By Leah Rush Easterby, Contributing Editor
Featuring comments by Marcus J. Susen, Esq.

Constitutional doctrine makes clear that federal law is supreme when state laws “interfere with, or are contrary to” federal law. Federal law can preempt state law either expressly or impliedly.

Corporate defendants routinely seek dismissal with three preemption theories.

• Express preemption, based on Congress’s stated intent within a statute or regulation;
• Conflict preemption, when it would be impossible to comply with both state and federal law; and
• Field preemption, when federal regulation is sufficiently comprehensive to predominate state laws.

Preemption disputes are often a matter of statutory interpretation, in which courts look to Congress’s purpose when passing the statute. When an express preemption clause could be read to allow some state regulation, courts disfavor preemption (the “presumption against preemption”).

The presumption against preemption applies to both express and implied preemption. The bar to a preemption finding is especially high when the federal law provides no remedy to an injured consumer because it would foreclose a remedy that was traditionally available at common law. Courts have refused to buy the notion that Congress would, without comment, remove all means of judicial recourse for injured consumers.

Express Preemption Overcomes Additional or Different State Requirements.

The Food, Drug, and Cosmetic Act (FDCA) has been found to preempt many state-law claims, including design defect, misbranding, and failure to warn, among others. State requirements that are substantively identical to federal law (“parallel requirements”) are not preempted, and the Supreme Court has been clear that states can provide remedies above and beyond what federal law would provide without being preempted.

Some express preemption clauses, as in the Medical Device Amendments of 1976 (MDA), preempt state requirements that are “in addition to, or different than” federal requirements. While some courts and, of course, manufacturers read the MDA with a blanket exemption of state law claims, such a reading would dispossess not only injured consumers but also private insurers and Medicare from compensation to which they might have an otherwise valid claim.

The MDA preemption analysis requires two findings:

• Whether the federal government has established requirements applicable to a specific medical device; and
• Whether the plaintiff’s claims impose requirements on the defendant that are different from, or in addition to the federal ones.

In Riegel v. Medtronic, the Supreme Court held that under the MDA’s preemption clause, manufacturers of Class III medical devices with FDA premarket approval (PMA) could not be held liable for state common law claims regarding the device’s safety or effectiveness.

Plaintiff Charles Riegel developed a heart block requiring coronary bypass when his doctor overinflated and ruptured a Medtronic balloon catheter while performing angioplasty. Riegel alleged the catheter’s design, label, and manufacturing violated New York common law.

The court found that PMA includes the device’s proposed label, and FDA evaluates safety and effectiveness under the conditions set forth in the label. After a device gets PMA, the manufacturer cannot alter the design or label to affect safety and effectiveness without FDA permission.

While generally applicable federal manufacturing and labeling requirements do not necessarily preempt common law claims, specific safety and effectiveness requirements applicable to the device at issue do preempt state law claims. The court reasoned that PMA is specific to individual devices and concluded the New York state law claims for negligence and strict liability would impose requirements preempted by the MDA.

Despite the MDA’s express preemption clause, it does not prohibit states from maintaining safety requirements that parallel federal law and does not expressly forbid lawsuits based in state tort law. “Contrary to Big Pharma’s position, preemption is not an absolute. It is a matter of pleading,” said Marcus Susen of Susen Law Group.

To keep claims from being preempted, claimants should plead conduct that violates PMA requirements that also can be framed as a breach of a common law duty. “More courts should allow for limited discovery prior to hearing a preemption defense,” Susen advised. “Oftentimes, evidence that can support a parallel claim is only in the hands of the defendant. For one example, to prove a manufacturer deviated from the manufacturing specs of an FDA approved device, you need to see the manufacturing standard first. This is usually not public information. One of the best tools for pleading parallel claims is a Freedom of Information Act (FOIA) request. The process is long but can yield invaluable information needed to plead parallel claims.”

Violating Conditions of a PMA Eliminates Preemption.

In Strimel v. Bayer, Essure plaintiffs alleged the permanent birth control device migrated after implantation, broke apart upon removal, and perforated organs, sometimes requiring hysterectomy or causing death. The plaintiffs were able to avoid dismissal by proving the manufacturer deviated from the specifications it submitted to FDA when seeking device approval.

Plaintiffs’ primary contention was that Essure’s PMA was conditioned upon postapproval conditions Bayer failed to uphold. Prior to the lawsuit, FDA had cited the manufacturer for nonconformance with its conditions for approval in several particulars.

• Not documenting or reporting known device failures.
• Using nonconforming material in manufacturing Essure.
• Failing to follow sterilization protocols.
• Manufacturing Essure in an unlicensed facility.
• Manufacturing essure for three years without a license to do so.
• Not analyzing to identify existing and potential causes of quality problems.
• Failing to provide quality assurance and properly track data. (Two lot history records showed rejected raw material which was not documented, leading to the question where the rejected components went.)
• Designing, manufacturing, assembling, marketing, and selling an “adulterated” and “misbranded” product under federal law.

The defendant based its preemption claim on its conditional premarket approval (CPMA)—the federal requirement. Plaintiffs countered that because Bayer violated the terms of its CPMA for Essure, as indicated by FDA’s citations, there was no valid federal requirement upon which to base a preemption defense. Without a valid federal regulation, there could be no preemption.

