[Drug and Device Law] N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law
We are determined not to end 2015 on a bad note. Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning. The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right. The case involves the usual panoply of product liability claims against a spinal fixation system. After a surgery on the plaintiff in 2011, two pedicle screws fractured. A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the spinal fixation system.
Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation. We wish every state enacted a product liability act. In fact, we wish every state enacted the MPLA. The MPLA requires a design defect claim to suggest a feasible alternative design. The plaintiff offered no such alternative design, so that theory was dismissed. The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.
The plaintiff’s amended complaint alleged that the “Pedicle Screws are not made in accordance with the defendants’ [sic] specifications or performance standards.” But the plaintiff never stated how the pedicle screws at issue deviated from manufacturing specifications. Nor did the plaintiff reference any manufacturing specifications at all. Rather, the plaintiff was reduced to arguing that the mere proof of malfunction created a genuine issue of material fact as to a manufacturing defect under the MPLA. Unfortunately for the plaintiff, Mississippi law says no such thing. There needs to be proof of an actual manufacturing defect. At this point, the plaintiff fell back on an accusation of spoliation, alleging that the defendant should have collected and maintained the broken pedicle screws after their removal. But remember what John Adams said about facts being stubborn things. It was undisputed that while the screws were not recovered after surgery, they had not been destroyed by the defendant or any of its representatives. Because there was no genuine issue of material fact as to bad faith on the part of the defendant, no spoliation instruction was warranted, and because there was no evidence of manufacturing defect, the manufacturing defect claim was dismissed.
Any failure to warn claim flunked the learned intermediary doctrine, because the plaintiff failed to establish that the treating physician would not have used the product had he received an adequate warning. Indeed, the treating physician did testify in his deposition “that he was aware of the risks of spinal fusion surgery and implantation of fusion devices, including the possibility of device failure.” That is not surprising. Most spinal surgeons undoubtedly know this. Further, even knowing those risks, the doctor testified he still used the spinal fixation system. The wrinkle here is what the plaintiff alleged had not been disclosed. The plaintiff was not focused only on undisclosed medical risks. Instead, the plaintiff alleged that the defendant had a duty to inform the hospital and the attending physician that the spinal fixation system had not been properly cleared and that a standalone 510(k) had not been submitted to the FDA. Again, there was no showing of warning causation. The doctor did not testify that a warning about the alleged FDA procedural problem would have changed his prescribing decision. Moreover, the plaintiff’s “own expert testified that connecting the Plaintiff’s injury with the alleged failure to properly file with the FDA would be improper as it was too speculative.”
On its own initiative (which we applaud), the Estes court raised the issue of whether the plaintiff’s claim that the spinal fixation system had not received proper FDA 510(k) clearance was foreclosed by Buckman. The court’s brief discussion of this point makes our flinty defense hearts warm and our minds optimistic. The court asked for further briefing as to whether federal law impliedly preempts the causes of action based on the propriety of submissions to the FDA. It is hard to see how the plaintiff wriggles out of that problem, particularly with a smart judge reading the briefs.
Finally, the breach of warranty claims also got consigned to the dustbin. There was no evidence of any express warranty being made to the plaintiff, or that the plaintiff relied on any such warranty (including whether the spinal fixation system had been properly cleared by the FDA). Lack of reliance also eliminated the claim for breach of an implied warranty of fitness for a particular purpose. Finally, the claim for breach of implied warranty of merchantability was dismissed because there was no proof that the plaintiff had attempted to contact the defendant when it was discovered that the pedicle screw was broken, or that the defendant had been afforded an opportunity to cure. Mississippi is a state that follows warranty law to the letter.
Thank you Mississippi, land of Faulkner, Viking ranges, great ballet, Manning football stars not named Peyton, and lovely product liability decisions.
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Posted By Steve McConnell to Drug and Device Law at 12/30/2015 07:30:00 AM --
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