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. 24)
Presently before this Court is the Motion to Dismiss filed by defendant Invasix. This is an action sounding in medical negligence, strict liability, and misrepresentation based upon a "BodyTite Procedure" that plaintiff underwent and was performed by co-defendant Dr. Dennis Hurwitz.*fn1 Invasix is the manufacturer of the medical device used in the "BodyTite Procedure" (hereinafter the "Invasix device"). In Count VI*fn2 of the Complaint, plaintiff alleges that Invasix was negligent in distributing the Invasix device. In Count VII of the Complaint, plaintiff alleges that Invasix is strictly liable. In Count VII [sic] (hereinafter Count VIII), plaintiff alleges that Invasix breached a warranty. In Count IX, plaintiff alleges that Invasix is liable for misrepresentation. After careful consideration of defendants' Motion to Dismiss (doc. no. 24) and Brief in Support (doc. no. 25), as well as plaintiff's Brief in Opposition (doc. no. 33), defendant's Motion to Dismiss will be GRANTED in PART and DENIED in PART.
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 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 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"*fn3 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. ¶¶ 188-89.
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 allegendly 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 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 participation as a subject of the investigation of the "BodyTite Procedure." Id., ¶¶ 88-90.
On March 9, 2010, approximately six days after surgery, Schiff complained of increased pain, swelling, and fever during her first post-op visit to Dr. Hurwitz's office. Id., ¶ 91. Over the course of several subsequent days, Schiff had increased pain on all areas of her body in which the procedure was performed and began taking medication prescribed by Dr. Hurwitz. Id., ¶ 93.
By Mid-April 2010, Schiff's pain was allegedly uncontrollable even with prescribed medication. Id., ¶ 94. The procedures performed by Dr. Hurwitz left Schiff with irregular scars and scar tissue, and in August of 2010, she was diagnosed with having developed a thermal mediated demyelination of the sensory and autonomic nerves in the thighs leading to a diffuse post RFAL dysesthesia of the thighs and lymphatic system compromise. Id., ¶¶ 95, 97. Schiff avers that her injuries were the direct and proximate result of negligence of each defendant. Id., ¶ 98.
A plaintiff is required to effectuate service upon all defendants. Fed.R.Civ.P. 4. If the defendant files a Motion to Dismiss Pursuant to Fed.R.Civ.P. 12(b)(5) for failure to effectuate service, "[T]he party making the service has the burden of demonstrating its validity when an objection to service is made." Reed v. Weeks Marine, Inc., 166 F.Supp.2d 1052, 1054 (E.D. Pa. 2001) (citing Grand Entertainment Group, Ltd. v. Star Media Sales, Inc., 988 F.2d 476, 488-89 (3d Cir.1993)).
In considering a Motion to Dismiss brought pursuant to Fed.R.Civ.P. 12(b)(6), federal courts require notice pleading, as opposed to the heightened standard of fact pleading. Federal Rule of Civil Procedure 8(a)(2) requires only "'a short and plain statement of the claim showing that the pleader is entitled to relief,' in order to 'give the defendant fair notice of what the . . . claim is and the grounds on which it rests.'" ...