Products Liability Law Daily Products liability suit against VenaTech™ manufacturer misses mark
Tuesday, November 5, 2019

Products liability suit against VenaTech™ manufacturer misses mark

By Leah S. Poniatowski, J.D.

Chronic pain without other injury supported dismissal of claims, but patient has second chance to amend complaint.

A patient with a long-term blood clot filter implant failed to establish a valid cause of action for design defect, manufacturing defect, or warnings defect under the New Jersey Products Liability Act (NJPLA) because she failed to meet the pleading standards, the federal district court in New Jersey ruled. The court also determined that the NJPLA subsumed several other claims based on common law because they arose from alleged harm caused by use of the product. Although the subsumed claims were dismissed with prejudice, the court granted leave to amend the NJPLA claims (Hindermyer v. B. Braun Medical Inc., October 30, 2019, Wolfson, F.).

Background. The patient suffered from recurrent pulmonary embolisms (PEs), a condition with a high risk of serious injury or death. In 2007, she underwent a procedure in which an inferior vena cava (IVC) filter was implanted. IVC filters trap and filter lower-extremity blood clots to prevent a clot from reaching the lungs and causing a thrombotic event. She had a VenaTech™ filter implanted, specifically at the L3-L4 level in her groin. Approximately eight years later, she was hospitalized for "chronic right side pain" at the filter site, and a medical scan showed that the filter was present where it had originally been implanted. Neither the patient nor her doctors have considered removing the device.

B. Braun Medical Inc. and B. Braun Interventional Systems received clearance to market the device from the Food and Drug Administration (FDA) in 2001, but by 2007 there was a Class II Device Recall for faulty packaging, sterility, and safety concerns. The agency lifted the ban in March 2008 and published an adverse event report regarding the device. The FDA issued additional alerts in 2010 and 2014 concerning IVC filters, urging removal of those devices.

The patient filed a multi-count lawsuit against the manufacturer, concerned that her chronic pain may indicate "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." Because the manufacturers marketed the device as being "safe and effective," the patient alleged that they concealed known risks of the device and failed to warn thereof. She based her complaint on both the NJPLA and common law.

Subsumption. The federal district court held that the NJPLA subsumed the patient’s common-law negligence, breach of implied warranties, and fraud-based claims. Case law clearly establishes that the state statute encompasses products liability-based claims, i.e., claims alleging a harm caused by a defective product. In the case at bar, the patient’s alleged personal injuries arose from the allegedly defective design and manufacture of the IVC filter. The patient argued that her common-law implied warranty claims could coexist with her NJPLA claims, but her reasoning was based on distinguishable case law.

The court explained that the harm at the core of the patient’s implied warranties claim arose from her personal injuries vis-a-vis the device and, thus, fell cleanly within the statute’s "harm" definition. Moreover, the court held that the patient’s fraud-based claims could not co-exist with the NJPLA claims for the same reason; i.e., they were based on the harm the statutory protection envelops. Further, her separate negligence claim also fell within the statute because it was solely based on the allegedly defective manufacture, design, and sale of the IVC filter. Consequently, all of these claims were dismissed as having been subsumed by the NJPLA.

NJPLA claims. With respect to her NJPLA claims, the patient alleged all three available causes of action under the statute: design defect, manufacturing defect, and warnings defect (failure to warn). The Act requires an injured party to establish that a product was not reasonably fit, suitable, or safe for its intended purpose by showing that: (1) the product was defective; (2) the defect existed when the product left the hands of the manufacturer; (3) the defect proximately caused injuries to the plaintiff; and (4) the injured plaintiff was a foreseeable user. Additionally, each theory of liability under the NJPLA has its own pleading requirements. The court determined that the patient in the present case did not meet those standards.

Design defect. The patient’s design defect claim failed because she did not sufficiently address the availability of a technologically feasible and practical alternative design that would have reduced the harm to her without substantially impairing the intended function of the product. She alleged that the filter’s inability to sustain "the normal anatomical and physiological loading cycles exerted in vivo" caused her pain and, thus, the device failed to be suitable for its intended purpose. However, her contention that the manufacturer’s development of a new IVC filter product met the pleading standard of proffering an alternative design did not meet the statutory requirement because she did not allege that the later-marketed product was available at the time the device at issue had been. The court also remarked that the later-marketed product was not comparable because it was removable, in contrast to her long-term device.

Manufacturing defect. The court found the patient’s manufacturing defect claim to be too conclusory and inconsistent with her theory of the case to survive. The core of her allegations was that the IVC filter failed to perform its intended purpose of being permanently implanted, but she could not establish that the device failed to conform to the manufacturer’s standards. Her complaint only made conclusory assertions that there was a manufacturing defect and malfunction when the device was implanted, which was not enough to survive the manufacturer’s motion to dismiss.

Failure to warn. The patient lacked standing vis-a-vis her failure to warn claim because she did not proffer facts or allegations that she was injured or faced an imminent harm as a result of the manufacturer’s alleged failure to warn. The court observed that the device remained at the site where it had been implanted, and that no medical provider had recommended that the device be removed or otherwise altered. Thus, it could not be inferred that she was harmed by a warning defect.

Breach of express warranty. The court clarified that the patient’s breach of express warranty claim was not encompassed by the NJPLA but, rather, arose under the state’s uniform commercial code. Pursuant to NJ UCC, N.J.S.A. §12A:2-313, express warranties arise when a seller’s affirmation of fact or promise relating to the good "becomes part of the basis of the bargain," and a description of the goods comprising this basis "creates an express warranty that the goods shall conform to the description." The patient conveyed the statements about the filter’s features and performance provided on the manufacturer’s website. However, the court noted, the patient did not sufficiently allege how the device failed to conform to those affirmations. Therefore, her breach of express warranty claim failed as well.

Punitive damages. Because the patient was unable to support her NJPLA claims or otherwise establish a cognizable claim for compensatory damages, her request for punitive damages also was dismissed.

Leave to amend. The court dismissed the common-law claims as being subsumed by NJPLA with prejudice, but the remaining claims were dismissed without prejudice and with leave to amend.

The case is No. 3:19-cv-06585-FLW-ZNQ.

Attorneys: Alexandra Colella (Marc J. Bern & Partners, LLP) for Darlene Hindermyer; Aaron Van Nostrand (Greenberg Traurig LLP) for B. Braun Medical, Inc. and B. Braun Interventional Systems, Inc.

Companies: B. Braun Medical, Inc.; B. Braun Interventional Systems, Inc.

MainStory: TopStory DesignManufacturingNews WarningsNews MedicalDevicesNews NewJerseyNews

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