The Ethicon Physiomesh hernia patch bellwether trials are set to go to trial in January, 2018, and all eyes will be on competing arguments from each side.
While the plaintiffs in the cases will say Physiomesh flexible composite hernia patches were defectively designed, Johnson & Johnson and Ethicon—the manufacturers of the mesh product—will claim the severe organ damage suffered by many plaintiffs was due to something other than the mesh.
What are Bellwether Trials?
Bellwether trials are common during mass tort litigation; these cases are carefully chosen as the most representative of all the cases, as a means to determining how a jury will react to evidence which will be common to all cases. In other words, while plaintiffs in an MDL may have varying degrees of injury, the bellwether cases are chosen from all the cases because they have evidence which will be common to all the cases, regardless of the level of injury sustained by the plaintiff.
Bellwether cases are followed very closely, as the outcome of these bellwether cases will determine whether the manufacturer will decide it would be more cost effective to settle the remaining cases, or to continue to fight the cases in court. Attorneys involved in the cases also map out their future strategies according to how the bellwether cases turn out. The future for a product liability case—in this case, the Physiomesh cases—depend on whether the court finds the plaintiffs’ cases or the defendant’s case more compelling.
“Typical” Arguments from Both Sides
While every case varies to some degree, most product liability cases focus on the plaintiffs’ claim that the manufacturer produced a dangerous or defective product. In some cases, it will be claimed the manufacturer was well-aware of the danger or defect, and the manufacturer could be charged with failure to warn. The defendants in product liability cases are generally attempting to show there was no dangers or defects in their product—and if there was, they had no knowledge of the issue.
Physiomesh gained approval in 2010 under the FDA’s 510(k) fast-track process, under the claim Physiomesh was similar to products Ethicon already had on the market. Physiomesh, used to repair hernias, is made of polypropylene. Ethicon’s transvaginal mesh is also made of polypropylene—and Ethicon is currently facing hundreds of lawsuits for injuries suffered by women who underwent surgery using Ethicon’s transvaginal mesh. Despite the years of doing battle over transvaginal mesh, Ethicon continues to assert Physiomesh—as well as their transvaginal mesh—is perfectly safe.
Despite these continued denials, Ethicon did issue a market withdrawal of Physiomesh in May 2016, although as of January 2018, there has been no FDA recall of Physiomesh. The voluntary withdrawal of Physiomesh came after independent studies revealed high rates of complications associated with the hernia mesh—the complaints and adverse event reports submitted by patients and doctors was never enough to sway the company, particularly as Physiomesh was making Johnson & Johnson and Ethicon a significant amount of money.
Even though Ethicon did eventually voluntarily recall the Physiomesh, they hedged their bets prior to removing Physiomesh by creating the Physiomesh Open. The Physiomesh Open was intended to fix the defects noted by patients and doctors regarding Physiomesh, and, like Physiomesh, was fast-tracked through FDA approval via a 510(k) application prior to Ethicon removing Physiomesh. Although an urgent field safety notice was issued for Physiomesh in Switzerland in mid-2016, apparently J & J and Ethicon did not feel American consumers deserved the same warning. The urgent field safety notice stated that re-operation and recurrence rates following laparoscopic ventral hernia repair using
What Ethicon and J & J Will Argue
Despite the fact that Physiomesh may well be one of the most defective hernia meshes on the market, it is likely Ethicon will argue that individual issues, such as activity, lack of activity, age and/or obesity played a significant role in the injuries suffered by the plaintiffs. This strategy of suggesting another cause for the injuries is specifically designed to create uncertainty, and is typically fairly effective in product liability cases. After all, judges and juries are not scientific experts, and the defendants must only cast doubt on the claims of the plaintiffs, without actually proving another suggested cause.
What the Plaintiffs Will Argue
Plaintiffs in the Physiomesh bellwether trials are expected to claim that the multi-layer coating on the mesh hernia patches prevented adequate incorporation of the mesh, creating or at least contributing to, a variety of serious complications. Further, it is expected the plaintiffs will claim the polypropylene mesh portion of the Physiomesh was simply not strong enough to withstand the normal abdominal movements. This resulted in herniation through the Physiomesh, deformation of the Physiomesh, rupture of the Physiomesh, and recurrent hernia formation.
Because Physiomesh is a lighter-weight mesh, some patients have actually had the mesh tear apart inside of them—as a matter of fact, one Physiomesh adverse report claimed that when the surgeon drew the mesh patch from its sterile package, it immediately began to disintegrate, while another found the Physiomesh fractured during the procedure. This would certainly lead one to believe that Physiomesh is simply not durable enough to withstand the rigors of hernia repair.
Perhaps even worse, some patients experienced “violent” pain after having a hernia repair using Physiomesh, only to find out that the mesh had either torn, or adhered to adjoining organs, such as the colon or bowel. In some cases, when surgeons attempted to repair the damage done by the Physiomesh, the patient suffered further injury. The upcoming bellwether trials are likely to give all those involved a good idea of how solid the Physiomesh cases are for the plaintiffs.
One New York Physiomesh patient claims J & J and Ethicon “promoted, marketed, sold, and distributed” the Physiomesh as a safe medical device when they knew otherwise, and that J & J and Ethicon had “sole access” to material facts which would have revealed the defective nature of the mesh, as well as the likelihood the Physiomesh would cause dangerous side effects. It remains to be seen which argument the juries in the bellwether trials will believe, but if recent decisions for defective or dangerous products, devices or drugs are any indication, J & J and Ethicon should probably get their checkbooks ready.
At Coxwell & Associates, PLLC, our pelvic mesh lawsuit attorneys believe in fighting aggressively for injured Mississippi pelvic mesh patients and their families – to ensure that they receive the money they need to fully recover. Contact Coxwell & Associates today at 1-601-948-1600, 1-877-231-1600 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.