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Jennifer L. Marshall v. I-Flow

August 7, 2012

JENNIFER L. MARSHALL, PLAINTIFF,
v.
I-FLOW, LLC F/K/A I-FLOW CORPORATION, DEFENDANT.



The opinion of the court was delivered by: Thomas J. McAVOY Senior United States District Judge

DECISION and ORDER

Plaintiff Jennifer Marshall commenced the instant action against Defendant I-Flow, LLC arising out of personal injuries she is alleged to have sustained as a result of using Defendant's pain pump to inject an anaesthetic into the joint space of her right shoulder. Presently before the Court is Defendant's motion for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c) seeking dismissal of Plaintiff's claims of fraud, strict product liability, strict tort liability, breach of implied warranty, and punitive damages.

I. FACTS

As of June 7, 2006, Plaintiff Jennifer Marshall was a 42 year old woman. Plaintiff consulted with Tamara A. Scerpella, M.D., an orthopedic surgeon, concerning a problem she was experiencing with her right shoulder. Scerpella recommended surgical intervention, to which Marshall consented.

On July 6, 2006, Plaintiff underwent a right shoulder arthroscopic surgery at Harrison Center Outpatient Surgery in Syracuse, New York. During the surgery, Dr. Scerpella noted that the "glenohumeral articular surfaces were entirely intact." Following surgery, Dr. Scerpella inserted an I-Flow ON-Q PainBuster, REF: PM012, LOT: 642472 ("ON-Q"), pain pump into Plaintiff's shoulder joint to continuously infuse local anesthetic into the joint space. The ON-Q continuously infused 100 ml of 0.5% Marcaine directly into Plaintiff's right shoulder joint for forty-eight hours or more following her surgery.

After a period of time, Plaintiff began to experience increased pain in her right shoulder. She was initially treated with physical therapy. As Plaintiff's pain worsened, x-rays were taken on January 26, 2009, which showed "arthritic changes involving the glenohumeral joint with some bony eburnation and joint space narrowing." Degenerative changes to the acromioclavicular joint also were noted.

Plaintiff went to Ilya Voloshin, M.D., an orthopedic surgeon for further evaluation and possible treatment. Voloshin recommended right shoulder arthroscopy, to which Plaintiff agreed. On August 1, 2011, Plaintiff underwent a right shoulder arthroscopic acromioplasty and extensive glenohumeral debridement at Strong Memorial Hospital in Rochester, New York. During the surgery, Dr. Voloshin observed "[g]rade 4 cartilage damage on the entire glenoid" and "[g]rade 2 to 3 chondral damage on the humeral head." After surgery, Dr. Voloshin informed Plaintiff that she would need a total right shoulder replacement. An MRI taken of Plaintiff's right shoulder on October 3, 2011 showed "severe glenohumeral joint osteoarthritis with complete loss of cartilage centrally and posteriorly with extensive subchondral cystic changes on both sides of the joint."

On November 7, 2011, Plaintiff was evaluated by orthopedic surgeon Mark V. Wilson, M.D. of Vestal, New York on November 7, 2011. Dr. Wilson diagnosed "severe glenohumeral osteoarthritis" of her right shoulder. Dr. Wilson referred Plaintiff to orthopedic surgeon Kevin J. Setter, M.D. of Syracuse. On January 3, 2012, Plaintiff presented to Dr. Setter for an evaluation and possible treatment. Dr. Setter recommended that Plaintiff undergo a total shoulder replacement should her symptoms continue.

Plaintiff contends that the continuous injection of anesthetic drugs over time directly into her shoulder joint after the July 6, 2006 surgery caused serious and permanent cartilage damage. It is alleged that, as a result of the continuous injection of the anesthetic, Plaintiff suffered a narrowing of the joint space and/or a condition called "glenohumeral chondrolysis," which is the complete, or nearly complete, loss of cartilage in the shoulder joint, an irreversible, disabling, and extremely painful condition.

Plaintiff claims that Defendant is liable to her because Defendant misled the medical community, the public at large, Plaintiff, and her treating physicians, by making false representations concerning the safety and proper use of its product. In support, Plaintiff claims that Defendant failed to conduct any testing concerning the safety of its product; did not review available literature concerning the safety of its product; sought, and failed to obtain, FDA clearance for an indication for use in intra-articular spaces; failed to advise that the safety of pain pumps in a joint space was unknown; and failed to warn of known and/or knowable risks associated with the use of its product. Plaintiff asserts claims of negligence, negligent misrepresentation, fraud, strict product liability (defective design and failure to warn), and breach of an implied warranty.

Presently before the Court is Defendant's motion for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c). Plaintiff opposes the motion.

II. STANDARD OF REVIEW

As the Second Circuit has explained: In deciding a Rule 12(c) motion, [courts] "employ[ ] the same . . . standard applicable to dismissals pursuant to [Rule] 12(b)(6). Thus, [the court] will accept all factual allegations in the [C]omplaint as true and draw all reasonable inferences in [Plaintiff's] favor." Johnson v. Rowley, 569 F.3d 40, 43 (2d Cir. 2009) (quotation marks and citation omitted).

In Ashcroft v. Iqbal, the Supreme Court set forth a "two-pronged approach" to evaluate the sufficiency of a complaint. 129 S.Ct. at 1949-50. "First, although a court must accept as true all of the allegations contained in a complaint, that tenet is inapplicable to legal conclusions, and threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Harris v. Mills, 572 F.3d 66, 72 (2d Cir. 2009) (quotation marks and alterations omitted). "Second, only a complaint that states a plausible claim for relief survives a motion to dismiss, and determining whether a complaint states a plausible claim for relief will ... be a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. (quotation marks and alteration omitted). "The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully." Iqbal, 129 S. Ct. at 1949 (quotation marks omitted). Plausibility thus depends on a host of considerations: the full factual ...


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