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Inside Medical Devices

Updates on Developments for Medical Devices from Covington & Burling LLP

Summary Report of European Commission’s mHealth Consultation Published

Posted in Device Regulation in Europe, Medical Information Technology, mobile medical apps, Privacy

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation.  The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health

The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, mHealth’s role in healthcare systems, equal access, interoperability, funding and reimbursement, liability, research and innovation, international cooperation, and market access issues, particularly for web entrepreneurs.

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Upcoming Webinar: Trends in Pharmaceutical and Medical Device Patent Litigation (February 11, 2015)

Posted in Antitrust, Intellectual Property

As part of Covington’s ongoing Life Sciences Essentials webinar series we will be presenting a program on pharmaceutical and medical device patent litigation trends on February 11, 2015 (12:30-2:00 p.m. EST).

Panelists and topics include:

  • Shara Aranoff – Current trends in Section 337 patent litigation at the ITC, including the evolving domestic industry requirement and the heightened focus on public interest and enforcement issues.
  • Andrea Reister – The growing wave of Patent Office challenges to pharma patents, the impending tsunami of inter partes review and other challenges from generic applicants, hedge funds, and competitors in the pharmaceutical industry.
  • Andrew Lazerow – Current trends in “reverse payment” antitrust litigation in the wake of FTC v. Actavis, the Supreme Court’s only decision in this area of the law standing at the intersection of antitrust law and patent law.

Click here to register. CLE credit will be available for CA and NY.

Myriad’s Fight Continues: Federal Circuit Finds Composition and Method Claims Ineligible under 35 U.S.C. §101

Posted in Intellectual Property

On December 17, 2014, the Federal Circuit released its decision in the matter of In re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (“In re: BRCA1/2”).  Myriad asserted a set of patent claims that were not part of the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics (“Myriad”).  The BRCA1/2 lawsuit involved four composition of matter claims directed toward DNA primers and two method claims directed to comparisons between wild-type BRCA gene sequences with a patient’s BRCA gene sequence.  The Utah District Court denied Myriad’s motion for preliminary injunction on the basis that the claims were likely drawn to ineligible subject matter. On appeal, the Federal Circuit affirmed the denial of the preliminary injunction and, in addition, invalidated the claims on de novo review as impermissibly claiming natural products and abstract ideas under 35 U.S.C. § 101.

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CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites

Posted in Device Regulation in China

On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct medical device clinical trials used by sponsors to support medical device registration applications for marketing in China. Medical institution is a term in Chinese regulation that is typically used to refer to hospitals and clinics, both public and private. However, nearly half of these institutions are state-owned, and most patient visits occur at state hospitals and clinics.

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FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

Posted in FDA Device Regulation, mobile medical apps

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software industry. 

FDA states in the draft guidance “General Wellness: Policy for Low Risk Devices,” that it will not regulate low risk products in one of two categories:

  • Category 1:  Products intended to maintain or encourage a general state of health or a healthy activity.  These products do not make any reference to diseases or medical conditions in the claim.  This category of general wellness products relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
  • Category 2:  Products that associate the role of a healthy lifestyle with helping to reduce the risk or impact of chronic diseases or conditions. An important requirement is that it must be “well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”  Examples provided by FDA of such chronic diseases include heart disease, high blood pressure, and type 2 diabetes.

FDA provides two subcategories of claims under Category 2: (1) “may help to reduce the risk of” and (2) “may help living well with.”  Thus, for example, a product that promotes physical activity as part of a healthy lifestyle “may help reduce the risk of” high blood pressure.  A software product that tracks caloric intake can help to maintain a healthy weight and balanced diet, which “may help living well” with high blood pressure and type 2 diabetes. 

In the Accessories draft guidance “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types,” FDA seeks to clarify and modify its policy concerning the classification of accessories.  FDA defines an accessory as a “device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”  FDA clarifies that medical device accessories will not automatically take on the classification of the parent device.  FDA intends to regulate accessories according to their individual risk in the same way FDA regulates all medical devices, and thus, accessories may be classified differently than the parent device.  For example, if the parent device is regulated as a Class III device but the accessory is low risk, the accessory could be regulated as Class I. 

