A European court will decide whether notified bodies can be held liable for failed devices.
A German court referred a liability case involving Poly Implante Prosthèse to the Court of Justice of the European Union earlier this month. PIP became notorious in 2010 when former executives and managers were charged with fraud for selling breast implants filled with industrial silicone instead of the medical silicone used in the CE- marked implants.
The plaintiff in the current case had filed suit against German notified body TÜV Rheinland for US $43,000 in damages suffered after receiving breast implants made by the company, plus liability for any future injuries. She argued that the notified body had not fulfilled its duty to audit PIP’s quality management system or examine the design and surveillance of the company’s implants. She also alleged that an adequate review of TÜV Rheinland would have stopped tainted implants from reaching the market much earlier.
Previous rulings on the issue in Europe have been mixed. Patients in France have successfully sued TÜV Rheinland in French courts. The notified bodies argued it was systemically deceived by PIP as well, but the French Commercial Court in Toulon ruled in 2013 that TÜV Rheinland is liable to French PIP implant victims. German courts have held that TÜV Rheinland can’t be held responsible.
The current German case has been appealed to the German Federal Court of Justice, which is asking the CJEU for clarification on several points of the medical device directive. In particular, the court wants to know whether notified bodies are responsible for protecting potential patients and can be sued for damages if they are injured. The court also asked whether notified bodies have a responsibility to test finished products and whether they are obligated to review devicemaker’s business records or carry out unannounced audits. The questions address Class III devices only.
The outcome of the case could have significant implications for the relationship between notified bodies and devicemakers in Europe, Covington & Burling attorneys say in a blog. If the plaintiff wins, German courts will need to reconsider whether devicemakers should be held solely responsible when their products fail. This could lessen the liability devicemakers face.
The decision could also help to create unified law on this point across EU nations. U.S. devicemakers could be affected if they place devices in the European market, says Adem Koyunco, head of Covington & Burling’s German life sciences division.
He anticipates the court will issue a verdict in 12 to 18 months. — Elizabeth Orr