What The $11 Million Vaginal Mesh Verdict Means For Other Patients

As one of the many law firms heavily invested in the nationwide transvaginal mesh and bladder sling litigation, we pay close attention to any legal developments that might help our clients, and this week a New Jersey jury ordered Johnson and Johnson and its subsidiary Ethicon to pay $3.35 million in compensation and $7.76 million in punitive damages to Linda Gross, a South Dakota nurse who had Gynecare Prolift implanted to treat pelvic organ prolapse. The mesh failed, eroded through her vaginal wall, and thereafter she has had so many complications that she has already had 18 revision and repair surgeries – and may need more in the future.

It was obviously a big win, but the big question for us, our clients, and the other thousands of women with complications from their vaginal mesh and bladder slings is: what does it mean for the other cases?

Initially, it doesn’t mean anything. Linda Gross alone now has a verdict against Johnson & Johnson and Ethicon (and a couple related companies). The defendants will inevitably file post-trial motions arguing that the judge made erroneous rulings during the trial and that the jury made factual findings that could not rationally be supported by the evidence. These are all standard legal procedures, and they will almost inevitably result in an appeal to the New Jersey Appellate Division, and that appeal will take months, potentially a year or more. Meanwhile, the thousands of mesh lawsuits filed in the federal multidistrict litigation will continue moving forward, as will the hundreds of mesh lawsuits filed in the consolidated New Jersey state court litigation – and the companies show no signs of offering reasonable settlements any time soon. (That’s okay, that’s what we expect at this stage.)

Although the $11.1 million verdict doesn’t do anything directly to help other mesh patients, the verdict and the evidence developed at trial do create indirect benefits for other mesh patients who have suffered complications and who have filed (or will file) claims.

First, the jury verdict shows how seriously jurors take the injuries suffered by women with complications from the mesh or sling.

Whenever you have prescription drug or medical device litigation of this size, the courts set up “bellwether” trials to assess factors such as how juries respond to the plaintiff’s damages. Here, the damages our clients are suffering are intensely personal, intimate, and psychologically challenging. In contrast to many of the prescription drug or medication cases, in which the dangerous drug gave patients a life-threatening condition like heart attacks (which is what happened with the improper Fresenius dialysis solution) or cancer (right now, we have other cases in which Actos gave patients bladder cancer and Januvia gave patients pancreatic cancer), the implanted vaginal mesh complications do not threaten women’s lives, but they rob women of their personal dignity and their intimacy with their partners. For example, women with erosion complications are often subjected to permanent incontinence and pain during intercourse so great that they cannot even attempt intimacy with their partners anymore.

We knew that juries would understand the extraordinary pain and emotional trauma that mesh erosion complications caused, and have deeply the affected women’s lives – many of our clients are in the midst of a separation or divorce in part because of their complications and the toll it took on their marriages – but we did not know what type of an award that would translate into. In a previous trial in California, a jury awarded $5.5 million in compensation to Christine Scott and her husband for their damages caused by a failing CR Bard Avaulta Plus implant, but we, as lawyers, were unsure what to make of that verdict. The Scott case was unusual for a variety of reasons, not least the fact that it included both a product liability claim against the mesh manufacturer and a medical malpractice claim against the implanting doctor, a rarity for these cases.

In contrast, the Gross case involved solely a product liability claim against the mesh manufacturer, as well as damages more specific to mesh failure (rather than mesh failure coupled with malpractice) and so the Gross case, at least in my mind, provided a better window into how juries will calculate the damages in most of the mesh lawsuits. As hoped, juries understand the significance of these damages, and are willing to provide compensation in accord with those damages, even against a household name like Johnson & Johnson.

Second, the evidence developed at trial shows the lax attitude towards patient safety held by Johnson & Johnson and its subsidiary Ethicon.

The big consortium of plaintiffs lawyers have conducted extensive discovery, including literally thousands of hours of testimony and millions of dollars in expenses, but, even in cases as simple as a car running a red light, you never really know what is going to happen at trial until you have the case there. In the Gross trial, a number of the more important employees and officers and Ethicon were called to testify, including:

• Ethicon’s product development manager for the Prolift surgical kit
• Ethicon’s medical director
• Ethicon’s principal scientist involved in Prolift’s development
• Ethicon’s senior project manager
• the supposed principal investigator of the Ethicon Registry (who testified he did not know that was his job at the time!)

In the end, the plaintiffs were able to confirm under oath many startling facts, including the fact that the clinical expert report for the Prolift mesh was largely a cut and paste job from the Gynemesh PS clinical expert report comes years earlier. Ethicon further admitted that, despite the device design safety assessment and the failure mode effects analyses, both of which are standard industry tools for ensuring that only safe medical devices are marketed, Ethicon knew when it first launched the Prolift that it had a high rate of erosion, causing problems like pain during intercourse and abdominal pain, but they launched the product anyway – even while their internal documents show that the company was looking for improved products that would be much safer.

In many ways, the most interesting evidence developed at trial related to a highly technical issue: the size of the pores in the mesh. As a rough generalization, it has been well known for decades that the pore size of an implanted mesh makes a big difference in the safety of the mesh. If the pores on an implanted mesh are too small, e.g., if it is “microporous,” then bacteria will be able to enter into the mesh but white blood cells won’t be able to, leading to terrible consequences, like the recurrent infections and uterine tract infections that many of our clients experience. The pore sizes also affect the tendency of the mesh to cause erosion of the vaginal wall; if the pore sizes are too small, then the tissue around the mesh will have an adverse reaction, causing severe inflammation.

At trial, the employees at Ethicon responsible for the development and safety testing of the mesh admitted that, while they believed the Prolift mesh was “macroporous,” they never performed any safety testing whatsoever to assess whether the pores in the mesh would collapse under pressure and become too small once implanted in an actual patient – which is exactly what has been happening to many of the women implanted with these mesh and sling kits. At trial, the plaintiffs called a professor of electrical engineering who specializes in the measurement of materials performance to talk about how, when put under strain, the mesh would retract and the pores would close up.

We, as lawyers pursuing these cases, knew all of that before the trial, but the trial confirmed the defendants don’t really have a good answer for any of those allegations. At one point, Ethicon tried to qualify one of their own researchers as an expert witness, but the court refused to let them do so, because they were trying to do it by surprise. Normally, parties have to disclose all of their expert witnesses before trial, and the expert witness has to produce a report explaining in detail what he was going to testify about, so that the other side can prepare. Seems Johnson & Johnson and Ethicon were trying to pull a fast one and were stopped by the judge.

All in all, there is reason to celebrate with the verdict, as the indirect benefits of the verdict are significant. The verdict, however, certainly does not end of litigation, which will still require many more months, and many more trials, but it does show that we are on the right path.