Vitolo v. Mentor H/S, Inc.

426 F. Supp. 2d 28, 2006 U.S. Dist. LEXIS 18528, 2006 WL 897979
CourtDistrict Court, E.D. New York
DecidedMarch 31, 2006
Docket98 CV 2837 (SLT)(VVP)
StatusPublished
Cited by24 cases

This text of 426 F. Supp. 2d 28 (Vitolo v. Mentor H/S, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Vitolo v. Mentor H/S, Inc., 426 F. Supp. 2d 28, 2006 U.S. Dist. LEXIS 18528, 2006 WL 897979 (E.D.N.Y. 2006).

Opinion

MEMORANDUM AND ORDER

TOWNES, United States District Judge.

In this diversity action, Plaintiff seeks damages for losses sustained in removing *31 and replacing certain saline breast implants from patients who suffered complications therewith. Plaintiff alleges that he was fraudulently induced to enter an agreement with the manufacturer, Defendant Mentor H/S, Inc., and was intentionally misled as to the safety of the implants, causing him monetary damages as well as damages to his professional reputation. Though the Complaint alleges causes of action sounding in negligence and breach of contract, those claims were dismissed pursuant to stipulations on June 4, 2002, and March 8, 2006, respectively. Defendant seeks summary judgment dismissing the remaining claims of fraud, fraudulent inducement to enter a contract, and a violation of New York’s General Business Law § 349. Based upon all submissions of the parties and oral argument held on March 17, 2006, and for the reasons stated below, Defendant’s motion is granted in full.

FACTS AND PROCEDURAL HISTORY

Plaintiff Robert V. Vitolo, M.D. (“Plaintiff’ or “Vitolo”) is a plastic surgeon with several offices in the New York City metropolitan area. (Def. 56.1 Stat. ¶ 1.) Defendant Mentor H/S, Inc., (“Defendant” or “Mentor”) is a subsidiary of Mentor Corporation, and manufactures, inter alia, saline-filled breast implants. (Def. 56.1 Stat. ¶ 2.) From approximately the early 1980s until August 1995, Defendant sold saline-filled implants known as the “1800 Series Smooth Round Marry Implant with Leaf Valve” (hereinafter “MLV”). (Def. 56.1 Stat. ¶ 3.) Though Plaintiff originally obtained his implants from McGhan Medical Corp. (“McGhan”), by late 1994, Plaintiffs business became extremely successful and his demand for implants began to exceed McGhan’s ability to supply them. In response to Plaintiffs inquiry, Michael Lawrence, a Mentor sales representative, came to New York to discuss Mentor’s implants with Vitolo. (Def. 56.1 Stat. ¶¶ 13-14.)

During their meeting, Plaintiff specifically requested the MLV implant. (Def. 56.1 Stat. ¶ 15.) At the time, Plaintiff had begun performing breast augmentation surgery using the umbilicus technique, in which, to reduce scarring, the implant would be inserted through the patient’s navel, Def. 56.1 Stat. ¶¶ 10-12, as opposed to prior techniques that involved insertion in the armpit or along the breast. (Def. 56.1 Stat. ¶ 6.) Defendant claims that Plaintiff was cautioned against use of the umbilicus technique with the MLV. (Def. 56.1 Stat. ¶¶ 8-11.) Defendant warned that the device “may be easily damaged by surgical instruments or ruptured by excessive stresses, manipulation with a blunt instrument or penetration by a needle.” (Def. 56.1 Stat. ¶ 9.) Though Defendant argues that, “[bjecause the umbilicus procedure involved the use of a surgical instrument to move the implant from the belly button to the breast, the use of this procedure was inconsistent with [its] recommendations,” Def. 56.1 Stat. ¶ 10, Plaintiff argues that all methods of implantation involve contact between the implant and surgical instruments, and that Defendant’s warning therefore did not serve as a warning specifically against the umbilicus technique. (PL 56.1 Stat. ¶ 10.) Furthermore, Plaintiff argues that Defendant knew of and condoned the umbilicus procedure and recruited him knowing that it was his procedure of choice. (Pl. Mem. of Law Ex 36 (Vitolo Aff.) ¶ 7.)

