During the last two decades, American medical technology manufacturers Atrium Medical Corporation, Davol, Inc., a subsidiary of C.R. Bard, Inc., and Ethicon, a subsidiary of Johnson & Johnson, manufactured, among others, hernia mesh implants. Hernias occur when an organ or fatty tissue squeezes through a weak area in a surrounding muscle or connective tissue. Hernia mesh implants are used post-surgery to reduce the likelihood of hernias recurring. Atrium Medical Corporation, C.R. Bard, Inc., and Ethicon, in particular, have been faced with lawsuits by patients who claim they were not adequately warned about the risks and possible side effects of using the mesh implants. Atrium Medical received a warning letter from the Food and Drug Administration, or FDA, as early as 2012 in which the FDA addressed violations of the manufacture of their mesh products which caused infections and yet Atrium failed to take corrective action. At issue in particular is Atrium’s C-QUR mesh. Three years later, a federal court granted the FDA a permanent injunction against Atrium to prevent the distribution of “adulterated and misbranded medical devices” due to Atrium’s “failure to establish…procedures for implementing corrective and preventive action” for the devices they manufacture, and shut down Atrium’s manufacturing facility. The Department of Justice alleged, in its complaint against Atrium that the violations by Atrium of the FDA’s Quality System in 2012 were similar to other violations made by Atrium in 2009, 2010, and 2013, detailing a pattern of repeated deviations from quality manufacturing.
Ethicon faces claims that its Physiomesh Flexible Composite Mesh product was allegedly defectively designed, manufactured, and labeled, In 2016, two European hernia registries reported higher than average failure rates for the Physiomesh Flexible Composite mesh, manufactured by Ethicon. Later that year, Ethicon issued a market recall for that same type of mesh.
C.R. Bard faced a more urgent and serious situation with their Composix Kugel hernia patch. In 2005, Bard had to issue a recall over their hernia mesh product citing that there was a danger that a piece of the patch could break. Bard feared this piece of plastic could cause bowel perforations and fistulas, which made the FDA label this recall a Class I recall – a type of recall reserved for the most delicate and dangerous situations.
Although the FDA says these side effects can happen with all mesh devices, the FDA claims that many complications associated with mesh products are with those that have been recalled but are still used. Atrium Medical, Ethicon, and C.R. Bard, are being accused of manufacturing and selling a defective product while also failing to warn both patients and doctors about the risk of mesh failure and its complications.
Each manufacturer, now defendant, will be handled through their own individual multi-district litigation which so far have not seen their first bellwether trials. After several postponements due to the COVID-19 pandemic, the first Ethicon bellwether trials are scheduled to start in June 2021. Although there have been no developments in the current lawsuits, it is worth noting that in 2010, C.R. Bard paid $1.5 million to a single plaintiff in a mesh related lawsuit before reaching a global settlement of $184 million to settle over 2,000 hernia mesh cases, equal to $92,000.00 an average per victim.
If you had a hernia mesh that was implanted after 2010, was removed or corrected, and caused injury, you may be entitled to compensation.
Our team at Oppenheim Law recognizes the emotional burden these impairments can have on individuals and their lives. That is why our firm provides a team of professionals committed to zealously represent our clients.