There is a 90 day public comment period for these guidances. Further analysis of the draft General Wellness Guidance can be found in our client alert, available here.

Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval

Posted in Products Liability

Discussion of the applicability of preemption doctrine in medical device product liability cases usually centers on two types of devices: (1) Class III medical devices approved pursuant to FDA’s premarket approval process, and (2) devices cleared through the less rigorous 510(k) process. A recent case reminds us of a different pathway to approval, which carries the same preemptive effect as premarket approval: Product Development Protocol (“PDP”).

The 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act establish two avenues for obtaining approval of a Class III medical device: (1) the PMA process or, in the alternative, (2) the PDP process. A device sponsor wishing to use the PDP process, rather than the PMA process, must obtain advanced permission from the FDA. The PDP process is usually reserved for devices with technology that is already well understood by the FDA. The PDP for a device reflects an agreement between the device sponsor and the FDA setting forth what the sponsor must do to demonstrate the safety and effectiveness of the device. The required contents of a PDP are set forth in 21 U.S.C. § 360e(f)(3)(B). If, upon review of documentation submitted by the sponsor, the FDA determines that the requirements of the PDP have been met, the FDA will declare the PDP complete.

Last month, the Fifth Circuit issued an unpublished decision in Rodriguez v. American Medical Systems, Inc., 2014 WL 7399048 (5th Cir. Dec. 31, 2014), affirming the district court’s grant of summary judgment on preemption grounds. The decision is noteworthy because Rodriguez appears to the be first federal appellate court decision addressing preemption in the PDP context. The device at issue in Rodriguez was a Class III inflatable implant device, manufactured by American Medical Systems, and approved through the PDP process. Id. at *1-2.

The Rodriguez court explained that, “A state law tort claim to recover for injuries allegedly caused by a medical device is preempted if two requirements are met: (1) ‘the Federal Government has established requirements applicable to [the device]; and (2) the claims are based on state law requirements that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.’” Id. at *1 (alteration in original). “Class III devices that are approved through the FDA’s rigorous pre-market approval process (‘PMA’) automatically satisfy the ‘federal requirements’ prong of the preemption analysis.” Id. at *2 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23 (2008)).

As the plaintiff presented “no argument that the PDP and PMA procedures should be treated differently under the preemption analysis” and other persuasive authority counseled that they should be treated the same, the court “assume[d] that a device which has been approved through the PDP process meets the federal requirements prong of the preemption analysis.” Id.at *2. It further found that the plaintiff’s claims were pleaded such that they would impose additional or different requirements than the federal ones and, therefore, satisfied the second prong of the analysis. Id. at *3-4.

While Rodriguez is the first appellate court decision to address the issue, PDP preemption has sporadically arisen before various district courts over the past decade. Each court to address the issue has held that “the PMA and PDP process are to be treated synonymously” for purposes of preemption. See, e.g., Betterton v. Evans, 351 F. Supp. 2d 529, 525 (N.D. Miss. 2004).

As several courts have acknowledged, there is statutory support for treating the PDP and PMA processes similarly for purposes of preemption. The MDA provides that a device which has been approved through the PDP process “shall be considered as having [PMA] approval.” 21 U.S.C. § 360(f)(1). Additionally, 21 C.F.R. § 814.19 states that, “A class III device for which a product development protocol [PDP] has been declared completed by FDA under this chapter will be considered to have an approved PMA.”

Moreover, the rationale that underlies preemption in cases of PMA approval applies equally to the PDP context. “The FDA approval of [a] product through the PDP process represents the FDA’s conclusion that it has received ‘reasonable assurance’ of the product’s safety.” Cowen v. Am. Med. Sys., Inc., 2006 WL 3542704, at *2 (E.D. Mich. Dec. 7, 2006). To permit a jury verdict finding a defect in the product or its warnings would “impliedly require more of [the] [d]efendant than what the FDA already required.” Id. “[S]uch requirements would be ‘different from’ or ‘in addition to’ those set forth by the FDA” and, accordingly, are preempted. Id.