The parties entered into an agreement whereby Defendant supplied Plaintiff with MLV implants. After Vitolo’s patients experienced a total of 19 deflations within four months, Defendant exchanged the MLV implants for the Mentor 1600 Series Diaphragm Valve implants and began investigating the “unusually high” number of *32 deflations that Plaintiffs patients suffered. (Def. 56.1 Stat. ¶¶ 19-21.) Pat Altavilla, Mentor’s Executive Vipe President of Marketing (“Altavilla”) hypothesized that the umbilicus procedure was related to the number of deflations. (Def. 56.1 Stat. ¶ 24.) Plaintiff disputes this allegation, pointing out Defendant’s failure to perform any scientific studies or analyses in support of this hypothesis. (PI. 56.1 Stat. ¶ 24.)

Thereafter, in mid-1995, Altavilla traveled to New York to observe Plaintiff performing the umbilicus procedure. (Def. 56.1Stat. ¶ 26.) The night before the surgery, Plaintiff and Altavilla went to dinner at a restaurant. Unbeknownst to Altavilla, Plaintiff was tape recording their conversation. (Def. 56.1 Stat. ¶ 26.) During the dinner conversation, Plaintiff was adamant that the umbilicus procedure was not responsible for the high number of defla-tions. (Ex 7 to Def. 56.1 Stat. at 39-43.) Altavilla encouraged Plaintiff to go to Dallas, Texas, to reproduce the surgery for the benefit of Defendant’s engineers, who would presumably study and determine the cause of the deflations. (Id. at 44-46.) Plaintiff never went, explaining that “that’s what [Altavilla] offered but it never came to pass. It’s just like me inviting you to dinner to be polite but you never get taken out to dinner.” (PI. 56.1 Stat. ¶ 33.)

The MLV came with a product replacement policy, providing that Defendant would provide a free replacement device and up to $1,000 in reimbursement for hospital and anesthesia fees. (Def. 56.1 Stat. ¶ 16.) Plaintiff argues that the offer for reimbursement was illusory, as it was conditioned upon patients signing a general release absolving Mentor for any tort liability, which patients were predictably reluctant to do. (PL 56.1 Stat. ¶ 16.) Nevertheless, after Plaintiff read a magazine article denouncing the umbilicus technique, he asked Altavilla to prepare a letter informing patients that Defendant would continue to honor its product replacement policy for patients who elected implantation using the umbilicus technique. (Def. 56.1 Stat. ¶¶ 34-5.) By this time, Plaintiff no longer used the MLV implant in new surgeries, though prior patients continued to complain of deflations thereof. (Def. 56.1 Stat. ¶¶ 36-7.)

Defendant conducted an investigation of the MLV implants, and discovered, inter alia, that an increased rate of deflation occurred when the implants were “auto-claved” (steam sterilized prior to implantation). Defendant issued a “Dear Doctor” letter on September 1, 1995, in which physicians were advised of the dangers of autoclaving, as well as Defendant’s finding that deflation could also occur when the MLV was implanted with the umbilicus procedure. (Def. 56.1 Stat. ¶¶ 46-47.) Plaintiff argues that the “Dear Doctor” letter is misleading, in that autoclaving a sterile implant prior to implantation is a rare event. (Pl. 56.1 Stat. ¶ 46.) Plaintiff alleges that Defendant knew the implants were defective but feared a public relations nightmare. (Pl. Mem. of Law Ex. 20.) As a result, Plaintiff argues, Defendant sent a copy of the “Dear Doctor” letter to the Food and Drug Administration (“FDA”), prompting a Class II recall (which does not require manufacturers to physically recall the product). (Def. 56.1 Stat. ¶ 48.) Despite the fact that this was not the type of recall that required Defendant to take the product off of the market altogether, Defendant nevertheless discontinued the MLV and destroyed its entire inventory. (Def. 56.1 Stat. ¶ 50.)

Plaintiff alleges that Defendant misrepresented the failure rate, inducing him to purchase the MLV implants.

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Cite This Page — Counsel Stack

Bluebook (online)
426 F. Supp. 2d 28, 2006 U.S. Dist. LEXIS 18528, 2006 WL 897979, Counsel Stack Legal Research, https://law.counselstack.com/opinion/vitolo-v-mentor-hs-inc-nyed-2006.