MASSDEVICE ON CALL — A bellwether trial against Johnson & Johnson (NYSE:JNJ) began this month with lawyers beginning to select jurors to hear a lawsuit accusing the healthcare giant of liability patient injuries allegedly caused by the company’s transvaginal mesh implants.
Plaintiff Linda Gross claims that J&J subsidiary Ethicon’s Prolift implant left her with severe chronic pain that prevents her from working or even sitting.
Decisions made in this trial, which is taking place in New Jersey and expected to take about 2 months, may trickle down to similar lawsuits against C.R. Bard (NYSE:BCR), Endo Pharmaceuticals Holdings (NSDQ:ENDP) and Boston Scientific (NYSE:BSX).
Courts in West Virgina are slated in February to begin hearing cases against makers of transvaginal mesh implants, starting with a lawsuit against Bard.
J&J’s Prolift device has been at the center of controversy over whether or not J&J marketed the device to doctors and patients without proper FDA approval.
J&J’s Ethicon division brought the original Prolift device to market in March 2005, based on the safety and effectiveness of an existing device, the Gynemesh PS, which won FDA clearance in 2002.
Prolift did not go through FDA review channels until 2007 when the federal watchdog agency noticed the device on a submission for a different product, the Prolift+M.
Communications released last summer between the agency and the company suggest that the FDA ordered J&J to halt sales on the Prolift device until the company had provided "adequate information," but J&J representatives insisted those reports were "referenced out of context."
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