Riegel v. Medtronic and Medical Equipment and Preemption Issues

This is a really difficult case, applying only to a few medical devices, arising out of a simple set of facts. The facts? Mr. Charles Riegel was having an angioplasty in a New York hospital on May 10, 1996 when the "Evergreen Balloon Catheter," manufactured by Medtronic, burst inside him. This resulted in complete heart block and loss of consciousness, requiring emergency coronary bypass surgery. Mr. Riegel, who has since died, survived the surgery but, as alleged in the complaint, suffered "severe and permanent personal injuries and disabilities."

One might think, on first glance, that the Riegel's would have all kinds of claims they could legitimately bring against Medtronic. Or, maybe against the attending physician, too. In this case, the Riegel's brought five causes of action against Medtronic. These are called "state law" or "common law" claims because they are based not on any particular statute but on the basis of traditional tort claims that in most cases have been available for decades in our English-derived legal system. In this case there were: (1) negligent design, testing, inspection, manufacture, distribution, labeling, marketing and sale of the Evergreen Balloon Catheter; (2) strict liability; (3) breach of implied warranty; (4) breach of express warranty; and (5) loss of consortium. To explain only a few: an implied warranty is an unspoken affirmation that the product is fit for its intended use. If the product is faulty, then, it would be a breach of implied warranty, even if nothing is said in writing about a "warranty" when the device is delivered to the doctor or hospital. Negligent manufacturing is a cause of action holding the manufacturer liable if the product doesn't live up to the approved standards for the product.

The Riegel's Claims are Thrown Out

But there is only one problem. Often there are many. When the Riegel's brought the claim they didn't do so in a vacuum. Congress had in 1976 passed a law regulating medical devices--the "Medical Device Amendments" to the "Food, Drug, and Cosmetic Act." The following provision appears in the Amendments:

"(a) General rule. Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter," 21 USC sec. 360k(a).

The language isn't crystal clear, but it is the important provision of law in this case. The question? Does this bolded language prohibit the Riegel's from bringing their common law causes of action, as detailed above? The crucial language is that "no State..may establish...any requirement...which is different from or in addition to, any requirement applicable under this chapter to the device.." Is the bringing of a lawsuit on common law claims, with possible winning of a big jury verdict, such a "requirement" that a state might impose?

Interpreting the Statute

The lower court (US Court of Appeals for the Second Circuit) dismissed the Riegel's claims. 451 F.3d 104 (2006). Here is how it argued. Under the law, the court stated, the catheter in question was a Class III medical device. Medical devices are categorized into three classes, based on the level of risk they pose. Class I devices are things like tongue depressers or band-aids; Class II devices are things like hearing aids; Class III devices are those which either operate to sustain human life or pose a potentially dangerous risk to patients. In order for some such devices to be approved, the device must undergo a rigorous "premarket approval" ("PMA") process. Most, however, go through what is known as the sec. 510(k) process--where a briefer inspection is done. This happens if the device is similar to a predecessor device that predated the 1976 law. The Second Circuit said that of 3180 new Class III devices entering the market in 2005, 3,148 of them went through the 510(k) process and only 32 went through the PMA process.

If the FDA (federal Food and Drug Administration), which oversees the PMA process, imposes device-specific requirements on a Class III device, the states cannot impose different or additional requirements without prior permission. That is the gist of the statute and how it has been implemented.

The court concluded that the FDA had imposed device-specific requirements on the Medtronic catheter. If the Riegel's sued and won, then, the awarded damages would be the equivalent of a state "requirement" which differed from or added to FDA requirements. Thus, the court said that all the Riegel's claims except one were "preempted" by the law. What is the one that might survive? The court said that the negligent manufacturing claim (which alleged that the particular catheter used in Mr. Riegel's operation was defectively made) would survive but, unfortunately in this case, the doctors threw the device out after surgery and no "genuine issue of material fact existed" with respect to this claim. Thus, the Riegel's were out of luck--in their suit against the manufacturer. The Second Circuit court said that it joined a long line of other circuit courts in so holding.

One Other Case

There is one Supreme Court case that interprets this law that appears to give plaintiffs opportunity to bring common law claims. In Medtronic v. Lohr, 518 US 470 (1996) a divided Supreme Court allowed the patient to sue Medtronic on common law causes of action. The difference between that and this case? In the 1996 case the device at issue, a pacemaker, didn't go through the rigid PMA process, and the FDA had not imposed "device-specific requirements."

Conclusion

Again, the Supreme Court will have an opportunity here to decide how broadly to read a statute for a plaintiff's benefit. There is not a particularly "plaintiff-friendly" majority on the Supreme Court today, but, then again, why would the Court have taken review if there is a consensus on the issue, and Riegel had just reiterated the consensus? It seems that the Court may want to differentiate clearly this case from Lohr and state precisely which, if any, state law legal claims are open to a plaintiff who uses a Class III medical device.

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