Plaintiffs successfully argued a jury could find Bayer’s deviation from FDA manufacturing or marketing requirements was unreasonably dangerous without imposing different or additional requirements to the federal ones. Plaintiffs claimed that while there are some common law restrictions on strict liability for unavoidably unsafe products, that is not a blanket exception.

“Parallel claims don’t have to be identical, just as train tracks are parallel but never truly identical, although they arrive at the same destination,” remarked Susen, who secured a $1.6 billion settlement as lead counsel in the Essure MDL. Unavoidably unsafe products can only escape strict liability when they are properly manufactured and marketed with adequate warnings. To hold otherwise would force patients to bear all the risks associated with unavoidably unsafe products while allowing manufacturers to reap all the rewards.

Susen explained: “Negligent misrepresentation, fraud, and express warranty claims are sometimes based on statements outside the warning and instructions for use. These types of claims, which often appear in marketing literature, are not approved or evaluated by FDA. In fact, most PMA letters from FDA expressly state that they do not evaluate such warranties. Therefore, these types of claims should not even be subject to a preemption analysis.”

Implied Preemption Requires Statutory Interpretation.

Implied preemption is a matter of judicial interpretation when the federal law doesn’t contain an express preemption clause. In implied preemption disputes, the courts try to favor interpretations that do not preempt state law.

Conflict preemption, a commonly argued defense, occurs when state law interferes with federal goals. Impossibility preemption, a commonly argued conflict theory, occurs when it would be impossible for a party to simultaneously comply with both state and federal law.

Claims Against Generic Manufacturers are Preempted by Impossibility.

More than 1,400 cases have been filed in the Zantac MDL against both brand name and generic manufacturers. The judge has dismissed claims against 32 generic ranitidine manufacturers and distributors, finding they’re preempted under federal law.

Under the Hatch-Waxman Amendments, generic drug manufacturers can get FDA approval by demonstrating the generic is equivalent to an existing FDA approved drug. Generic manufacturers cannot unilaterally change the drug label, but must use the same label as the brand name they replicate.

In April 2020, FDA pulled Zantac and generic ranitidine from the market following an investigation into the potential for the drugs to cause cancer. The investigation uncovered high levels of N-Nitrosodimethylamine (NDMA), a cancer-causing agent, in some batches of ranitidine, the active ingredient in Zantac. The defect was found long after brand patents had expired and generic ranitidine products had made it to market.

In August 2020, generic ranitidine manufacturers argued impossibility preemption because they could not alter the drug’s composition or label without violating FDA requirements. The defendants further argued that because all plaintiff claims, including general negligence, breach of express warranties, and deceptive acts, were based around the drug’s defective design, all claims were preempted by federal law.

The court initially found claims against the generic manufacturers preempted and dismissed the claims without prejudice. Plaintiffs replead their claims against generic defendants to no avail. The court dismissed them with prejudice in July 2021 upon finding the replead claims were essentially the same design defect claims as before and that it would have been impossible for generic defendants to comply with both state and federal law.

Impossibility Preemption is a Demanding Defense for Brand Name Manufacturers. 

When Congress enacted express preemption for medical devices, it declined to do the same for prescription drugs. The Supreme Court has rejected impossibility preemption claims by brand name manufacturers who have authority to strengthen their own labels before receiving supplemental FDA approval.

The plaintiff in Wyeth v. Levine was injected via IV-push with Wyeth’s FDA-approved antinausea drug Phenergan. The drug causes irreversible gangrene when it enters an artery. It did. Doctors amputated Levine’s forearm, effectively ending her career as a professional musician.

The Phenergan label did contain a warning of the risks of gangrene and amputation with inadvertent intra-arterial injection. Levine argued the warning was inadequate and should have emphasized the risks of administering Phenergan with IV-push instead of a drip. The jury concluded that if the drug label had contained her proposed warning, Levine’s injury would not have occurred.

Wyeth argued that because Phenergan was FDA approved, it would have been impossible to comply with both state and federal law by adding a stronger warning to the Phenergan label.

Eventually, the U.S. Supreme Court found Levine’s claims were not preempted, rejecting Wyeth’s argument that it couldn’t simultaneously comply with both state and federal law. Rather, FDA’s “changes being effected” (CBE) regulation permits stronger warning label changes by brand manufacturers upon filing a supplemental application. Without clear evidence FDA would have rejected Phenergan’s stronger warning label, the court could not conclude it would have been impossible for Wyeth to comply with both state and federal law.

Featuring Marcus J. Susen, Esq.

Marcus Susen is a board certified civil trial lawyer in Florida. Mr. Susen was lead counsel in the consolidated Essure birth control litigation in the Eastern District of PA. The national litigation settled for approximately $1.6 billion in 2020. He then went on to launch his own nationwide practice, Susen Law Group, representing consumers injured by defective drugs, medical devices, sex abuse, and more. He currently serves on the Plaintiffs’ Steering Committee for the Paragard birth control litigation and focuses his practice on women’s health advocacy.