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 usBone 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 instructions that are included with a device that the FDA permits to proceed into the marketplace.

Seaveyslip op. at 11-12.  Thus, Seavey is useful precedent for applying the New Jersey presumption of warning adequacy to §510k medical devices.

Nor was the presumption rebutted.  The FDA specifically considered off-label use and required a warning.  Defendant gave it.  Defendant “also warned of the risks of screw breakage, hardware failure, and non-union.”  Slip op. at 12.  Plaintiff claimed that the defendant’s sales representative knew that the defendant surgeon was going to use the device off-label.  Id. at 12-13.  So what?  Off-label use is legal, and manufacturers have no duty to try to prevent it:

Plaintiff has no evidence that any [sales representative] encouraged [defendant surgeon] to use the [device] off-label.  At most, he has produced evidence suggesting that [defendant’s representative] may have known that [the surgeon] planned to do so and did not prevent this from occurring.  Plaintiff has cited no law indicating that a device manufacturer has any duty to prevent off-label use of its products.  The FDA does not regulate the use of medical devices by doctors, and does not purport to control how doctors use a given device.  Nor can the FDA intrude upon the practice of medicine, through its regulation of the marketing and sale of medical devices.  Thus, it follows that a manufacturer has no affirmative duty to intervene in order to prevent off-label use of its product by a surgeon.  Plaintiff’s claim that [defendant’s] representative allowed the misuse of the product through calculated silence is insufficient to create an issue of material fact for trial as to failure to warn.

Slip op. at 15-16 (citations and quotations from Blazoski omitted) (emphasis added).  While Seavey cites only Blazoski, this result is actually in accord with considerable other precedent.  See Carson v. Depuy Spine, Inc., 365 Fed. Appx. 812, 815 (9th Cir. 2010) (applying California law); Haley v. I-Flow, LLC, 853 F. Supp.2d 868, 881 (D. Minn. 2012); Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270, 1292 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011); Rohlik v. I Flow Corp., 2011 WL 2669302, at *3 (E.D.N.C. July 7, 2011); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. March 29, 2000).

Nor would off-label promotion – alleged but not proven in Seavey – defeat the New Jersey presumption:

Plaintiff has produced no evidence showing that [defendant manufacturer] marketed the device for use in an off-label manner, and has cited no law indicating that “calculated silence” that fails to prevent a doctor from using a device off-label, is the equivalent of off-label marketing.  Further, even if [its] representatives had encouraged off-label use of their devices − which has not been demonstrated − this conduct would not support a product defect case for inadequate warning. . . .  While such action, if true, might be actionable, it would not result in a viable products liability action under a failure to warn theory.

Slip op. at 16 (emphasis added).  As a federal court sitting in diversity, Seavey refused to create a judicial exception to the New Jersey presumption for off-label promotion.  Id. at 16-17. That is for either the FDA (which prescribed an off-label warning) or the New Jersey legislature (which enacted the statute).  Id. We’ve been pushing Erie-based conservatism since this blog started.  It’s gratifying to see it properly applied.

Nor was a court applying state law in position to question product “testing” that the FDA had found sufficient:

Plaintiff has asserted that he was not warned that the device did not undergo certain tests. . . .  The FDA ultimately viewed the testing done on the [device] as adequate, as it approved the marketing of the device pursuant to its 510(k) approval process, provided that certain warnings were included. . . .  [I]t is not this Court’s place to challenge the adequacy of the FDA’s regulatory process in a warning context, particularly in light of the New Jersey Legislature’s decision to enact the presumption of adequacy standard.

Seaveyslip op. at 17 n.9 (citations omitted).  We point out, although Seavey did not reach the issue, that there is no viable claim for failure to test in New Jersey in any event.  For cases, see our duty to test cheat sheet (which includes three New Jersey decisions).

As an alternative holding, Seavey also invoked the learned intermediary rule.  The manufacturer defendant’s warning was “clearly” adequate.  The implanting surgeon “knew”:  he was engaging in off-label use, the risks of the off-label procedure he selected, and that the medical community viewed this off-label use as “safe.”  Slip op. at 18.  The surgeon also knew he had the right to pursue off-label use where, in “his medical judgment,” he believed it would be of therapeutic benefit to his patient:

[H]is decision was based upon Plaintiff’s individual condition and needs, and because he knew that the FDA does not prohibit a surgeon’s use of any device off-label, he concluded that such a course was the best possible treatment for his patient.

