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This post is from the non-Reed Smith side of the blog only.
It has been almost two months since we’ve posted about an InFuse decision and in case you’ve forgotten, the InFuse litigation has been making a lot of great off-label use law (see most recent post with links to early posts). And now…
This post is from the non-Reed Smith side of the blog only.
This year has seen many decisions in the InFuse litigation and we’ve tried to highlight the key rulings. See here and here. They mostly have been very strong preemption decisions and this month’s addition to the collection is no exception – Cook …
This post is from the non-Reed Smith side of the blog only.
A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation. We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013). Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.
Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell. The allegations are more or less the same. The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process. The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery. Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage. Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7. At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law. Id. at *57-58.
This post is from the Dechert side of the blog only.
This summer saw a flood of decisions involving Medtronic’s Infuse bone graft system from all across the country. State and federal courts ruled on defendant’s motions to dismiss and overwhelming agreed with Medtronic that the bulk of plaintiffs’ claims are preempted. Because the decisions were coming down so quickly, we decided to wait and bring them to you as a group. And, collectively they make quite a statement. That statement is that you can’t circumvent preemption by alleging off-label use.
For your convenience, here are the names and cites for all the favorable cases:
To be fair, we are aware of two others: Ramirez v. Medtronic, Inc., 2013 WL 4446913 (D. Ariz. Aug. 21, 2013) and Alton v. Medtronic, Inc., 2013 WL 4786381 (D. Or. Sept. 6, 2013). But they don’t make our list because they went the other way – finding most of plaintiffs’ state-law claims weren’t preempted because they were premised on off label promotion. But these are cases out of the Ninth Circuit and as such are burdened by that court’s decision in Stengel v. Medtronic Inc., 704 F.3d 1226 (9th Cir. 2013) (en banc) allowing a negligent failure to warn claim (see our post here). So, much of the reasoning that held the day across the country wasn’t as persuasive out west. That should mean their influence is geographically limited. Their authority is further undercut by the fact that courts themselves don’t agree. See Alton at *22 (disagreeing with Ramirez). But, with the count at 8 to 2, we’ll let you check out Ramirez and Alton on your own and instead focus on the good stuff. We’ve said before, and we’ll say it again, as a defense blog, we don’t do the other side’s research for them.Continue Reading The Infuse Litigation – Making Good Off-Label Use Law
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We have always wondered why judges are hesitant to sever the claims of plaintiffs who never should have joined their claims together in the first place. You know what we mean—multiple plaintiffs, sometimes dozens of them, who join their claims together in one complaint based only on the allegation that they used the same or…
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With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents. Still, that’s no reason not to praise good results. …
It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist Healthcare Sys., Inc., No. 2015-CA-001103-MR, 2017 Ky. App. LEXIS 10 (Ky. Ct. App. Jan.…