A couple of weeks ago we compared New Jersey litigation with New Jersey food and decided we liked the food better. No aspersions were intended. After all, we grew up in New Jersey and still worship at the altars of Seton Hall Prep, Bruce Springsteen, and the New York football Giants. Anyway, we might need to revisit that comparison. New Jersey product liability law is pretty good. It might not be as tasty as a DeLorenzo's tomato pie, but it is clear and logical. Gazing across the Delaware River from our current perch in Philly, we are green (definitely not Eagle green) with envy.
A recent decision, Hindermyer v. B. Braun Med., 2019 U.S. Dist. LEXIS 189193 (D.N.J. Oct. 30, 2019), stokes that envy. The plaintiff in Hindermyer alleged existing and threatened injuries from an implanted IVC filter. An IVC filter is a medical device that traps and filters blood clots that develop in the lower extremities. The goal is to prevent such blood clots from reaching the lungs. Originally, IVC filters were implanted permanently. But manufacturers later offered another type of IVC filter that was retrievable and intended for removal after the risk of a thrombotic event subsides. The IVC filter implanted in the plaintiff was of the permanent variety. Over the years, the FDA issued alerts regarding potential complications from IVC filters possibly migrating or causing perforations. Those alerts urged doctors to remove the filters after the risk of pulmonary embolisms subsided. The plaintiff in Hindermyer alleged that despite those alerts, the defendants manufactured and promoted their IVC filters for long term use. Eight years after the IVC filter was implanted, she went into he hospital for pain that was possibly caused by the IVC filter. The IVC filter was still located where it had been implanted. There was no migration. The plaintiff's doctors did not counsel removal of the filter. The filter had not caused any of the feared serious complications, such as fracture, etc. Nevertheless, the plaintiff alleged that the filter put her at greater risk of those complications. In the complaint, the plaintiff asserted the following ten causes of action against the 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. The defendants moved to dismiss the complaint, arguing that all the claims were subsumed by the NJPLA and did not meet that statute's standards.
The threshold issue was whether the NJPLA did, indeed, govern all the claims in the case. The Hindermyer court explained that the legislative intent behind the NJPLA was “to limit the expansion of product liability law" and to "limit the liability of manufacturers so as to balance the interests of the public and the individual with a view towards economic reality." [We have heard plaintiff lawyers argue that the NJPLA is aberrational. They have even had the chutzpah to argue that position to a New Jersey MDL court as a reason to steer clear of New Jersey bellwether trials! Apparently the concepts of balance and economic reality are aberrational.] In Hindermyer, it was clear that the NJPLA controlled. However the claims were styled, whether as implied warranty, fraud, or whatever, the plaintiff was alleging physical injuries from a product. The case looked like a product liability duck and quacked like a product liability duck. The claims sought product liability damages, so it was subsumed by the NJPLA.
The NJPLA contemplates the usual trio of product liability theories: design defect, manufacturing defect, and failure to warn. The plaintiff in Hindermyer did not allege what needed to be alleged to sustain any of those theories. First, the plaintiff failed to plead a feasible alternative design – that is, "the availability of a technologically feasible and practical alternative design that would have reduced or prevented the plaintiff's harm without substantially impairing the reasonably anticipated or intended function of the product." Her notion seemed to be that the permanent IVC filter implanted in her should have been retrievable. But retrievable and permanent are not alternative designs; rather, they are alternative products. The plaintiff did not allege that the temporary version was capable of being made when her IVC filter was implanted. Moreover, her filter was marketed and sold as a permanent filter, whereas retrievable filters are designed to be removed. In the court's view, permanent and retrievable filters are "inadequate comparators." Because are entirely different products, the court dismissed the design defect claim.
The plaintiff in Hindermyer fared no better with her manufacturing defect cause of action. Such a claim must plead a deviation from the intended design of the product. The plaintiff did not manage to do that. She had "not identified, within even in general terms, a particular error or mishap in the manufacturing process that caused her Vena Tech filter to deviate from Defendants' own standards, nor does she contend that her device failed to conform to other identical units." The gravamen of the plaintiff's complaint was that her IVC filter did, in fact, conform to the fundamental design of the product as being a permanent implant. Accordingly, the court concluded that the manufacturing defect claim was "inconsistent with [the plaintiff's] theory of the case,” and dismissed it.
Finally, the Hindermyer court held that the plaintiff lacked standing to sue over a failure to warn of risks that she did not suffer. The plaintiff had not alleged that the defendants "had a duty to warn about chronic right side pain – her only alleged symptom." Merely being at risk of other complications is not enough. The same reasoning requires dismissal of the plaintiff's express warranty claim.
So there it is: a fully praiseworthy New Jersey product liability opinion. (Sure, the court refers to the FDA substantial equivalence process as 501(k) instead of 510(k), putting us in mind of Levi's jeans as opposed to an unfairly maligned FDA regulatory regime, but we assume that error will be corrected before too long – certainly before the next Eagles-Giants tilt.)
This article is presented for informational purposes only and is not intended to constitute legal advice.