Medtronic InFUSE Cases Signal That Off-Label Promotion Probably Not Illegal

A majority of plaintiffs seeking damages based on off-label promotion of Medtronic’s InFUSE Bone Graft system have been stopped in their tracks following several recent federal court decisions holding that such challenges were barred on preemption grounds.  Indeed, with the exception of two district court cases out of the Ninth Circuit, these preemption rulings not only underscore the limits of off-label promotion arguments in medical device cases, but also show that courts remain skeptical about whether off-label promotion is illegal under federal law.Background

The InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device, manufactured by Medtronic Sofamor Danek in Tennessee, is a multi-part device approved by the FDA to help fuse vertebrae in the lower spine in order to treat degenerative disc disease.  InFUSE was approved by the FDA as a Class III medical device in 2002 under the Premarket Approval (“PMA”) process.  The treatment was developed as an alternative to painful bone transplants.

Litigation over the InFUSE system has been the latest headache for Medtronic.  In 2011, the medical device manufacturer agreed to pay a fine of $23.5 million to resolve Department of Justice allegations that the Company paid physicians for favorable treatment of the company’s pacemakers and defibrillators.  That settlement was part of two qui tam lawsuits brought under the False Claims Act, which netted the relators almost $4 million as part of their deal with the Government.  At about the same time of the settlement, the InFUSE system came under direct fire, when the U.S. Senate and the DOJ investigated the accuracy of the device’s safety claims, including significant omissions associated with clinical trial data, and alleged off-label use of the product.

The problems with InFUSE erupted into public view when the respected publication Spine Journal devoted its entire June 2011 issue to criticism of the InFUSE system.  The article reported allegations that Medtronic had made payments to prescribing doctors, who then failed to report on safety concerns relating to the product’s use.  Following the article, the Yale University Open Data Access project agreed to take the lead on two independent reviews of Medtronic data.  Yale researchers found that treatment with the InFUSE system was equivalent to the body’s own bone transplantation (a treatment not suitable for all patients), as well as a slight increased risk of cancer.  While the news could have been much worse, Medtronic ended up paying an $85 million settlement in 2012 to resolve shareholder charges alleging failure to disclose that 85 percent of InFUSE sales were attributable to off-label uses.

Although various plaintiffs sought to piggy back on Medtronic’s InFUSE woes, recent federal court rulings have, in the majority of cases, held that off-label claims fail to trump federal preemption.  For example, in one typical case, Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013), the plaintiff filed state-law claims (negligence, strict products liability – failure to warn, breach of warranty, fraud, etc.) against Medtronic, based on the off-label use of InFUSE during her posterior lumbar surgery.  Specifically, although InFUSE had been approved for use in lumbar surgery through the abdomen (anterior), it had not been approved for use in lumbar surgery through the back (posterior).  Thus, by couching her state court claims on Medtronic’s supposed violations of FDCA rules against off-label promotion, the plaintiff had hoped to avoid preemption under both the express provisions of 21 U.S.C. § 360k — which essentially prohibits safety and efficacy-based claims against a PMA approved medical device that are “different from, or in addition to” any FDA requirements — and the doctrine of implied preemption.  Although the plaintiff had hoped that her off-label allegations would be construed as a “parallel violation” of a state law claim (albeit based on conduct that supposedly violated the FDCA), which is not preempted under Riegel v. Medtronic, 552 U.S. 312 (2008), the district court held that the plaintiff’s claims were not based on conduct that would give rise to a recovery in the absence of the FDCA:

[T]he conduct plaintiff complains of — how defendants are promoting and marketing to physicians the off-label use of the Infuse Device in posterior-approach lumbar spine surgery — is governed by the FDCA.  To determine whether said conduct is improper would require reliance on the requirements of the FDCA.  Further, even the concept of ‘off-label use’ is a creature of the FDCA, is defined by the FDCA, and is not a part [of state] substantive law.  While plaintiff couches her claim as a state law negligence claim, this claim is, in substance, a claim for violating the FDCA and, thus, is clearly preempted under [Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001)].  Caplinger, 921 F. Supp. 2d at 1223-24.

Since the plaintiff in Caplinger, was really just trying to enforce her interpretation of the FDCA’s rules regarding off-label promotion, the court found that her suit did not establish a parallel violation of state law and, therefore, was subject to preemption and dismissal.  Even additional information about Medtronic’s manipulation of clinical trial data related to InFUSE, did not move the court this past April to reconsider its February ruling or to allow the plaintiff leave to file an amended complaint.  Most courts facing similar suits to Caplinger have arrived at the same conclusion.  See e.g., Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 9, 2013); Lawrence v. Medtronic, Inc., 2013 WL 4008821 (D. Minn. Aug. 7, 2013); Gavin v. Medtronic, Inc., 2013 WL 3791612 (E.D. La. Jul. 19, 2013).


While Caplinger and similar court decisions underscore the limits of using off-label promotion in lawsuits involving PMA-cleared medical devices, what is perhaps far more important for medical device and pharmaceutical manufacturers in other contexts is the utter lack of sympathy some courts have for the premise that off-label promotion is unlawful conduct in the first instance.  As the court in Dawson made clear,

[F]or any of these claims to survive . . . the court must accept Plaintiff’s premise  that off-label promotion is illegal under the FDCA, and this court cannot do so . . . This court is not convinced that off-label promotion violates the FDCA.  Consequently, any state laws proscribing off-label promotion would establish requirements ‘different from, or in addition to, any requirement under the MDA and would be expressly preempted.  Dawson, 2013 WL 4048850 at *6.

See also Lawrence, 2013 WL 4008821 (“This court does not necessarily agree that federal law prohibits all promotion of off-label uses of medical devices”).

These decisions signal that, when given the opportunity, judges harbor real doubts that off-label marketing is illegal in the first place.  As we approach the one year anniversary of the Caronia decision, in which a divided Second Circuit ruled that truthful, accurate and non-misleading off-label promotion is constitutionally protected free speech, it is frustrating that so little has changed the “status quo.”   All “good” and “bad” things come to an end, however, and, while it may take years for another Caronia to come down the pike, this writer is certain that day will come.







About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

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