Medicolegal Issues

The mesh mess, enmeshed in controversy

OBG Manag. 2019 July;31(7):35-41

References

Maral I, Ozkardeş H, Peşkircioğlu L, et al. Prevalence of stress urinary incontinence in both sexes at or after age 15 years: a cross-sectional study. J Urol. 2001;165:408-412.
Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.
Chang J, Lee D. Midurethral slings in the mesh litigation era. Transl Androl Urol. 2017;6(suppl 2): S68-S75.
Mattingly R, ed. TeLinde's Operative Gynecology, 5th edition. Lippincott, William, and Wilkins: Philadelphia, PA; 1997.
Burch J. Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol. 1961;81:281-290.
Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210-213.
Kuhlmann-Capek MJ, Kilic GS, Shah AB, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelvic Med Reconstr Surg. 2015;21:241-243.
Powell SF. Changing our minds: reforming the FDA medical device reclassification process. Food Drug Law J. 2018;73:177-209.
US Food and Drug Administration. Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence. September 2011. https://www.thesenatorsfirm.com/documents/OBS.pdf. Accessed June 19, 2019.
Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;(4):CD004014.
Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:919-925.
Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008;112:1131-1142.
FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed February 14, 2019.
Riegel v. Medtronic, 552 U.S. 312 (2008).
Whitney DW. Guide to preemption of state-law claims against Class III PMA medical devices. Food Drug Law J. 2010;65:113-139.
Alam P, Iglesia CB. Informed consent for reconstructive pelvic surgery. Obstet Gynecol Clin North Am. 2016;43:131-139.
Nosti PA, Iglesia CB. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obstet Gynecol. 2013;56:221-228.
Shepherd CG. Transvaginal mesh litigation: a new opportunity to resolve mass medical device failure claims. Tennessee Law Rev. 2012;80:3:477-94.
Karlovsky ME. How to avoid and deal with pelvic mesh litigation. Curr Urol Rep. 2016;17:55.
Cohn JA, Timbrook Brown E, Kowalik CG, et al. The mesh controversy. F1000Research website. https://f1000research.com/articles/5-2423/v1. Accessed June 17, 2019.
Obstetrics and Gynecology Devices Panel Meeting, February 12, 2019. US Food and Drug Administration website. https://www.fda.gov/media/122867/download. Accessed June 19, 2019.
Mucowski SJ, Jurnalov C, Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol. 2010;203:103.e1-e4.
American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: informed consent. Obstet Gynecol. 2009;114(2 pt 1):401-408.
Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24:21-25.
Goldstein M. As pelvic mesh settlements near $8 billion, women question lawyers' fees. New York Times. February 1, 2019. https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed June 19, 2019.
Johnson G. Surgeons fear pelvic mesh lawsuits will spook patients. Associated Press News. January 10, 2019. https://www.apnews.com/25777c3c33e3489283b1dc2ebdde6b55. Accessed June 19, 2019.
Clarke RN. Medical device marketing and the ethics of vaginal mesh kit marketing. In The Innovation and Evolution of Medical Devices. New York, NY: Springer; 2019:103-123.
Top 5 drug and medical device developments of 2018. Law 360. January 1, 2019. Accessed through LexisNexis.
Frankel A, Dye J. The Lien Machine. New breed of investor profits by financing surgeries for desperate women patients. Reuters. August 18, 2015. https://www.reuters.com/investigates/special-report/usa-litigation-mesh/. Accessed June 19, 2019.
Sullivan T. New report looks at intersection of "medical lending" and pelvic mesh lawsuits. Policy & Medicine. May 5, 2018. https://www.policymed.com/2015/08/medical-lending-and-pelvic-mesh-litigation.html. Accessed June 19, 2019.
Goldstein M, Sliver-Greensberg J. How profiteers lure women into often-unneeded surgery. New York Times. April 14, 2018. https://www.nytimes.com/2018/04/14/business/vaginal-mesh-surgery-lawsuits-financing.html. Accessed June 19, 2019.

