A lawsuit filed in a U.S. District Court in New York earlier this month alleges that Ethicon, Inc., manufacturer of the Physiomesh hernia repair system, was aware of serious problems associated with the device, yet “failed to warn or notify doctors, regulatory agencies and consumers of the known severe and life-threatening risk” associated with the product. The complaint lists a number of serious allegations, which indicate that Ethicon was more than willing to put patient lives at risk rather than sacrifice profits.
According to the product website, the Physiomesh device is “the only skirted macroporous, partially absorbable mesh designed for open ventral hernia repair…designed to promote strong and comfortable healing.” This hernia patch contains non-absorbable polypropylene plastic filaments that are integrated into the fabric.
An “absorbable film coating” is then applied, which is supposed to aid incorporation of the mesh into the patient’s body while reducing the risk of inflammation and infection. However, this unique construction has had the opposite effect. It turns out that the multi-layer coating prevents fluid from draining, which in turn provides ideal conditions under which infectious bacteria can thrive.
Ethicon withdrew the Physiomesh from the market in May of 2016 following reports from Europe indicating an association with abnormally high recurrence rates and revision surgeries. However, in its Urgent Field Notice, Ethicon claimed it “has not been able to fully characterize these factors,” instead attributing the failures to “possible product characteristics, operative and patient factors.”
The complaint tells a different story:
“Prior to the introduction of the Physiomesh to the market [in 2010], Defendants had been notified and warned about the risk of widespread and sometimes catastrophic complications associated with the Physiomesh by leading hernia repair specialists, surgeons, hospitals, patients, internal consultants, and employees. Instead of improving the design of Physiomesh, Defendants chose to push Physiomesh to market while misrepresenting the efficacy and safety of the Physiomesh through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”
Furthermore,
“Defendants failed to perform or rely on proper and adequate testing and research in order to determine and evaluate the risks and benefits of the Defendants’ Physiomesh product…[and] failed to design and establish a safe, effective procedure for removal of the Defendants’ Physiomesh product.”
The plaintiff notes that
“Feasible and suitable alternative procedures and instruments, as well as suitable alternative designs for implantation and treatment of hernias and soft tissue repair have existed at all times relevant as compared to the Defendants’ Physiomesh.”
Ethicon stands accused of engaging in aggressive, deceptive marketing as well as “providing incomplete, misleading training and information to physicians” in order to drive sales of the product.
In retrospect, none of this should come as a surprise. On one hand, Ethicon was able to obtain FDA approval for the device through the 510(k) process, allowing the company to bypass human clinical trials by demonstrating the product to be “substantially similar” to one already on the market. On the other hand, the worldwide market for hernia mesh repair devices is expected to grow to as much as $4.5 billion over the next seven years.
This is yet one more example of how a manufacturer of a defective product was willing to put lives at risk in order to pad its own profits – while dismissing potential liability as simply part of the cost of doing business.