Braun v. Medtronic Sofamor Danek

CourtCourt of Appeals for the Tenth Circuit
DecidedDecember 14, 2017
Docket15-4173
StatusUnpublished

This text of Braun v. Medtronic Sofamor Danek (Braun v. Medtronic Sofamor Danek) is published on Counsel Stack Legal Research, covering Court of Appeals for the Tenth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Braun v. Medtronic Sofamor Danek, (10th Cir. 2017).

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* This order and judgment is not binding precedent, except under the doctrines of law of the case, res judicata, and collateral estoppel.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

2 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

3 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.

4 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

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