Delango v New York-Presbyterian Healthcare Sys.

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Delango v New York-Presbyterian Healthcare Sys. 2012 NY Slip Op 30424(U) February 24, 2012 Supreme Court, New York County Docket Number: 106815/10 Judge: Joan B. Lobis Republished from New York State Unified Court System's E-Courts Service. Search E-Courts (http://www.nycourts.gov/ecourts) for any additional information on this case. This opinion is uncorrected and not selected for official publication. SCANNED ON 212712012 [* 1] SUPREME COURT OF THE STATE OF NEW YORK - NEW YORK COUNTY / um PRESENT: PART 6 MOTION OATE -vMOTION UEQ. NO. PAPER8 NUMB= Notloe of Motfonl Order to Show Cause Anrwering Affldsvtta - Affldavhg - Exhlbltr ... - Exhlblts 1 01 4 1 0 --/z 133I+ Replylng Afffdavlts a/al///z- Dated: Check one: FINAL DISPOSITION Check if appropriate: DO NOT POST SUBMIT ORDER/ JUDG. REFERENCE SETTLE ORDER/ JUDG. [* 2] SUPREME COURT OF THE STATE OF NEW YORK NEW YORK COUNTY: IAS PART 6 --____-___--__*_-_______Yu__ X I - JOAN DELANO0 and DENIS DELANGO as Adminisbatom of The Estate of DANLELLE M. DELANGO, deceased; and ANDREW DENIS DELANGO, an infant under the age of 14 years, by his Ouardians, Denis Delango and Joan Delango, Plaintiffs, Index No. I06815/10 -against- NEW YORK-PRESBYTERIANHEALTHCARE SYSTEM, LAWRENCE HOSPITAL, CENTER,DANIEL GEOFFREY DAVIS, D.O., ALLEROAN, INC., INAMED HEALTH (a wholly owned subsidiary of Allergan, Inc.), BIOENTERICS CORPORATION and JOHN DOES 1-5, . . . . -. . . ... . JOAN B. LOBIS, J.S.C.: Motion Sequence Numbers 003 and 004 are consolidated for disposition. In Motion Sequence Number 003, defendants Allergan, Inc. ( Allergan ), Inamed Hat ( lnamed ), and elh BioEnterics Corporation ( BioEnterics ) (collectively the Moving Defendants ) seek summary judgment and dismissal of the causes of action against them based on federal preemption. In Motion Sequence Number 004, plaintiffs Joan and Denis Delango, as co-administrators of Danielle M. Delango s estate and as guardians of her son, Andrew D n s Delango, seek leave to amend their ei complaint to assert a viable state claim against the Moving Defendants. - ~ ~ I The court notes that neither the Moving Defendants nor plaintiffs annexed copies of the original pleadings to their papers. All references to the original pleadings in this decision and order refer to the summons and attorney-verified complaint dated May 24,20 10, and the a s e on behalf nwr of Allergan dated July 9, 2010, as contained in the Supreme Court Records On-Line Library ( SCROLL ),available a http://iapps.courts.state.ny.us/iscroll(enter index number 1068 15/2010 and follow hyperlinks to Summons and Complaint and Answer ). [* 3] In this lawsuit, the allegations ofmedical malpractice, products liability,and wrongful death stem from decedent Danielle M. Dtlango s laparoscopic gastric band surgery on Janu8.1~ 15, 2008, during which a LAP-BANDAdjustable Gastric Banding System ( Lap Band ) was surgically implanted i Ms.Delango s abdomen. Ms.Delango subsequently died on M r h 3,2008. The n ac autopsy report indicated that the cause of death was cardiac arrest with fever of unknown etiology. The Lap Band is a Class I11 medical device currently manufacturcd and sold by Allergan. In 2001, BioEnterics, then a subsidiary of Inamed, obtained premarket approval ( PMA ) the Lap Band of f o the Food and D u Administration ( FDA ). Allergan is the succcssor-in-interest of rm rg BioEnterics and Inamed, having acquired these entities in 2006. Plaintiffs complaint contains seven causes of action alleged against the Moving Defendants: negligence; strict products liability; strict products liability for defective design; breach of implied warranty; breach of express warranty; loss of consortium; and wrongfirl death. The Moving Defendants seek dismissal of these causes of action on the grounds that the state tort claims art preempted under the express preemption provision of the Medical Device Amendments ( MDA ) (21 U.S.C.6 360k) to the Federal Food, D u & Cosmetic Act ( FFDCA ) (21 U.S.C.8 rg 301 a&, W v . 