Ethicon Hernia Mesh Litigation – The Next TVM?

On June 2, 2017, the United States Judicial Panel on Multidistrict Litigation issued an order centralizing pre-trial proceedings in actions against Johnson & Johnson subsidiary, Ethicon, Inc., and their Physiomesh hernia repair products. The litigation, docketed as In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL No. 2782, currently consists of 84 separate actions pending in different districts across the country which will now be centralized in the Northern District of Georgia. The Panel found that all actions involved common questions of fact arising out of allegations that the defendants’ Physiomesh hernia mesh products cause complications and health risks when implanted into patients.

The centralization of the Ethicon pre-trial proceedings was ordered with the purpose of eliminating duplicative discovery, preventing inconsistent pretrial rulings, and conserving judicial resources. The Panel noted that there are 49 other related cases pending in 29 districts, which are considered potential “tag-along” actions to this MDL. When the order was originally issued, it applied to eighteen cases, though that number has steadily increased. Over 330,000 Physiomesh devices have been sold worldwide, and the plaintiffs estimate that 50% of the devices were sold within the United States. Based off these numbers, it is likely that many more causes of action will be filed against Ethicon in the near future.

What is Physiomesh? The Allegations Against Ethicon

Physiomesh is a hernia repair device that is implanted in patients through laparoscopic surgery. When first marketed, the device boasted a unique five-layer design coated with polypropylene mesh that was promoted to “prevent or minimize adhesion and inflammation and to facilitate incorporation and fixation of the mesh into the abdomen.” Such a multi-layer coating had never been used in any other hernia repair product. The device was first approved for use by the United States Food and Drug Administration in 2010, but shortly thereafter, faced complications. By the end of 2012, an estimated 90 adverse event reports were filed by surgeons and medical providers. By the time that Physiomesh was withdrawn from the market in 2016, approximately 650 reports were filed with the FDA. Ethicon has suggested that complications could be caused by operative and patient factors.

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Many plaintiffs in the pending cases claim that the implanted mesh caused complications such as herniation, recurrent hernia formation, hernia rupture, mesh deformation, and other adverse effects. It is also alleged that the device’s five-layer design prevented “adequate incorporation of the mesh” and could not withstand normal abdominal forces, resulting in serious complications. The lawsuits allege that the implanted devices were defectively designed and manufactured, and that Ethicon failed to provide adequate warnings as to the dangers of Physiomesh. The injuries alleged by the plaintiffs are severe and permanent in nature, often requiring additional surgeries, costly medical expenses, and ongoing medical complications.

Will History Repeat Itself? Parallels Between Physiomesh and Ethicon’s Transvaginal Mesh Lawsuits

While no settlements have been reached thus far, attorneys and litigants alike cannot help but wonder if the Physiomesh litigation will be as extensive as another massive Ethicon product liability case. Ethicon’s transvaginal mesh products, which are used to treat women with pelvic organ prolapse and stress urinary incontinence, have been subject to an increasing number of lawsuits over the safety of the devices. The FDA first issued a warning in 2008, stating that Ethicon’s transvaginal mesh products were associated with over 1,000 reports of serious injuries in the past three years. In July 2011, reported complications tripled. By 2016, the FDA issued regulations reclassifying transvaginal mesh products, making them ineligible to take part in the FDA’s 510(k) clearance program, which had previously allowed the products to be sold without first undergoing clinical trials.

Currently, Ethicon and their parent company, Johnson & Johnson, are named defendants in more than 55,000 transvaginal mesh product liability lawsuits. The plaintiffs are all women who suffered complications such as mesh erosion, scarring, and organ damage. A majority of lawsuits have been consolidated in multidistrict litigation in the United States District Court of the Southern District of West Virginia. A number of lawsuits are also pending in the Pennsylvania mass tort program. In January 2016, Johnson & Johnson agreed to pay $120 million to settle thousands of mesh lawsuits, marking the company’s first attempt to settle a large number of suits. The four out of five cases that have proceeded to trial and resulted in verdicts for the plaintiffs had awarded damages in the amounts of $20 million, $12.5 million, $13.5 million, and $2.1 million.

There are some parallels between the litigation of Ethicon’s transvaginal mesh and their hernia mesh products, which may serve as an indicator for the future of Physiomesh and the likelihood of the parties reaching a settlement. Both products, though used for different purposes, are polypropelene mesh devices that are alleged to have inadequately attached to the intended organ due to poor design, resulting in serious and permanent internal injuries. Interestingly, Ethicon had been approved for use through the FDA’s 510(k) Substantial Equivalent Clearance protocol, which allows a manufacturer to bypass the otherwise intensive testing of a device if it is “substantially equivalent” to an existing product on the market. The transvaginal mesh products also took advantage of the FDA’s 510(k) clearance program, meaning that no clinical trials were conducted prior to the devices hitting the market.

With no clinical trial history to use as a reference, Physiomesh plaintiffs, like the plaintiffs in the transvaginal mesh lawsuits, will need to conduct their own research as to Physiomesh’s safety. A slew of medical device experts on both sides will be needed to testify to Physiomesh’s purpose and design. Unlike other hernia mesh devices, Physiomesh was created with a unique multi-layer design, which was never previously used in any other marketed hernia repair device. Originally touted as innovative but is now alleged to be a major cause of the plaintiffs’ injuries, the questions surrounding the safety of this design are precedential in nature. Medical experts specializing in gastrointestinal surgery and plastic surgery will also likely be utilized to testify to the implantation of the device. In addition, a failure to warn expert can testify to the inadequacy of Ethicon’s warnings and how the plaintiffs’ injuries could have been avoided if they were provided proper instructions and warnings.

Overall, if Ethicon’s past history of lawsuits is any indicator, the Physiomesh product liability cases may develop into massive tort litigation as the years go on.