Vaginal Mesh Erosion Lawyer

The transvaginal mesh litigation has for some time been the largest medical mass tort ever, at least as measured by filings in the federal multi-district litigation (MDL), which is currently being handled in the Southern District of West Virginia. There are over 42,000 cases in the MDL — more than the combined total of cases ever filed in the Prempro MDL (9,761), the Yasmin and Yaz MDL (11,423), the Vioxx MDL (10,319), and the DePuy ASR Hip Implant MDL (8,900). (See this chart under “Total Actions.”) Add to that the over 6,000 mesh cases pending in New Jersey state court, and numerous cases filed in other state courts, and there are nearly 50,000 transvaginal mesh claims pending in courts across the country against six different manufacturers.

So what are the courts supposed to do with that many cases?

There’s no shortage of inventive (and often problematic) suggestions for how to resolve mass torts cases, ranging from ‘offensive collateral estoppel’ to ‘statistical sampling of verdicts.’ (Naturally, defense-oriented interests are quite fond of coming up with “solutions” that are merely veiled ways either to drag the litigation on forever or to put insurmountable pre-trial barriers in front of plaintiffs.) But the only tried-and-true method is the one I mentioned a year and a half ago in “How Judges Can Settle Mass Torts Cases:” “defendants and their insurance companies don’t willingly make reasonable settlement offers. The only thing that brings them to the table is the immediate threat of trial. If judges want to resolve these cases, they need to move them along to trial.”

But when you’re talking about 50,000 medical device cases, that’s easier said than done. The federal courts conduct fewer than 3,500 civil trials each year.

So where can we look for guidance? The closest analogy to the transvaginal mesh litigation is the Diet Drugs litigation, which had roughly 20,000 claims filed in the federal MDL and about 12,000 filed in Philadelphia’s Complex Litigation Center, making it about three-fifths the size of the transvaginal mesh litigation. But some of the lessons learned there might not help us here, because that litigation was comparatively less complicated: the litigation was against a single company (Wyeth), and it involved products that the company had at least implicitly admitted were defective by way of withdrawing them from the market. In the transvaginal mesh lawsuits, however, there are four different major defendants — Ethicon, C.R. Bard, Boston Scientific, and American Medical Systems each have thousands of cases filed against them — and, not only do the defendants adamantly maintain that their products are perfectly fine, but many of the products are still on the market. There’s thus a potential, perhaps even a likelihood, for this litigation to grow endlessly as only a handful of claims are resolved each year while hundreds, potentially thousands, of new claims accumulate each year.

That scenario raises the question: is the transvaginal mesh litigation headed towards the same “black hole” in which the over 180,000 cases in the asbestos MDL sat for nearly thirty years? If so, how do we get out? 
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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.
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Some of the largest drug companies in the United States are based in, of have their U.S. headquarters in, New Jersey — e.g., Johnson & Johnson is in New Brunswick, Merck is in Whitehouse Station, Roche is in Nutley, Barr (now owned by Teva) is in Montvale, Sanofi is in Bridgewater — and so New Jersey state courts are home to a huge volume of pharmaceutical injury litigation.

There’s so many Accutane (Roche) and Fosamax (Merck) cases they’re deemed a mass tort, and there’s a good chance that Propecia (Merck) might end up as one, too. Same goes with a large number of the vaginal mesh erosion cases, because Ethicon / Gynecare are made by Johnson & Johnson, and C.R. Bard is in Murray Hill. (But not the two new huge drug cases: Boehringer Ingelheim, maker of Pradaxa, is in Connecticut, while Takeda, maker of Actos, is in Illinois.)

All of which to say is: when the New Jersey Supreme Court releases a new drug or medical device opinion, it’s a big deal. A thousands-of-cases big deal.

There’s thus been a lot of anticipation surrounding the Court’s opinion in Kamie S. Kendall v. Hoffman-LaRoche, Inc., et al., which was decided Monday. The opinion is here. Some reporting has already come out at Pharmalot, and there’s commentary from the mass torts defense firms Ballard Spahr and Dechert (I’ll get that in a moment).

Kendall is an Accutane case, in which the plaintiff developed inflammatory bowel disease (apparently both ulcerative colitis and Crohn’s Disease; her symptoms were so severe she had her colon removed) as the result of Accutane. A jury awarded her $10.5 million back in 2008, then the case then went into a complicated appellate posture. Roche argued (1) that the case should have been barred by the statute of limitations and (2) that its defense was unfairly prejudiced by the trial court’s restriction on the way the parties could present the number of adverse case reports as evidence that Roche acted too slowly in responding to reports that Accutane caused IBD. The New Jersey Appellate Division held the case was filed within the statute of limitations, but nonetheless ordered a new trial on the adverse case reports issue.

The New Jersey Supreme Court then granted an appeal on only the statute of limitations issue. It was a bit of a “head’s you lose, tails I win” situation for the plaintiffs: if they lost in front of the New Jersey Supreme Court, they lost for good, whereas if they won they still had to go through a retrial to fix the adverse events issue. I don’t fault the New Jersey Supreme Court for that — it’s appropriate for Supreme Courts to cherry-pick issues from cases — but I mention it to further dispel tort reform myths that these types of cases are easy money for injured patients and trial lawyers. Kendall’s lawsuit was filed in December 2005, and now, seven years later, neither she nor her lawyers have been paid a dime, and they still have to go through another trial where they could lose.

