United States District Court, E.D. Pennsylvania
MICHAEL R. HRICIK,
STRYKER BIOTECH, LLC, et al
For MICHAEL R. HRICIK, Plaintiff: BIJAN ESFANDIARI, LEAD ATTORNEY, PRO HAC VICE, BAUM HEDLUND ARISTEI & GOLDMAN PC, LOS ANGELES, CA; DEREK T. BRASLOW, POGUST & BRASLOW LLC., CONSHOHOCKEN, PA.
For STRYKER BIOTECH, LLC, STRYKER CORPORATION, Defendants: JAMIE K. NEAL, LEAD ATTORNEY, STITES & HARBISON, PLLC, LOUISVILLE, KY; ROBERT M. CONNOLLY, LEAD ATTORNEY, PRO HAC VICE, STITES & HARBISON, PLLC, LOUISVILLE, KY; STEPHEN J. FINLEY, LEAD ATTORNEY, MADELINE M. SHERRY, GIBBONS P.C., PHILADELPHIA, PA.
For HOWMEDICA OSTEONICS CORP., A/K/A STRYKER ORTHOPEDICS, Defendant: ROBERT M. CONNOLLY, LEAD ATTORNEY, PRO HAC VICE, STITES & HARBISON, PLLC, LOUISVILLE, KY; STEPHEN J. FINLEY, LEAD ATTORNEY, MADELINE M. SHERRY, GIBBONS P.C., PHILADELPHIA, PA.
For MICHAEL COWGILL, KEVIN O'DARE, Defendant: MADELINE M. SHERRY, STEPHEN J. FINLEY, GIBBONS P.C., PHILADELPHIA, PA.
Juan R. Sánchez, J.
Plaintiff Michael R. Hricik brings claims against Stryker Biotech, LLC, Howmedica Osteonics Corporation, and Stryker Corporation (collectively, " Stryker" ), and two individual Stryker sales representatives, Michael Cowgill and Kevin O'Dare, arising out of Defendants' allegedly illegal promotion of an off-label use of
OP-1 Implant and Calstrux, two medical devices manufactured and marketed by Stryker. Hricik underwent spinal fusion surgery in which his surgeon used OP-1 Implant and Calstrux in the off-label manner promoted by Defendants and sustained serious and permanent injuries as a result. He seeks to hold Stryker and the sales representatives who promoted the off-label use to his surgeon liable for his injuries under a variety of legal theories.
After Hricik filed suit in state court, Stryker removed the case to this Court, asserting the case is within the district courts' original jurisdiction under the diversity statute, 28 U.S.C. § 1332. Although Hricik, Cowgill, and O'Dare are all alleged to be citizens of Pennsylvania, Stryker argues the requirement of complete diversity is nevertheless satisfied because Cowgill and O'Dare were fraudulently joined and their citizenship should therefore be disregarded for jurisdictional purposes. Hricik disputes that Cowgill and O'Dare were fraudulently joined and asks this Court to remand the case to the Court of Common Pleas of Philadelphia County. Because Stryker has not met its " heavy burden" to persuade the Court that there is " no reasonable basis in fact or colorable ground supporting" any of Hricik's claims against Cowgill and O'Dare, Boyer v. Snap-on Tools Corp., 913 F.2d 108, 111 (3d Cir. 1990) (citations omitted), Hricik's motion to remand will be granted.
OP-1 Implant is a Bone Morphogenic Protein (BMP) with the ability to stimulate, repair, and regenerate bone. In 2001, OP-1 Implant received limited FDA approval for use in patients with long bone fractures that failed to heal with other treatment and for whom autograft (i.e., bone harvested from the patient him or herself) was not feasible. A companion Stryker OP-1 product--OP-1 Putty--received limited FDA approval in 2004 for use in patients needing spinal fusion surgery after a prior spinal surgery had failed and for whom autograft was not feasible.
After receiving complaints from surgeons that the OP-1 products had " poor handling" and " insufficient volume," Stryker developed Calstrux for use as a " carrier" or " extender" with the OP-1 products to address these handling and volume issues. See Compl. ¶ ¶ 33-36. Although Stryker intended to promote Calstrux for use with its OP-1 products, it represented otherwise during the FDA approval process, and Calstrux ultimately received FDA approval to be marketed as " a bone void filler . . . indicated for surgically created osseous [bony] defects or osseous defects resulting from traumatic injury." Id. ¶ 41. FDA has never approved Calstrux for use with BMPs such as OP-1 Implant and OP-1 Putty. In August 2004, FDA specifically advised Stryker that Calstrux would " not be approved with use of other products such as BMPs." Id. ¶ 39. Moreover, in December 2005, FDA declined to
permit Stryker to initiate clinical trials to test the safety and efficacy of the combined use of OP-1 products and ...