A new hernia surgical mesh lawsuit was filed on January 19, 2018, against Ethicon Inc. and Johnson & Johnson Inc. in U.S. District Court for the Central District of California. Up to 40 potential defendants in this medical device product liability case remain to be named and are identified at this point as DOES. The complainant in this hernia mesh lawsuit is Sharon S., a U.S. citizen and patient consumer of the Ethicon Physiomesh flexible composite mesh.

The Plaintiff’s Story

The plaintiff Sharon S., according to the hernia surgical mesh lawsuit, had surgery to correct an incisional hernia that developed from a prior surgery. Incision hernias are where the bowel pops through the muscle wall of the abdomen at the site of a former cut. The incisional hernia repair was done by Houlman Solomon M.D. at Torrance Memorial Medical Center in Los Angeles on August 17, 2012.

According to the hernia surgical mesh lawsuit, Sharon suffered pain which severely interfered with her day-to-day life for a little over five years before her surgeon decided the Physiomesh product was the source of the problem and made the decision to remove the medical device. The removal surgery occurred on October 9, 2017.

The Design and Approval of Physiomesh

The Physiomesh flexible composite mesh is made up of five layers. The base layer is comprised of a polypropylene plastic covered in polydioxanone film. The film bonds a polyglecaprone coatings to either side of the base layer. All layers except the base polypropylene plastic were created with the intention that they would be eventually absorbed by the body.

Ethicon Inc. sought approval of the Physiomesh flexible composite mesh through the U.S. Food and Drug Administration’s 510k program. This program does not require extensive premarket safety testing and no such testing was done. In May 2016, Ethicon decided to no longer market Physiomesh and has made statements that hernias have come back after repairs with this product at a much higher rate than average.

Physiomesh Adverse Side Effects

According to the hernia surgical mesh lawsuit, the problems associated with Physiomesh include the polypropylene sticking to organs and initiating injuries as a consequence. One of the most common injuries associated with the device is a bowel obstruction. The coating on the polypropylene base layer is supposed to prevent this sticking from happening by preventing direct exposure to the organs and bowels. The coating of the base layer, however, can also prevent bodily incorporation and allow for the mesh to float around the interior of the body causing its own havoc. Sharon Smith experienced repeat hernia, problems with the functioning of her bowels and bouts of unremitting pain. It is believed that she will continue to suffer despite having had revision surgery.

Sharon is bringing the following actions against the defendants: negligence, design defect, manufacturing defect, failure to warn, breach of express and implied warranties. She is asking for compensatory damages for her past, present, and future suffering—both physical and mental. Sharon hopes that consideration for her court and attorney fees are included with her award. She also asks that punitive damages be assessed against the company.

The Ethicon Lawsuit is Case No. 2:18-cv-00497-AB-RAO in U.S. District Court for the Central District of California.