Conklin v. Medtronics, Inc., __Ariz. Adv. Rep. __ No. 1 CA-CV 16-0252 (App. Div. I, October 19, 2017) (J. Howe)

WHERE FEDERAL GOVERNMENT HAS EXPRESSLY PREEMPTED STATE LAWS REGARDING DEFECTIVE DESIGN AND MANUFACTURE OF MEDICAL DEVICES PRODUCT LIABILITY THEORIES WHICH ADD TO OR ARE DIFFERENT FROM THE CONTROLLING FEDERAL LAW GOVERNING THESE DEVICES ARE PREEMPTED/STATE LAW THEORIES WHICH PARALLEL THE FEDERAL LAW WITH LIKE REQUIREMENTS BUT ALLOW FOR ADDITIONAL DAMAGES ARE NOT PREEMPTED/MOTION TO AMEND MUST BE MADE BY SEPARATE MOTION WITH PROPOSED AMENDED PLEADING ATTACHED

Plaintiff sued defendant Medtronics for product liability arising out of alleged injury caused by a pain infusion pump and catheter manufactured and marketed by defendant. The Food, Drug, and Cosmetic Act ("FDCA") classifies this device as a Class III medical device "subject to the FDA's rigorous pre-market approval ("PMA") process." Additionally, the federal statute requires a manufacturer to report any injury or deaths caused by a malfunction of the device as well as the danger of potential future injury, to the FDA. 21 U.S.C. § 360i(a)(1); 21 C.F.R. § 803.50(a).

Plaintiffs alleged, that before being injured, the FDA had sent warning letters to Medtronic, advising that the pump was adulterated and misbranded and stating that Medtronic had failed to report adverse events to the FDA after PMA. Plaintiffs also claimed that before the injury occurred, the FDA had issued two Class I recalls of the Medtronic Pain Pump. Plaintiffs further alleged that after plaintiff's injury, the FDA issued another Class I recall of the Medtronic Pain Pump regarding the unintended delivery of drugs that could result in a drug overdose. Finally plaintiffs alleged that Medtronic's failure to report post-PMA adverse events to the FDA in violation of federal law gives rise to liability under Arizona common law.

The trial court granted defendant's motion to dismiss all plaintiffs' claims for failure to state a claim based upon federal preemption. The Arizona Court of Appeals affirmed in part, vacated in part and remanded.

The U.S. Congress has the power to preempt state laws and withdraw powers from the States by enacting statutes with express preemption provisions. U.S. Const. art. VI, cl. 2. The defendant has the burden to prove preemption and there is a presumption that Congress did not intend to preempt except where Congress expressly preempts in the language of the statute. For  preemption to apply "(1) the federal government must have established requirements applicable to the device at issue and (2) the plaintiff's common-law claims concerning the device must include requirements that are "different from, or in addition to" those federal requirements." 21 U.S.C. § 360k(a). In addition to express preemption, the MDA also "impliedly preempts any action for the enforcement or restriction of violations of the FDCA because such actions can only be brought by or in the name of the United States." 21 U.S.C. § 337(a)

Despite these preemption restrictions, a plaintiff's state-law
claim concerning a medical device may be viable if it is a "parallel claim,"
a claim based on state requirements that are "equal to or substantially
identical to, requirements imposed by or under the act." Thus, a state-law
claim is not preempted when it provides "a damages remedy for claims
premised on a violation of FDA regulations; the state duties in such a case
'parallel,' rather than add to, federal requirements.

Here, plaintiffs' claims of strict product liability, breach of express warranty, and negligent design and manufacture are preempted because each theory would add requirements to the FDA requirements governing design and manufacture as well as the FDA approval process.

However, failure to warn, loss of consortium, and punitive damages claims would not be expressly or impliedly preempted by federal law. Defendant's alleged failure to comply with the FDA by reporting prior and potential future failures is a parallel claim based upon the alleged failure of the defendant to comply with the FDA reporting requirement by reporting to the FDA. This state law theory is essentially the same as the FDA requirement to the extent the theory is based upon a failure to report to the FDA. To the extent the theory is based upon a failure to report directly to plaintiffs or plaintiff's doctor, there would be preemption because this would be adding to the FDA requirements which only require reporting to the FDA itself. Further violation of the FDA requirement may also constitute negligence per se-violation of a statute designed to protect a class of people of which plaintiff is a member.

Plaintiffs' loss of consortium claim being derivative of the surviving failure to warn theory will likewise avoid preemption claims and because punitive damages are likewise derivative and have no special pleading requirements, even a failure to plead "evil mind" does not render that claim defective.

Finally, the trial court properly denied plaintiffs' request for leave to amend the complaint and correct defects because this relief was sought in the response to the motion to dismiss and not in a separate motion with an attached copy of the proposed amended complaint as required by  Ariz. R. Civ. P. 15(a)(4).