Amanda Pedersen 1

June 26, 2017

3 Min Read
AdvaMed Backs J&J in Supreme Court Appeal

Seeking fairness on the admissibility of FDA 510(k) clearance decisions in court, AdvaMed is throwing its support behind Johnson & Johnson subsidiary Ethicon in a high-profile court case involving the company's TVT-O pelvic mesh.

Amanda Pedersen

In 2014, a court in West Virginia stopped Johnson & Johnson subsidiary Ethicon from using its FDA 510(k) clearance as evidence in a pelvic mesh product liability lawsuit. Now, AdvaMed is asking the Supreme Court to review the lower court's ruling, which could potentially reverse a trend that has plagued the device industry since the 1996 Supreme Court decision Medtronic Inc. v. Lohr.

AdvaMed filed what is called an amicus curiae brief with the Supreme Court in the case of Ethicon v. Huskey. According to Matthew Wetzel, assistant general counsel to the trade group, the appeal represents much more than a disagreement over what evidence is admissible. "The case provides a chance to restore fundamental principles of fairness and transparency in fact-finding efforts at trial," he said in a statement.

Not allowing defendants in medical product liability cases from presenting evidence of a product's premarket clearance "prevents juries from hearing the full story, which is fundamentally unfair," Wetzel argued. "Worse, it can result in FDA's assessment of a product's safety and effectiveness being supplanted by a court ruling."

The case could offer the Supreme Court an opportunity to "level the playing field," and give device companies a fair shake at defending themselves against product liability lawsuits, according to Ann Bunnenberg, chair of AdvaMed's legal committee, and the president and CEO of Electrical Geodesics.

Thousands of lawsuits have been filed over vaginal mesh devices from multiple manufacturers, including American Medical Systems, Boston Scientific, C.R. Bard, Cook Medical, Endo Health, and Coloplast. Ethican has won some and lost some of the lawsuits filed against it over the devices, and has settled more than 100 others.

This also isn't the first time a case like this has attracted the attention of a large trade group. In 2015, the Product Liability Advisory Council (PLAC) and the U.S. Chamber of Commerce filed a similar amici curiae brief in support of C.R. Bard in a pelvic mesh liability case filed by a patient, Donna Cisson.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image credit: Pixabay]

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