In Re: Orthopedic Bone Screw Products Liability Litigation
Decision Date | 07 October 1999 |
Docket Number | Nos. 98-1762,s. 98-1762 |
Citation | 193 F.3d 781 |
Parties | (3rd Cir. 1999) IN RE: ORTHOPEDIC BONE SCREW PRODUCTS LIABILITY LITIGATION Plaintiffs Legal Committee, Appellant at 98-1762 American Academy of Orthopaedic Surgeons, North American Spine Society, and Scoliosis Research Society (the Medical Associations), Appellants at 98-1829 & 98-1829 |
Court | U.S. Court of Appeals — Third Circuit |
On Appeal from the United States District Court for the Eastern District of Pennsylvania MDL No. 1014 (Honorable Louis C. Bechtle) [Copyrighted Material Omitted] MICHAEL D. FISHBEIN, ESQUIRE (ARGUED) ARNOLD LEVIN, ESQUIRE SANDRA L. DUGGAN, ESQUIRE Levin, Fishbein, Sedran & Berman 510 Walnut Street, Suite 500 Philadelphia, Pennsylvania 19106, for Plaintiffs Legal Committee, Appellant at 98-1762/ Cross-Appellee at 98-1829
FREDERICK KRUTZ, ESQUIRE (ARGUED) Forman, Perry, Watkins, Krutz & Tardy 188 East Capitol Street One Jackson Place, Suite 1200 Jackson, Mississippi 39225-2608 Attorney for American Academy of Orthopaedic Surgeons, North American Spine Society, and Scoliosis Research Society, Appellees at 98-1762/ Cross-Appellants at 98-1829
MITCHELL A. STEARN, ESQUIRE Porter, Wright, Morris & Arthur 1667 K Street, N.W., Suite 1100 Washington, D.C. 20006, NORMAN J. JEDDELOH, ESQUIRE Arnstein & Lehr 120 South Riverside Plaza, Suite 1200 Chicago, Illinois 60606 Attorneys for American Academy of Orthopaedic Surgeons, Appellee at 98-1762/ Cross-Appellant at 98-1829
DANIEL J. MULHOLLAND, ESQUIRE Forman, Perry, Watkins, Krutz & Tardy 188 East Capitol Street One Jackson Place, Suite 1200 Jackson, Mississippi 39225-2608, SHAWN M. COLLINS, ESQUIRE The Collins Law Firm 1979 North Mill Street, Suite 109 Naperville, Illinois 60563 Attorneys for North American Spine Society, Appellee at 98-1762/ Cross-Appellant at 98-1829
JANET L. MacDONELL, ESQUIRE Deutsch, Kerrigan & Stiles 755 Magazine Street New Orleans, Louisiana 70130 Attorney for Scoliosis Research Society, Appellee at 98-1762/ Cross-Appellant at 98-1829
PHILIP H. LEBOWITZ, ESQUIRE (ARGUED) Pepper, Hamilton & Scheetz 18th & Arch Streets 3000 Two Logan Square Philadelphia, Pennsylvania 19103-2799 Attorney for Danek Medical, Inc., Sofamor, S.N.C., Sofamor Danek Group, Inc., Warsaw Orthopedic, Inc., Sofamor, Inc., Texas Scottish Rite Hospital for Children,
SUSAN S. WETTLE, ESQUIRE DOUGLAS W. LANGDON, ESQUIRE Brown, Todd & Heyburn 400 West Market Street, Suite 3200 Louisville, Kentucky 40202 Attorneys for Youngwood Medical Specialties, Inc., f/k/a National Medical Speciality, Inc., f/k/a Stuart Medical Specialty, Inc.; Stuart Medical, Inc., f/k/a Stuart Drug and Surgical Supply, Inc., Appellees at 98-1762/1829
BRENDA N. HIGHT, ESQUIRE McManemin & Smith 600 North Pearl Street, Suite 1600 Dallas, Texas 75201 Attorney for Estate of David K. Selby, Appellee at 98-1762/1829
Before: SCIRICA, ROTH and McKAY,* Circuit Judges
This is an appeal of the District Court's dismissal under Fed. R. Civ. P. 12(b)(6) of conspiracy and concert of action claims alleged by thousands of plaintiffs in multidistrict litigation involving allegedly defective bone screw implantation devices. The District Court held the claims, insofar as they alleged a conspiracy to violate the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.A. S 301397 (West Supp. 1999), did not state a cause of action upon which relief can be granted. Accordingly, the court granted defendants' motions to dismiss those claims.
