A federal judge in Georgia ordered Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery to produce documents subpoenaed in a product liability lawsuit against another J&J subsidiary, Mentor Corp.
The case involves Mentor’s ObTape device for women suffering from stress urinary incontinence, which was designed to provide support to the vaginal wall by reinforcing the muscles that control the flow of urine. Unlike other, similar devices, the Mentor product was not made of woven material, meaning it could block nutrients and oxygen, potentially causing severe pain, vaginal extrusions, urinary tract erosion and infection. Plaintiff Geraldine Doria sued Mentor, stating that she experienced significant mental and physical pain after a surgeon implanted her with the device Feb. 4, 2005. The device caused "erosion of her internal bodily tissue, including her vaginal wall … and painful infections," according to the original complaint, and eventually had to be surgically removed.
(In an interesting twist, Mentor is now also a Johnson & Johnson subsidiary, after a $1.07 billion acquisition in December, 2008.)
Doria subpoenaed records from Ethicon relating to its competing product, the Gynecare TVT Prolene mesh device. Ethicon moved to quash the subpoena, arguing that the records aren’t relevant to the case, that they contain trade secrets, that the subpoena presents an undue burden and "seeks to compel unretained expert testimony," according to court documents.
But Judge Clay Land of U.S. District Court for Middle Georgia denied the Ethicon motion on all but the latter count, ruling that the company must produce the records but not the unretained expert testimony.
"In support of their defective design claim, Plaintiffs contend that Ethicon’s product, TVT, provided a safer feasible alternative design to the ObTape design and that information regarding the design of TVT is relevant to Plaintiffs’ design defect claim and also relevant to refute Mentor’s alleged contention that its design was as safe as the TVT design," Land wrote. "Evidence of a feasible and safer alternative design is clearly
relevant to Plaintiffs’ design defect claim."
Specifically, the plaintiffs want Ethicon to produce a product pamphlet for the TVT device called "Selecting the Right Mesh: Important properties of implant materials used in urogynecological surgery," testimony and documents from Mentor’s 510(k) application to the Food & Drug Administration for the Ob-Tape device (Mentor cited Ethicon’s TVT device as a predicate device in its application) and records from published clinical trials and internal studies of the TVT device.
Land ruled that Ethicon must produce the pamphlet and employees involved in its creation, even though they are based in Europe, as well as supplying the plaintiffs with copies of the 475 published studies of the TVT device and the 55 internal studies the company conducted. Ethicon does not have to provide expert testimony on the 510(k) process for the ObTape, Land wrote, because itw as not involved in that process.
"However, to the extent that Plaintiffs seek factual information regarding TVT so that Plaintiffs’ own experts can determine whether TVT is the substantial equivalent of ObTape, which may be relevant to the feasible alternative design issue, Ethicon has not shown that permitting such discovery would impose an undue burden. Thus, Plaintiffs shall be permitted to discover from Ethicon such factual information regarding TVT," Land wrote, according to court documents.
It’s the latest development in the case, following Land’s December decision to allow Mentor Corp. founder and CEO and its president to be deposed by the plaintiffs. Earlier that month, the judge reversed his decision to dismiss the case on preemption grounds.