Hindermyer v. B. Braun Med. Inc.

• Decision Date: 30 October 2019
• Docket Number: Civil Action No. 19-06585 (FLW)
• Citation: 419 F.Supp.3d 809
• Parties: Darlene HINDERMYER, Plaintiff, v. B. BRAUN MEDICAL INC., et al., Defendants.
• Court: U.S. District Court — District of New Jersey

419 F.Supp.3d 809

Darlene HINDERMYER, Plaintiff,

v.B. BRAUN MEDICAL INC., et al., Defendants.

Civil Action No. 19-06585 (FLW)

United States District Court, D. New Jersey.

Signed October 30, 2019

Alexandra Colella, Gordon Drew Kessler, Marc J. Bern & Partners, LLP, New York, NY, for Plaintiff.

Aaron Van Nostrand, Greenberg Traurig LLP, Florham Park, NJ, for Defendant.

WOLFSON, United States District Judge:

This matter comes before the Court on Defendants B. Braun Medical Inc. and B. Braun Interventional System's (collectively, "Defendants") Motion to dismiss Plaintiff Darlene Hindermyer's ("Plaintiff") Complaint, pursuant to Federal Rule of Civil Procedure 12(b)(6). This suit arises from the alleged personal injuries that Plaintiff sustained as a result of a defective medical device that Defendants manufactured, designed, and sold. In the Complaint, Plaintiff asserts the following ten causes of action against Defendants: (1) negligence; (2-4) design, manufacturing, and warning defect claims pursuant to the New Jersey Products Liability Act, N.J.S.A. 2A:58C-1 et seq. ("NJPLA"); (5) breach of the express warranty; (6-7) breaches of the implied warranty of fitness and implied warranty of merchantability; (8) fraudulent misrepresentation; (9) fraudulent concealment; and (10) negligent misrepresentation.

For the reasons set forth below, Defendants' Motion is GRANTED , and Plaintiff's Complaint is dismissed in its entirety. Plaintiff's claims for negligence (Count I), fraudulent misrepresentation (Count VIII), fraudulent concealment (Count IX), negligent misrepresentation (Count X), breach of the implied warranty of merchantability (Count VI), and breach of the implied warranty of fitness (Count VII) are dismissed with prejudice, as those claims are subsumed by the NJPLA. Plaintiff's NJPLA claims, including defective design (Count II), manufacturing defect (Count III), and failure to warn (Count IV), as well as her breach of the express warranty claim (Count V), are dismissed without prejudice. Plaintiff is given leave to amend those claims in accordance with the dictates of this Opinion, within fourteen (14) days of the date of the accompanying Order.

I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

The following factual allegations are taken from Plaintiff's Complaint and are accepted as true for the purposes of this Motion. A pulmonary embolism

("PE") occurs when a blood clot "travels from the blood vessels in the legs and pelvis, through the inferior vena cava ("IVC"), which is "the vein that returns blood to the heart from the lower extremities," and into the lungs. Complaint ("Compl."), ¶ 18. Blood clots can also form in the deep leg veins, causing a dangerous condition known as deep vein thrombosis ("DVT") that, like PE, "can often result in death." Id.

An IVC filter is a medical device that traps and filters blood clots

that develop in the lower extremities to prevent them from reaching the lungs. These device are used to treat patients who are prone to high risks of PE and DVT, in order to reduce the likelihood of a thrombotic event. Id. at ¶¶ 20-21. Developed in 1967, IVC filters were originally designed for permanent implantation in a patient, but eventual concerns over long-term health complications prompted the creation of a retrievable filter. Id. at ¶¶ 23-24. Unlike their permanent counterparts, which remain in a patient indefinitely, retrievable filters are intended for removal after the risk of a thrombotic event subsides. Id.

In 2001, Defendants obtained U.S. Food and Drug Administration ("FDA") clearance to market the B. Braun VenaTech™ vena cava filter

(the "VenaTech Filter") under Section 501(k) of the Medical Device Amendment,¹ which obviated the requirement of having the FDA conduct an independent evaluation of the device. Id. at ¶¶ 29-31. As manufactured, the VenaTech Filter possesses a cone-like shape comprising cobalt-chromium-nickel alloy, and it is designed to prevent "recurrent pulmonary embolism via placement in the vena cava." Id. at ¶¶ 8, 25-27, 39-40. In addition, the VenaTech Filter is "self-centering, with patented stabilizing legs which [are] intended to prevent filter tilting during the implantation to eliminate the possibility of perforation or migration." Id.

