Braun v. Medtronic Sofamor Danek

Court of Appeals for the Tenth Circuit·Decided December 14, 2017·No. 15-4173·Unpublished

Opinion

FILED

United States Court of Appeals Tenth Circuit

December 14, 2017

UNITED STATES COURT OF APPEALS Elisabeth A. Shumaker Clerk of Court

TENTH CIRCUIT

JOHN T. BRAUN, M.D.,

Plaintiff Counterclaim

Defendant - Appellee,

v. No. 15-4173 (D.C. No. 2:10-CV-01283-RJS)

MEDTRONIC SOFAMOR DANEK, (D. of Utah) INC.,

Defendant Counterclaimant -

Appellant.

ORDER AND JUDGMENT *

Before KELLY and HOLMES Circuit Judges. **

*

This order and judgment is not binding precedent, except under the doctrines of law of the case, res judicata, and collateral estoppel. It may be cited, however, for its persuasive value consistent with Fed. R. App. P. 32.1 and 10th Cir. R. 32.1.

**

The Honorable Neil Gorsuch heard oral argument in this appeal, but has since been confirmed as an Associate Justice of the United States Supreme Court; he did not participate in the consideration or preparation of this order and judgment. The practice of this court permits the remaining two panel judges, if in agreement, to act as a quorum in resolving the appeal. See 28 U.S.C. § 46(d); see also United States v. Wiles, 106 F.3d 1516, 1516 n.* (10th Cir. 1997) (noting this court allows remaining panel judges to act as a quorum to resolve an appeal); Murray v. Nat’l Broad. Co., Inc., 35 F.3d 45, 47–48 (2d Cir. 1994) (remaining two judges of original three-judge panel may decide petition for rehearing without third judge), cert. denied, 513 U.S. 1082 (1995).

INTRODUCTION

This case arises out of a dispute over a licensing agreement between an inventor, Dr. John Braun, and a medical device manufacturer, Medtronic Sofamor Danek (“Medtronic”). Dr. Braun conceived a device and method to treat adolescent scoliosis—a severe deformity of the spine—less invasively than current surgical treatment, which fuses the vertebrae and transforms what is normally a flexible series of joints into a rigid rod. As consideration for the assignment of his intellectual property in the invention, Medtronic offered Dr. Braun a higher than typical royalty and upfront payment and committed itself to uncommon and costly human trials for the device, which were anticipated to be necessary to obtain Food and Drug Administration (“FDA”) approval. But Medtronic instead attempted to obtain regulatory approval through a much less costly method, the 510(k) pathway, which does not require human trials, and never applied for permission to conduct human clinical studies. Dr. Braun, who over the course of about six years performed animal studies on his invention, became frustrated with the lack of development, and the relationship with Medtronic soured. This litigation resulted. At trial, Dr. Braun won an over $37 million dollar judgment, and Medtronic now appeals from the district court’s disposition of its Rule 50 and 59 post-trial motions, and also contends that the jury verdicts are inconsistent.

For the reasons stated below, we affirm the district court’s judgment in all

respects.

I. REGULATORY & MEDICAL BACKGROUND Before narrating the facts of the case, some background on the FDA approval process for medical devices as well as on scoliosis and its treatment will be helpful. Under the Medical Device Amendments of 1976, the FDA classifies medical devices according to the risk that they present, from Class I to Class III according to increasing degrees of risk. Medtronic, Inc. v. Lohr, 518 U.S. 470, 476–77 (1996). Class III devices are those “that either ‘presen[t] a potential unreasonable risk of illness or injury,’ or which are ‘purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.’” Id. at 477 (quoting 21 U.S.C. § 360c(a)(1)(C)). To bring a Class III device to market requires premarket approval (“PMA”), which requires rigorous and substantial proofs of safety and efficacy. Id.

Generally, to obtain PMA requires first obtaining an Investigational Device Exemption (“IDE”), which permits the device to be shipped for the limited purpose of human clinical trials to determine safety and efficacy. See TMJ Implants, Inc. v. Aetna, Inc., 498 F.3d 1175, 1189 (10th Cir. 2007). Human trials can be enormously costly, running into eight figures. But not all Class III devices must run this gauntlet.

Devices marketed before 1976 were permitted to remain on the market

without PMA. Lohr, 518 U.S. at 478. The FDA also subjects devices substantially equivalent to grandfathered devices to less rigorous scrutiny. Section 510(k) premarket notification is a relatively brief and inexpensive process and has become the most common means for bringing to market Class III medical devices. See id. at 477–79. No clinical trials are required for 510(k) approval.

Scoliosis is a spinal deformity affecting 2% to 4% of the population, and 90% of scoliosis cases are idiopathic, that is, of unknown cause. This disease mostly affects adolescents, hence the term “adolescent idiopathic scoliosis” (“AIS”). The other major variant of the disease is early onset scoliosis (“EOS”), which afflicts children under the age of 10. 1 Treatment options are limited to observation, bracing (of limited effectiveness), and fusion surgery. Fusion surgery is a “brutal[,] maximally invasive” procedure that “eliminates the spine as a spine and makes it a big, long, rigid segment.” App., Vol. XXIV, at 6129 (Tr., Test. of Dr. Braun, dated Feb. 20, 2014); see also id. at 6131 (“It’s now like a femur in your back.”).

Fusion surgery requires two steps. First, hardware (typically rods and screws) are installed along the vertebrae to straighten the spine and hold it in place. Next, the vertebrae are prepared for fusion. This requires “rip[ping] the

1 EOS is subject to different treatment protocols and surgeries, which typically require regular surgery every six months to adjust the hardware installed along the spine to account for the child’s growth. See App., Vol. XXIV, at 6133.

surfaces off the bone” in order for the bone to heal “and form a bridge across all the segments” to which hardware was installed. Id. at 6130. This removal of the outer surface of the bone to reveal the interior “spongy bone, . . . the part that bleeds,” results in serious pain and requires six months to heal. Id. In the long term, fusion prevents the growth of the spine, resulting in a shorter trunk and decreased lung function. It also causes long-term back issues in the unfused vertebrae below the fusion because the forces that the spine bears become concentrated on the disks of those vertebrae. Additionally, fusion results in massive scarring, and can result in psychological issues. Because of the drawbacks of fusion surgery, Dr. Braun and others have investigated less invasive ways of correcting scoliosis while also permitting the spine to continue to move. Fusionless scoliosis surgery aims to achieve these goals both by correcting the spine at the time of surgery and obtaining correction over time by redirecting the growth of the spine.

Generally, fusionless treatment involves the installation of hardware to the vertebrae which are then linked by some flexible material that can be tensioned to both provide correction and prevent further curvature. Various approaches to this treatment include staple, screw and tether (sometimes termed “anterior tether”), and anchor and tether—the last of which is Dr. Braun’s invention. 2

2 The terms anterior and posterior are frequently used to describe whether the device is intended to be installed from the back (posterior)—a more (continued...)

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