Expert Commentary

The crushing of innovation for treating female pelvic floor disorders: A story of “lead or be led”

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Litigation and negative public media attention threaten therapeutic innovations for pelvic floor disorders, reducing patients’ treatment options. This leader in female pelvic medicine galvanizes you to action, with a focus on scientific evidence and patient advocacy.


 

References

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.1 In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take


How do we do this? I suggest the following:

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

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