Infuse

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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:

  • Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. 2013)
  • Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 9, 2013)
  • Gavin v. Medtronic, Inc., 2013 WL 3791612 (E.D. La. Jul. 19, 2013)
  • Harris v. Medtronic, 2013 WL 4011624 (Cal. Super. Aug. 1, 2013)
  • Houston v. Medtronic, Inc., ___ F. Supp.2d ___, 2013 WL 3927839 (C.D. Cal. Jul. 30, 2013)
  • Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Ct. Aug. 7, 2013)
  • Otis-Wisher v. Fletcher Allen Health Care, Inc., __ F.Supp.2d ___, 2013 WL 3214714 (D. Vt. Jun. 25, 2013)
  • Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. Ct. Jun. 24, 2013)

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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This post is from the Dechert half of the blog as the Reed Smith team is involved in this litigation.

We’ve seen courts struggle applying preemption in device cases when the plaintiff’s claim is based on off-label promotion.  Plaintiffs have argued that the PMA process addresses only the approved use of the product and that the FDA’s regulation therefore doesn’t extend to off-label use or promotion.  And, so the argument goes, state-law claims based on off-label promotion are not preempted.

This is hogwash.  The FDA regulates the device, not just a particular use.  In fact, as we all know, the FDA has regulations that specifically address off-label promotion, something that would strike us as highly unusual for a body that supposedly doesn’t regulate off-label promotion of products.

In any event, while some courts get caught up in this argument, others – like the court in Caplinger v. Medtronic, Inc., No. CIV-12-630-M (W.D. Ok. Feb. 6, 2013)  – don’t.  The plaintiff in Caplinger had posterior lumbar interbody fusion surgery on his back, a surgery that involved the defendants’ Infuse Bone Graft device (“Infuse Device”).  Id. at 1.  This was an off-label use of the Infuse Device, as the FDA had approved it for anterior (through the stomach), not posterior (through the back), surgery.  Id. at 1-2.  It had nevertheless been approved under the FDA’s PMA process, which brought into play FDCA §360k, which preempts any state-law claim that is “different from or in addition to” the FDA’s regulation.  Id. at 2.

The plaintiff had significant problems after the surgery and filed claims against the manufacturers of the Infuse Device for fraud, failure to warn, design defect, breach of implied and express warranties, negligence and negligent misrepresentation.  Id. at 1-2.  Defendants moved to dismiss.  The court easily found the majority of plaintiff’s claims to be preempted.  We highlight here, however, two important areas of the court’s decision that focus on plaintiff’s off-label allegations.  Because this is a court that got it right.Continue Reading How to Apply Preemption to Off-Label Claims: Caplinger v. Medtronics, Inc.

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