TÜV Rheinland has scored another victory in a French court in a case involving faulty breast implants. However, its fate in another case is up in the air as it awaits a decision from the European Court of Justice.

At issue was whether TÜV properly conducted its role as a certification body after it awarded safety certificates to Poly Implant Prothèse. The now-defunct French manufacturer ignited an international scandal when it was exposed for using industrial-grade silicone in breast implants. More than 400,000 women received the implants in 68 countries before they were pulled from the market in 2010.

After PIP dissolved, six distributors of the implant, along with 1,700 women, brought suit against the notified body based on allegations of negligence. France’s Toulon Commercial Court found in favor with the plaintiffs and ordered TÜV to pay about US $3,300 to each woman involved in the case. An additional 1,600 plaintiffs joined the case on appeal.

The Aix-en-Provence Court of Appeal disagreed with the lower court’s ruling, determining that TÜV was not obliged to take samples of the product or initiate tests on marketed prostheses. The ruling followed favorable decisions for the notified body in the Paris Civil Court and Marseille Criminal Court, according to a company statement.

“This decision is in line with a long series of positions taken in favor of TÜV Rheinland by courts and authorities to date and constitutes an important step in the court disputes as a result of the fraud perpetrated by PIP to the detriment of the women concerned but also of TÜV Rheinland,” company spokesman Frank A. Dudley tells IDDM. He adds that TÜV always has worked to perform its inspection duties “in compliance with all applicable laws and regulations.”

The furor over PIP prompted calls for more unannounced audits of medical device manufacturers. Prior to the scandal, notified bodies could conduct these audits, but it was not a routine practice (IDDM, April 23).

In September 2013, the European Commission recommended unexpected audits every two years for manufacturers of high-risk devices, and every three years for those making low- and moderate-risk products.

David Clerk, founder of Ganymede Consulting in Zug, Switzerland, says he has had extensive discussions with devicemakers about the PIP case, and many in industry think TÜV was following regulations. “However, the discussion usually finishes with the question of whether the regulations in Europe are not stringent enough, and if such a situation could happen with a company operating on American soil,” he explains.

“An unannounced inspection from a notified body in Europe — this is simply not something a device manufacturer needs to worry about,” Clerk adds. “The general consensus, however, is that any company that deliberately doctors products for financial gain could do so no matter how stringent the quality system regulations are.”

Awaiting ECJ Clarification

A case involving a woman who sued TÜV after receiving the defective implants remains pending in the German Federal Court of Justice after she suffered defeats in lower court rulings. Until now, the courts have held that notified bodies are not liable if a person is injured, as they act in the public interest and not in the interest of individuals, Wolfgang Rehmann, international head of life sciences & healthcare at the law firm Taylor Wessing in Munich, tells IDDM.

The woman’s appeal went to Germany’s highest court, which is seeking clarification from the ECJ on points of law. The European court’s decision will give guidance as to whether a notified body is negligent, says Rehmann.

“The European Court, therefore, will have an impact on the question whether there can be liability as such, or whether it has to be ruled out for legal reasons,” he explains. “The court will rule on the principle. Whether there was negligence in a given case needs to be assessed by the respective national court deciding on the specific case.” — Elizabeth Hollis