Lawsuits line up

The widespread use of a product with a significant percentage of injuries and eventually with warnings about injuries from use sounds like the formula for a lot of lawsuits. This certainly has happened. A large number of suits—both class actions and individual actions—were filed as a result of mesh injuries.²⁴ These suits were overwhelmingly against the manufacturer, although some included physicians.⁷ Device makers are more attractive defendants for several reasons. First, they have very deep pockets. In addition, jurors are generally much less sympathetic to large companies than to doctors. Large class actions meant that there were many different patients among the plaintiffs, and medical malpractice claims in most states have a number of trial difficulties not present in other product liability cases. Common defendants have included Johnson & Johnson, Boston Scientific, and Medtronic.

Some of the cases resulted in very large damage awards against manufacturers based on various kinds of product(s) liability. Many other cases were settled or tried with relatively small damages. There were, in addition, a number of instances in which the manufacturers were not liable. Of the 32 plaintiffs who have gone to trial thus far, 24 have obtained verdicts totaling $345 million ($14 million average). The cases that have settled have been for much less—perhaps $60,000 on average. A number of cases remain unresolved. To date, the estimate is that 100,000 women have received almost $8 billion from 7 device manufacturers to resolve claims.²⁵

Some state attorneys general have gotten into the process as well. Attorneys general from California, Kentucky, Mississippi, and Washington have filed lawsuits against Johnson & Johnson, claiming that they deceived doctors and patients about the risks of their pelvic mesh. The states claim that marketing and instructional literature should have contained more information about the risks. Some physicians in these states have expressed concern that these lawsuit risks may do more harm than good because the suits conflate mesh used to treat incontinence with the more risky mesh for POP.²⁶

The “ugly” of class action lawsuits

We have discussed both the sad (the injuries to patients) and the bad (the slow regulatory response and continuing injuries). (The ethics of the marketing by the manufacturers might also be raised as the bad.²⁷) Next, let’s look briefly at the ugly.

Some of the patients affected by mesh injuries have been victimized a second time by medical “lenders” and some of their attorneys. Press reports describe patients with modest awards paying 40% in attorney fees (on the high side for personal injury settlements) plus extravagant costs—leaving modest amounts of actual recovery.²⁵

Worse still, a process of “medical lending” has arisen in mesh cases.²⁸ Medical lenders may contact mesh victims offering to pay up front for surgery to remove mesh, and then place a lien against the settlement for repayment at a much higher rate. They might pay the surgeon $2,500 for the surgery, but place a lien on the settlement amount for $60,000.^29,30 In addition, there are allegations that lawyers may recruit the doctors to overstate the injuries or do unnecessary removal surgery because that will likely up the award.³¹ A quick Google search indicates dozens of offers of cash now for your mesh lawsuit (transvaginal and hernia repair).

The patient in our hypothetical case at the beginning had a fairly typical experience. She was a member of a class filing and received a modest settlement. The attorneys representing the class were allowed by the court to charge substantial attorneys’ fees and costs. The patient had the good sense to avoid medical lenders, although other members of the class did use medical lenders and are now filing complaints about the way they were treated by these lenders.

Take-away lessons

Maintain surgical skills and be open to new technology. Medical practice requires constant updating and use of new and improved technology as it comes along. By definition, new technology often requires new skills and understanding. A significant portion of surgeons using mesh indicated that they had not read the instructions for use, or had done so only once.¹ CME programs that include surgical education remain of particular value.
Whether new technology or old, it is essential to keep up to date on all FDA bulletins pertinent to devices and pharmaceuticals that you use and prescribe. For example, in 2016 and 2018 the FDA warned that the use of a very old class of drugs (fluoroquinolones) should be limited. It advised "that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options."² Continued, unnecessary prescriptions for fluoroquinolones would put a physician at some legal risk whether or not the physician had paid any attention to the warning.
Informed consent is a very important legal and medical process. Take it seriously, and make sure the patient has the information necessary to make informed decisions about treatment. Document the process and the information provided. In some cases consider directing patients to appropriate literature or websites of the manufacturers.
As to the use of mesh, if not following FDA advice, it is important to document the reason for this and to document the informed consent especially carefully.
Follow patients after mesh placement for a minimum of 1 year and emphasize to patients they should convey signs and symptoms of complications from initial placement.³ High-risk patients should be of particular concern and be monitored very closely.

References

Kirkpatrick G, Faber KD, Fromer DL. Transvaginal mesh placement and the instructions for use: a survey of North American urologists. J Urol. https://doi.org/10.1016/j.urpr.2018.05.004.
FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. July 26, 2016. https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Accessed June 19, 2019.
Karlovsky ME. How to avoid and deal with pelvic mesh litigation. Curr Urol Rep. 2016;17:55.

