The recent decision issued by the US Supreme Court in the Riegel v. Medtronic case has surely produced a shock wave for the plaintiff bar in the US.  And to find that Trial Inc. was shocked is surprising.

It is surprising, in the first place, on the facts. The claimant brought suit against the manufacturer of a catheter which ruptured during heart surgery when the surgeon used it notwithstanding the fact that it was contraindicated by the manufacturer for the conditions suffered by the patient (his coronary artery was heavily calcified, and the device’s labeling stated that its use was contraindicated for patients with diffuse or calcified stenoses). In addition, the device was used by the surgeon against the instructions of use (the catheter rated burst pressure was eight atmospheres, but it was inflated to ten atmospheres by the surgeon). What appeared to be then a clear medical malpractice case against the surgeon was converted into a claim directed solely against the manufacturer of the device on the basis of negligence and various product liability claims that criticized the catheter’s design, manufacturing and instructions.

It was surprising, in the second place, on the Law. The Riegel v. Medtronic case followed the path of a previous US Supreme Court decision (Medtronic, Inc. v. Lohr) issued in 1996. The Supreme Court held then that medical devices approved by the Food and Drug Administration (FDA), the well known regulatory authority in the US for food, drugs and medical devices, under a complex procedure called “Premarket Approval” (PMA) were not subject to certain state tort law claims. An interesting report from Kim M. Schimd and Shane V. Bohnen shows, in this regard, that the vast majority of the US federal Courts of Appeal had reached the same conclusion before Riegel v. Medtronic was issued by the US Supreme Court.

The Legal Grounds of Riegel v. Medtronic

Riegel v. Medtronic may not be fully understood if it is not put in the context of the separation of powers in the US between the federal government (and its regulatory agencies such as the FDA) and the States.

Riegel v. Medtronic was grounded on a preemption clause included in the Medical Devices Amendments of 1976 to the Food, Drug and Cosmetic Act. According to the said amendment, no State may establish requirements related to the safety or effectiveness of a medical device different or in addition to the requirements established in the said Act. On this basis, the Supreme Court ruled (as in the previous Medtronic, Inc. v. Lohr decision) that common-law causes of action for negligence and strict liability do impose requirements on medical devices and are therefore pre-empted by the federal regulation. Consequentially, and also in according to the federal civil procedure regulations, a cause of action cannot legally survive a finding of preemption as such a finding results in the dismissal of the claim.

It is worth noting, in this regard, that a catheter is a Class 3 medical device under US regulations, this meaning that it receives the most oversight by the FDA because its implications on human health. On this basis, the Supreme Court decision considered the PMA as a “rigorous” process, detailing that it includes full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant. It was also noted in the decision that the FDA grants PMA only if it finds that there is a reasonable assurance of the device’s safety and effectiveness. It also evaluates the device’s proposed labeling, and must determine that it is neither false nor misleading. The decision also took into account that once a device has received PMA, the manufacturer may not make any change in design specifications, manufacturing process, labeling, or any other attribute that would affect safety or effectiveness without FDA permission. And of course, after PMA, the devices are subject to reporting requirements on new clinical investigations and on incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred. To summarize it, the Supreme Court ruled that PMA “is federal safety review”. 

The Deference Issue and the Spanish Side of It

Following the opinion of Professor James T. O’Reilly, deference may be loosely defined as the willingness of a court to accept an agency’s interpretations of a statute or policy over competing interpretations offered by regulated persons or public interest groups. Traditionally, the US Supreme Court has granted deference to the FDA on the basis that it was an expert agency with a primary role to ensure that new drugs/medical devices were safe and effective in order to enter into the market, but of course there have been decisions where deference was not granted for a number of reasons (in fact, the Riegel v Medtronic decision disregards the opinion of the FDA as unnecessary even taking into account that the FDA’s view is the same as that of the Court).

As of Riegel v. Medtronic on, product liability claims grounded on a defective design or misleading labeling of a Class III medical device which has obtained PMA will probably be dismissed by the US Courts on the ground of preemption (the underlying reason being that the FDA has reasonably checked that such device is safe and efficient and the label is correct).

It is well known that Spain belongs to the civil law system, and as such, the Courts usually have in high regard the regulations issued by regulatory or supervisory agencies as well as their administrative decisions in civil cases where no public body is a part of the proceedings as claimant or defendant. Then, is there any thing to be learnt from Riegel v. Medtronic with regards to Spanish case law on medical devices?

To answer that question one must look first to the Spanish regulations on medical devices, which are founded in the EU Directive 93/42/CEE, as implemented by different Royal Decrees into the Spanish national legal system. As in the US, there are three categories of medical devices, the Class III being those receiving most supervision for being “critical” to human health. However, the primary evaluation of the device is not necessarily undertaken by a public regulatory body such as the FDA (in Spain, the Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), but by certain publicly approved Notified Bodies. These Notified Bodies grant a CE mark to the medical devices which comply with the requirements of the said EU Directive. On the other hand, manufacturers, importers and distributors of medical devices must be registered with the AEMPS, and they have to notify to the AEMPS first that they intend to market or to put into service a medical device.

On the above grounds, some Spanish Courts have applied the deference principle to medical devices. In 2005, the Madrid Court of Appeal decided for the first time that a medical device which holds the EC mark may not be held to have a defective design or, at least, the EC mark in itself is a successful state of art defence under the Spanish Defective Product Liability Act. The legal grounds of such decision are not far from the reasoning to be found in Riegel v. Medtronic with regards to the meaning of PMA and the role of the FDA, as the Madrid Appeal Court ruled that medical devices holding the EC mark complied with the essential requirements of the medical devices regulations, amongst which is safety, therefore rejecting that the design was flawed. It shall be noted that some other Spanish Courts of Appeals have later followed the criteria applied in Madrid whilst other have rejected it.

To Make It Short…

The defendants facing defective design or incorrect labeling claims resulting from medical devices in Spain have available a defense based on the deference principle to the regulatory authorities. Such defense is not a foolproof dispositive defense as experience has shown, but it is still an option to carefully consider for the defendants.

Jacobo de Salas
jsalas@mpslegal.com

MPS Legal

Madrid - Spain