As the late baseball legend Yogi Berra reportedly said, “It's déjà vu all over again.”
Even as litigation continues over the pelvic mesh and judgments against manufacturers continue to pile up, more litigation over the hernia mesh – a nearly identical device – is growing. In many cases, this litigation involves the same defendants, including Endo LLC, Johnson & Johnson's Ethicon division, and Bard Medical. Other mesh manufacturers now facing legal action include Atrium, Medtronic, American Medical Systems, Boston Scientific and Coloplast.
All of this raises a number of questions, such as why these companies would continue to manufacture and market a product that has already cost them billions of dollars in judgments and settlements.
Part of the answer lies in the very nature of the profit-driven U.S. health care system. It also has to do with corporate tax laws that allow them to escape true accountability, as well as corrupt federal agencies and flawed regulations that enable these companies to knowingly bring defective and dangerous products to the market.
A Brief History
Polyethylene mesh was first used for hernia repair in the 1960s. In May of 1967, Dr. Howard Patt, who had performed 70 hernia repairs using the Marlex polyethylene mesh, published an article in the Archives of Surgery, in which he wrote that the device was “well tolerated by the tissues, even in the presence of infection.”
However, by that point, polypropylene was replacing polyethylene as the material of choice, primarily because the latter offered greater flexibility and was able to withstand the temperatures of an autoclave, unlike the former, which could only be sterilized by boiling or by using alcohol.
Over the next two decades, studies indicated that use of polypropylene mesh resulted in much lower recurrence rates. By the 1990s, this type of mesh was being used in laparoscopic procedures.
In 2002, the FDA approved the use of polypropylene mesh for the treatment of pelvic organ prolapse and stress urinary incontinence. The manufacturers of these products claimed that complications associated with these devices were rare. However, within eight years, the FDA had received 1500 adverse event reports involving pelvic mesh devices.
Nonetheless, medical device companies continued to aggressively market and promote the hernia mesh. Selling points included low cost and “incredible clinical acceptance” by surgeons as well as private and public health agencies. These companies went even further, promoting the hernia mesh for purposes that were largely unnecessary, including minor hernia injuries that could be repaired with simple sutures.
History began to repeat itself. By 2016, one device, the Ethicon Physiomesh, had been implicated in the deaths of ten patients over a six-year period. When the company finally issued an “urgent” Field Safety Notice, it stated only that “recurrence/reoperation rates…...were higher than the average rates of the comparator set of meshes among patients”. The company failed to give any clear reason for why this should be.
The culprit turns out to be an “impermeable multi-layer coating,” which was designed to make the product easier for surgeons to use. Instead, it wound up preventing the drainage of fluids, which in turn has led to serious infections. Such coatings have been used on numerous mesh devices from many manufacturers.
Of course, the hernia mesh has had many of the same issues as the pelvic meshes, including erosion and adhesion into the surrounding tissues, organ perforation, and a range of internal injuries, as well as sexual dysfunction. In addition, the coating, when absorbed into the bloodstream, has been linked to neurological and nerve damage, auto-immune reactions, and even dental problems.
The reason that medical device manufacturers have been able to get such devices approved despite their questionable track record is well-known. The 510(k) Pre-Market Clearance Process, which allows health care product companies to bypass normal clinical study and testing requirements, has allowed for the sale of dozens, possibly hundreds, of drugs and medical devices that have proven to be injurious to patients. The nature of this loophole has allowed these companies to get away with misrepresenting products submitted for approval, claiming they are “substantially similar” to products and devices previously approved for the market. Surgical mesh devices are only a few examples of products that have been “fast-tracked” to market via this regulatory loophole.
Profit and Loss
According to Mike Papantonio of the Pensacola firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, these companies have little concern with patient safety or product efficacy. In a recent interview, he said, “[A] company looks at the numbers, they say we can harm this many people, we’re making this many billions of dollars. At the end of the game, we may have to pay out one billion, but we’ve made 10 billion, so it is a good profit margin.”
In other words, having to pay out a few hundred million in fines and judgments is simply the cost of doing business. Furthermore, in many cases, these corporate offenders are able to write these penalties off as business expenses. Although money paid to settle actual or potential liability is technically not deductible under federal law, tax attorney Robert W. Wood has pointed out that “The tax deduction for business expenses is broad enough to include most settlements and judgments” – meaning that ultimately, these costs are borne by individual taxpayers.
What Can Be Done?
Unfortunately, because of the power of lobbyists and the “revolving door” in Washington D.C., these healthcare product companies wield tremendous power over legislators and regulators. It will take significant and meaningful changes in the law before these companies can truly be held accountable. In the meantime, the best that can be done is to make every effort to obtain compensation for injured parties from those responsible.