In Re: Orthopedic Bone Screw Products Liability Litigation

Decision Date07 October 1999
Docket NumberNos. 98-1762,s. 98-1762
Citation193 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
CourtU.S. Court of Appeals — Third Circuit

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

THOMAS G. STAYTON, ESQUIRE Baker & Daniels 300 North Meridian Street, Suite 2700 Indianapolis, Indiana 46204, ALBERT J. DAHM, ESQUIRE Baker & Daniels 111 East Wayne Street, Suite 800 Fort Wayne, Indiana 46802 Attorneys for Zimmer, Inc., Appellee at 98-1829

MICHAEL R. FRUEHWALD, ESQUIRE Barnes & Thornburg 11 South Meridian Street, Suite 1313 Indianapolis, Indiana 46204 Attorney for Ace Medical Company and DePuy Motech, Inc., Appellees at 98-1762

J. KURT STRAUB, ESQUIRE Obermayer, Rebmann, Maxwell & Hippel 1617 John F. Kennedy Boulevard One Penn Center, 19th Floor Philadelphia, Pennsylvania 19103 Attorney for Scientific Spinal, Ltd., Appellee at 98-1762

ROBERT R. REEDER, ESQUIRE Cozen & O'Connor The Atrium 1900 Market Street Philadelphia, Pennsylvania 19103 Attorney for Synthes, Inc., Synthes (USA), and Synthes North America, Inc., Appellees at 98-1762/1829

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,

Eduardo Luque, M.D., Charles E. Johnston, II, M.D., Richard Ashman, Ph.D., Gary Lowery, M.D., George S. Rapp, M.D., Ensor Transfeldt, M.D., John A. Herring, M.D., Thomas Whitecloud, III, M.D., Thomas Zdeblick, M.D., Appellees at 98-1762

RAYMOND J. PAJARES, ESQUIRE Aubert & Pajares 3850 North Causeway Boulevard Two Lakeway Center, Suite 1650 Metarie, Louisiana 70002 Attorney for Advanced Spine Fixation System, Inc., Appellee at 98-1762

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

JAMES B. IRWIN, ESQUIRE NATHAN T. GISCLAIR, ESQUIRE Montgomery, Barnett, Brown, Read, Hammond & Mintz 1100 Poydras Street 3200 Energy Centre New Orleans, Louisiana 70163-3200 Attorneys for Smith & Nephew, Inc., Appellee 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

CAROLINE P. GOLDEN, ESQUIRE JOHN N. SCHOLNICK, ESQUIRE BRADLEY C. TWEDT, ESQUIRE Neal, Gerber & Eisenberg Two North LaSalle Street, Suite 2300 Chicago, Illinois 60602 Attorneys for GICD/USA Institute, Inc., Appellee at 98-1762/1829

Before: SCIRICA, ROTH and McKAY,* Circuit Judges

OPINION OF THE COURT

SCIRICA, Circuit Judge.

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.

I. BACKGROUND

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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