Court Rules Johnson & Johnson’s Data On Gynecare Mesh Injuries Not Confidential

The transvaginal mesh implant erosion litigation continues to move forward, with an interesting ruling last week. In short, Judge Carol Higbee, who is presiding over the consolidated In re Pelvic Mesh/Gynecare Litigation in New Jersey state court, denied Ethicon and Johnson & Johnson’s motion to keep a number of “product and regulatory related” documents confidential. We already knew, thanks to the FDA’s warning last year, that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare,” and that the FDA’s Obstetrics & Gynecology Devices Advisory Committee was trying to figure out what the real risks and benefits were, but now the public and medical researchers might get a glimpse at the best source of data on the most common meshes out there: the Gynecare Prolift, TVT Sling, and Gynemesh Prolene.

To understand why that’s a big deal requires a bit of background. As the Supreme Court of New Jersey has explained, “the universal understanding in the legal community is that unfiled documents in discovery are not subject to public access.” Estate of Frankl v. Goodyear Tire, 853 A. 2d 880 (2004); compare Keddie v. Rutgers, The State Univ., 148 N.J. 36, 51, 689 A.2d 702 (1997) (distinguishing between filed and unfiled discovery, holding that “[o]nce the records and documents were filed with courts . . . without being sealed, Rutgers no longer retained any expectation of confidentiality in them”). Then again, “a person’s desire for confidentiality is not honored in litigation. Trade secrets, privileges, and statutes or rules requiring confidentiality must be respected, see Fed.R.Civ.P. 45(c)(3)(A)(iii), but litigants’ preference for secrecy does not create a legal bar to disclosure.” Gotham Holdings, LP v. Health Grades, Inc., 580 F. 3d 664 (7th Cir. 2009).

Summing up, documents that are “filed” in discovery — meaning they were attached to some court filing or another — are public record, while documents that were produced to the other side but had no reason to make it in front of the court are assumed to remain private, with the exception being for trade secrets and records that are by law meant to be confidential, which can remain private even if they would’ve otherwise become public due to the document being “filed.” It’s confusing, and, despite the New Jersey Supreme Court describing it a “universal understanding in the legal community,” it’s also not how a lot of judges see it: I have had more than one judge tell me that they presume all materials produced in discovery to be public, even if the documents haven’t yet been “filed” the court.

That’s the law, but here is how it works in practice.  Whenever an injured patient files a complaint against a pharmaceutical company or medical device manufacturer, the injured patient has to publicly describe the bulk of their injuries, even deeply personal injuries like impotence, pain during sexual intercourse, fistulas, and incontinence. Even in your run-of-the-mill personal injury case, if your spouse wants to bring a claim for loss of consortium, they will have to allege in the publicly-filed complaint that the injury caused harm to their sexual relationship. (And, as Eric Turkewitz notes, only in rare cases will the court let a plaintiff proceed anonymously.) The defendant, however, need not publicly file anything in their defense, and instead gets to conduct the bulk of the litigation in private, stamping millions of documents with “confidential” labels, even if the documents are most embarrassing to the company and are not in any way a “trade secret.”

Some types of companies are more prone to fight to keep non-trade secret information hidden. Notice the name of the defendant in that New Jersey case: Goodyear. The company was fighting tooth and nail to keep out of the public eye a wide swath of documents relating to tread separation on their tires, and they succeeded. Remington, yet another example, opposes every single request it gets for data on misfires. Automotive companies are particularly keen on keeping their internal safety studies out of the public eye; it’s well-known among trial lawyers that you have to dig, and dig, and dig to get crashworthiness evidence, like data relating to airbag failures, seat back collapses and seatbelt failures. That’s part of why those cases are only viable if the plaintiff either passed away or suffered catastrophic brain or spine injury: if you’re the lawyer handling one of those cases, you can expect to advance a quarter million dollars in costs and spend every other week in discovery court just trying to get documents that you know the company has sitting in the office of their general counsel.

Secrecy in litigation to the detriment of public health is a big problem, which is why the confidentiality ruling in the In re Pelvic Mesh/Gynecare Litigation is so important. It’s a win for plaintiffs in a battle that plaintiffs rarely win. Consider what happened with Yaz last winter, when the lawyers for the plaintiffs’ steering committee in the consolidated Yaz / Yasmin litigation asked the court for permission to present many of the documents they had to the FDA in advance of an FDA committee meeting to consider the warning labels for birth control medications. The plaintiffs contended that these documents were concealed from the FDA, but that they were precluded from just handing them over to the government because of the confidentiality order. (Before you dismiss the plaintiffs attempt to hand over the documents to the FDA as some sort of trial lawyer publicity stunt, consider this: the Yaz / Yasmin steering committee has as one of its experts witnesses the former Commissioner of the FDA, David Kessler, M.D., who is going to testify that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from premarketing to the present.”)

The Yaz plaintiffs lost, and so the data still to this day hasn’t made it to the FDA. The Yaz cases, which are ready for their bellwether trials, remain stayed nationwide pending court-ordered mediation.

Thankfully, it seems the Ethicon / Gynecare data won’t end up in the same blackhole as the Yaz data did. That’s a good thing: these procedures are extraordinarily common, with about 100,000 women annually undergoing pelvic organ prolapse surgeries (for cystocele or urethrocele), and 200,000 women undergoing surgeries for stress urinary incontinence, with transvaginally implanted mesh. That’s a lot of women, and no one has a clue how high the complication rate is — some studies show the rate to be up to 18% just for vaginal wall erosion — and what the risks and benefits are compared to anterior colporrhaphy for prolapse. Even studies funded by Ethicon show “mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events,” but many organizations like the American Urological Association still waffle on the issue, saying “the incorporation of mesh into surgical POP repair has potential advantages and disadvantages.”

The medical community (and the FDA) needs as much information as they can get to determine whether or not to use the mesh at all, or to use it with limitations. The FDA isn’t even sure how to regulate mesh, i.e. whether to keep it a Class II medical device or make it a Class III device requiring premarket approval.  There are over two dozen studies investigating treatment of pelvic organ prolapse still looking for volunteers. It’s a big deal, and there’s no good reason — in public policy or in the law — to withhold this information from the public just because it would be embarrassing to Johnson & Johnson.

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  • Chip

    Thanks for posting this, Max. So timely, as this issue is on the front burner in a couple of pharma-related JCCPs in LA.