The Superior Court of New Jersey Appellate Division (“New Jersey Appellate Court”) overturned two large pelvic mesh verdicts in favor of the plaintiffs in two pelvic mesh product liability lawsuits, stating in its published opinion dated March 2, 2021, “we conclude the two respective judges who tried these difficult, complex cases erred by categorically excluding any proof that defendants had obtained what is known as “Section 510(k) clearance” from the Food and Drug Administration (“FDA”), see 21 U.S.C. § 360c, for the devices implanted by plaintiffs’ surgeons. We conclude the total disallowance of such proof had the patent capacity to deprive defendants of a fair trial, most poignantly with respect to the state-of-mind and venal conduct issues that underlie the punitive damages awards.”
“Although several courts in other jurisdictions have chosen in their discretion to exclude such 510(k) evidence from jury trials involving the design and safety of mesh devices, we adopt the approach of other courts that have deemed such proof admissible with appropriate limiting instructions. We are persuaded there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k) clearance process before defendants’ sales in these cases. The complete ban of such proof was unfairly and repeatedly capitalized upon by plaintiffs’ counsel at both trials, in a manner that easily could have given the jurors a skewed impression of the totality of circumstances. We are further persuaded that countervailing concerns under N.J.R.E. 403 about potential juror confusion and consumption of time, while legitimate, can be capably addressed by the trial court through appropriate means … ”
Mesh Medical Devices
The mesh devices are intended to address the medical conditions of pelvic organ prolapse (often referred to as “POP”) and stress urinary incontinence (“SUI”). Pelvic organ prolapse occurs when the muscles that support the pelvic organs become weak, causing connective tissue attachments to stretch or break and the organs to become displaced. A POP may occur in the anterior or posterior vaginal wall, or in the vaginal apex. An anterior prolapse occurs when the bladder drops into the vagina (cystocele), a posterior prolapse occurs when the rectum protrudes upward (rectocele) or the intestine pushes the top part of the vagina, creating a bulge (enterocele), and an apical or medial prolapse occurs when the uterus pushes into the vagina (uterine prolapse), or, for women with hysterectomies, the top of the vagina pushes into the lower vagina (vaginal vault prolapse).
Multiple factors can cause POP, such as childbirth, increasing age, obesity, a chronic cough, and a hysterectomy. Depending on its severity, a prolapse may cause pelvic pressure and discomfort, pain, dyspareunia (i.e., pain during sexual intercourse), and urinary and bowel problems.
Mesh devices also have been used to treat patients with SUI, which is leakage of urine as a result of coughing, straining, or some sudden voluntary movement, due to incompetence of the sphincteric mechanisms.
The pelvic mesh medical devices in the two cases reviewed by the New Jersey Appellate Court were designed and manufactured by the defendants. They were surgically implanted in the female plaintiffs in each case, and severe adverse complications ensued for them and their spouses. In one of the cases, a Bergen County jury found the defendants liable under independent theories of defective design and inadequate warning under New Jersey products liability laws and awarded the patient and her husband a total of $5 million in compensatory damages, and additionally awarded them punitive damages of $10 million. In the other case, a different Bergen County jury found the defendant liable for design and failure-to-warn defects under the products liability laws of North Carolina, the home state of those plaintiffs. The jury awarded the patient and her husband a combined sum of $33 million in compensatory damages, plus stipulated medical expenses. The jury further awarded them $35 million in punitive damages.
Source Hrymoc v. Ethicon, Inc., A-5151-17/A-1083-18.
If you or a family member were implanted with pelvic mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your mesh claim for you and represent you or your family member in a claim against the manufacturer, distributor, and/or supplier of the mesh, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find mesh claim attorneys who may assist you.
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