Antitrust Law Daily Wrap Up, ADVERTISING—S.D. Cal.: Deceptive claims against Bausch & Lomb preempted by Medical Device Amendments, (Mar 13, 2015)

By Greg Hammond, J.D.

A patient that allegedly suffered injury after an artificial lens was surgically implanted in her eye could not state valid deceptive advertising and deceptive business practices claims against eye health product supplier Bausch & Lomb, Inc. under California’s False Advertising Law (FAL) and Unfair Competition Law (UCL). In partially granting Bausch & Lomb’s motion to dismiss, the federal district court in San Diego determined that the FAL and UCL claims were preempted under the Medical Device Amendments of 1976 (Michajlun v. Bausch & Lomb, Inc., March 11, 2015, Miller, J.).

Background. Irena Michajlun was surgically implanted with Crystalens in April 2012, an artificial lens that replaces an individual’s natural lens after removal during cataract surgery. Michajlun, however, experienced “Z syndrome,” a condition in which one of the Crystalens’ arms that attach to the eye muscle detaches and folds forward inside the eye, causing the lens to assume a “Z” shape and to stop working. Michajlun and her husband filed claims, in part, for violations of the FAL and UCL, arguing that: (1) Bausch & Lomb’s August 2010 advertising circular contained false and misleading statements; and (2) that Bausch & Lomb’s failure to comply with its reporting duty diminished physicians’ ability to assess and warn of the risk of Z syndrome.

Bausch & Lomb moved to dismiss the plaintiffs’ complaint, arguing that the pleading fails to state a claim because they are expressly preempted by the express-preemption provision of the Medical Device Amendments of 1976 (MDA). Conversely, the plaintiffs argued that their claims fall within the narrow exception for “parallel” state and federal claims.

MDA preemption. The MDA expressly preempts state requirements that are “different from, or in addition to” federal requirements applicable to a medical device. The only state-law claims that are not expressly preempted are claims premised on violations of state duties that “parallel” duties imposed by the FDA. However, claims concerning medical devices can also be impliedly preempted by the MDA if they seek to enforce a violation of the medical device provisions and do not rely on traditional state tort law.

The first step in this analysis, according to the court, is a determination on whether the federal government has established requirements applicable to Crystalens. Both parties agreed that Crystalens is a Class III medical device that was approved under the FDA’s premarket approval process.

The court noted that the second step is to decide whether the plaintiffs’ state-law claims would impose requirements different from, or in addition to the federal requirements. As such, the court found that any claims premised on the theory that Bausch & Lomb’s advertising circular was false and misleading were expressly preempted under the MDA, because the only way the plaintiffs could win on a theory that the circular was false and misleading would be by showing that Bausch & Lomb had a duty to provide warnings or advisories “different from, or in addition to” those approved by the FDA.

The plaintiffs’ second theory of liability, however, was not preempted by the MDA, because it fell under the parallel state and federal claims exception. Specifically, the plaintiffs asserted that Bausch & Lomb failed to comply with its duty under federal law to report all adverse events to the FDA, and therefore violated its duty under California law to warn consumers of the risk of Z syndrome. Consequently, the plaintiffs’ claims were not expressly or impliedly preempted to the extent they are premised on Bausch & Lomb’s alleged failure to comply with its parallel state and federal duties to report adverse events to the FDA, the court declared.

FAL, UCL claims. With regard to the plaintiffs’ deceptive advertising and deceptive trade practices claims, the court first determined that they sufficiently alleged relevant date ranges for the supposedly unreported adverse events that occurred prior to Michajlun’s surgery. This “thin causal connection” was deemed sufficient to survive Bausch & Lomb’s motion to dismiss for insufficient causal allegations.

The deceptive advertising claims were nevertheless dismissed without leave to amend as expressly preempted by the MDA. The court reasoned that the FAL prohibits any “unfair, deceptive, untrue, or misleading advertising,” and the plaintiffs would be required to show that Bausch & Lomb should have provided warnings to the public “different from, or in addition to” those approved by the FDA.

The deceptive business practices claims under the UCL were also dismissed without leave to amend. First, the court noted that the plaintiffs failed to address Bausch & Lomb’s argument that the UCL claim should be dismissed because the equitable relief the plaintiffs seek is unavailable as a matter of law. The plaintiffs consequently waived this issue. Second, the court determined that the remaining theory, that Bausch & Lomb violated its duty under California law to warn the FDA, and at the same time ran afoul of FDA reporting requirements, could not support a cognizable claim under the UCL. Specifically, the court determined that because common-law claims cannot be the basis of a UCL “unlawful” claim, and private actions to enforce the Federal Food, Drug, and Cosmetic Act are barred, combining them cannot result in a viable claim under the unlawful prong of the UCL.

The plaintiffs were allowed to proceed with their claims for strict liability for failure to warn, negligent failure to warn, and loss of consortium, to the extent they are premised on Bausch & Lomb’s alleged failure to warn the FDA.

The case number is 14-cv-1365 JM (JMA).

Attorneys: Samuel A. Ceballos (Ceballos Law: West, APC) for Irena Michajlun. Brian Patrick Ziska (Shook Hardy & Bacon LLP) for Bausch & Lomb, Inc.

Companies: Bausch & Lomb, Inc.

Cases: Advertising CaliforniaNews