Minisan v. Danek Medical, Inc.

• Decision Date: 24 November 1999
• Docket Number: No. 3:96 CV 183 AS.,3:96 CV 183 AS.
• Citation: 79 F.Supp.2d 970
• Parties: Amy MINISAN, Plaintiff, v. DANEK MEDICAL, INC., Defendant.
• Court: U.S. District Court — Northern District of Indiana

79 F.Supp.2d 970

Amy MINISAN, Plaintiff, v. DANEK MEDICAL, INC., Defendant.

No. 3:96 CV 183 AS.

United States District Court, N.D. Indiana, South Bend Division.

November 24, 1999.

Richard W. Morgan, Sweeney Pfeifer & Morgan, South Bend, for Amy L. Minisan, plaintiffs.

Mary J. Hoeller, Dina M. Cox, Lewis and Wagner, Indianapolis, for Sofamor-Danek Group, Inc., an Indiana Corporation, Sofamor S N C, an Indiana Corporation doing business in the United States of America, Sofamor Inc., a Georgia Corporation, defendants.

MEMORANDUM AND ORDER

ALLEN SHARP, District Judge.

This cause is before the Court on Defendant's, Danek Medical, Inc. (Danek) Motion for Summary Judgment. Defendant filed its Summary Judgment motion on June 30, 1999. The Court provided Plaintiff with several extensions of time in which to respond. The November 15, 1999 deadline has passed with no further filings by Plaintiff, accordingly, this motion is now ripe for ruling.

JURISDICTION

This case was originally filed in the St. Joseph County Circuit Court. Defendants filed for removal claiming jurisdiction pursuant to 28 U.S.C. § 1331 (Federal Question), the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 and 21 C.F.R. § 800.

I. BACKGROUND

This case is another of more than two thousand separate products liability actions filed in this country by more than five thousand plaintiffs claiming that defective "pedicle screw fixation devices" which were surgically attached to the pedicles of their spines during spine fusion surgery have caused them to suffer physical injuries. Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multi district Litigation (MDL) transferred these cases to the United States District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings. The MDL court, through Judge Louis C. Bechtle, managed the litigation through extensive procedural matters, including dismissal of the original complaints, the filing of amended omni complaints, discovery, and the resolution of numerous motions. In April 1997, Judge Bechtle issued a thorough opinion in In re: Orthopedic Bone Screw Products Liability Litigation, No. MDL 1014, 1997 WL 186325 (E.D.Pa. Apr.16, 1997), aff'd, 193 F.3d 781 (3d Cir.1999), detailing the plaintiffs' allegations in the consolidated omni actions, describing the pertinent regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and its Medical Device Amendments, 21 U.S.C. § 360(a) et seq. The pre-trial proceedings have now been completed as respects pleading, discovery, and motions that the transferee court determined could and should be considered in the transferee court. The motions that remain to be considered, when filed in the transferor courts are those that are both case and fact specific as opposed to motions that would affect issues that apply to either substantial numbers of cases or all cases in MDL No. 1014. Accordingly, the MDL court has remanded Minisan's case to this Court. See In re: Orthopedic Bone Screw Products Liability Litigation, 1998 WL 411380 (E.D.Pa. June 30 1998).

A. Medical Device Amendment

Under the Medical Device Amendments ("MDA") to the Federal Food, Drug and Cosmetic Act ("FDCA"), medical devices intended for human use are classified as Class I, II, or III devices. Class I devices are considered to present the least risk to human safety and are subject to "general controls;" Class II devices present more risks to human safety than Class I devices and are subject to special controls; and Class III devices present the most risk to human safety and are subject to "premarket approval," which is designed to provide a "reasonable assurance of ... safety and effectiveness" for the most dangerous medical devices. See 21 U.S.C. §§ 360c(a)(1)(C), 360e(e) and 360i(a). Premarket approval under the MDA requires applicants to submit an application detailing: 1) extensive safety testing data; 2) the contents and operation of the device; 3) a description of methods used to manufacture, process, package, and install the device; 4) samples of the device; 5) proposed labeling for the device; and 6) all other information requested by the FDCA. 21 U.S.C. § 360e(c)(1). Once the device is approved, the Federal Food and Drug Administration ("FDA") regulations prohibit the device from being manufactured, packaged, stored, labeled, distributed, or advertised in a manner inconsistent with the conditions of approval. 21 C.F.R. § 814.80. The FDA retains the power to monitor the device and withdraw approval if the device becomes unsafe. 21 U.S.C. §§ 360e(e)(1)-(3) and 360(I).

