Preview Newsletter
Ethicon Media Monitoring 12/16/2016
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Ten Deaths Associated With J&J Physiomesh Hernia Mesh
Dec 15, 2016 | Mesh Medical Device Newsdesk
At least 10 deaths and seven injuries, associated with PHYSIOMESH™ (JNJ) hernia mesh, have been reported to the U.S. Food and Drug Administration (FDA). -
A Gem On Alternative Design From A Pelvic Mesh MDL
Dec 15, 2016 | Mondaq
By Steven Boranian
We don't write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem.
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Ten Deaths Associated With J&J Physiomesh Hernia Mesh
Dec 15, 2016 | Mesh Medical Device Newsdesk
At least 10 deaths and seven injuries, associated with PHYSIOMESH™ (JNJ) hernia mesh, have been reported to the U.S. Food and Drug Administration (FDA). Device Events worked with Mesh News Desk in preparation of this story.
Civil lawsuits that become mass torts involving many plaintiffs, with similar injuries, tend to run with the trends.
For many years, transvaginal mesh was the top tort. Now, with many of those cases settling, trial lawyers, and their legal referral services, are turning their attention to hernia mesh.
Also made of polypropylene, more than a million hernia repairs are done every year. Recipients are reporting the same complications as transvaginal mesh patients – chronic pain and infection, mesh shrinkage, mesh migration, and organ perforation etc.
Lawyers are focusing specifically on coated hernia meshes, preparing cases for future litigation, specifically Atrium C-Qur and PHYSIOMESH™ made by Ethicon, a division of Johnson & Johnson (JNJ). Ethicon voluntarily recalled PHYSIOMESH™ from the market in May.
The Urgent: Field Safety Notice, notes two unpublished studies that found PHYSIOMESH™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical Registry.
The Voluntary product recall states unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
It’s estimated 300,000 patients have been implanted with PHYSIOMESH™ since it was cleared by the FDA for sale via the 510 (k) process in 2010. (here)
The Field Safety Notice says nothing about deaths.
TEN DEATHS ASSOCIATED WITH PHYSIOMESH™
Device Events, is an investigative tool that uses proprietary algorithms designed by developer Madris Tomes. Formerly with the FDA, Tomes investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.
In all, Ms. Tomes shared 7 injury and 10 death reports associated with PHYSIOMESH™ hernia mesh with Mesh Medical Device News Desk.
“While the FDA requires manufacturers and hospitals to report deaths due to devices, if there is any leeway or room for interpretation, often the reports come in as injuries or malfunctions. Tens of thousands of deaths have been extremely difficult to find due to this regulatory ambiguity and dirty data. This can be the critical data point needed for mesh and countless other medical device cases.”~Madris Tomes, Device Events
Further exploration of deaths and injury via additional search terms (such as manufacturer and a host of search terms used to unearth findings), are available via a subscription to Device Events.
MANUFACTURER MUST REPORT ADVERSE EVENTS TO FDA
Hospitals, the manufacturers and importers are required to filed adverse event reports with the FDA. Lawyers, doctors, and patients may file an adverse event report to the FDA. See how to here. An Adverse Event report means the device “may” have caused or contributed to death or serious injury, according to Isaac Chang, Ph.D, Director of the Division of Postmarket Surveillance with the FDA.
Certain malfunctions, such as a product failure, improper design, labeling and manufacturing problems, failure to meet performance specifications and use error must also be reported. Those incidents may have been a factor in a death or serious injury.
SEPSIS AND INFECTION
The ten deaths reported to the MAUDE database, almost always involved infection.
Sepsis is the most common word for a bacterial, fungal or viral infection of the bloodstream according to Mayo Clinic here. It should be treated in the early stages before progressing to severe septic shock which can be fatal, especially in an older person or someone with a weakened immune system.
Its origin can be introduction of an invasive device or injury to the bowel which releases bacteria into the system.
Organs can fail from severe sepsis, gangrene or tissue death.
Bowel violation, says a report on Patient 8. The patient died from sepsis after straps of the mesh were turned into the fascia violating the bowel.
Patient 14 (above) is listed as an injury report, even though it later said the “patient had a generalized infection and died” after a PHYSIOMESH™ implant and suffering two injuries to the small intestine.
In some cases, initial injury reports are not updated when the patient expires.
Patient 23 is an injury report with sepsis and the “mesh breaking up” and a “hole in the mesh” necrosis, and “resection of small bowel,” (see above) yet the reporter, JNJ, says the “mesh met the finished goods criteria,” in other words, it did not test as defective.
PHYSIOMESH™ problems have included a failure of the mesh to incorporate with the body, largely blamed on the laminated coating on the polypropylene (PP).
The PHYSIOMESH™ is constructed of knitted filaments of extruded PP with an additional dyed polydioxanone film marker, added for orientation purposes. The coatings were added to each side to avoid contact with tissue and organs and bowel. But with no PP exposed, the hernia mesh may not incorporate into the body, leaving it potentially floating and moving around in the patient.
Also, since less PP was used to make PHYSIOMESH™ “lightweight,” it is considered to be weaker than standard hernia mesh made of polypropylene.
The PHYSIOMESH™ may tear apart as a result, according to trial attorneys pursuing these cases.
NATURAL DEATH
Patient 20 was considered obese with chronic steroid use.
Those are the factors contributing to his surgical site infection and wheezing, according to the entry. The mesh separated and did not adhere to the intestinal loops. Fasciitis and infection were observed.
A new mesh was implanted. He died four weeks after the PHYSIOMESH™ was implanted.
His death was attributed to bronchoaspiration and respiratory failure.
