By Edward P. Richards, 16 IEEE Engineering In Medicine And Biology Magazine (Jan-Feb 1997) #1 p. 87.
In previous articles we have discussed the evolution of federal preemption for state products liability claims against medical device manufacturers. This is a controversial approach, and federal district and appeals courts have made opposing ruling on cases that are legally identical. Some courts have refused to allow any products liability claims for devices, some have limited claims against only some devices, and some courts refused to limit claims in any cases. The United States Supreme Court has now reviewed this law to resolve the conflicts between the lower courts. The Court rendered its decision in Medtronic, Inc., v. Lora Lohr, 116 S.Ct. 2240, June 26, 1996. The Court did not find preemption in the case it reviewed, but neither did it clearly eliminate the chance of preemption in other cases. Ruling in a split decision, it assured that confusion will still reign.
The United States Constitution reserves certain powers to the federal government, chiefly the right to regulate interstate commerce, the right to control foreign policy, and the right to raise an army. The remaining powers are left to the states. When a state law and a federal law overlap, the courts must decide which to enforce. If the laws have the same provisions, as is often the case when states enact their own version of a federal law, then there is no conflict and both laws can be enforced. This can result in an individual being prosecuted twice for the same crime: once by the state and once by the federal government if it does not like the outcome in the state case. An example would be the federal prosecution of the police offices who were acquitted in the state prosecution for beating Rodney King.
If the state and federal law have different requirements, the courts must decide which to enforce. In the cases involving powers reserved to the federal government, such as the regulation of interstate commerce, the federal law will prevail. In cases that involve the right of the state to protect the public health and safety (called the police powers), the courts must balance the federal interests against those of the state and determine which is more important. If the court believes that the state regulation is necessary to protect the public health or safety and it does not impermissibly interfere with exclusively federal interests, then it may find that the state law takes precedence over the federal law for matters within the state.
The courts are reluctant to find preemption because it puts the states and federal government at odds. The courts will try to reconcile the laws when possible, and will only find preemption in two circumstances - when Congress explicitly says it intends to forbid state laws on the subject, and when Congress passes a law that regulates the matter in such detail that there is no room for state regulation, impliedly preempting any state laws.
Prior to 1976 there was little federal regulation of medical devices. The FDA could bring a court action to have a dangerous device removed from the market. These actions were based on the FDA's authority to embargo adulterated or misbranded products. While these concepts were well understood for drugs, the courts took them to mean that only the proven dangerous devices, or those that were openly fraudulent could be removed from the market. Even when the courts were willing to act, these proceedings took many years, with the device freely available until the final appeals were over. (It took more than 20 years to remove the orgone accumulator from the market.) To escape regulation, the manufacturer need only modify the device and it could start selling it again, forcing the FDA to begin a new court proceeding.
In the early 1070s, consumer advocates persuaded Congress to have hearings on the risks of the medical devices industry. Alarmed by the evidence that dangerous products could come to market with no review by the FDA, Congress passed the Medical Device Amendments of 1976 (MDA). The MDA required the FDA to approve a device before it could be marketed, through a process called pre-market approval (PMA). PMA is a rigorous review modeled after the review process for drugs. PMA requires that a device must be proven safe and effective, that it carry an FDA approved labeled, and that it not be sold in a deceptive manner. Preparing a PMA application can take 1000 hours of work and many years of clinical studies, depending on the nature of the device.
Recognizing that it would be unfeasible to remove all medical devices from the market while the FDA reviewed them, Congress allowed devices on the market on the effective date of the MDA to stay on the market pending review by the FDA. After pressure by the device manufacturers, Congress also allowed new devices to be marketed without PMA if they were "substantially equivalent" to a device on the market before the MDA went into effect. This is termed 510k review for the section of the MDA that sets out the process of establishing substantial equivalence. 510k looks only at whether the device resembles a pre-1976 device, it does not require safety or effectiveness data, and is thus a much faster and cheaper review.
510k review was intended to be a short-lived process, to be phased out as soon as the FDA finished reviewing all the pre-1976 devices. Congress established a device classification system to establish priorities for FDA's review of existing devices. In this system, Class I devices pose little risk, Class II devices pose some risk, and Class III contains devices that either pose significant risk (such as pacemakers), or those for which there is not enough information to access their risks. Unfortunately, the FDA never finished its review of pre-1976 devices and fell farther behind each year as more devices were marketed with 510k approval. Despite amendments to the MDA in 1990 that were intended to reduce the use of 510k review, recently more than 80% of devices were marketed with 510k approval. More critically, many of the devices approved with 510k review were Class III devices, defeating the priority Congress established for reviewing devices.
Some states had established medical device regulations prior to 1976. When the MDA was proposed, device manufacturers complained that they could not operate efficiently if they were subject to differing state regulations. Using its power to prohibit state regulations that interfere with interstate commerce, Congress included a provision in the MDA to prevent states from regulating medical devices:
as provided in subsection (b) of this section [a minor exception for consumer
fraud regulations], 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 U.S.C. § 360k(a)).
For the first 10 years after the MDA, this provision was used only to block some state laws that attempted to put additional restrictions on the sale of medical devices. Then several courts began to look at a similar provision in the Cigarette Labeling Act and found that it preempted state products liability and general tort claims. The theory behind this preemption was that a state judgment in a products liability case was a prohibited "requirement of state law" in addition to the federal regulations. Defendants argued that they had to change their products in response to plaintiff's litigation or risk ruin because of products liability lawsuits. Since these lawsuits reflected state law, and required changes in the products, they were held to be "requirements in addition to the federal law" and were thus preempted.
In Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), the United States Supreme Court found that the Cigarette Labeling Act did preempt most state products liability and other tort claims. Shortly after this decision, several courts found that the MDA also preempted these state claims. The federal courts were split on MDA preemption, with a substantial number of judges holding that MDA provided no grounds for preemption and thus that medical device manufacturers were fully liable under state products liability and torts laws. The Supreme Court agreed to review Medtronics v. Lohr to resolve this split in the lower courts.
There is an adage that "bad cases made bad law." More specifically, the facts of a case can influence the interpretation of the laws at issue in a case: if what is a legitimate interpretation of a law works is manifestly unfair in the case before the court, then the court will seek a different interpretation of the law. From one perspective, the United States Supreme Court chose to review Medtronic because it is a potentially dangerous product brought to market with little review. From another, it was chosen because the members of the court who oppose the preemption of state tort claims in all cases felt it would drive the other justices to rule against preemption in general.
Out of perhaps 100 cases that the Court could have chosen to review, Medtronics was one of the worst for the supporters of preemption. This was not because the evidence against Medtronics was overwhelming, which it was not, or because the plaintiff suffered a particularly grievous injury: The allegation in Medtronic was that the plaintiff's pacemaker failed, probably because of a broken lead, forcing the plaintiff to have emergency surgery to replace the pacemaker. Plaintiff was not otherwise injured. Medtronic is a bad case because the pacemaker had received almost no FDA review. It had been approved through a 510k review because it was "substantially equivalent" to a pacemaker on the market in 1976. This was in contrast to other cases that involved products that had gone through PMA review. In King v. Collagen, for example, the product was an injectible collagen compound for cosmetic enhancement. Since there was no equivalent pre-1976 device, the collagen had to go through PMA review, which lasted 10 years and involved many clinical studies.
Given that the precedent for reviewing possible federal preemption of state laws is to find preemption only if the laws cannot be reconciled, the choice of Medtronic preordained the courts finding that the MDA did not preempt state products liability and other tort claims. The Court found that 510k review was only intended to maintain the status quo, not to make any determinations about the safety of the device. Despite pacemakers being a Class III device, the highest priority for phasing out 510k review, the FDA had failed to establish detailed standards for pacemakers and had not gone back and demanded that the manufacturers of pre-1976 pacemakers and those marketed with only 510k review since 1976 show that their devices met these standards. The Court held that these devices had never met a federal standard for safety, and thus there was no federal requirement for the state laws to conflict with. Since there was no conflict, the Court found that was no basis for preemption.
As regards preemption based on a conflict between state and federal laws, the court could have come to no other holding. To have found preemption on a conflicts theory for 510k devices would also have given 510k devices an unfair advantage over the grandfathered pre-1976 devices: since pre-1976 devices had received no FDA review, they have no claim for preemption under this court's analysis.
The Court gives great deference to the FDA, as is proper in the Court's review of an agency decision. The Court finds that it is the FDA that determines the extent of preemption by passing specific regulations establishing the requirements for a given device and stating that these requirements preempt conflicting state regulations. Unfortunately, for almost a decade the FDA director has been hostile to device manufacturers and biased in favor of plaintiff's attorneys. The FDA's official position is that there is no preempt of state regulations for any medical devices, and no need for it. The Court's majority opinion goes further and finds that the language of the MDA is so ambiguous and general that the judges participating in the majority opinion find it hard to believe that the MDA can ever preempt state products liability and other tort claims.
Medtronic illustrates an interesting quirk of Supreme Court jurisprudence. Once the Court decides who will write the majority opinion, this judge can include dicta - non-binding speculations on what the lower courts should do - even if a majority of the justices do not agree with it. In this case, most of the justices believed that there should not be preemption for all of the plaintiff's claims in Medtronic. Only four judges were are opposed to preemption of products liability and tort claims in almost all circumstances. Justice Stevens, being one of the four and the author of the "majority" opinion, put strong language against preemption in his opinion. He also ignored an important purpose of preemption. While preemption is certainly important when state and federal laws conflict, it is as important to assure that medical device manufacturers do not face different requirements in each state. This can happen even if the federal government has no specific regulations on the device.
The five justices who believe that preemption can be appropriate under the MDA joined in a separate opinion. They agreed that some of plaintiff's claims in Lohr should not be preempted, but would have preempted others. Unlike the majority, which focused on the lack of specific regulations governing pacemakers and 510k devices in general, these justices pointed to the FDA good manufacturing practices (GMP) standards. GMP are very detailed regulations that govern the actual production of the device. These justices believe that product liability and tort lawsuits that claim a manufacturer should do something different from its FDA approved GMP plan should be preempted. One of these five, in a separate opinion, added that he believed that the MDA would also preempt claims based improper design if the FDA had approved the design as part of a PMA review.
In trying to make sense of this split decision, it is clear that four justices do not like preemption of state claims and will probably never support preemption under the MDA unless Congress rewrites it to explicitly say that they intend to preempt state products liability and tort claims. None of the justices will grant a 510k device preempt for claims related to design defects or labeling, because there are no federal regulations on these for a 510k device. Five justices might find preemption if the plaintiff's claim the manufacturer should have done something that conflicts with GMP standards. These five justices would also consider preemption for design and labeling claims if the device underwent PMA review. This would also seem to further the public policy of encouraging more rigorous review of devices by giving manufacturers an incentive to participate in the more expensive and time-consuming PMA review.
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