The MDA was enacted in response to faulty medical devices that caused thousands of tort claims, preempting state regulation over medical devices. During his heart attack surgery, Riegel underwent an emergency coronary bypass surgery due to an improperly used Medtronic catheter. He sued Medtronic for design, labeling, and manufacturing defects.
State requirements are preempted to the extent that they are “different from, or in addition to” requirements imposed by the MDA.
Several thousand tort claims followed the marketing and sale of the Dalkon Shield intrauterine device, which was linked to serious infections, several deaths, and a large number of pregnancies. In response, several states adopted regulatory measures requiring premarket approval of medical devices. Congress swept back state obligations and imposed a regime of detailed federal oversight via the MDA.
The MDA includes an express preemption provision that gave the FDA almost total oversight for medical devices. Once a device receives premarket approval, the MDA subjects the devices to reporting requirements and forbids a manufacturer to make any changes in the product without FDA approval that would affect the safety or effectiveness of the medical device.
Under the MDA, Class III devices receive the most stringent federal oversight. This class includes devices that support or sustain human life and are of substantial importance to prevent impairment of human health, such as replacement heart valves and pacemaker pulse generators.
Medtronic’s Evergreen Balloon Catheter is a Class III device that received FDA premarket approval in 1994.
Riegel went into surgery for a heart attack that was caused by a blocked artery. During the procedure, Riegel’s doctor inserted Medtronic’s catheter, though the labeling of the catheter warned that it should not be used for patients with conditions like Riegel. Additionally, Riegel’s doctor inflated the catheter higher than the maximum pressure recommended by the catheter’s label. The catheter burst, causing Riegel to develop a heart block, be placed on life support, and undergo an emergency coronary bypass surgery.
Riegel and his wife sued Medtronic, alleging that its catheter was designed, labeled, and manufactured in a manner that violated New York common lawand that these defects caused Riegel to suffer severe and permanent injuries.
Are the New York state requirements for Medtronic’s catheter different from, or in addition to, the requirements applicable under the MDA?
If so, do New York’s tort duties constitute “requirements” under the MDA?
Affirmed. The Riegels’ claims are preempted by the MDA.
Yes. The requirements under New York law for Medtronic’s catheter are different from, or in addition to, the requirements under the MDA.
Yes. New York’s tort duties constitute “requirements” under the MDA.
The majority incorrectly holds that the MDA’s preemption clause protects medical device manufacturers from personal injury claims alleging flaws in a design or label once the application has received premarket approval from the FDA.
Preemption analysis starts with an assumption that the states’ police powers will not be superseded unless there was a clear and manifest purpose to do so by Congress, especially with regard to fields of traditional state regulation. Because traditional state regulation exists for matters of health and safety, courts will generally assume that state and local regulation related to matters of health and safety can coexist with federal regulations when multiple interpretations of a provision exist.
Given that the MDA was enacted during the Dalkon Shield litigation, it is important to note the absence of any legislative design to preempt state common-law tort actions within the MDA. The express preemption provision was included in the MDA in response to state premarket regulation of medical devices and not to suppress tort suits. Courts have overwhelmingly held that FDA approval of a new drug application does not preempt state tort suits, so Medtronic’s argument that Congress would not want juries to second-guess the FDA’s approval of a new medical device application does not make sense. FDA regulation and state tort claims are not mutually exclusive.
The MDA does not need to provide an automatic bar to state common-law tort claims because: (1) a preemption provision does not limit the possibility of conflict preemption (where a medical device manufacturer could defend by identifying an actual conflict between the plaintiff’s theory and the FDA’s premarket approval) and (2) there may be a regulatory compliance defense based on the FDA’s premarket approval of the device.
1. New York vs. MDA Requirements
In Lohr, a medical device was grandfathered in under the MDA as an exemption to premarket approval. The Court held that federal manufacturing and labeling requirements applicable to almost all medical devices, though device specific, did not preempt common law claims of negligence and strict liability because the federal requirements reflected generic concerns about device regulation.
In contrast, premarket approval imposes requirements under the MDA and provides for case-by-case review of individual devices to evaluate whether there is reasonable assurance of the device’s safety and effectiveness.
2. New York Tort Duties under the MDA?
In Lohr, the majority held that common-law claims for negligence and strict liability impose requirements that are preempted by federal requirements specific to medical devices because a state’s requirements include its common law duties. Otherwise, a state law could require a manufacturer’s medical device to be safer but less effective than the model approved by the FDA, where juries care more about the cost of a more dangerous design and not the benefits that could be reaped by other patients.