Is fear of injury the same thing as injury? The question answers itself. At least it should. They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury. We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury. Think of diet drug cases where the claim was an increased risk of heart valve injury. Most courts concluded that such fear did not amount to actionable injury. Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it. But not always. So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger. In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT). The implant was intended to be permanent. In subsequent years there were reports of IVC filters causing problems via misalignment and migration. In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides. The defendants in this case continued to market their IVC filter for long-term use — according to the court, “defying the FDA’s general recommendations.” Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted. That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit. The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury. The court granted the motion to dismiss. It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.
1. Personal Injury Claims
The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter. The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context. To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.” But those are more rote formulas than factual allegations. The complaint certainly never described the nature of the injuries. New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint. Perhaps the best thing that the plaintiff had was the defendants’ marketing of permanent filters even after the FDA counseled against it, but that did not happen until after the plaintiff’s implant.
2. Breach of Warranty Claims
The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed. New York’s statute of limitations for warranty claims is four years. The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation. But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short. Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury, New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.” Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.
3. Fraud Based Claims
Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard. Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use. But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe. Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries. Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive. The plaintiff simply had not made out a case for fraud.
4. New York General Business Law Claim
The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<http://www.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000081&cite=NYGBS350&originatingDoc=Ib48241005e2b11e89868e3d0ed3e7ebe&refType=LQ&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.FindAndPrintPortal)>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.” As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”
What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims. What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device. Most of the good cases on our no injury scorecard involved drugs. Arguably, a plaintiff has a little more to work with when there is a device implanted in the body. There is a continuing exposure. Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.