The opinion of the court was delivered by: Arthur J. Schwab United States District Judge
Memorandum Opinion re: Defendant's Motion To Dismiss (Doc. No. 29)
Presently before this Court is the Motion to Dismiss filed by defendant Essex Institutional Review Board (hereinafter "Essex"). This is an action sounding in medical negligence based upon a "BodyTite Procedure" that plaintiff underwent and was performed by co-defendant Dr. Dennis Hurwitz.*fn1 Co-defendant Invasix is the manufacturer of the medical device used in the "BodyTite Procedure" (hereinafter the "Invasix device"). After careful consideration of defendants' Motion to Dismiss (doc. no. 29) and Brief in Support (doc. no. 30), as well as plaintiff's Brief in Opposition (doc. no. 54), defendant's Motion to Dismiss (doc. no. 29) will be DENIED.
Under Rule 12(b)(6) of the Federal Rules of Civil Procedure, at this stage the Court accepts all of the factual allegations in the Complaint as true and all reasonable inferences are drawn in plaintiff's favor. See Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009).
Taking plaintiff's factual allegations as true solely for the purposes of this Memorandum Opinion, the facts of this case are as follows:
Invasix allegedly failed to properly label the Invasix device and failed to get proper approval as required by the Code of Federal Regulations (CFR). See generally doc. no. 1, ¶ 155. Invasix was allegedly aware that the device was unsafe but failed to notify plaintiff of this fact. Id.
On April 23, 2009, during an initial consultation with Schiff, Dr. Hurwitz planned surgery in two stages-stage one would include a "tummy tuck" and stage two would include a lower body lift. Id., ¶ 72. On December 1, 2009, Schiff spoke with Dr. Hurwitz about dividing the operations into smaller procedures; however, Dr. Hurwitz allegedly never discussed nor documented the potential risk of the device used to perform these procedures, the Radio-Frequency Assisted Lipolysis ("RFAL"). Id., ¶ 74.
On March 2, 2010, Schiff was given pre-operative markings, and according to Dr. Hurwitz's chart, RFAL was discussed with Schiff but not the specific risks of the procedure. Id.,
¶ 76. On March 3, 2010, Dr. Hurwitz performed a "BodyTite Procedure"*fn2 on Schiff using the Invasix Device. Id., ¶¶ 78-79. Prior to the surgery, plaintiff signed a form in which Invasix agreed to pay her a sum of $175 and any treatment of injury arising out of the Invasix device. Id.
During the procedure, Dr. Hurwitz was serving as an investigator for the Invasix Device in a clinical trial sponsored by Invasix and approved by Essex Institutional Research Board. Id.,
¶ 80. Schiff was allegedly unaware that Dr. Hurwitz was a paid investigator for the Invasix Device, that the Invasix Device was being used in a clinical trial sponsored by Invasix, and that the Food and Drug Administration ("FDA") neither was aware of nor approved of the clinical trial of the Invasix Device. Id., ¶¶ 86-87.
Prior to the "BodyTite Procedure" on March 3, 2010, Dr. Hurwitz allegedly failed to disclose to Schiff that: (1) she was not a candidate for the procedure due to the clinical study's protocol; (2) the clinical study's protocols limited the Invasix Device from being used on more than three areas of the body; and (3) Schiff could be paid for her ...