Products Liability Law Daily Product liability claims against maker of vena cava filter move forward
Monday, March 30, 2020

Product liability claims against maker of vena cava filter move forward

By Joshua Frumkin, J.D.

Patient’s design defect, manufacturing defect, and failure to warn claims were adequately pleaded under the Ohio Product Liability Act.

In an action brought by a patient who alleged that she sustained injuries as a result of an implantable filter, a federal district court in Ohio partially granted and partially denied the manufacturer’s motion to dismiss. The court ruled that the patient adequately pleaded most of her claims by alleging specific facts, including that the manufacturer intentionally misrepresented the "permanent" nature of the filter. However, the patient’scommon law breach of implied warranty claims were dismissed as duplicative of her design and manufacturing defect claims (Gordon v. B. Braun Medical Inc., March 27, 2020, Black, T.).

The patient brought suit against B. Braun Medical Inc. and B. Braun Interventional Systems Inc. (collectively, Braun) after experiencing complications from an implantable medical device designed, manufactured, and sold by Braun. The device, a "B. Braun VenaTech vena cava filter" (the filter), was a metal cone-shaped filter inserted in a vein to prevent pulmonary embolism. The filter is designed with "patented stabilizing legs" intended to prevent the possibility of migration or movement, and is designed and marketed for permanent implantation. Subsequent to the patient's implantation of the filter in April 2014, medical scans showed that the filter had moved. She allegedly suffered from pain, complications, and a heightened risk of future injuries as a result. She alleged numerous claims under both the Ohio Product Liability Act (OPLA) and common law. Braun sought to dismiss the complaint on the grounds that the common law claims were abrogated by the OPLA or,in the alternative, that all claims were insufficiently pleaded. In response, the patient sought leave to amend her common law warranty claims.

Implied warranty claims.The OPLA expressly abrogates all common law product liability claims. The patient sought to amend her complaint to properly recast those claims under the OPLA. The Federal Rules of Civil Procedure provide that leave to amend may be granted when justice so requires, but that courts need not grant it when the proposed change would not survive a motion to dismiss. The court held that while granting leave would not be futile, the implied warranty claims were duplicative of the OPLA design defect and manufacturing defect claims. As a result, the court dismissed the patient's common law implied warranty claims.

Breach of express warranty. The court found that the patient adequately pleaded that the filter did not conform to Braun's representations. Common law claims for breach of express warranty are preempted by the OPLA, which provides that a product is defective if it did not conform to representations made by the manufacturer. The court noted that the complaint alleged that Braun's webpage and brochure stated that the filter met a "Trusted Standard for Permanent Filtration," but the design was subject to breakage, collapse, and injury. The patient also alleged that her physicians relied on Braun's express warranties of safety and reliability, and would not have recommended it absent those warranties. Accordingly, the court held that the patient adequately pleaded an OPLA failure to conform claim and may amend.

Negligence. The court also held that the patient's OPLA negligence, design defect, manufacturing defect, and failure to warn claims were all sufficiently pleaded. Concerning the negligence claim, a supplier is subject to liability for negligence that proximately caused harm. "Supplier" was expressly defined as distinguishable from a "manufacturer." Braun argued that neither of the Braun companies manufactured the filter and that only Braun Interventional supplied it to the market; moreover, Braun argued that labeling either company as a "supplier" was conclusory and dismissible. The court noted that, at this early stage of the proceedings, the patient was permitted to plead in the alternative that the defendants were liable as suppliers. Moreover, the court found that the negligence claim was pleaded with reasonable specificity: the complaint alleged that Braun had a duty of reasonable care in the sale and distribution of the filter; that Braun breached this duty; and that Braun knew or should have known of the likelihood and severity of harm, and negligently failed to disclose or warn patients of these dangers.

Design defect. A product's design is defective under the OPLA if the foreseeable risks associated with its design exceeded its benefits. The patient alleged that the filter's design was unable to withstand the normal anatomical and physiological pressures of long-term implantation, which resulted in a foreseeable risk of harm that exceeded the design's benefits. Braun argued that the patient could not object to the filter's intended permanence as a design defect, as it was an inherent characteristic that could not constitute a defect under the OPLA. The court disagreed, as the subject of the design defect claim was not the filer’s permanence; rather, it was the filter’s alleged failure to function on a permanent basis. Thus, the patient sufficiently pleaded a design defect.

Manufacturing defect. To plead a manufacturing defect under the OPLA, the patient must have alleged that the product materially deviated from the standards set by its manufacturer. Here, the patient alleged that the filter was manufactured for long-term implantation but that a manufacturing defect prevented it from serving that purpose. Based on the outcome of implantation (the patient's injury) and other evidence, the court found that the patient successfully pleaded this claim.

Failure to warn. Braun argued that the OPLA failure to warn claim should be dismissed because it fell within the "learned intermediary doctrine. "This doctrine shields manufacturers of medical devices from liability for inadequate warning to patients when physicians are adequately warned. Here, the patient specifically alleged that her health care providers were not adequately warned of the filter's risks. The court ruled that her complaint as a whole sufficiently alleged this claim by alleging, inter alia, that Braun failed to provide her health care providers a product brochure, instructions for use, or a warning to medically monitor the device or have it removed after sufficient time.

Commonlaw fraud. Courts have found that the OPLA precludes commonlaw fraud claims to the extent they are based on a failure to warn, but that commonlaw fraud claims based on a general duty not to actively deceive may proceed. As a result, the court held that the negligent misrepresentation claim and fraudulent concealment claims were precluded. However, the fraudulent misrepresentation claim was not precluded to the extent the patient alleged active misrepresentation; further, the court concluded that the time, place, and manner of the alleged fraudulent misrepresentation were adequately pleaded. Braun alleged that the patient failed to specifically plead by her allegation that both Braun Medical and Braun Interventional were responsible for the alleged fraud. However, the court ruled that discovery regarding Braun's corporate structure will uncover which defendant was the proper party to the claims.

Punitive damages. The court also found that the patient adequately pleaded facts to support an award of punitive damages under the OPLA. While state-law punitive damages for medical devices are usually preempted by federal law, a request for punitive damages can survive a motion to dismiss if the patient pleads facts sufficient to support a finding that the product did not conform with the Food and Drug Administration (FDA)-approved design. Here, the patient alleged that multiple FDA "MAUDE Adverse Event Reports" were issued that highlighted the dangers of such filters as a long-term solution to preventing blood clots. The court held that this was sufficient for her request for punitive damages to survive a motion to dismiss, but more will be needed to survive a motion for summary judgment. Finally, the court ruled that the patient was not precluded from seeking punitive damages for her surviving common law claims.

The case is No. 1:19-cv-121.

Attorneys: Ethan T. Vessels (Fields, Dehmlow & Vessels LLC) for Celestine Gordon. Daniel I.A. Smulian (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 MedicalDevicesNews WarningsNews DamagesNews OhioNews

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