Baker v. Danek Medical
| Decision Date | 05 August 1998 |
| Docket Number | No. GCA 95CV10154 MMP.,No. GCA 95CV10033 MMP.,GCA 95CV10033 MMP.,GCA 95CV10154 MMP. |
| Citation | 35 F.Supp.2d 865 |
| Parties | Shirley BAKER, Plaintiff. v. DANEK MEDICAL, et al., Defendants. |
| Court | U.S. District Court — Northern District of Florida |
Thomas J. Kliebert, Jr., Kliebert & Heltz PC, Gramercy, LA, for Shirley A. Baker, plaintiff.
Stephen B. Gallagher, Victor M. Halbach, William M. Corley, M. Scott Thomas, Marks, Gray, Conroy, J. Richard Moore, Moore, Smith & Moore, Jacksonville, FL, Mitchell A. Stearn, K. Thomas Shahriari, Porter, Wright, Morris, Washington, DC, Edwin S. Gault, Jr., Roland M. Slover, Fred Krutz, III, Daniel J. Mulholland, David H. Fulcher, Forman, Perry, Watkins, Jackson, MS, Janet L. MacDonell, W. Lee Kohler, Joseph L. McReynolds, Douglas R. Elliott, Deutsch, Kerrigan & Stiles LLP, New Orleans, LA, James Craig Corbett, Fisher, Rushmer, Werrenrath, Orlando, FL, Daniel J. Santaniello, Daniel J. Santaniello PA, Daniel J. Koleos, Luks, Koleos & Santaniello, Fort Lauderdale, FL, Rutledge, Richardson, Liles, Liles, Gavin & Costantino, Raymond Scott Costantino, Liles, Gavin & Costantino, Jacksonville, FL, Robert O. Stripling, Stripling, McMichael & Stripling PA, Gainesville, Constance Daniels, Constance Daniels PA, Tampa, FL, Charles R. Daniels, II, Stanton Shuler, Jr., Leake & Andersson LLP, New Orleans, LA, Richard J. Suarez, Hardeman & Suarez, Miami, FL, William S. Daskam, IV, Butler, Burnette & Pappas, John W. Weihmuller, Butler, Burnette & Pappas, Tampa, FL, Robert Reeder, Thomas R. Harrington, Elizabeth J. Chambers, Cozen & O'Connor, Philadelphia, PA, Gordon James, III, Heinrich, Gordon, Hargrove, Fort Lauderdale, FL, Cathy J. Goodwin, Heinrich, Gordon, Hargrove, Orlando, FL, Thomas G. Stayton, Baker & Daniels, Indianapolis, IN, Albert J. Dahm, Baker & Daniels, Fort Wayne, IN, Susan S. Wettle, Ann E. Eberle, Brown, Todd & Heyburn PLLC, Louisville, KY, for defendants.
This matter is before the Court on the following motions, following remand of this case from the MDL court:
(1) the Medical Associations' motion for summary judgment (doc. 60);
(2) Zimmer, Inc.'s motion for summary judgment (doc. 69);
(3) Warsaw Orthopedic, I., Sofamor, S.N.C., Sofamor-Danek Group, Sofamor, Inc., Danek Medical, Inc.'s motion for summary judgment (doc. 71);
(4) Richard Ashman, Ph.D., John A. Herring, M.D., Charles E. Johnston, II, M.D., Gary Lowery, M.D., Ph.D., George Rapp, M.D., Ensor E. Transfeldt, M.D., Thomas Whitecloud, III, M.D., Thomas A. Zdeblick, M.D., and Texas Scottish Rite Hospital for Children's motion to dismiss for lack of personal jurisdiction and motion for summary judgment (doc. 74);
(5) Youngwood Medical's motion for summary judgment (doc. 64);
(6) Synthes, USA, Synthes, Inc., and Synthes North America's motion for summary judgment (doc. 70);
(7) DePuy-Motech, Inc.'s motion for summary judgment (doc. 76);
(8) Cross Medical Products Inc.'s motion for summary judgment (doc. 63);
(9) Smith & Nephew Richards, Inc.'s motion for summary judgment (doc. 67);
(10) Spinal Science's Motion for Summary Judgment (doc. 72);
(11) Richard Treharne and Ermon Pickard's Motion for Summary Judgment (doc. 73); and
(12) Advanced Spine Fixation Systems, Inc.'s motion to dismiss for lack of personal jurisdiction (doc. 66).
The plaintiff has responded to all of these motions, and both parties have filed voluminous documentation supporting their positions. This matter is now ripe for disposition.