Thus, as with PMA preemption cases, in the context of PDP preemption, we will likely see plaintiffs attempting to avoid dismissal on preemption grounds by asserting “parallel claims”—claims premised on allegations that the device manufacturer violated a federal requirement specific to the FDA’s PMA approval of the device. In affirming the decision to dismiss in Rodriguez, the Fifth Circuit found that no such parallel claims had been pleaded. Rodriguez, 2014 WL 7399048 at *3 (plaintiff failed to plead a parallel claim because he “d[id] not plead a violation of any federal requirement relating to designing or manufacturing of the implant, either those specific to the AMS 700 MS or those generally applicable to the manufacturing of medical devices”). Accordingly, the plaintiff’s claims were a straightforward attempt to impose on the manufacturer requirements that were “different from” or “in addition to” those set forth by the FDA in the PDP process.

Latest Proposal to Repeal Medical Device Excise Tax Gains Traction

Posted in FDA Device Regulation, Federal Taxation, Government Contracts

On January 6, Representative Erik Paulsen (R-MN) introduced the latest bill to repeal the 2.3% excise tax on medical devices imposed by the Affordable Care Act, commonly referred to as “ObamaCare.”  Legislators have introduced similar legislation each year since the tax was passed in 2010.  The current bill (H.R. 160) has over 250 cosponsors, including 26 Democrats, and would apply retroactively to sales made after December 31, 2012.

As we previously reported, the repeal of the tax played a prominent role in negotiations over the government shutdown in October 2013.  Although this prior effort had bipartisan support as well, the final compromise to end the government shutdown did not include a repeal.  Proponents have argued that the tax is justified because the Affordable Care Act benefits the medical device industry by expanding the pool of insured patients that will utilize medical devices.

Representative Paulsen’s latest effort seeks to capitalize on Republican victories in the House and the change of control in the Senate.  Further, momentum to repeal the tax has increased since November 2014, when the Congressional Research Service issued a report finding that, among other things, the tax imposed “administrative and compliance costs that may be disproportionate to revenue” and that under traditional economic and tax theory, “the tax is challenging to justify.”

One hurdle in repealing the tax is finding offsets to generate revenue—which is where past efforts stalled.  However, different members of Congress have expressed divergent views on whether finding such offsets represent a significant roadblock to repeal.  The tax is estimated to raise net revenues of $29 billion to fund the Affordable Care Act.

We will continue to post updates on efforts to repeal the device tax.

CDRH Releases 2015 Guidance Document Agenda, Announces Retrospective Guidance Document Review

Posted in FDA Device Regulation

On January 9, FDA announced the availability of a website that includes two lists of guidance documents that the Center for Devices and Radiological Health (“CDRH” or the “Center”) plans to publish in Fiscal Year (“FY”) 2015.  The first is a list of draft and final guidance documents that the Agency “fully intends” to publish (the “A-list”), while the second is a list of draft and final guidance documents that the Agency “intends to publish as resources permit” (the “B-list”).  These lists resulted from the Medical Device User Fee Amendments of 2012 (“MDUFA III”), enacted as part of the Food and Drug Administration Safety and Innovation Act. Continue Reading

FDA Is Exploring Options for Regulating Next Generation Sequencing Diagnostic Tests

Posted in FDA Device Regulation

On December 29, 2014, FDA issued a public workshop notice and associated discussion paper entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests–Preliminary Discussion Paper.”  The Discussion Paper describes opportunities and regulatory challenges presented by next-generation sequencing (NGS) tests, and requests public comment on possible new approaches to demonstrating analytical performance and clinical performance of NGS tests.

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FDA Issues Draft Guidance on 510(k) Transfers

Posted in FDA Device Regulation

In late December 2014, FDA published a draft guidance entitled, “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers,” which provides information to industry on how to notify FDA of the transfer of a 510(k) clearance from one person to another.  The draft guidance also outlines procedures that FDA staff and industry should use to ensure that public information in FDA databases (such as the database of 510(k) premarket notifications) about the current 510(k) holder for a specific device is accurate and up-to-date.

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