References

Maral I, Ozkardeş H, Peşkircioğlu L, et al. Prevalence of stress urinary incontinence in both sexes at or after age 15 years: a cross-sectional study. J Urol. 2001;165:408-412.
Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501-506.
Chang J, Lee D. Midurethral slings in the mesh litigation era. Transl Androl Urol. 2017;6(suppl 2): S68-S75.
Mattingly R, ed. TeLinde's Operative Gynecology, 5th edition. Lippincott, William, and Wilkins: Philadelphia, PA; 1997.
Burch J. Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol. 1961;81:281-290.
Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210-213.
Kuhlmann-Capek MJ, Kilic GS, Shah AB, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelvic Med Reconstr Surg. 2015;21:241-243.
Powell SF. Changing our minds: reforming the FDA medical device reclassification process. Food Drug Law J. 2018;73:177-209.
US Food and Drug Administration. Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence. September 2011. https://www.thesenatorsfirm.com/documents/OBS.pdf. Accessed June 19, 2019.
Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;(4):CD004014.
Ganj FA, Ibeanu OA, Bedestani A, Nolan TE, Chesson RR. Complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:919-925.
Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008;112:1131-1142.
FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Accessed February 14, 2019.
Riegel v. Medtronic, 552 U.S. 312 (2008).
Whitney DW. Guide to preemption of state-law claims against Class III PMA medical devices. Food Drug Law J. 2010;65:113-139.
Alam P, Iglesia CB. Informed consent for reconstructive pelvic surgery. Obstet Gynecol Clin North Am. 2016;43:131-139.
Nosti PA, Iglesia CB. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obstet Gynecol. 2013;56:221-228.
Shepherd CG. Transvaginal mesh litigation: a new opportunity to resolve mass medical device failure claims. Tennessee Law Rev. 2012;80:3:477-94.
Karlovsky ME. How to avoid and deal with pelvic mesh litigation. Curr Urol Rep. 2016;17:55.
Cohn JA, Timbrook Brown E, Kowalik CG, et al. The mesh controversy. F1000Research website. https://f1000research.com/articles/5-2423/v1. Accessed June 17, 2019.
Obstetrics and Gynecology Devices Panel Meeting, February 12, 2019. US Food and Drug Administration website. https://www.fda.gov/media/122867/download. Accessed June 19, 2019.
Mucowski SJ, Jurnalov C, Phelps JY. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol. 2010;203:103.e1-e4.
American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Opinion No. 439: informed consent. Obstet Gynecol. 2009;114(2 pt 1):401-408.
Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24:21-25.
Goldstein M. As pelvic mesh settlements near $8 billion, women question lawyers' fees. New York Times. February 1, 2019. https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed June 19, 2019.
Johnson G. Surgeons fear pelvic mesh lawsuits will spook patients. Associated Press News. January 10, 2019. https://www.apnews.com/25777c3c33e3489283b1dc2ebdde6b55. Accessed June 19, 2019.
Clarke RN. Medical device marketing and the ethics of vaginal mesh kit marketing. In The Innovation and Evolution of Medical Devices. New York, NY: Springer; 2019:103-123.
Top 5 drug and medical device developments of 2018. Law 360. January 1, 2019. Accessed through LexisNexis.
Frankel A, Dye J. The Lien Machine. New breed of investor profits by financing surgeries for desperate women patients. Reuters. August 18, 2015. https://www.reuters.com/investigates/special-report/usa-litigation-mesh/. Accessed June 19, 2019.
Sullivan T. New report looks at intersection of "medical lending" and pelvic mesh lawsuits. Policy & Medicine. May 5, 2018. https://www.policymed.com/2015/08/medical-lending-and-pelvic-mesh-litigation.html. Accessed June 19, 2019.
Goldstein M, Sliver-Greensberg J. How profiteers lure women into often-unneeded surgery. New York Times. April 14, 2018. https://www.nytimes.com/2018/04/14/business/vaginal-mesh-surgery-lawsuits-financing.html. Accessed June 19, 2019.

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The mesh mess, enmeshed in controversy

References

Lawsuits line up

The “ugly” of class action lawsuits

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