Mitaro v Medtronic, Inc.

[*1] Mitaro v Medtronic, Inc. 2009 NY Slip Op 50888(U) [23 Misc 3d 1122(A)] Decided on April 9, 2009 Supreme Court, Westchester County Nicolai, J. Published by New York State Law Reporting Bureau pursuant to Judiciary Law § 431. This opinion is uncorrected and will not be published in the printed Official Reports.

Decided on April 9, 2009
Supreme Court, Westchester County

Norma Mitaro and Joseph Mitaro, Plaintiffs,

against

Medtronic, Inc. a/k/a MEDTRONIC, MEDTRONIC PUERTO RICO, INC., MEDTRONIC INTERNATIONAL TECHNOLOGY, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., INC., MEDTRONIC PUERTO RICO OPERTIONS CO., MEDTRONIC USA, INC., JOSHUA TRUTT, M.D., DAVID STUHLMILLER, MD., WESTCHESTER MEDICAL CENTER and WESTCHESTER COUNTY HEALTH CARE CORP., Defendants.



3642/08



William P. Harrington, Esq.

Bleakley, Platt & Schmidt, LLP

One North Lexington Avenue

White Plains, New York 10601

Mayer, Brown, LLP

1675 Broadway

New York, New York 10019

Attorneys for the Medtronic Defendants

Anthony Pirrotti, Jr., Esq.

Pirrotti Law Firm, LLC Two Overhill Road

Suite 200

Scarsdale, New York 10583

Attorneys for the Plaintiffs

Benvenuto, Arciero & McAndrew

67 North Main Street

New City, New York 10956

Attorneys for the Defendants Trutt, and Stuhlmiller

Bartlett, McDonough, Bastone & Monaghan, LLP

81 Main Street

White Plains, New York 10601

Attorneys for the Defendants Westchester Medical Center

and Westchester County Health Care Corp.

Francis A. Nicolai, J.

The following papers numbered 1 to 7 were read on this motion by the defendants, Medtronic, Inc., aka Medtronic, Medtronic Puerto Rico, Inc., Medtronic International Technology, Inc., Medtronic Puerto Rico Operations Co., Inc., Medtronic Puerto Rico Operations Co., and Medtronic USA, Inc. (hereinafter to be referred to jointly as Medtronic), for an order pursuant to CPLR 3211, dismissing the plaintiffs' amended complaint as asserted against them, upon the grounds of federal preemption and the failure to state a cause of action upon which relief can be granted.[FN1]

Notice of Motion - Affirmation; Exhibit1-2; 3 [*2]

Appendix of Cases4

Memo of Law5

Affirmation in Opposition: Exhibit6

Reply Memo of Law7

This motion shall be determined in the Central Calendar Part pursuant to the Memorandum of the Hon. Francis A. Nicolai, Administrative Judge, Ninth Judicial District, dated November 30, 2007.

Upon the foregoing papers, it is ordered that this motion is decided as follows:

Medtronic is one of the world's largest manufacturers of medical devices, including implantable cardiac defibrillators (ICDs). ICDs are small devices implanted in patients' chests to monitor heart rhythm abnormalities. They do so through small wires called leads that on one end are attached to the ICD and on the other end are attached directly to the patient's heart muscle through a coronary vein. If electrodes on the leads detect that the patient's heart is out of rhythm, the ICD sends an electric shock to the heart muscle through the leads in order to correct the problem (see, Matter of Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F Supp2d 1147, 1153 [D. Minn, Jan 5, 2009]).

The plaintiff, Norma Mitaro, was implanted with a Model 6949 Sprint Fidelis lead manufactured by Medtronic. In this action the plaintiffs, Norma Mitaro and her husband Joseph Mitaro, bring a number of claims against Medtronic relating to Norma Mitaro's Sprint Fidelis lead which allegedly fractured. Medtronic has filed this motion to dismiss the amended complaint insofar as asserted against it.

By decision dated February 20, 2008, the Supreme Court in Riegel v Medtronic, Inc. (___US___, 128 S Ct 999), held that state law tort claims against a manufacturer of an allegedly defective medical device which had received premarket approval from the Food and Drug Administration (FDA) were exempted by the preemption clause enacted in § 360k (a) of the Medical Device Amendments (MDA) of 1976.

In his 8 to 1 opinion for the Court, Justice Scalia wrote that Congress had imposed a regime of detailed federal oversight for medical devices depending on the risks they presented. The devices receiving the most federal oversight are those in Class III which include, among others, pacemaker pulse generators. Class III devices are deemed either: (i) important to sustaining human life or (ii) important in preventing impairment of human health but which devices also present a potential unreasonable risk of injury.

The Court noted that the premarket approval process is a rigorous one. The FDA spends an average of 1200 hours reviewing each application and grants premarket approval only if it finds there is a reasonable assurance of the device's safety and effectiveness. This process includes review of the device's proposed labeling and must determine that the proposed labeling [*3]is neither false nor misleading. Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling or any other attribute that would affect safety or effectiveness. If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as the initial application. Furthermore, after premarket approval, the devices are subject to reporting requirements. These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of, or reasonably should know of, and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned.