552 U.S. 3 12 (2008). In opposition, plaintiffs ask the court to deny summary judgment and permit further discovery. Plaintiffs assert that state tort claims against manufacturers of Class I11 medical devices are permitted where it is alleged that the manufacturer failed to adhere to the specificationsimposed by the device s PMA. However, plaintiffs essentially concede that their claims against the Moving -2- [* 4] Defendants as set forth in the initial complaint are preempted by federal law. Thus, plaintiffs move separately to amend their complaint. The proposed amended complaint contains none of the tort claims originally asserted against the Moving Defendants, but adds a claim sounding in negligence, by which plaintiffs allege that thc Lap Band was defective and w s manufactured in violation of the a FFDCA;Section 360k(a) of the MDA;and the PMA.Plaintiffs M e r allege that the Lap Band w s a adulterated in violation of 21 U.S.C. 0 351, in that it failed to mcct established performance standardsand that the methods of manufacturing violated federal requirements. Plaintiffs also allege that the first application for PMA of the Lap Band was rejected by the FDA,and that the model of Lap Band implanted in Ms.Delango was part of a C a s 2 recall initiated on September 16,2010. ls Based on the aforementioned claims, plaintiffs allege that the Moving Defendants breached their duty to use reasonable care, thereby causing Ms. Delango s injury and death. Plaintiffs annex an afidavit from William A. Hyman, Sc.D., an engineer, who asserts that without further discovery of documents only within the Moving Defendants possession, it is impossible for him to determine whether the device was changed without FDA approval. Mr. Hyman maintains that he is prepared to review these materials once they are available and offer his opinion on the case. In opposition to plaintiffs motion to amend the complaint, the Moving Defendants argua that plaintiffs new cause of action is so broad and boilerplate that it could not withstand a motion to dismiss. They contend that plaintiffs fail to assert a true parallel state claim because they have not shown a malfunction of the device and a causal connection between the regulatory non- compliance and the alleged injury. They argue that plaintiffs allegations that the FDA initially rejected the Lap Band for P M A and that there has been a C a s 2 recall of model of the Lap Band ls -3- [* 5] implanted in the decedent are irrelevant and fail to establish either a device malfunction or causation. Additionally, they assert that permitting plaintiffs to add this claim and requiring them to defend it is unduly prejudicial and unfair to them on a case that has been pending for seventeen months. Under C.P.L.R. 3025,leave to amend a pleading shall be freely given upon Rule such terms as m a y be just. .. . InNew York, it is well established that, absent prejudice or surprise resulting f o the delay, leave to amend should be granted. Fahey v, c o w of 0 rm - 44N.Y.2d 934,935 (1978); P.tlosla v. City of New Y a k 85 A.D.3d 694,694 (1st Dep t 2011). The party seeking to amend must show that the proffered amendment is not palpably insufficient or clearly . Inc. 74 A.D.3d 499,500 (1st Dep t 2010) devoid of merit. (citation omitted). Absent palpable insufficiency or a patent lack of merit, [tlhc sufficiency or underlying merit of the proposed amendment is to be examined no further. W o n a d o v Newgut Garde.. A.D.3d-,2012N.Y. SlipOp. 341 (2dDep t 2012). *&QMBLAI~S, Corn, 74 A.D.3d at 500 (in seeking leave to amend a pleading, plaintiff need not establish the merit of its proposed new allegations ), &in.g M i d o v m 49 A.D.3d 220,227 (2d Dep t 2008). The amended pleading meets the basic pleading requirements set forth above. Additionally, the Moving Defendants have failed to articulate that the proposed amended complaint prejudices them to any cxtcnt beyond their complaint that this case is seventeen months old. At this stage of the litigation and under the circumstances of this case, plaintiffs proposed amended complaint is sufficient to permit the proposed amendment and permit further discovery. Accordingly, it is hereby [* 6] ORDERED that the Moving Defendants motion (Sequence 003) for summary judgment is partially granted to the extent that they arc granted summary judgment on the third, fourth, fifth, sixth, and seventh causes of action in the initial complaint dated May 24,2010, and those causes of action are dismissed; and it is further ORDERED that the remainder of the Moving Defendants motion (Sequence 003) is denied; and it is further ORDERED that plaintiffs motion (Sequence 004) for leave to amend the complaint is granted, and the amended complaint in the proposed form annexed to the moving papers shall be deemed served upon service of a copy of this order with notice of entry thereof; and it is further ORDERED that defendants shall serve answers to the amended complaint or othewisc respond thereto within twenty (20) days from the date of said service; and it is further ORDERED that counsel are directed to appear for a previously scheduled status conference on May 22,20 12, at 1O:OO a.m. Dated: FA. 2y FILED ,2012 ENTER: -5-

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