So let’s move to the big issue in the Kendall case. New Jersey, like every state, has a statute of limitations for negligence and product liability lawsuits, and also has an exception called the “discovery rule” for cases where the plaintiff didn’t learn until later that their injury could have been the result of negligence. The rule is:

Those considerations [of fairness] comprise the so-called “discovery rule,” the goal of which is to avoid [the] harsh results that otherwise would flow from mechanical application of a statute of limitations. Accordingly, the doctrine postpones the accrual of a cause of action so long as a party reasonably is unaware either that he has been injured, or that the injury is due to the fault or neglect of an identifiable individual or entity. Once a person knows or has reason to know of this information, his or her claim has accrued since, at that point, he or she is actually or constructively aware of that state of facts which may equate in law with a cause of action.

Caravaggio v. D’Agostini, 166 N.J. 237, 245 (2001). 
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A few days ago I reviewed the list of “worst” pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the “best” prescription drug and medical device decisions.

The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries’ factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn’t find a federal statute or regulation in support of granting generic drug manufacturers legal immunity and so contrived an argument the Court admitted “makes little sense,” or Garza v. Merck & Co., in which the Texas Supreme Court held that it was unreasonable for a jury to agree with two cardiologists that Vioxx caused a heart attack?

As with their “worst” list, the “best” list is most interesting for what it reveals about the current state of drug and medical device company liability: heads defendant wins, tails plaintiff loses. In Mensing (#1), a plaintiff’s claim was dismissed because the Court didn’t want to speculate about what the FDA would do if a drug company proposed strengthening a warning label, while in Dobbs (#8) a plaintiff’s claim was dismissed because the Court speculated that the FDA wouldn’t accept a drug company’s proposal for a strengthened warning label. In Williams (#4), a plaintiff’s claim was dismissed because her doctors disposed of the pieces of the device in question, while in Wolicki-Gables (#6), a plaintiff’s claim was dismissed because, even though the plaintiff asked in writing for her doctors to preserve the device, a representative of the device manufacturer slipped into the surgery without the patient’s consent, took the device, lied to the patient about testing it and destroyed it, leaving the plaintiff nothing to examine or to test.

Let’s roll the tape.
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[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like ActosPradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
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Another day, another multi-billion-dollar industry looking for a handout.

This time it’s the Wall Street hedge funds and venture capital funds — you know, the ones that talk “free market” but somehow always need government assistance — that have invested heavily in medical device manufacturers:

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

The New York Times found that “people associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years.” Shocking, I know.

Take a look at how thoroughly the Republican-controlled House of Representatives examined the issue:

Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”

(Emphasis mine.)

Not one. A little over a year ago, Johnson & Johnson and the FDA announced the recall of nearly 100,000 defective DePuy hip replacement implants because the metal-on-metal bearings degrade and release metal shavings into surrounding tissues and patient’s bloodstreams, requiring revision surgery and treatment for blood poisoning, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Maybe Congress thought that was an exception and all the other medical implants are totally safe. So what about July of this year, when the FDA reported:

In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients.  Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh.  A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008 – December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions.  Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.

Just under 3,000 vaginal mesh problems because the surgical mesh eroded the vaginal wall causing painful sexual intercourse, infection, urinary problems, vaginal shrinkage, bleeding, and organ perforation, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Or maybe the Republicans in Congress didn’t want to hear what patients and their advocates might say: the FDA does too little to ensure medical devices are safe. The FDA needs more regulations, not fewer.

The Depuy ASR hip implant and transvaginal mesh implant debacles both had the same cause: the 510(k) clearance loophole. Under that loophole, if a medical device manufacturer can convince the FDA that the implant is “substantially equivalent” to something else on the market, then it’s approved, even without any actual testing to see if it’s safe or even useful.

It’s a bad idea, which is why the Institute of Medicine — which investigated 501(k) clearance at the request of the FDA — recommended the process be abolished. Consider this depressing section from the FDA’s safety update on transvaginal mesh placement:

Surgical mesh products are currently regulated as Class II devices and are reviewed under the 510(k) Premarket Notification Program.  The FDA’s premarket review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety.  Bench and/or animal testing have been used to confirm that engineering specifications are met and that the mesh material is biocompatible.  Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products.

In other words, they just checked to make sure the transvaginal surgical mesh was made like normal surgical mesh. The FDA didn’t even bother to review “clinical performance data” on actually implanting the mesh to treat POP or SUI to see if it worked and if it was safe. It just made sure the vaginal mesh looked like surgical mesh and that was that. Those are the ‘overly burdensome’ regulations medical device manufacturers think are too stringent. There are Representatives and Senators who believe we need less FDA regulation?

There’s another important aspect to this debate: medical device manufacturers already have a special exemption from the negligence laws that apply to all the rest of us. Lowering FDA standards will make that special exemption even bigger.

As I’ve written before, it’s already particularly difficult to sue drug makers even for breaking federal law, and some courts are considering eliminating manufacturers’ legal duty to make safe drugs, leaving plaintiffs with a single potential claim, i.e. the “failure to warn” based on the drug maker not honestly describing how dangerous their drugs really are. 
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