adverse event reports involving fentanyl overdoses and deaths associated with the use of pain patches, causing many to question whether they can be safely manufactured.

According to allegations raised in the Watson fentanyl patch lawsuits, plaintiffs indicate that the problems could have been avoided through the use of a matrix design to hold the fentanyl in the patch, which eliminates the risk of leakage. The complaints allege that Watson knew about the safer alternative design, but instead continued to use a reservoir design, which was prone to leakage, in order to save money.

A motion was filed in April, by some of the plaintiffs who have brought lawsuits against Watson, arguing that all claims filed in federal courts throughout the United States involving patches manufactured by the generic drug maker should be consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.

Such consolidation is common in complex product liability claims, where a large number of lawsuits are being pursued involving common facts. Centralizing the cases before one judge reduces duplicative discovery, eliminates contradictory pre-trial rulings from different courts and serves the convenience of the parties, the witnesses and the courts.

In a response filed on May 11, Watson agreed that the fentanyl patch litigation should be consolidated as part of an MDL, but argued that lawsuits against other fentanyl patch manufacturers should also be included, identifying additional complaints filed against Mylan and Alza/Sandoz, which manufacture other generic versions of the patch.

Mylan has filed an opposition to the suggestion that they be included in any fentanyl patch MDL, arguing that their patch features a dramatically different manufacturing process. Mylan fentanyl pain patches feature the matrix design, as opposed to the reservoir design that Watson pain patches utilize. Therefore, Mylan indicates that the cases have absolutely nothing in common other than the fact that they share the same active pharmaceutical ingredient.

Oral arguments will be heard on July 26, at a hearing held at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio.

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