This post is from the non-Reed Smith side of the blog.
We do have two opinions to talk about, they’re just from the same case. They are the magistrate’s Report and Recommendation and the district court’s subsequent ruling in Lyles v. Medtronic, Inc. This is the latest Infuse victory but it’s not all about preemption this time. There’s a little statute of limitations, a little statutory exclusivity, some judicial notice, and of course a bit of preemption. We’ll break it down for you.
Plaintiff underwent spinal surgery on May 10, 2013. On February 6, 2014 he began to suffer from complications that necessitated a revision surgery. Plaintiff alleges that on February 13, 2014 he was told by his doctor that the plate used in his surgery had failed. Lyles, 2015 U.S. Dist. LEXIS 175042 at *1-4 (W.D. La. Nov. 23, 2015) (Report and Recommendation (“R&R”). Then plaintiff started filing complaints. He first filed on February 10, 2015 alleging products liability claims against Medtronic, Inc. He amended his complaint with additional knowledge gained on May 8, 2015. He filed a second amended complaint substituting Medtronic Sofamor Danek USA, Inc. for Medtronic, Inc. on June 11, 2015. At this point, Medtronic, Inc. is no longer a defendant. Id. at *4. Plaintiff still wasn’t done. He filed a third amended complaint on July 17, 2015 asserting claims for fraud and violation of the Louisiana Unfair Trade Practices Act against both Medtronic Sofamor Danek USA, Inc. andMedtronic, Inc. Id. at *5. That’s four complaints and none of them were sufficient to survive a motion to dismiss.
As to Medtronic, Inc. plaintiff’s claims were time-barred. The allegations in the third amended complaint didn’t related back to the original filing. Medtronic, Inc. may not have been an entirely new party, but the allegations against it are. Fraud and consumer protection violations were not alleged in the original complaint – “they do not arise out of the same occurrence previously set forth as those were all products liability claims and cannot relate back.” Id.at *7. Plaintiffs also argued that the Medtronic defendants were solidary obligors and therefore the statute of limitations was stayed from the original filing date. But without an allegation of conspiracy, this argument was without merit. Id. at *6-7.
In his objection to the magistrate’s ruling, plaintiff made the new argument that the Medtronic defendants are joint tortfeasors and as such the statute of limitations was stayed (or interrupted in Lousiana) as to the later named joint tortfeasor. The court goes through the history of what claims were brought against which defendants at what point in time to demonstrate that at no time in all of the various complaints did plaintiff allege the parties were joint tortfeasors. Lyles, 2016 U.S. Dist. LEXIS 6924 at *5-6 (W.D. La. Jan. 20, 2016).
So that leaves the products liability and fraud/consumer protection claims against Medtronic Sofamor Danek. In Louisiana, products liability claims are governed by the Louisiana Products Liability Act. Under the LPLA, plaintiff alleged a claim for defective design, but nowhere in the complaint does he allege that an alternative design existed capable of preventing his alleged injuries. Lyles R&R, 2015 U.S. Dist. LEXIS 175042 at *9. So that claim was dismissed but plaintiff was given 14 days by the district judge to amend his complaint on this sole surviving claim.
Next, both the magistrate and the district court judge dismissed the fraud and consumer protection claims. The crux of these claims are allegations that the defendant provided false and misleading information about the safety and effective use of the device to plaintiff’s doctors. Id. at *9-10. But the LPLA is the exclusive remedy for products liability claims in Louisiana – meaning all other claims, such as fraud, are barred. Plaintiff tries to dodge the exclusivity provision by arguing that his fraud and consumer protection claims aren’t brought against the defendant in its capacity as the “manufacturer,” but rather as the “marketer” of the device. Id. at *10. To-mae-to, To-mah-to. We've seen plaintiffs try to use this "different capacity" theory in trying to push innovator liability in generic drug cases -- fortunately with little success (innovator liability scorecard). Plaintiffs cannot recover for damage caused by a product other than under the LPLA. End of story. Well, almost.
The magistrate surmised that plaintiff’s fraud and consumer protection claims were similar to failure to warn claims which could be asserted under the LPLA. However, there was no need to allow the plaintiff’s an opportunity to try to plead a failure to warn claim because that claim would be preempted. Id. at *11-12. As the bulk of plaintiff’s allegations are about the safety and effectiveness of Infuse, those claims are expressly preempted and would be dismissed. Id. at *12. The district court didn’t believe it needed to reach the preemption question, but agreed with the magistrate’s reasoning. Lyles, 2016 U.S. Dist. LEXIS 6924 at *9n.8.
Finally, defendant also filed a motion asking the court to take judicial notice of certain FDA documents. Although neither the magistrate nor the district judge appears to have relied on the documents in reaching their conclusions, the court granted the motion finding it appropriate to make FDA public records part of the record. Id. at *4.