In Riegel, the complaint alleged that a Medtronic catheter that was inserted into the plaintiff's coronary artery ruptured. It was alleged that the catheter was designed, labeled and manufactured in a manner that violated New York common law and Riegel raised a number of common law claims. The Court held that the claims were preempted because they would, if successful, impose state requirements that differed from, or added to the device-specific federal requirements.

The Court also noted that the MDA expressly preempts only state requirements that are different from, or in addition to, any requirement applicable to the device under federal law. The MDA does not prevent a state from providing 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. In other words, the Court did not eliminate all product liability claims against medical device manufacturers. If a medical device is not manufactured with the specifications approved by the FDA, a state common-law claim that the device was defective would not be preempted.

In his commentary, Professor J. David Prince noted that Riegel does not answer all preemption questions nor does it completely eliminate the prospect of lawsuits against device manufacturers whose products are alleged to be defective. He said that some claims, particularly manufacturing defect claims, are clearly not preempted. For example, if a medical device is not manufactured in accordance with the specifications approved by the FDA, a state common-law claim that the device was defective would not be preempted (see, Prince, David J. Riegel v Medtronic: US Supreme Court Upholds Federal Preemption of State Tort Claims Against Medical Device Manufacturers. LexisNexis Expert Commentary, April 16, 2008).

In their first cause of action the plaintiffs claim that Medtronic is strictly liable due to its failure to warn and instruct; that is, that Medtronic knew or should have known through testing, adverse event reporting, or otherwise, that the leads created a high risk of injury and that it failed to provide adequate and timely warnings or instructions regarding the known defects. In discussing this "duty to warn" claim, the Riegel Court stated that the MDA would preempt a jury determination that the FDA-approved labeling for a device violated a state common-law requirement for additional warnings (see, Riegel at 1011; Horowitz v Stryker Corp., ___F Supp [*4]2d___ [EDNY, Feb 20, 2009]; Matter of Medtronic, Inc., 592 F Supp 2d 1147, 1159 [D. Minn, Jan 5, 2009]; Lake v Kardjian [NY Sup Court, Madison County, Dec 17, 2008]). Therefore, this claim is preempted.

In their second cause of action the plaintiffs claim that Medtronic is strictly liable due to a manufacturing defect in the specific lead implanted in the plaintiff Norma Mitaro, that the Sprint Fidelis leads are defectively manufactured, and that the facilities and controls used by Medtronic in the manufacture of the leads are not in conformity with the applicable federal requirements. More particularly, in their complaint the plaintiffs allege that the manufacturing process of the Sprint Fidelis leads relied on direct resistance spot welding of two different metals to affix lead cables and that this process can damage the fine, small wires in the cables. As noted herein above, the Riegel Court specifically noted that the MDA does not prevent a state from providing damages for claims premised on a violation of FDA regulations. Such a claim would not be preempted since it would be a parallel claim that does not impose a requirement that is different from, or in addition to, any federal requirement. CPLR 3013 provides that statements in a pleading shall be sufficiently particular to give the court and parties notice of the transactions and occurrences intended to be proved and the material elements of each cause of action. The allegations stated herein are sufficient to provide the requisite notice under state law and at this juncture, to avoid dismissal of the second claim asserted against Medtronic.

In their third cause of action the plaintiffs claim that Medtronic is strictly liable for defectively designing the Sprint Fidelis leads in a manner that is in violation of the Federal Food, Drug and Cosmetic Act (FDCA) and the MDA. More particularly, the plaintiffs assert that on or about May 15, 2007, Medtronic submitted an application to the FDA for design changes to its leads but after the approval, Medtronic continued to sell the old, already-manufactured leads. A design-defect claim which challenges the FDA's findings concerning the safety of a device's design, necessarily imposes requirements that are different from, or in addition to, federal regulations and therefore such claims are pre-empted (see, Horowitz v Stryker Corp., ___F Supp 2d___ [EDNY, Feb 20, 2009]). Furthermore, the plaintiffs' design-defect claim herein would require a jury to find that the older design of the Sprint Fidelis leads was unsafe. Such a finding would usurp the FDA's role in evaluating the safety and effectiveness of the leads and would therefore interfere with the premarket approval process. Therefore, this claim is pre-empted (see, Matter of Medtronic, Inc., 592 F Supp 2d 1147, 1159 [D. Minn, Jan 5, 2009]).

In their fourth cause of action the plaintiffs claim that Medtronic was negligent in the design, testing, inspection, manufacture, distribution, marketing and advertising of the Sprint Fidelis leads. This claim, which is not premised on a federal violation is preempted by the MDA (see, Riegel v Medtronic, Inc.,___US___, 128 S Ct 999, 1006; Horowitz v Stryker Corp., ___F Supp 2d___ [EDNY, Feb 20, 2009]) . The plaintiffs' fifth cause of action which asserts negligence per se in that Medtronic violated the law by selling adulterated and misbranded Sprint Fidelis leads not only, in part, parallels their design-defect and failure to warn claims and is therefore preempted but is also preempted under 21 USC § 337 (a) which provides that all proceedings to enforce or to restrain violations of the FDCA are in the domain solely of the [*5]federal government.