Id.  Thus, the manufacturer defendant adequately warned the physician under the learned intermediary rule and “cannot be held liable for failing to prevent [the surgeon defendant] from using the device in an off-label fashion.”  Id. at 19.  For all these reasons,the manufacturer defendant received summary judgment against plaintiff’s warning claims.

Plaintiff’s design claim also failed.  Plaintiff was required by New Jersey law to come forward with a safer alternative design, and failed to do so.  Slip op. at 19-21.  “It is insufficient to merely recite that such an alternative design exists. Rather, a plaintiff must demonstrate the reasonableness and feasibility of the alternative design.”  Id. at 21.  Plaintiff offered neither an alternative nor proof that “an alternatively designed product would have prevented the harm to Plaintiff.”  Id.  It is not a design defect that the surgeon “used the device incorrectly.”  Id. at 22. That argument is “a medical malpractice claim under the guise of a design defect claim.”  Id. at 22 n.12.  Summary judgment for the right side of the “v.” on design defect.

The implanting surgeon also received summary judgment.  We’re not as interested in those claims, but we do care about informed consent.  Plaintiff predictably claimed that his surgeon “did not inform him of the FDA status of the device.”  Slip op. at 23. We’ve been fighting that battle since Bone Screw, and the precedent from that litigation once again (as we recently discussed here) stood the test of time:

[W]hen a surgeon uses a medical device in an “off-label” manner, a failure to disclose that information to the patient is, alone, insufficient to support a claim that the physician failed to meet the applicable disclosure standard.  A physician must disclose all material information that a ‘prudent patient’ might find significant for a determination whether to undergo the proposed therapy.  However, the FDA regulatory status does not speak directly to the medical issues surrounding a particular surgery.  This is the case because the FDA’s concern is to regulate the marketing and labelling of medical devices, not to intrude upon the practice of medicine or redefine the doctrine of informed consent.  Doctors may use medical devices for off-label purposes that are not FDA approved, provided that the FDA has approved the device for some other purpose.  Thus, the law is established in New Jersey that the fact that a device is being used in a manner unapproved by the FDA does not fall under the umbrella of information that a “prudent patient” would find significant. Doctors routinely use devices for purposes that are not approved by the FDA.

Seaveyslip op. at 23-24 (numerous Blazoski citations and quotation marks omitted) (emphasis added).  An off-label use is not a use that was “rejected” by the FDA, and in any event that doesn’t matter because “the FDA cannot, and does not attempt to, prevent the use of an approved device in an unapproved or 'rejected' manner by a physician.”  Id. at 25.

Nor could informed consent liability be justified because a device is “experimental.”  The FDA simply doesn’t govern medical practices:  

Plaintiff has also not shown that the FDA makes any distinction between experimental and prohibited devices with respect to the general marketplace for a device.  The FDA can only regulate the marketing and labelling of devices.  It cannot regulate what physicians do with the devices with respect to their patients.  Plaintiff has cited nothing indicating that the FDA indicated anywhere that physicians were “prohibited” from using the device for any purpose . . . .  [T]he FDA either gives its approval for a device manufacturer to market a device for a particular purpose or it does not.  If it does not issue approval, the manufacturer may not market the device. . . .  The FDA Clearance letter that Plaintiff cites . . . does not indicate any such rejections with respect to physicians.

Seaveyslip op. at 27 (more Blazoski citations omitted).  We’ve seen these same tired informed consent arguments used over and over in off-label use cases.  We’re happy to report on yet another rejection.

Of course, if the underlying medical risks of off-label use are material, then they have to be disclosed to the patient – regardless of a product’s FDA status.  Seaveyslip op. at 28. That, however, requires expert testimony, which the plaintiff did not produce.  Therefore summary judgment.  Id. at 28-31.

Finally, plaintiff also asserted product liability claims against the defendant physician.  You can’t do that in New Jersey, as in most places, unless the physician leaves his/her role as a doctor and engages in manufacturing activities – which did not happen here. Id. at 31-33.

Plaintiff’s products liability claim against [defendant physician] constitutes an attempt to shoehorn a medical malpractice or informed consent claim into a products liability cause of action by attempting to characterize off-label use and the risks associated with such use as a “defect.”  Plaintiff has cited no law, and the Court is aware of none, suggesting that he can use a products liability claim as a second attempt at a negligence claim against a physician, without having to demonstrate the standard of care.

Seaveyslip op. at 33.

Seavey demonstrates that bone screw cases are no more meritorious today than they were the first time around.  Some things don’t change. Thanks to Terry Henry at Blank Rome for passing along Seavey to us.  Sometimes word of mouth is faster than Lexis or Westlaw.