In 2007, faulty packaging, sterility, and safety concerns promoted a Class II Device Recall of the VenaTech Filter, which the FDA lifted on March 2, 2008. Id. at ¶ 41. The FDA also published "MAUDE Adverse Event Reports," detailing instances where the VenaTech Filter caused adverse health complications in certain patients, who, for medical reasons, had to surgically remove the device. Id. at ¶¶ 42-47. In 2010 and, once again, in 2014, the FDA issued "alerts" about "the problematic nature of permanent and retrievable filters," urging "doctors to remove IVC filters," particularly those which were retrievable, within one to two months after the risk of a pulmonary embolism

subsides. Id. at ¶¶ 48-50. Notwithstanding these alerts, however, Plaintiff alleges that Defendants continued to manufacture and promote the VenaTech Filter for "long-term use." Id. at ¶ 51.

As to the specific factual allegations concerning Plaintiff, on June 20, 2007, Plaintiff underwent a surgical implant of the VenaTech Filter at the Robert Wood Johnson University Hospital as treatment for recurrent PEs. Id. at ¶¶ 58-61. Dr. Reza Shah, M.D. performed the procedure by inserting the filter in Plaintiff's right groin at the L3-L4 level, in accordance with Defendants' "specific instructions, guidelines, and directives." Id. at ¶¶ 62, 64. Approximately eight years after her surgical procedure, on December 7, 2015, Plaintiff alleges that she was hospitalized for "chronic right side pain" in the area where the IVC filter was inserted. Id. at ¶ 66. A medical scan confirmed that "an IVC filter was present at the L3-L4" level, at which the VenaTech Filter was originally implanted; importantly, Plaintiff has not "considered for revision or removal of the device," nor has she been provided with such a recommendation from her physicians. Id. at ¶¶ 65-66.

Although she has not experienced any of the following medical issues, Plaintiff alleges that her chronic pain "can be an indicator of further complications, including "migration, tilt, fracture or breakage of the filter, perforation of the vena cava or other soft tissue," and other unspecified "serious problems," because the medical device is unable to withstand "the normal anatomical and physiological cycles exerted in vivo." Id. at ¶¶ 67, 70-71, 77. Plaintiff alleges that Defendants promoted the VenaTech Filter as a "safe and effective" medical device, concealing "the known risks and fail[ing] to warn of known or scientifically knowable dangers and risks associated with" its product. Id. at ¶¶ 72-73, 78-80. Because of Defendants' "wrongful acts and omissions," Plaintiff alleges a higher "risk of suffering from serious health complications ... and future injuries." Id. at ¶¶ 81-82.

Based on these allegations, Plaintiff filed the instant Complaint in the New Jersey Superior Court, Law Division, Mercer County, seeking punitive damages and asserting various common law claims and violations under the NJPLA. On February 22, 2019, Defendants removed this action on the basis of diversity jurisdiction to this Court. Now, Defendants move for dismissal of Plaintiff's Complaint pursuant to Fed. R. Civ. P. 12(b)(6), arguing that the NJPLA subsumes her common law causes of action for negligence, breach of the implied warranties, and her fraud-based claims. As to Plaintiff's remaining claims, Defendants contend that Plaintiff has neither pled a cognizable theory of design, manufacturing, or warning defect under the NJPLA, nor has she alleged a breach of the express warranty. Plaintiff opposes the motion.

II. DISCUSSION

A. Standard of Review

In reviewing a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), the court must, as an initial matter, separate the factual and legal elements of the claims, accepting the well-pleaded facts as true and drawing all reasonable inferences in the plaintiff's favor. See In re Ins. Brokerage Antitrust Litig. , 618 F.3d 300, 314 (3d Cir. 2010) ; see also Fowler v. UPMC Shadyside , 578 F.3d 203, 210-11 (3d Cir. 2009). To survive a motion to dismiss, the plaintiff must provide "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). "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." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).

The Third Circuit requires a three-step analysis to meet the plausibility standard mandated by Twombly and Iqbal . First, the court should "outline the elements a plaintiff must plead to a state a claim for relief." Bistrian v. Levi , 696 F.3d 352, 365 (3d Cir. 2012). Next, the court should "peel away those allegations that are no more than conclusions and thus not entitled to the assumption of truth." Id. ; see also Iqbal , 556 U.S. at 678-79, 129 S.Ct. 1937 ("While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations."). Indeed, it is well-established that a proper complaint "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (internal quotations and citations omitted). Third, the court should assume the veracity of all well-pled factual allegations, and then "determine whether they plausibly give rise to an entitlement to relief." Bistrian , 696 F.3d at 365 (quoting Iqbal , 556 U.S. at 679, 129 S.Ct. 1937 ). A claim is facially plausible when there is sufficient factual content to support a "reasonable inference that the defendant is liable for the misconduct alleged." Iqbal , 556...