The District Court also made several rulings unfavorable to the defendants. The court denied with prejudice their motions to dismiss based on improper pleading and First Amendment protection. Additionally, the District Court denied the motions of several defendants for attorney's fees, costs, and sanctions. These rulings are now challenged on cross-appeal.
We will affirm the judgment of the District Court on all issues.
This multidistrict litigation comprises more than 2,000 civil actions originally filed in approximately sixty of the ninety-four federal districts. In August 1994, the cases were consolidated in the Eastern District of Pennsylvania under 28 U.S.C. S 1407. All of the approximately 5,000 individual plaintiffs claim to have suffered physical injuries caused by defective orthopedic bone screw devices affixed to the pedicles of their spines during spinal fusion surgery. The devices, which are intended to stabilize the spine and achieve fusion of the vertebrae, consist of rods or plates that are screwed into the vertical axis of the lumbar spine. In most cases, plaintiffs allege the devices broke after being implanted in their spines. In some instances, plaintiffs have undergone surgery to have the devices removed; in others, the broken devices could not be removed.
Plaintiffs' original claims, filed in early 1994, set forth causes of action based on both federal statutes and state law tort and contract principles. Generally, they named as defendants only the manufacturers and distributors of the bone screw devices. Subsequent actions named a broader array of defendants and stated additional theories of recovery. In particular, hundreds of so-called "omni" actions, first brought in October 1995, name as defendants the manufacturers, designers, and distributors of the devices; trade associations that conducted seminars on their use; regulatory consultants; and physicians who promoted the product. There are two types of omni actions. The Plaintiffs' Legal Committee ("PLC") actions allege both a horizontal conspiracy involving manufacturers and a vertical conspiracy involving all of the defendants. The Lestelle actions (so named after the attorney who drafted the form complaint that served as the basis of these actions) allege only a horizontal conspiracy involving manufacturers. In addition to the conspiracy and concert of action claims, the omni complaints allege fraud; negligent misrepresentation; strict liability in tort; liability per se; negligence; breach of implied warranty of merchantibility; and (in some cases) loss of consortium.
In August 1996, the District Court dismissed the PLC omni complaints in their entirety because the complaints failed to demonstrate subject matter jurisdiction. See In re Orthopedic Bone Screw Prods. Liability Litig., MDL No. 1014, 1996 WL 482977 (E.D. Pa. Aug. 22, 1996) (Pretrial Order No. 477). The court also dismissed the conspiracy claims in both the PLC and the Lestelle complaints for failure to state a claim upon which relief could be granted, and it dismissed the fraud claims in the Lestelle complaints because the circumstances of fraud were not averred with sufficient particularity. See id. All of these dismissals were without prejudice. Plaintiffs subsequently filed hundreds of amended omni complaints, which are the subject of this appeal.1
Twice before, we have issued decisions in this litigation. First, we denied the petitions of some defendants for a writ of mandamus invalidating the District Court's dismissal of the conspiracy and concert of action claims. See In re Orthopedic Bone Screw Prods. Liability Litig., No. 97-1426, 1427, 1438, 1450, 1453, 1465, mem. op. (3d Cir. Nov. 10, 1997) (unpublished opinion). There we considered two of the arguments raised by defendants here: their claim that the First Amendment prohibits imposition of liability for their speech at the seminars, and their contention that the omni complaints fail to plead reliance and causation adequately. Although these arguments did not persuade us to grant the "extraordinary remedy" of mandamus relief, In re Asbestos Sch. Litig. (Pfizer Inc.), 46 F.3d 1284, 1288 (3d Cir. 1994), we noted that the standards governing a mandamus petition are more stringent than those governing a direct appeal, and that our disposition did not preclude defendants from asserting their arguments at a later stage in the proceedings. Accordingly, our denial of a writ of mandamus has no binding effect in the present appeal. More recently, we determined that plaintiffs' state law claims of fraud on the FDA were not preempted by the Medical Device Amendments of 1...
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