[Drug and Device Law] Deflate-Gate Wasn't the Only Blowout Last Week
This past week you probably heard the low monotone sound that emanates from Patriot head coach Bill Belichick’s mouth whenever he’s explaining deflate-gate and trying to muster up the energy to drool out words that ultimately reveal only that he’s not interested in saying them. His barely operating mouth doesn’t tell you what his eyes so clearly communicate: “This is stupid. It was a blowout. It’s stupid, stupid, stupid. Really stupid.” His eyes make a better point than his mouth. It was a blowout and was always going to be.
The same is true of Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015). Like most blowouts, you knew it early on. Before the court even began analyzing the defendant’s motion to dismiss, it said this, which we describe as foreshadowing with a mallet:
Plaintiffs did not timely respond to the motion. On December 3, 2014, after their response to the motion was due, Plaintiffs mailed the Court a short letter asking the Court to deny the motion. Citing no case or other authority, the letter attached what it alleged were medical records of Deborah Becker and an earlier letter from Plaintiffs’ counsel to Defendant’s counsel describing those records. Plaintiffs later filed the letter and attachments on ECF.
Id. at *3. Uh-oh. This was a mismatch from the start. On one side, we have no cases, no authority, an almost fact-less complaint, and a letter to the opponent that attaches some medical records that was later filed with the court in lieu of a brief, amended complaint or something legal sounding like that. On the other side, we have TwIqbal and New Jersey product liability law. If you deflated defendant’s brief by removing half the authorities, you’d still get a blowout.
Plaintiff, who had revision surgery after her hip implant device was recalled, relied on six claims, all based in negligence. The negligence theory and breach of implied warrant went away quickly. New Jersey’s Product Liability Act subsumed such theories and claims long ago:
The PLA “no longer recognizes negligence or breach of warranty (with the exception of an express warranty) as a viable separate claim for harm, including personal injury, caused by a defective product or an inadequate warning.” Plaintiffs’ causes of action for negligence and breach of implied warranty must be dismissed.
Id. at *4-5 (quoting Koruba v. American Honda Motor Co., Inc., 935 A.2d 787, 795 (N.J. App. Div. 2007); citing Fidelity and Guar. Ins. Underwriters, Inc. v. Omega Flex, Inc., 936 F. Supp. 2d 441, 447 (D.N.J. 2013)).
The court proceeded to dismiss the rest of plaintiffs’ claims with reasoning that reads like a check-list of the items that a product liability plaintiff must plead with actual facts to survive TwIqbal. For the manufacturing defect claim, here’s what plaintiffs left out:
Plaintiffs do not allege facts to indicate that this particular implant deviated from the manufacturer’s specifications or otherwise identical units. The complaint does not allege that a defect existed when the product left the manufacturer’s control, specify how the defect proximately caused injuries to Deborah Becker, or identify her as a reasonably foreseeable end user of this particular device. The specific name of the implant does not appear in the complaint, nor does the medical condition which it was intended to treat. Though alleging “high levels of cobalt toxicity in [Deborah Becker’s] system,” the complaint does not allege that the product was the proximate cause of this condition, or that the high levels caused a specific injury. Apart from labeling the product a “Smith & Nephew hip implant,” Plaintiffs do not expressly identify Defendant’s relationship to the product or role in the chain of commerce, vaguely stating that either Smith & Nephew or a fictitious defendant did one of a number of activities, including and potentially limited to “own[ing]” or “packag[ing]” the product.
Id. at *6-7 (citations omitted). For the design defect claim, plaintiffs left a lot out too:
The complaint . . . neither addresses the seven factors [used for a risk-utility analysis in New Jersey] nor specifies a defect in the product’s design. As with a manufacturing defect theory, a design defect theory cannot be maintained without allegations that the defect existed when the product left the manufacturer’s control, the particular defect was the proximate cause of injuries to Deborah Becker, and Deborah Becker was a reasonably foreseeable or intended user.
Id. at *8-9.
It was the same story for failure to warn:
There is no identification of the latent danger, assertion that the danger is not obvious, or allegation that Defendant knew or should have known about it at a particular time. The complaint is silent as to whether Defendant gave a warning that did not reveal a particular danger, gave a warning that was untimely, or gave no warning at all. Plaintiffs do not assert that the inadequacy of the warning was the proximate cause of Deborah Becker’s injuries. The complaint does not identify Deborah Becker as an intended user of the product, or state how the warning was inadequate in light of the ordinary knowledge common to intended users.
Id. at *11. The court then dismissed plaintiffs’ loss of consortium and punitive damages claims as derivative and, with that, all of plaintiffs’ claims were gone. Id. at *12.
Unlike the Indianapolis Colts, though, plaintiffs will get a rematch. The court noted that the complaint had originally been filed in state court under a more lenient pleading standard, and so it gave plaintiffs, in the interest of “fairness and justice,” a chance to fix their pleading (though plaintiffs had to have been fully aware that the complaint had been removed to federal court). Id. at *13-14.
They’d better do better next time around, because the initial complaint never stood a chance. The court left nothing out in explaining everything that the complaint left out. You can almost hear Belichick reading the words of the court’s opinion with that same dead-eyed, “what are you kidding me” look on this face. It was a blowout.
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Posted By John J. Sullivan to Drug and Device Law at 1/26/2015 08:30:00 AM --
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