Pelvic mesh ()
The New England Journal of Medicine is contesting a judge’s order requiring it to turn over information to plaintiffs lawyers in mass litigation over a pelvic mesh product made by Ethicon, a Johnson & Johnson subsidiary.
The Journal on April 18 asked Superior Court Justice Diane Kottmyer in Woburn, Mass., to reconsider her April 9 refusal to quash subpoenas for communications between its editors and the author of an article about a scientific study of Ethicon’s Prolift mesh system.
Plaintiff lawyers in the New Jersey-based litigation say the journal failed to disclose fully the influence Ethicon had over the study, including a $750,000 payment to its author, both in the article’s initial disclosure statement and in a subsequent correction.
The plaintiffs—who first filed cases in 2010, five years after Prolift came to market—claim they experienced complications as a result of implantation to treat organ prolapse, where organs slip or sink out of place, or urinary incontinence.
They claim Prolift has a high failure rate, causes serious complications and necessitates corrective surgeries, despite its billing as safer than other surgical methods. It allegedly erodes into organs and vaginal walls, causing chronic pain, pain during sexual intercourse, scar tissue and other injuries.
As of Monday there were 4,900 individual cases against J&J and another 1,022 in connection with a similar pelvic mesh product made by C.R. Bard, all consolidates as In Re Pelvic Mesh/Gynecare Litigation, No. 291, in Atlantic County Superior Court.
Trial of a bellwether case, held early last year, ended with an $11.1 million verdict against J&J: $7.76 million in punitive damages and $3.35 million in compensatory damages.
A second trial may come as early as this summer, plaintiff lawyers say.
In May 2011, the New England Journal of Medicine published an article authored by Danish doctor Daniel Altman, detailing a study that compared vaginal wall surgery using Prolift mesh to surgery performed without it. The results boded well for Prolift’s effectiveness and were touted by Ethicon.
As per its common practice, the journal printed, along with the article, a disclosure stating that Ethicon had “no involvement in the study design, data collection, and analysis, the writing of the manuscript or the decision to submit the results for publication.”
But discovery revealed that Ethicon co-sponsored the study, paid Altman $750,000 to perform it, had input into the study’s parameters, reviewed a draft version and suggested changes.
In December 2012, Adam Slater of Mazie Slater Katz & Freeman in Roseland, the plaintiffs’ lead counsel, wrote to Jeffrey Drazen, M.D., the journal’s editor-in-chief, informing him of the discovery.
The next month, the journal published a correction, saying the disclosure should have stated that Ethicon, as a co-sponsor of the trial, “reviewed the original study protocol and a presubmission draft of the manuscript.”
But the correction reiterated that Ethicon had “no involvement in data collection and analysis or in the decision to submit the results for publication.” That, says Slater, is inaccurate.
Slater petitioned for an order allowing for service of third-party subpoenas in Massachusetts, where the journal is based. Superior Court Judge Carol Higbee obliged. Slater then filed the action and sought documents and deposition of Drazen and Gregory Curfman, the journal’s executive editor.
The journal petitioned to quash the subpoenas, calling them unreasonable, oppressive and burdensome.
On April 9, Kottmyer partially grant the motion, blocking the subpoenas that sought deposition and documents related to the journal’s prepublication peer reviews because that is a proprietary editorial decision-making process.
“Any probative value” of discussions between editors and peer reviewers is “outweighed by the fact that disclosure would have a detrimental effect on the peer review process,” she said.
But Kottmyer let stand subpoenas seeking communications between the editors and Altman or anyone from Ethicon, as well as any information pertinent to the wording of the January 2013 correction.
“Because it is held in such high regard, publication of an article in the [journal] carries with it an assurance of scientific merit,” and the “subpoenaed information is relevant to the reliability of the results of the study,” Kottmyer wrote, noting the requested information is not easily attainable through Altman since he’s in Europe.
Kottmyer said “disclosure of conflicts and potential conflicts on the part of the investigators are matters of public interest not only to practitioners and researchers in the medical specialty in question, but also…to the general public.”
Kottmyer noted that Higbee might apply New Jersey’s shield law, which protects journalists’ sources, to exclude information the subpoenas produce.
Higbee on April 14 began a two-month temporary assignment to the Appellate Division, but in advance she issued orders and deadlines in the case. “She was very conscious of not letting the litigation come to a halt,” Slater says.
Kathleen Guilfoyle of Campbell Trial Lawyers in Boston, who was local counsel to J&J and also sought to block the subpoenas, declines comment.
Paul Shaw of K&L Gates in Boston, who argued on the journal’s behalf, didn’t return a call Monday.
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