Last week, a German court referred a liability case involving breast implants to the Court of Justice of the European Union (CJEU) to provide further clarity on the responsibilities and liability scheme for medical devices in the European Union. The key questions relate to the responsibility of the Notified Bodies, which are in charge of granting the CE mark that is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies in the EU and could also be relevant for the liability of medical device manufacturers in the EU.
The German plaintiff in the case had sued the Notified Body — TÜV Rheinland — for damages when the breast implant manufacturer went bankrupt. TÜV Rheinland was the Notified Body for the devices and in charge of conducting the conformity assessment pursuant to Article 11 of the Medical Devices Directive 93/42/EEC. This included the auditing of the manufacturer’s quality management system, the examination of the design of the product, and postmarket surveillance. In her claim, the plaintiff alleged that TÜV Rheinland did not comply with these obligations. She further argued that if TÜV Rheinland had adequately reviewed the manufacturer’s business records and conducted unannounced audits and product tests, the Notified Body would have detected misconduct and stopped the devices from being placed on the market.
Before deciding the case, the German Federal Court of Justice (BGH) has asked the CJEU to address the question whether the work of a Notified Body is supposed to have a protective effect towards patients such that patients are entitled to claim damages directly from the Notified Body. The lower German courts had dismissed the plaintiff’s claims, holding that the legal purpose of the Notified Body’s activities did not aim to protect potential patients. In contrast to the German lower courts, plaintiffs have been successful in the French courts in obtaining verdicts against TÜV Rheinland.
The decision of the CJEU should provide useful clarity on the scope of responsibilities of Notified Bodies in the EU, so that divergent decisions in different EU Member States on the same issue can be avoided. If this case should confirm a liability of the Notified Body, a subsequent question will be what this means for the product liability of the medical devices manufacturers.
Overall, medical devices manufacturers need to be more cautious with respect to their product liability risks and medical devices vigilance obligations in the EU. This is recommended in the light of the recent CJEU decision in which the court substantially increased the product liability risks for medical devices manufacturers in the EU (Judgment of the CJEU of 5 March 2015 in joined cases: C-503/13 and C-504/13).
For a more detailed discussion of the BGH case and the referral to the CJEU, please see our post here.
On March 19, 2015, FDA published a public workshop notice entitled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment.” This meeting is being held on April 21 in order for FDA to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise in the postmarket setting.” These risks may be novel risks that were not known at the time of FDA approval or clearance or they may be known risks that are occurring at an unexpected rate in the clinical setting or in unexpected populations or use environments. Continue Reading
Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) — diagnostic tests developed by and used within individual laboratories across the country. As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA), though the FDA has claimed that it has the authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The deadline to comment on FDA’s draft guidance was February 2 with FDA receiving hundreds of comments.
On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices. FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July 2014 (see our previous blog post).
Specifically, FDA states that it does not intend to enforce compliance with FDA regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulations (QSRs), for the following device types:
- Medical device data systems (MDDS) (as defined in 21 C.F.R. § 880.6310),
- Medical image storage devices (as defined in 21 C.F.R. § 892.2010), and
- Medical image communications devices (as defined in 21 C.F.R. § 892.2020).
These devices had been regulated as Class I, 510(k) exempt devices and were, therefore, subject to certain FDA regulatory requirements. FDA is now limiting agency oversight over these device types “due to the low risk they pose to patients and the importance they play in advancing digital health.” Continue Reading
As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST).
Our panelists, including two alumni of the FDA Office of Chief Counsel, will address:
- What factors determine whether an eHealth product is considered a medical device and subject to active FDA regulation?
- What avenues are there to obtain information from FDA about whether your eHealth Product will be actively regulated, and how can you affect/influence that determination?
- What role may eHealth play in personalized medicine and genetic screening, and what are FDA’s policies in this area?
- How might legislation impact the regulation of eHealth products?
- A comparison of FDA regulation of eHealth and mobile apps to regulation in the EU and China.
The program panelists are Scott Danzis, Cassie Scherer, John Balzano and Brian Kelly.
Click here to register. CLE credit will be available for CA and NY.
Two years after issuing a final rule on current good manufacturing practice (cGMP) requirements for combination products, FDA has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers can comply with cGMP requirements. As we noted in our write-up of the final rule, following the rule’s issuance, industry requested additional guidance from FDA about the rule’s implementation, and FDA promised to provide such guidance. FDA has now made good on that promise.
A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are spread over almost 400 pages. As stated in the white paper accompanying the Draft Act, discussion regarding the proposed changes is still ongoing, and the E&C Committee requests feedback on the proposals.
The Draft Act proposes changes to federal law which, if enacted, could streamline FDA’s premarket review process, establish a new regulatory framework for health software separate from medical software, enhance the efficiency of FDA review of combination products, encourage use of Bayesian and other statistical methodologies for clinical trials, and add supply chain security for devices.
There are also several placeholders in the Draft Act for future provisions that could be very important to the regulation of medical devices, including section 2161 – “Modernizing Regulation of Diagnostics,” section 2181 – “Interoperability,” and section 2301 – “Precision Medicine.” It will be important to continue to monitor this legislation as new provisions are added and modifications are made to the current language. We will continue to report on this draft legislation as it progresses. To read more about these proposed changes to medical device regulation and other features of the Draft Act, see our alert.
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.
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.
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.