An autopsy was not ordered due to the “natural death.”
When Patient 24 presented with a 104.5 fever following his PHYSIOMESH™ implant, as well as sepsis, he had the mesh removed. In 12 hours, the report says, “the patient got better.”
Two of the reports to the FDA appear to go out of their way to avoid connecting the mesh to the patient’s death.
In the Patient 21 death report, which notes complications and sepsis after a mesh implant, the manufacturer reports there is “no reason to suspect the mesh malfunctioned and caused the patient death.”
Patient 16’s death, J&J reports, is “not related to mesh but to co-morbidity.” The patient had two surgeries, was bleeding from the trocar site and had necrosis of the colon.
Another death report, Patient 17, reports he died six days post-op. The patient was enrolled in a study of patients with peritonitis to prevent incisional hernias. The patient suffered three small bowel resections during the procedure. The patient passed out in the hospital and hit his head. He died after 45 minutes of resuscitation.
ETHICON RESPONDS
Ethicon’s newer version of Physiomesh, ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, approved October 23, 2014, remains on the market and is not related to the product withdrawl of PHYSIOMESH.
Here is its 510 (K) report.
Removing PHYSIOMESH™ from the market does not qualify as an FDA recall.
A call to JNJ to respond to these reports had gone unanswered by deadline. Any additional comments will be added when and if they are received. ###
http://www.meshmedicaldevicenewsdesk.com/ten-deaths-associated-jj-physiomesh-hernia-mesh/
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A Gem On Alternative Design From A Pelvic Mesh MDL
Dec 15, 2016 | Mondaq
By Steven Boranian
We don't write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem. The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you. We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.
Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices. The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect: "A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe." (emphasis added).
Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design. Or it might not. The point is that the plaintiff has to prove it. Take also the example we discussed in Bexis' aptly named post " On Alternative Design." That case involved hernia mesh, not pelvic mesh, and the plaintiffs' claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer. Consider hormone-based contraceptives. Cholesterol drugs. We could go on and on. All these products bear known and unavoidable risks, and those risks should not be labeled "defects" and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them. And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all. As we observed in the aforementioned post, that would convert strict liability into absolute liability. As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer? You get the point.
So back to the Mullins order. The district court had previously ruled that the plaintiffs bore no burden under West Virginia law to prove that a safer alternative design would have reduced an individual plaintiff's specific injuries. 2016 WL 7197441, at *1. But the manufacturer defendant asked the court to reconsider in light of a newly published West Virginia pattern jury instruction, which reads, "There are many designs which although they may eliminate a particular risk, are not practicable to produce. To prove that a design is defective [the plaintiff] must prove that there was an alternative, feasible design that eliminated the risk that injured [him/her]." Id. at *2 (citing W. Va. Pattern Jury Inst. § 411, emphasis added). The pattern jury instructions were promulgated by a committee that included a justice of the West Virginia Supreme Court, and the official reporter of the pattern instructions is the Chief Justice.
The instruction seems pretty clear to us, but the plaintiffs did not agree. First, they argued that pattern jury instructions are not binding. That is true, but the district court replied that "[a]t best, the plaintiffs ask me to simply ignore § 411 because it is not binding, and at worst, the plaintiffs ask me to find that § 411 is an incorrect statement of West Virginia law. I will do neither." Id. at *3. This is really interesting because the district court invoked the Erie doctrine and relied on the pattern jury instruction as a reliable indicium of state law upon which a federal court can rely.
Second, the plaintiffs argued that the pattern jury instruction applies only in a "non-consolidated trial context" and only when a plaintiff "chooses to defend her design defect claim by advocating a safer alternative design." Id. The district court found no support for these arguments, which is not the least bit surprising. If a "non-consolidated trial context" refers to multidistrict litigation, the obvious response is that an MDL is a procedural device, a venue transfer under section 1407. MDL transfer does not affect substantive law, which is what pattern jury instructions endeavor to reflect. Consolidating cases for trial should not affect substantive law either, because that too is just another procedural device. As for the argument that a plaintiff can "choose to defend her design defect claim" by reference to alternate design or not, this is like saying a plaintiff can opt out of the elements of her cause of action. The district court rejected that argument.
Third, the plaintiffs argued another variation on choice—that there are alternate pathways to prove design defect. Id. at **3-4. In our view, this is where the district court's order really sings, as the district court systematically walks through a plaintiff's burden under West Virginia law. The plaintiff has to prove that the defendant made the product, that the plaintiff was harmed while using the product in a foreseeable way, that the product was defective in design, and causation. Id. at *4 (citing W. Va. Pattern Jury Inst. § 409). Drilling down further, the plaintiff has to prove design defect by reference to multiple factors, three of which require consideration of an alternative feasible design. Id. (citing W. Va. Pattern Jury Inst. § 410). This is very similar to the Restatement (Third), which assesses a design defect only by comparison to a feasible alternative design.
Finally, section 411 "ties everything together by instructing the jury on what exactly an alternative, feasible design must achieve," i.e., that an alternative, feasible design "eliminated the risk that injured [the plaintiff]." Id.at *4. In other words, the pattern jury instruction requires proof of a feasible alternative design when considered on its own and in the context of the entire scheme. There is no other path that the plaintiffs can "choose" under West Virginia law.
We do not know exactly the impact that this order will have, and we will not purport to speculate. We do know, however, that the order makes a great deal of sense in adopting what we consider to be a prevailing rule of product liability.
http://www.mondaq.com/unitedstates/x/553586/food+drugs+law/A+Gem+on+Alternative+Design+from+a+Pelvic+Mesh+MDL
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