Suit Against FDA Challenged Legality of FDA’s Detention Without Physical Examination Process for Imports of Medical Devices and Reminds us that Sometimes Litigation is the Answer

By Allyson B. Mullen –

On November 3, 2014, the law firm of McKenna Long & Aldridge LLP filed suit on behalf of Plymouth Direct, Inc. (Plymouth) and Natures Pillows, Inc. (NPI) in the United States District Court for the District of Columbia against FDA claiming that FDA unlawfully detained multiple shipments of the companies’ medical device, the BeActive® Brace, that were imported into the U.S. 

According to the companies’ Complaint, BeActive is manufactured in China and sold by Plymouth and NPI in the United States through retail and mail order channels.  BeActive is a wrap brace that puts pressure on the wearer’s calf muscle, thereby reducing tension on the sciatic nerve, which can reduce lower back pain.  In April 2014, Plymouth and NPI’s supplier (Base4 Group Inc.) sent an email to FDA with BeActive’s packaging and labeling and sought FDA’s opinion as to the product’s classification (see court document here).  Based on the information provided in the court filings, the draft labeling explained that the brace was used to apply pressure to the calf muscle to relieve back pain – the device’s fundamental principle of operation.  FDA responded stating that BeActive was a Class I, 510(k)-exempt, Limb Orthosis, pursuant to 21 C.F.R. § 890.3475. 

Plymouth and NPI began selling BeActive in August 2014.  The Complaint states that between September 27, 2014 and October 20, 2014, FDA subjected seven shipments of the product to Detention without Physical Examination because BeActive lacked 510(k) clearance.  Specifically, FDA indicated that BeActive’s claim that it can relieve back pain caused by pregnancy and piriformis syndrome requires 510(k) clearance.  In addition, FDA indicated that BeActive could be an acupressure device because of how the product achieves its intended effect, and acupressure devices could be subject to 510(k) premarket notification requirements (see court document here).   FDA subsequently released all seven shipments on the grounds that although the product appeared violative, the violation was a minor violation. 

According to the Complaint, two more BeActive shipments were detained on October 28, 2014 – six days before the Complaint was filed.  As part of the detention, FDA indicated that it was in the process of adding BeActive to an Import Alert for failure to have a 510(k) clearance. 

In an effort to resolve the import detentions, the Complaint states that Plymouth and NPI proposed changing BeActive’s packaging, labeling, and promotional materials to remove the “objectionable” claims.  In addition, the companies offered to file a 510(k) for BeActive, provided that they could continue selling while the 510(k) was pending.  The Complaint reports that these proffers were made between October 24 and 28, 2014, and as of the date of the Complaint, FDA had not responded. 

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) establishes procedures for the FDA and U.S. Bureau of Customs and Border Protection (CBP) to work together to admit or deny import of medical devices into the U.S.  Through this process, set out in the statute and regulations, FDA or CBP can take samples of devices to determine if they are adulterated or misbranded.  21 U.S.C. § 381(a). If samples are taken, the medical devices must be held until they are cleared for sale into interstate commerce.  21 C.F.R. § 1.90.  These procedures also allow for an informal hearing if import is denied.  21 C.F.R. § 1.94.  In addition, as an alternative to the process in the statute and regulations, FDA has created the “Detention without Physical Examination” process in its Regulatory Procedures Manual.  Through the Detention without Physical Examination process, FDA does not actually take samples of the devices.  Rather, FDA requires the recipient of the devices to hold the devices while the importer provides documentation demonstrating that the devices do not meet the criteria for import refusal. 

The Detention without Physical Examination process is the method employed by FDA in this case, and it is also the method most commonly used to detain imports of medical devices subject to enforcement action (e.g., a Warning Letter that includes an import alert).  FDA believes this process is less burdensome on FDA’s resources than having to take physical samples of products that are delivered into the U.S., when FDA has already determined that the product is adulterated or misbranded.  Thus, if a court found this process to be unlawful, it could significantly change the way that FDA and CBP handle import detentions of medical devices.

Additionally, this case raised an interesting question about how FDA handles enforcement actions that are based on a regulatory finding that is contrary to an earlier FDA opinion.  At least according to Plymouth and NPI’s recital of the facts in this case, FDA concluded that BeActive was 510(k) exempt after reviewing draft copies of the product’s packaging and labeling.  FDA’s import detention, however, was based on the premise that BeActive lacked 510(k) clearance (which would not be necessary if the product is 510(k) exempt).  Based on the materials provided in the court filings, the specific claims for piriformis syndrome and pregnancy that FDA objected to were not included in the packaging and labeling reviewed by FDA in April.  However, the April labeling appeared to explain that the device operated by applying pressure to the calf muscle to relieve back pain.  Therefore, at least from an outsider’s perspective, it appears that FDA changed its mind as to the device classification based on the devices mode of action, even though FDA knew the mode of action when it reviewed the device’s labeling in April.  Certainly, if FDA did change its mind regarding the device classification based on the mode of action without any explanation to the company, this action would appear to be arbitrary and capricious.

Given the very short timeframe in which these facts have transpired, we wonder if FDA considered Plymouth and NPI’s offer to modify BeActive’s packaging, labeling and promotional claims before the companies filed this lawsuit.  This offer was likely made about a week and a half before the companies filed this suit.  However, it appears to have worked in Plymouth and NPI’s favor. 

While the information regarding the two most recent shipments of BeActive in FDA’s import system has not been updated, this case was voluntarily dismissed by the companies on November 6, 2014.  We can assume that, based on the voluntary dismissal, that FDA and the companies likely came to an agreement to release the detained product and a pathway forward for future shipments.

Although we will not have any legal resolution as to the interesting questions raised by this case, it is a recent example of a lesson that can often be forgotten in a regulatory framework where companies usually want to work with the Agency to resolve disputes – sometimes litigation is the answer.  Particularly when it comes to import alerts and detentions that companies have trouble (or cannot) resolve with FDA, history shows us that litigation can be a very effective tool.  A recent review by HPM of cases in which companies challenged an FDA import alert or detention in court showed that the company typically prevailed.  In fact, in most of these cases, soon after the case was filed, it was dismissed, usually, if not always, because the import alert or detention was vacated by FDA.