FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse
On July 14, 2014, FDA publicly posted its response denying Public Citizen’s August 2011 citizen petition concerning the marketing of non-absorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). In its response, FDA took the position that a ban or recall of POP devices is not warranted at this time.
As background, in August 2011, Public Citizen filed a citizen petition asserting that POP devices “offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh” and “have high rates of serious complications.” Public Citizen requested that the agency take the following actions: (1) ban the marketing of all available non-absorbable surgical mesh products for transvaginal repair of POP; (2) order all manufacturers to recall these products; and (3) classify all new non-absorbable surgical mesh products for transvaginal repair of POP as class III devices and approve the products only under a premarket approval application (PMA).
In its response, dated May 1, 2014, FDA denied the citizen petition. While the agency rejected Public Citizen’s call for a ban or recall of POP devices, FDA noted that it shares some of the concerns outlined in the citizen petition and is taking actions to address these concerns. In addition, the agency also determined that “a citizen petition is not the appropriate mechanism for requesting a reclassification of a device.”
FDA explained that in September 2011, the agency convened an advisory committee meeting of the Obstetrics and Gynecology Devices Panel to discuss the safety and efficacy of transvaginal surgical mesh products used for repair of POP. The Panel determined that “a favorable benefit-risk profile” for these devices “had not been well-established” and that the devices should be reclassified from class II to class III. The Panel also recommended that manufacturers conduct postmarket studies of currently marketed surgical mesh products for transvaginal repair of POP. As of May 2014, FDA had issued 126 postmarket surveillance orders to 33 manufacturers of these devices.
FDA explained that it has evaluated information from the Panel’s recommendations and the published scientific literature and has tentatively determined that the device should be reclassified as a class III device. On May 1, 2014, FDA published a proposed order in the Federal Register to reclassify surgical mesh for transvaginal repair of POP from class II to class III. On the same day, FDA published another proposed order in the Federal Register to require the filing of a PMA following the reclassification of the device to class III. Thus, although FDA did not grant Public Citizen’s third request, the agency “initiated the process that could ultimately result” in reclassification of the device and the requirement to submit a PMA for these devices.
Our Letter of the Law series is focused on current employment law developments, anddonning and doffing wage disputes are anything but “new” to the courts. The U.S. Supreme Court and Congress were dealing with donning and doffing work clothing and equipment in the 1940s. (Perhaps that is obvious given that nobody really says “donning” or “doffing” in recent years other than in this context.)
But donning and doffing, and when employees must be paid for getting dressed for work, continues as an important and tricky wage/hour law issue. That and the 7th Circuit U.S. Court of Appeals’ “novel approach” to judicial curiosity in Mitchell v. JCG Industries, Inc. merits inclusion as this week’s letter D. The court in Mitchellrecently weighed in on the proper compensation for workers who are required to don and doff safety protective gear at work. Union workers in a poultry processing plant brought the suit, alleging violations of state and federal wage laws for the employer’s failure to pay wages for time spent donning and doffing protective work gear. Workers were required to put on jackets, aprons, gloves, hairnets, and other items at the start of every shift. In addition, they had to remove and put back on the gear at the start and end of lunch breaks. The principal issue was whether the employer had to compensate workers for the time spent changing in and out of gear.
Relying on Section 203(o) of the federal Fair Labor Standards Act, the court concluded that donning and doffing time is excluded from compensable time. In its opinion, the court noted that it took very little time to dress in the gear – and indeed noted that the court staff had done so. Additionally, the court noted that it would be overly burdensome to require employers to track such time for every employee.
Donning and doffing remains a tricky issue, a perfect example of what lawyers call “fact specific” cases. Compare DeKeyser v. Thyssenkrupp Waupaca, Inc., 735 F.3d 568 (7th Cir. 2013) (holding that summary judgment was improper to the employer in the case involving foundry employees who were required to shower and change after their shifts). Employers who require safety and other equipment or clothing must, decades after the law was first passed, continue to watch cases like Mitchell that might affect their decision making on what donning and doffing time must be paid.