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= FDA Preemption = FDA Preemption is a defense that drug and medical device manufacturers can raise in state tort suits against them. In the United States, the Food and Drug Administration (FDA) directly regulates the approval and sale of drugs and medical devices while states may indirectly regulate drugs and medical devices through tort law by allowing consumers to sue manufacturers if there is a problem with their products. When FDA regulations conflict with state law, the regulations preempt state law under the Supremacy Clause, protecting manufacturers from suit. However, the application of FDA preemption has been controversial.

FDA Regulation
The FDA has the authority to regulate drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Though the FDA has some authority to monitor once a product has reached the market, it primarily regulates drugs and medical devices by requiring manufacturers to go through an approval process prior to selling their products.

New drugs are subject to the FDA's extensive approval process. For example, the FDA will oversee clinical trials for a drug, monitor its manufacturing. As part of that process, the drug manufacturer also proposes a label for its drug, which must meet FDA requirements to include information such as side effects and other health warnings. When developing the label, both the FDA and manufacturer will work together, discussing scientific evidence as well as the costs and benefits of weaker or stronger warnings. The goal is to create a statement that conveys the risks but isn't so frightening that patients and doctors won't use the drug. Once the label is approved and the drug enters the market, manufacturers can only change the label in limited circumstances for which they must seek FDA approval at some point.

Medical devices are regulated somewhat differently. Some medical devices will have to go through a process known as Pre-Market Approval, a rigorous review of the safety of that device. Other devices, however, do not need to go through that safety review as long as the manufacturer can show that its device is "substantially equivalent" to an earlier device that is already in the market.

State Regulation
Although the FDA is the primary regulator of drugs and medical devices, states have the power to regulate as well. Many states also have their own version of the FDCA. These typically do not create any new regulations, but rather play a coordinating function between the state and FDA. The main source of additional state regulation is tort law. Tort law supplements FDA regulations by allowing for more extensive post-approval monitoring and also by allowing injured patients to seek compensation from manufacturers. Because the FDA's pre-approval safety process is so extensive, most tort claims that arise are "failure-to-warn" claims where consumers allege that the label on a prescription drug did not adequately disclose all risks. In most states, a label is defective when "reasonable instructions or warnings regarding foreseeable risks of harm are not provided" to either the prescriber or patient.

Medical Devices
In 1976, Congress amended the FDCA to explicitly address preemption of medical device regulations : Except as provided in subsection (b), 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. Despite the general language of the amendment, it does not preempt all tort claims against medical devices equally. There is a distinction between medical devices that the FDA approved as "substantially equivalent" and medical devices approved after going through the entire Pre-Market Approval process. In Medtronic, Inc. v. Lohr (1996), the U.S. Supreme Court ruled that devices approved as "substantial equivalents" of older devices did not undergo rigorous safety review, so FDA regulations did not preempt state tort law. However, in Riegel v. Medtronic, Inc. (2008), the Supreme Court ruled that when devices went through the more rigorous "Pre-Market Approval" process, the FDA's determination that a device was safe does preempt state tort claims.

Questions about preemption for medical devices remain though. Both Lohr and Riefel leave open the possibility that "parallel-violation" claims are not preempted. These claims are ones which parallel what the FDA requires from medical devices, so that there is no conflict between state law and federal law. Yet, states are not allowed to simply make a violation of FDA requirements sufficient to establish a tort claim, as doing so would allow private citizens to enforce FDA regulations when only the FDA itself has that authority. Another unanswered question is whether tort claims unlike those raised in Lohr and Riegel are preempted. So far, there has been no consensus between Circuit courts.

Prescription Drugs
Unlike with medical devices, the FDCA does not contain an explicit preemption provision for drugs. Still, courts have held that preemption applies in some cases.

In Wyeth v. Levine (2009), the Supreme Court declined to find that FDA actions preempted a state tort suit for a failure-to-warn. In Wyeth, the manufacturer attempted to argue that the FDA did not allow it to modify the warning label for its drug, but the Court did not accept that argument. However, the Court did suggest that some FDA actions could prevent a manufacturer from updating its label and would be a proper defense, saying that "absent clear evidence that the FDA would not have approved a change to [the drug's] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements."

Following Wyeth, the Supreme Court found that preemption applied in a pair of cases involving generic drugs. In PLIVA, Inc. v. Mensing (2011), plaintiffs argued that the warning label for a generic drug should have stated that there was a risk of developing a neurological disorder. The Court found that FDA regulations requiring generic labels be the same as brand name labels made this impossible though. As a result, FDA regulations preempted state tort law on failure-to-warn. The Court decided a similar case in favor of FDA preemption in Mutual Pharmaceutical Co. v. Bartlett (2013).

More recently, the Supreme Court revisited the question of preemption for brand name drugs in Merck Sharp & Dohme Corp. v. Albrecht (2019). There, the Court elaborated on the "clear evidence" test that it introduced in Wyeth. Specifically, it held that: " 'clear evidence' is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning."

Other Areas
The FDA also has responsibilities to regulate products beyond drugs and medical devices, and some of those areas are also subject to preemption. For example, FDA regulations preempt state tort claims against both vaccines and food nutrition labeling.

Further, "fraud-on-the-FDA" claims that allege a manufacturer received approval only because it misled the FDA are preempted.

State Responses
States have approached FDA preemption with varying levels of approval. As of 2008, Michigan was the only state that expressly adopted FDA preemption as a defense in its laws. Other states have incorporated the principles of FDA preemption in a more limited fashion. Most commonly, states that do so allow compliance with FDA regulations and procedures to either create a rebuttable presumption that the manufacturer did nothing wrong, or to bar punitive damages against the manufacturer. On the other end of the spectrum, courts in several states - including Pennsylvania, Alabama, California, and Georgia - have resisted FDA preemption, and have sought to preserve the ability of patients to raise tort claims again drug and medical device manufacturers.

Controversy
The viability of FDA preemption as a defense has stirred significant debate. Proponents of the doctrine point to federal interests in allowing the FDA's regulations to control over state tort law. One argument they raise is that labeling requirements are calibrated not only to set a floor for minimally acceptable warnings, but also to set a ceiling so that warnings do not scare away doctors and patients from legitimate uses of a drug or device. Under this argument, proponents worry that state tort law would require manufacturers to over-warn, defeating one of the goals of federal labeling requirements. Proponents also raise the practical concern that the FDA in practice has control over what can be on a warning label. Manufacturers cannot include information that the FDA has not approved, so if state tort law forces manufacturers to add unapproved language, it means that those manufacturers will be unable to comply with both FDA regulations and tort law.

On the other side, critics of FDA preemption note that it can deny compensation to patients who have been injured, and that doing so would be unjust. In addition, some observers have noted that there may be utility to having disparate state and FDA regulations - states can propose new regulations as a way of influencing federal policy.