Health Law Daily Removal for federal question jurisdiction requires more than claim based on violation of federal requirement
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Thursday, March 14, 2019

Removal for federal question jurisdiction requires more than claim based on violation of federal requirement

By Rebecca Mayo, J.D.

A parallel state law cause of action that is based upon the violation of a federal requirement does not necessarily trigger federal question jurisdiction.

A district court held that it did not have subject matter jurisdiction over a case against a device manufacturer where the causes of action were formulated as state law claims. A patient’s claims for failure to warn and negligence were properly pleaded as parallel state claims and the issues presented were not substantial enough to rise to the level of a federal question. Therefore, removal from state to federal court was improper where there was no federal question (Barone v. Bausch & Lomb, Inc., March 12, 2019, Wolford, E.).

The complaint. A patient had a Bausch & Lomb Crystalens® AO Lens and Morcher® and FCI Opthalmics, Inc. Capsular Tension Ring implanted into his right eye to improve his vision. Within a matter of weeks the patient began having pain and discomfort and was forced to have multiple follow-up surgeries which impacted his ability to see and left him with permanent injuries. The patient alleges that he later discovered that the Crystalens device has a history of failure due to a defect referred to as "Z syndrome" which causes the device to assume a Z shape and stop functioning. According to the patient, Bausch & Lomb became aware of the malfunction as early as April 2009 and failed to file adverse reaction reports for all known incidents of Z syndrome, in violation of the conditions set but the FDA’s initial premarket approval for the Crystalens.

The plaintiff filed claims against Bausch & Lomb for strict liability and negligent failure to warn and filed claims of breach of warranty, negligence, defective design and manufacture, and strict liability failure to warn against Morcher and FCI. Bausch & Lomb removed the action to federal court, asserting federal question jurisdiction. Bausch & Lomb then filed a motion to dismiss for failure to state a claim, arguing that the claims are preempted by the Federal Food, Drug, and Cosmetic Act (FDC Act). The court raised, sua sponte, the issue of subject matter jurisdiction.

Decision. In certain rare cases, federal-question jurisdiction may lie over state-law claims that implicate significant federal issues. According to the Supreme Court, this occurs if the federal issue is necessarily raised, actually disputed, substantial, and capable of resolution in federal court without disrupting the federal-state balance approved by Congress. In this case the patient alleges a violation of a duty created by federal law that also exists independently under state law. The patient contends that Bausch & Lomb violated federal law and Bausch & Lomb expressly disputes that any such violation took place.

Although the action raises a federal issue that is actually disputed, the issue presented is not sufficiently substantial to warrant the assertion of federal subject matter jurisdiction. The court found that the patient’s claims are based upon the alleged violation of federal regulatory requirements, however this alone is insufficient to satisfy the substantiality prong. To be considered substantial, a case generally must be one in which the federal government itself seeks access to a federal forum, an action of the federal government must be adjudicated, or where the validity of a federal statute is in question. There is no action by a government arm. Further, there is no need to create a federal remedy where there is no national character to the original claim.

Additionally, under the well-pleaded complaint rule, the plaintiff is the master of the complaint and may avoid federal jurisdiction by pleading only state claims even where a federal claim is also available. In this case, the patient sufficiently formulated the claims as parallel state law causes of action based upon the violation of independent federal requirements. The fact that the claims are based upon the violation of federal law does not alter their essential character as state causes of action.

The case is No. 6:17-cv-06877-EAW.

Attorneys: Anne Katherine Bowling (Rupp Baase Pfalzgraf Cunningham LLC) for Joseph Barone. Daniel I.A. Smulian (Greenberg Traurig, LLP) for Bausch & Lomb, Inc. Arnd Von Waldow (Reed Smith LLP) for Morcher GmbH and FCI Opthalmics, Inc.

Companies: Bausch & Lomb, Inc.; Morcher GmbH; FCI Opthalmics, Inc.

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