The last opinion available on Lexis or Westlaw for Seavey v. Globus Medical, Inc., is from early 2012, when the manufacturer defendant failed to get the plaintiff’s express warranty claim thrown out on the pleadings. See 2012 WL 253116 and/or 2012 U.S. Dist. Lexis 9435. Fortunately, all the defendants did better on summary judgment – much better, since all claims against all of them were recently dismissed. See In Seavey v. Globus Medical, Inc., Civ. No. No. 11-2240 (RBK/JS), slip op. (D.N.J. March 11, 2014).
First, to satisfy your (or at least our) curiosity, how did the express warranty claim that the court had allowed previously fare? The way almost all such claims do when facts finally replace allegations: “Plaintiff has now indicated that he does not oppose summary judgment on the manufacturing defect and express warranty claims.” Slip op. at 34. Forget TwIqbal, we wish courts would enforce Rule 11 as to express warranty, since any such warranty would be in a plaintiff’s possession, and should be pleaded truthfully.
Now, on to the fun stuff.
Seavey is an off-label use case involving a “spinal fixation device.” Slip op. at 2. See Seavey, 2012 WL 253116, at *1 (employing the unusual term “off brand”). Sound familiar? To us Bone Screw veterans it does. Not only does the plaintiff bring product liability claims against medical device manufacturer, but also “informed consent” claims against his surgeon. We’ve got you covered there. See Blazoski v. Cook, 787 A.2d 910 (N.J. Super. A.D. 2002) (bone screw case). Anyway, plaintiff appears to have been treated quite conservatively for intractable back pain caused by two-level degenerative disc disease (L4-S1 – the most common locations) including both herniation and a “large extruded disc fragment,” and complicated by something called “Normokalemic Periodic Paralysis.” Slip op. at 2-3. He was treated nonsurgically for six years, had uninstrumented surgery, which didn’t resolve his pain, and the instrumented procedure that is the subject of suit was only performed three years after the first, unsuccessful surgery (and with a diagnosis of “complete collapse” at L5-S1). Id. at 2-4.
The off-label use involved the manufacturer defendant’s device being used in a “dynamic stabilization technique”:
Prior to Plaintiff’s surgery, [the surgeon defendant] had used several dynamic stabilization devices that were not manufactured by [the manufacturer defendant]. He attended lectures by doctors who were utilizing the dynamic stabilization technique with a semi-rigid fixation device in their practices, with the disclaimer made by those doctors that such use was “off-label.” Subsequently, [the surgeon defendant] began using dynamic stabilization with semi-rigid devices in a manner not approved by the FDA.
Slip op. at 6 (citations omitted). That surgery helped plaintiff’s pain for a while, but in less than a year he was “explor[ing] other options regarding pain relief.” Id. at 6-7.
And yes, pedicle screws (“screws that run through the pedicles”) were used. Id. at 5. Despite failure of fusion, id. at 6, 8, the instrumentation remained “intact” for almost two years. Id. at 8. Then, one of the screws at L4 – the “dynamic stabilization” level of plaintiff’s surgery – broke. Id. Despite multiple revision surgeries, other hardware, and pain medication pumps, plaintiff remained in pain. Id. at 8-9. In short, Seavey sounds like a bog standard bone screw case.
Ditto for the device. It also sounds pretty standard − cleared by the FDA, as all such devices are, pursuant to non-preemptive (thanks to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) §510k clearance. Slip op. at 7. There is one significant difference from the cases we dealt with 15-20 years ago. Pursuant to the Agency’s authority that we previously discussed here, the FDA required a warning specifically about off-label use:
The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with autogenous bone graft is being performed at all instrumented levels.
Id. The manufacturer complied with the FDA’s requirement and included this warning every place it was supposed to. Id. at 8
Plaintiff had the surgery in question in New Jersey, so that state’s law applied. That means the New Jersey product liability statute, including its presumption of adequacy for warnings “approved or prescribed” by the FDA. Slip op. at 11 (quoting N.J.S.A. 2A:58C-4). While this §510k device might not have been “approved,” its warnings were certainly “prescribed” by the FDA:
Here [the device] underwent a federal regulatory evaluation process, which ultimately resulted in the FDA’s grant of permission for [the manufacturer defendant] to place the device on the market, provided that a warning prescribed by the FDA was given. The approval includes the label and other...