In their sixth cause of action, the plaintiffs allege that Medtronic impliedly warranted that their Sprint Fidelis lead, which it designed, manufactured, assembled, promoted and sold, was merchantable and fit and safe. In their seventh cause of action the plaintiffs allege that Medtronic expressly warranted to the plaintiffs, in publications, package inserts, the internet and other communications intended for doctors and patients that the Sprint Fidelis leads were safe and effective and fit and proper for their intended use. Medtronic breached this warranty by continuing sales and marketing campaigns highlighting the safety of the product while it knew of the defects and risk of product failure.

Insofar as a claim would require a jury to determine that Medtronic impliedly warranted that the Sprint Fidelis leads were safe and effective and that Medtronic breached that implied warranty- for example, a jury would have to find that the leads were unsafe in their design and manufacture- such a determination would interfere with the premarket approval process. Therefore, such a claim is preempted (see, Riegel v Medtronic, Inc., 451 F3d 104, 121, affd ___US___, 128 S Ct 999; Matter of Medtronic, Inc., 592 F Supp 2d 1147, 1164 [D. Minn, Jan 5, 2009]). However, this is not the case regarding the express warranty claims. Such a claim would be preempted to the extent that it is premised on FDA approved representations made by the manufacturer (see, Horowitz v Stryker Corp., ___F Supp 2d___ [EDNY, Feb 20, 2009]; Lake v Kardjian [NY Sup Court, Madison County, Dec 17, 2008]). At this juncture, on a motion to dismiss (as opposed to a motion for summary judgment where the plaintiff has not or cannot identify specific representations which exceed the scope of FDA-approved statements), this claim remains viable.

In their eighth to twelfth causes of action the plaintiffs have alleged: negligent misrepresentation, intentional misrepresentation, fraud, constructive fraud and, negligent infliction of emotional distress. These claims are preempted (see, Matter of Medtronic, Inc., 592 F Supp 2d 1147 [US Dist Court, D. Minn, Jan 5, 2009]; In Re: Sulzer Hip Prosthesis, 455 F Supp 2d 709, 718, 720 [US Dist Court, N. Ohio, Oct 3, 2006]). This court notes that insofar as two of these claims, intentional misrepresentation and fraud, are premised on false representations to the FDA, they are clearly preempted (see, Buckman Co. v Plaintiffs' Legal Comm., 531 US 341, 348; Kemp v Medtronic, Inc., 231 F 3d 216 [6th Cir [Nov 1, 2000]).

In their thirteenth cause of action the plaintiffs allege unjust enrichment in that Medtronic wrongfully profited and benefitted from their purchase of the Sprint Fidelis lead. They also allege, as their fourteenth cause of action, that Medtronic violated one or more sections of Article 22-a of New York's General Business Law when they failed to comply with FDA requirements. These claims, too, must fail (see, Pa. Empls. Benefit Trust Fund v Zeneca, 499 F3d 239, 251 [3rd Cir, Aug 17, 2007]; Horowitz v Stryker Corp., ___F Supp 2d___ [EDNY, Feb 20, 2009]; Matter of Medtronic, Inc., 592 F Supp 2d 1147 [D. Minn, Jan 5, 2009]).

In their final cause of action against Medtronic, the plaintiffs allege that pursuant to the [*6]private cause of action provisions of the Medicare as Secondary Payer Statute, they bring an action to recover double damages of all medicare expenditures resulting from the injuries caused by the recalled Sprint Fidelis leads. This court finds that the recall of the subject leads does not invalidate the preemption defense. Clearly, in this case, the plaintiff, Norma Mitaro, was implanted with the ICD before the recall such that, at the time they were implanted, the premarket approval for the Sprint Fidelis leads was in place (see generally, Matter of Medtronic, Inc., 592 F Supp 2d 1147, 1155 [D. Minn, Jan 5, 2009]; but see, Prince, David J. Riegel v Medtronic: US Supreme Court Upholds Federal Preemption of State Tort Claims Against Medical Device Manufacturers. LexisNexis Expert Commentary, April 16, 2008). This last claim against Medtronic also fails.

In view of the foregoing, Medtronic's motion for an order dismissing the complaint is granted to the extent that the plaintiffs' claims against it for: strict liability for failure to warn and instruct; strict liability for defective design; negligence; breach of implied warranty: misrepresentation and fraud; unjust enrichment; and violations of New York's General Business Law; as well as the claim pursuant to the Medicare as Secondary Payer Statute, are dismissed. Medtronic's request to dismiss the claims of strict liability due to a manufacturing defect and the breach of express warranty is denied.

Dated: White Plains, New YorkApril9, 2009____________________________FRANCIS A. NICOLAIJ.S.C Footnotes

Footnote 1: The plaintiffs' sur-reply has not been considered insofar as such is not provided for in the CPLR.