B. Danek's TSRH Spinal System

Danek's Texas Scottish Rite Hospital (TSRH) Spinal System device consists of screws, hooks, rods, transverse traction devices, connectors and other components which may be customized, for spinal fusion surgery purposes, on a patient-by-patient basis. The TSRH construct, once surgically inserted, is intended to immobilize the diseased portion of the patient's spine by connecting adjacent spinal vertebrae with steel rods or plates. The rods or plates are anchored to the patient's spine by metal screws which are themselves inserted into the spinal pedicles.¹ Bone graft material, often in the form of small chips taken from the patient's hip bone, is then packed between and alongside the TSRH device. If spinal fusion surgery is successful, the grafted bone material eventually fuses together to form a solid bony mass that stabilizes the diseased portion of the spine. Danek initially sought to market the TSRH for fixation in the sacrum, and did not seek clearance from the FDA to market the TSRH screws for use in the pedicles. Because the FDA considered the TSRH screws as being substantially equivalent to another pre-enactment device various of its components were approved in early 1989, for marketing and labeling pursuant to the 510(k) process.² The FDA specified, however, that the screws could not be labeled nor promoted for pedicular fixation. (Treharne Aff. Ex. 1.)

In November, 1991 Danek received conditional approval to conduct an IDE trial to obtain clinical data on the safety and efficacy of pedicle fixation using the TSRH system. In January, 1992, the FDA approved the Danek TSRH Variable Angle Sacral Screw for use in the sacrum, ilium, and anterior portions of the spine as a substantially equivalent device. In January, 1995 the FDA cleared the stainless steel TSRH Spinal System to be marketed and labeled for pedicle fixation, only with certain restrictions. (Treharne Aff. Ex. 2.) The notice also asserted that Danek "may not label or in any way promote this device system and the TSRH spinal system, for which it is part of, for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis."

C. Amy Minisan

Plaintiff, Amy Minisan (Minisan) injured her back at work in July of 1992. She was initially diagnosed with a back strain, however, medical follow-up found her suffering from grade 2 spondylolisthesis.³ From July of 1992 until May of 1993, Minisan tried to relieve her pain through conservative treatment including pain medication, physical therapy and steroid injections. The treatment was unsuccessful. After obtaining several medical opinions, Minisan opted for spinal surgery to fuse her L5 and S1⁴ vertebrae.⁵ The surgery was performed on May 10, 1993 using Danek's implant device. The screws used in her surgery were marketed, labeled and sold under the January 22, 1992 clearance letter issued by the FDA.⁶ (Treharne Aff. Ex. 4.) She received some relief after the surgery and returned to work in August of 1993 only to have her back and leg pain recur. By January 26, 1994 tests revealed that at least two of the screws in the device had broken and Minisan had a second surgery implanting a new device in early May, 1994. She again returned to work and her pain recurred. She was diagnosed with pseudoarthrosis in November of 1995.⁷ In August of 1995 it was determined that Minisan's sacral screws had broken, however no further surgery was done. On September 24, 1996, Minisan injured her back in an auto accident and subsequently had a third spinal surgery. The procedure and results of that surgery are not involved in this case.

Minisan claims that Danek was negligent in designing, manufacturing, promoting, and providing warnings about the TSRH device and that the negligence proximately caused her continued pain and injury. Danek moves for Summary Judgment asserting that no proof of a product defect and no proof of medical causation exists.

I. SUMMARY JUDGMENT STANDARD

Summary judgment is proper if the pleadings, depositions, answers to interrogatories and admissions on file, together with any affidavits, show that there exists no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R.Civ.P. 56; Russo v. Health, Welfare & Pension Fund, Local 705, 984 F.2d 762 (7th Cir.1993). See also, Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

The initial burden is on the moving party to demonstrate, "with or without supporting affidavits," the absence of a genuine issue of material fact and that judgment as a matter of law should be granted in the moving party's favor. Celotex, 477 U.S. at 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 at — (quoting Fed.R.Civ.P. 56). A question of material fact is a question which will be outcome determinative of an issue in the case. The Supreme Court has instructed that the facts material in a specific case shall be determined by the substantive law controlling the given case or issue. Anderson, 477 U.S. at 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 at —.⁸ Once...