Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers

Are state law personal injury suits against drug and device manufacturers preempted by federal regulation of these products?June 30, 2008

This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one case pending. But the preemption waters are likely to remain roiled for some time to come. A new twist involves combination device-drug or device biologic products.

Supremacy Clause
The U.S. Constitution’s Supremacy Clause makes federal law “the supreme law of the land . . . any thing in the constitution or laws of any state to the contrary notwithstanding.” U.S. Const. Art. VI, c1.2.

The question is always whether a law passed by Congress is intended to preempt state law. If Congress so intended, then federal law trumps state law.

Types of Preemption
The Supreme Court has identified two basic types of federal preemption.

• Express preemption; and
• Implied preemption, consisting of: (1) conflict preemption; or (2) field preemption.

Express preemption
This arises when congressional intent to preempt state law is expressly set forth in a statute. For instance, § 521 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts state law imposing any requirement on medical devices that is “different from, or in addition to any requirement applicable under [the FDCA]” or “which relates to the safety or effectiveness of the device or to any other matter included in a requirement under [the FDCA].” Section 521 clearly intends to preempt some state laws. The problem is that the language is confusing and has given rise to much litigation over exactly what state laws are preempted.

As previously reported in the FDA Law Blog, in Riegel v. Medtronic, the Supreme Court held that FDCA § 521 expressly preempts personal injury lawsuits at common law that challenge the safety or effectiveness of medical devices. This holding applies only if the device reaches the market via a Premarket Approval (“PMA”) application. If the device reaches the market via 510(k) clearance, the Supreme Court previously held in Medtronic v. Lohr that FDCA § 521 preemption does not apply.

There is no express preemption in the FDCA for prescription drugs or biological products. See Abbott v. American Cyanamid Co., 844 F.2d 1108, 1111 (4^th Cir. 1988) (finding no express preemption provision applicable to biologics); Eve v. Sandoz Pharm. Corp., 2002 WL 181972, *1 (S.D. Ind. 2002) (“The portion of the FDCA that is applicable to drugs does not contain a preemption provision.”).

Implied preemption
This arises when congressional intent to preempt state law can be implied from the structure and purpose of federal law or regulations. Conflict preemption and field preemption are the two forms of “implied preemption.”

Conflict preemption arises “where it is impossible for a private party to comply with both state and federal law” or where state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372-73 (2000) ; see also Int’l Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987) (state law preempted if it interferes with the methods by which a federal law is implemented and its purposes realized); Florida Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963) (conflict preemption occurs where “compliance with both federal and state [law] is a physical impossibility”).

Field preemption arises “where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress ‘left no room’ for supplementary state regulation.” Hillsborough County v. Automated Medical Labs., Inc., 471 U.S. 707, 713 (1985) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).

Even though drug products do not enjoy the protection of express preemption, they may argue for implied preemption on a case-by-case basis. An example of implied preemption has actually arisen in a case involving medical devices (but it applies to drug products as well). In Buckman Co. v. Plaintiffs’ Legal Comm., the plaintiffs alleged injuries resulting from the implantation of orthopedic bone screws in the pedicles of their spines. They sued the regulatory consultant who had assisted the manufacturer in obtaining 510(k) clearance for the screws.

The plaintiffs claimed that the consultant made fraudulent representations to the FDA. Since the device was cleared on the basis of the representations, the plaintiffs took the position that such representations were a “but for” cause of their injuries. The Supreme Court held that the “fraud on the FDA” claim was impliedly preempted by the FDCA, because it conflicted with the FDA regulatory scheme.

The Supreme Court continues to flesh out the contours of implied preemption. In Warner-Lambert v. Kent, the Court was asked to elaborate on the Buckman decision. The FDA Law Blog previously reported on this case.

The issue was whether a state product liability statute is preempted if it creates a general “safe harbor” from liability for FDA approved drugs but carves out an exception for cases in which the approval was obtained through fraud. As noted above, the Buckman decision declined to permit a common law “fraud on the FDA” cause of action. The Court split 4-4, leaving intact the U.S. Court of Appeals for the Second Circuit’s October 2006 decision upholding the statute.

An important pending preemption case is Wyeth v. Levine, described here. Here is an excerpt from the foregoing link:

The case, Wyeth v. Levine, No. 06-1249, arose when Diana Levine went to the hospital suffering from nausea associated with a migraine headache. Physicians initially gave her Phenergan, a drug manufactured by Wyeth, by injecting it into her muscles. When her nausea persisted, they gave her the drug using the so called “IV push” method, involving injection of the drug into her vein. They bypassed administration via an IV drip. The drug made contact with her arteries, leading to gangrene and forcing doctors to amputate her arm.

