In January of this year, yet another hernia mesh lawsuit was filed against Johnson & Johnson and its subsidiary, Ethicon. The lawsuit was filed by Sharon Smith, in the U.S. District Court for the Central District of California.
In 2012, Smith’s surgeon repaired her hernia with Ethicon’s Flexible Composite Physiomesh. Unfortunately, the surgical area did not heal well, and Smith says she was in constant pain for the next five years.
During that time, Smith’s quality of life, as well as her financial situation and her relationships, steadily deteriorated. Finally, in 2017, her doctor determined the surgical mesh (Physiomesh) used in the hernia repair was at fault. The U.S. District Court for the Northern District of Georgia already has a number of hernia mesh cases in multidistrict litigation, with plaintiffs alleging harm from the mesh, including:
- Recurrences of hernias, requiring additional surgical procedures
- Sticking together of tissues and organs (adhesions)
- Chronic pain
- Intestinal fistulas
- Obstructions in the bowel
Did J & J and Ethicon Exhibit Failure to Warn?
Smith’s California lawsuit is aggressive, alleging that Johnson & Johnson and Ethicon were negligent, that they breached both express and implied warranties, and that they are liable for design defects, manufacturing defects, loss of consortium for those harmed, and, finally, that the companies failed to warn consumers regarding the potential dangers of the Physiomesh.
Nearly 500 Physiomesh Cases Consolidated in Georgia
Currently, there are more than 460 J & J and Ethicon Physiomesh lawsuits in Georgia, under Judge Richard Story. The judge ordered plaintiffs and defendants to begin selecting bellwether cases from the file lawsuits. It is expected that the Physiomesh bellwether trials will begin in September 2019.
Another Patient’s Physiomesh Story
In Raleigh, North Carolina, a patient underwent hernia repair in 2015, which he failed to recover from. The patient complained to his surgeon on multiple occasions, regarding the chronic pain and excess swelling in the hernia repair area. The patient states that his surgeon and general practitioner basically ignored his repeated statements regarding the lack of healing after his surgery, and that it was not until he saw a commercial regarding the potential dangers of hernia mesh that he understood why his body had not healed.
This patient eventually sought a second opinion, following an arduous battle with his insurance company to cover a second surgery. During this surgery, it was discovered that the patient’s tissue had grown around the mesh, making it impossible to remove during a laparoscopic surgery. The patient was forced to undergo a third surgical procedure, in the form of a traditional hernia surgery, then spent several days recovering from the back-to-back surgical procedures.
Even after these two surgeries, the patient was left with bits and pieces of hernia mesh inside his body, as these pieces had eroded into his bowel. The patient was told he would either be forced to undergo additional surgical procedures, or would likely be in pain for the remainder of his life. Although this patient initially considered filing a medical malpractice suit against his original surgeon, after finding out Ethicon’s Physiomesh—which was used in his first hernia surgery—had been withdrawn from the market and was the target of many lawsuits.
Hundreds, Possibly Thousands, of Patients Living in Chronic Pain Due to Physiomesh Complications
Hundreds of patients who are now living in chronic pain and must undergo additional surgical procedures due to J & J and Ethicon’s Physiomesh are angry—angry with their surgeons who failed to warn them about potential issues with Physiomesh, angry with manufacturers who continued to sell Physiomesh even after adverse events associated with the mesh were reported, and angry with the FDA.
FDA Fast-Tracked Physiomesh
Physiomesh, like many medical devices, was fast-tracked via the 510(k) process, which allows a new medical device to enter the market without undergoing human clinical trials, so long as the manufacturer can show the device is “substantially equivalent” to a device already on the market. An argument could be made that the thousands of patients implanted with Physiomesh, and other similar mesh products, were actually taking part in a clinical trial—without their knowledge, consent or any compensation. In fact, these patients were forced to pay for being part of a de facto clinical trial.
Recalled Mesh Products Responsible for Multiple Complications
Just one month prior to Ethicon’s withdrawal of Physiomesh from the market, an article about the mesh asserted that multiple complications associated with hernia repair using surgical mesh were associated with recalled mesh products. Such issues as adhesions, obstructions, perforations, infection, chronic pain and a recurrence of the hernia were all listed as potential complications. In fact, in an analysis of the adverse event reports sent to the FDA by patients, the FDA noted that recalled mesh products were the primary cause of obstructions and bowel perforations.
Potential Causes of Mesh Problems
Some believe the multi-layer coating on the mesh prevented adequate incorporation, causing or contributing to the many serious complications. Others allege the polypropylene mesh portion of the Physiomesh was not sufficiently strong to withstand normal abdominal forces, therefore the mesh patch would fold, move, and cause further damage.
How Ethicon is Expected to Respond
Ethicon is expected to argue that individual patient issues, such as age, activity (or lack thereof) or obesity was the cause of the injuries, rather than defects in the mesh. This strategy is meant to create uncertainty among jurors, and is often quite effective in product liability cases, due to the fact that judges and jurors are not scientific experts. The bellwether Physiomesh trials will let both sides know how the bulk of the cases can be expected to go, which will, in turn, determine whether J & J and Ethicon will offer a settlement to patients harmed by the mesh, or continue to fight.
Bellwether Cases Will Determine Future of Physiomesh Lawsuits
The decision will be a financial one for sure. The manufacturers will determine whether it is more cost-effective to continue to fight the mounting number of Physiomesh lawsuits, or whether it makes more financial sense to settle with the patients who have a filed Physiomesh lawsuit. If you or a loved one have suffered injuries due to the use of Physiomesh in your hernia surgery, you should contact an experienced Mississippi product liability attorney as quickly as possible to explore your options.
At Coxwell & Associates, PLLC, our attorneys believe in fighting aggressively for injured Mississippi hernia mesh patients and their families – to ensure that they receive the money they need to fully recover. Contact Coxwell & Associates today at (601) 265-7766 or click on the button below.
Disclaimer: This blog is intended as general information purposes only, and is not a substitute for legal advice. Anyone with a legal problem should consult a lawyer immediately.