Opinion
No. 7411/11.
2012-08-17
Philomena MAYEN and Kenneth Mayen, Plaintiffs, v. Russell TIGGES, MD; Orthopedic Associates of Dutchess County; ST. Francis Hospital; Northern Dutchess Hospital and DePuy Orthopaedics, Inc., Defendants.
Steinberg, Symer & Platt, LLP, Poughkeepsie, attorney for plaintiffs. Russell Tigges, MD and Orthopedic, Associates of Dutchess County, Poughkeepsie, Feldman, Kleidman & Coffey, LLP, St. Francis Hospital and Northern Dutchess Hospital, Fishkill, John D. Winter, Esq., Patterson, Belknap, Webb & Tyler, LLP, Depuy Orthopaedics, Inc., attorneys for defendants.
Steinberg, Symer & Platt, LLP, Poughkeepsie, attorney for plaintiffs. Russell Tigges, MD and Orthopedic, Associates of Dutchess County, Poughkeepsie, Feldman, Kleidman & Coffey, LLP, St. Francis Hospital and Northern Dutchess Hospital, Fishkill, John D. Winter, Esq., Patterson, Belknap, Webb & Tyler, LLP, Depuy Orthopaedics, Inc., attorneys for defendants.
James D. Pagones, J.
Defendant Depuy Orthopaedics, Inc. moves for an order pursuant to CPLR R3211 dismissing the plaintiffs' complaint against it in its entirety. The plaintiffs oppose the instant application.
The plaintiffs seek damages for injuries allegedly sustained during plaintiff Philomena Mayen's knee replacement surgery. The knee replacement unit was manufactured by defendant Depuy. As it relates to defendant Depuy, the plaintiffs assert causes of action based on design and manufacturing defect, negligent design defect, failure to warn of negligent design, breach of Uniform Commercial Code warranties.
It is well settled that on any motion pursuant to CPLR Rule 3211, the court “must take the allegations (of the complaint) as true and resolve all inferences which reasonably flow therefrom in favor of the pleader.” (Cron v. Hargro Fabrics, Inc., 91 N.Y.2d 362, 366 [1998].) To dismiss a cause of action pursuant to CPLR Rule 3211(a)(7) on the ground that the plaintiffs have failed to state a cause of action, the court must liberally construe the complaint and accept all facts as alleged therein to be true, accord the plaintiffs the benefit of every favorable inference, and determine only whether the facts as alleged fit within any cognizable legal theory. (Fishberger v. Voss, 51 A.D.3d 627, 858 N.Y.S.2d 257 [2nd Dept.2008]. Applying these principles, this court finds that the complaint fails to state a cause of action against defendant Depuy in that each alleged cause of action is preempted by federal law.
Plaintiff Philomena Mayen's knee was replaced with defendant DePuy's rotating platform P.F.C. Sigma Knee (“RP Knee”). The RP Knee is a Class III medical device approved by the FDA, whose authority to regulate medical devices is set forth in the Federal Drug Cosmetics Act as amended by the Medical Device Act of 1976, pursuant to the Pre–Market Approval Process. Defendant Depuy contends that pursuant to the Supreme Court decision Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), the plaintiffs' action is not viable because it is preempted as a matter of law by the FDA's approval.
New York courts, in applying Riegel, have held that “causes of action alleging strict liability based on failure to warn of defective design, negligence, negligence per se, and breach of implied warranty are preempted by the Federal Drug Cosmetics Act” and are therefore properly dismissed based upon federal preemption. (Mitaro v. Medtronic, Inc., 73 A.D.3d 1142, 900 N.Y.S.2d 899 [2nd Dept.2010].) Here, defendant Depuy has established entitlement to dismissal of the plaintiffs' action based upon federal preemption because the RP Knee was approved by and continues to be monitored and regulated by the FDA through the Pre–Market Approval Process. The claims alleged by the plaintiffs under state law impose requirements with respect to the medical device at issue that are “different from, or in addition to [the federal] requirements” and relate to either the “safety or effectiveness” of the medical device under the Medical Device Act of 1976. ( Id. at 1143, 900 N.Y.S.2d 899, citing 21 USC § 360[k][a][1], [2].)
The cases relied on by the plaintiffs in opposition to the defendant's application are inapposite to the instant proceeding or no longer good law. As defendant Depuy amply details, IMS Health v. Sorrell, 631 F.Supp.2d 434 [D. Vt.2009], was reversed by the Second Circuit. Fosamaz Products Liability Litigation, 742 F.Supp.2d 460 [S.D.NY 2010], dealt with prescription drugs, which carry a different preemption analysis than Pre–Market Approval medical devices. Notmeyer v. Stryker, 502 F.Supp.2d 1051 [N.D. Cal.2007], was decided prior to Riegel, and to the extent it is inconsistent with Riegel, has been overruled. Huber v. Howmedica Osteonics, 2008 U.S. Dist. LEXIS 106479 at *1 [D.N.J. Dec. 31, 2008], dealt with a specific provision in an express warranty claim. Here, the plaintiffs have failed to allege the terms of any express warranty or their alleged reliance on the same. Moreover, New York courts have routinely dismissed express warranty claims regarding Pre–Market Approval medical devices. [ See, e.g., Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751 [NY Sup.Ct.2008].)
Moreover, while the plaintiffs contend that the motion must be denied because they are in need of discovery of facts exclusively within the knowledge of the defendant, they have failed entirely to indicate what the facts may be or what discovery may be required and how it could relate to the issue of federal preemption. Additionally, the plaintiffs' request for leave to amend their pleading is unavailing. They have neither suggested what such an amendment would consist of nor have they demonstrated how the proposed amendment would reconcile with the issue of federal preemption.
Therefore, it is ordered that the defendant's motion is granted and the plaintiffs' complaint against defendant Depuy Orthopaedics, Inc. is dismissed in its entirety, with prejudice.
The Court read and considered the following documents upon this application:
+----------------------------------------+ ¦PAGES NUMBERED ¦ +----------------------------------------¦ ¦1.Notice of Motion ¦1–2 ¦ +-----------------------------------+----¦ ¦¦Affirmation–Winter ¦1–2 ¦ ++----------------------------------+----¦ ¦¦Exhibits ¦A–D ¦ ++----------------------------------+----¦ ¦¦Affidavit–Kimberly A. Dwyer ¦1–13¦ ++----------------------------------+----¦ ¦¦Exhibits ¦1–10¦ ++----------------------------------+----¦ ¦¦Memorandum of Law ¦1–24¦ +-----------------------------------+----¦ ¦2.Affirmation in Opposition–Gabiger¦1–2 ¦ +-----------------------------------+----¦ ¦¦Memorandum of Law ¦1–13¦ +-----------------------------------+----¦ ¦3.Reply Memorandum of Law ¦1–12¦ +----------------------------------------+
The foregoing constitutes the decision and order of the Court.