The Phenergan label had been approved by the FDA in 1955, and re-evaluated and approved in the late 1980s. Wyeth knew that if the drug reached the arteries it could cause gangrene. Its approved label cautioned that if the drug were administered by and IV drip, care should be taken to avoid arterial exposure and noted the risk. The label did not mention the IV push method of injection, and evidence suggested that the FDA did not evaluate whether the label should address the risk associated with the IV push method.

After settling with her health care providers, Levine went to trial against Wyeth. A Vermont jury awarded her $6.7 million, concluding that Wyeth had failed to warn of the risks associated with IV push administration of Phenergan.

On appeal, the Vermont Supreme Court ruled that the state tort claim was not preempted by the FDA approval of the Phenergan label. The state high court reasoned that it would have been possible for Wyeth to provide the FDA approved label and additional warnings cautioning against IV push administration. It further found that requiring Wyeth to do so would not obstruct any goals of the [FDCA].

If the Supreme Court reverses the Vermont Supreme Court, the most likely rationale will be that FDA’s approval of the labeling strikes a balance between the health benefits and detriments of particular labeling, and the balance would be disrupted if state juries may award damages based upon alleged deficiencies in the very same FDA approved labeling. On that basis, the Supreme Court could find that Levine’s failure-to-warn claim is impliedly preempted (field preemption). Based upon the trend in the case law, this outcome seems probable.

Combination Products: The Next Frontier
The different preemption standards for devices versus drugs/biologics has created an unsettled issue as to how preemption applies to combination products such as device drug or device biologic combinations. The issue has been described this way:

Whether a product is regulated as a device or as a drug can have profound differences if the product is ever the subject of product liability challenge brought under state law. While the FDCA expressly preempts state product liability suits involving medical devices in certain circumstances, no such express preemption is provided under the FDCA for prescription drug products [footnote omitted]. It is not clear how this divergent approval to express preemption of state law applies to combination products. Sponsors will be in the strongest position to invoke preemption of products liability suits . . . if their combination products receive a single PMA approval or, at a minimum, include a PMA approval as part of a dual approval (with an NDA or BLA).

Fox and Shapiro , Combination Products How to Develop the Optimal Strategic Path for Approval (FDA News 2005), p. 65.

In pending personal injury cases, plaintiffs apparently are now taking the position that express preemption does not apply to combination products, because only medical devices enjoy the protection of the express preemption in FDCA § 521, and not drugs or biologic products. For instance, one plaintiff reportedly is arguing that silver added to a St. Jude heart valve as an antimicrobial acts as a drug, thereby creating a combination product not subject to § 521 preemption. See The Gray Sheet, March 17, 2008, “Combo Products Offer Ambiguity for Product Liability Pre emption.”

A logical and administratively simple approach to this issue would be to apply preemption based upon the type of marketing application FDA requires. Thus, if FDA requires a PMA for a combination product, then § 521 preemption would be available. On the other hand, if FDA requires an NDA, then § 521 preemption would not be available.

This approach simply follows FDA’s lead in deciding whether to apply device or drug statutory authorities to a combination product. If FDA has chosen to regulate a combination product under the device authorities (e.g., by requiring a PMA rather than an NDA), it makes sense that one incident of that decision would be the availability of § 521 preemption. This result also comports with the statutory scheme, which makes § 521 preemption available for products subject to regulation as devices.

There are some combination products that are regulated under both drug and device authorities. In these cases, FDA typically requires two separate marketing applications. For example, an iontophoretic delivery device labeled for use with a specific drug is cleared through the 510(k) process, while the specific drug labeled for use with the device requires an NDA. In this situation, it is sensible to apply the appropriate preemption provisions separately to each component of the combination product. It should not be difficult to do so, because typically each component will have its own labeling, and will be sufficiently separate and complex that FDA has chosen to regulate each one under a separate marketing application. and associated statutory authority

In the St. Jude case, if FDA regulates silver coated heart valves solely under the device authorities, then § 521 preemption should be available. It does not matter for this purpose whether FDA is regulating the silver as a device or a drug within this product, so long as FDA has chosen to regulate the overall product as a device.

Allowing a plaintiff to argue that the silver component is really functioning as a drug, and thus that § 521 preemption should not be available, would lead the parties to engage in unproductive metaphysical arguments over whether the silver is acting as a “drug” or “device” in this product. Also, it would push the case in an alternate universe direction, in which preemption is applied based upon the way a party convinces a judge that FDA should have (or could have) regulated the product, as opposed to the way in which FDA is actually regulating the product.

Bottom line: for combination products, the outcome determinative fact in the choice of preemption authority should be FDA’s actual choice of regulating authorities. Any other approach would simply invite chaos and confusion in preemption litigation.

Acknowledgement
The explanation of the different types of preemption in the first part of this post borrows heavily from Fox and Shapiro, Combination Products How to Develop the Optimal Strategic Path for Approval (FDA News 2005), p. 65 n. 31.