This case is one of more than two thousand separate products liability actions filed by more than five thousand plaintiffs claiming that defective "pedicle screw fixation devices" which have been surgically attached to the pedicles of their spine have caused them to suffer physical injuries.1 Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multi-district Litigation transferred these cases to the United States District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings, following which two separate groups of plaintiffs filed consolidated "Omni Actions." Generally speaking, the group of plaintiffs including Ms. Baker sued not only the manufacturers, designers and distributors of the devices on products liability theories of recovery, but they sued, as well, a number of medical associations, charging that these defendants had unlawfully conspired with the device manufacturers to promote, market and sell pedicle screw flxation devices to medical providers.
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. Notably, in December 1996, defendants filed motions to dismiss the Amended Omni Complaints. The motions were granted to the extent that they sought dismissal of the conspiracy and concert of action claims based on fraudulent submissions to the FDA. The motions were denied with prejudice to the extent that they were based on improper pleading and the First Amendment. The motions were denied without prejudice to the extent that they were based on state conspiracy law. See In re Orthopedic Bone screw Products Liability Litigation, MDL 1014, 1997 WL 186325 (E.D.Pa. April 16, 1997). Defendants petitioned the United States Court of Appeals for the Third Circuit for mandamus relief from the rulings concerning the First Amendment and state conspiracy law. The Third Circuit denied mandamus relief on both Issues. See In re Orthopedic Bone Screw Products Liab. Lit., No. 97-1426 (3d Cir.Sept. 23, 1997). Additionally, the MDL court granted partial summary judgment on all claims based upon fraud on the FDA. The Court concluded that no implied private right of action existed for violations of FDA regulations because the FDA alone has exclusive prosecutorial discretion regarding such violations. Finally, in In re Orthopedic Bone Screw Products Liability Litigation, 176 F.R.D. 158 (E.D.Pa.1997), the MDL court approved a $100 million settlement releasing all claims against AcroMed.
The following review of the factual allegations of plaintiff's complaint is taken from the MDL court's order in this case dismissing the conspiracy and concert of action claims based on allegedly fraudulent submissions to the FDA. In re Orthopedic Bone screw Products Liability Litigation, MDL 1014, 1997 WL 186325 (E.D.Pa. April 16, 1997). In Count II of the Amended Omni Complaints, Plaintiffs allege two distinct but overlapping conspiracies. The vertical conspiracy, titled the "Danek Conspiracy," comprises Danek and affiliated spine surgeons and engineers (the "Danek Conspirators").2 (Amended Complaint ¶ 130.) The horizontal conspiracy, titled the "Intercompany/Association Conspiracy," comprises Danek, other manufacturers,3 and associations of spine doctors (the "Intercompany/Association Conspirators").4 Id. ¶¶ 204, 206-10. According to the complaint, the conspiracies share the same three objectives: (1) causing certain spinal fixation devices to be placed in interstate commerce even though such devices had not received the proper FDA approvals; (2) promoting and marketing such devices for pedicle screw fixation and representing that they were safe and effective for pedicle screw fixation even though the devices were "investigational devices" when intended for such use and even though pedicle screw fixation was an "investigational use" only; and (3) promoting and marketing such devices through deceptive and misleading conduct. Id. ¶¶ 131, 205.
Because the conspiracies allegedly have the objective of unlawfully promoting and marketing pedicle screw fixation devices in violation of federal law, it is necessary to summarize the regulatory framework regarding such devices.
The FDA regulates the devices at issue in this litigation under 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., and regulations promulgated thereunder. The statute defines "device" as any article "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals...." 21 U.S.C. § 321(h). As this definition implies, whether an article is considered to be a regulated "device" under the FDCA depends on the article's "intended use." The intended use of a product may be derived from the manner in which the product is characterized in the marketplace — through labeling, marketing, advertising, and the like — by the product's vendor. See 21 C.F.R. § 801.4; United States v. Articles of Drug for Veterinary Use, 50 F.3d 497, 500 (8th Cir.1995). The FDA has classified the bone screw devices that are intended to achieve a fusion in the pedicle of the lumbar spine as "Class III" devices because they "present[ ] a potential unreasonable risk of illness or injury."5 21 U.S.C § 360c(a)(1)(C)(ii)(II). Class III devices generally require "pre-market approval" before they may be commercially distributed or sold. 21 U.S.C. §§ 360c(a)(1)(C), 360e. The FDA must deny pre-market approval, among other reasons, if there is a "lack of a showing of reasonable assurance" that the device is safe and effective "under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." 21 U.S.C. § 360e(d)(2)(A),(B). A demonstration of safety and efficacy sufficient to warrant marketing approval of a drug or device requires evidence from "well-controlled" clinical investigations conducted in accordance with generally accepted principles of epidemiology that minimize the risk of bias, confounding, or random error that would produce erroneous outcomes. 21 U.S.C. §§ 360e & 355(d); 21 C.F.R. §§ 814.20, 130.12.
A manufacturer may generate the scientific data necessary to obtain pre-market approval...
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