Failure to Warn Doctrine Affirmed in Pharmaceutical Product Defect Case

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In a recent pharmaceutical product defect case involving pelvic mesh, a New Jersey Appellate Court upheld an $11.1 million verdict, affirmed the applicability of the failure to warn doctrine, and issued a decision that has far-reaching implications for pelvic mesh implant litigation both in New Jersey and nationwide.

If you are in need of legal counsel for a pelvic mesh or other pharmaceutical product injury case in New Jersey, contact Fronzuto Law Group for a free consultation with an experienced member of our team. You can reach our product liability and medical malpractice law firm 24/7 by contacting us online or calling

Pelvic Mesh Injury Lawsuit

The case in question involves plaintiff, Linda Gross, who filed a lawsuit against Ethicon Inc., a subsidiary of Johnson & Johnson, that designs and manufactures the Gynacare Prolift pelvic organ prolapse repair kit. The product, which is intended to bolster weak pelvic muscles, allegedly causes severe complications, including organ displacement, organ damage, chronic pain, and scarring.

Many who have filed product liability lawsuits against Ethicon have undergone several corrective surgeries to repair the damage caused by the pelvic mesh implants. Gross is among these patients, having had 20 surgeries since her health began to deteriorate.

Gross, and the thousands of people like her across the United States, are subsumed within the overarching civil action known as In re Pelvic Mesh/Gynecare Litigation, No. 291. In this case, the plaintiff claimed that the company’s failure to warn her of the potential dangers of the product led her to make an uniformed medical decision that ultimately caused her significant harm.

After a jury deliberated on the matter, they affirmed Gross’s contentions and awarded her $3.35 million in compensatory damages, including $1.1 million for pain and suffering, $1 million for future medical expenses, $500,000 for future lost wages, $385,000 for past medical expenses, $180,000 for past lost wages, and $185,000 for a per quod claim. Additionally, Gross was awarded $7.76 in punitive damages, which is highly uncommon in defective pharmaceutical cases.

After the matter was taken up on appeal, a three-judge Appellate Division panel affirmed the damages awarded, noting that punitive damages were applicable because Gross was injured prior to FDA approval of the pelvic mesh implant.

Overall, this case sets a significant precedent for future pelvic mesh litigation and may provide support for the many pending cases in New Jersey and across the United States.

For additional information pertaining to this case, access the following article: NJ Court Affirms $11M Pelvic Mesh Verdict

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