We frequently post about developments in medical device preemption.  Preemption doctrine is a key issue in medical device product liability cases, and often a powerful tool for medical device manufacturers defending product liability claims.  As a general matter, under preemption doctrine, devices approved by a premarket approval application (PMA) are exempt from common law claims that impose requirements different from or in addition to FDA’s requirements, see Riegel v. Medtronic, 552 U.S. 312, 330 (2008), while 510(k) devices are generally not subject to preemption, see Medtronic v. Lohr, 518 U.S. 470, 492 (1996).

In products liability litigation, plaintiffs are constantly searching for strategies to avoid preemption.  Some have made arguments that preemption does not bar their claim(s) because even though the FDA granted PMA approval to the medical device as whole or as a system, it did not grant PMA approval of the specific component they claim is defective and caused the alleged injury.  This argument has particular appeal where the allegedly defective component of the device had independently been cleared through the 510(k) process.

However, there have been string of cases rejecting such attempts to break down medical devices into their component parts for purposes of imposing liability.  Indeed, over the past several years, there have been a number of cases holding that preemption applies to all components of a PMA-approved device, even if the component at issue had previously been marketed through the 510(k) clearance process.  For manufacturers that face similar arguments in product liability actions, marshaling this favorable case law can provide a powerful counterargument.   Accordingly, below is a list of the cases we have found addressing this issue.

  • Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) – The court of appeals affirmed the district court’s preemption finding in a case involving the acetabular shell of the Trident artificial hip system, holding that district court was correct not to break device into component parts.
  • Eidson v. Medtronic, Inc., 2013 WL 5533081, *8 n.3 (N.D. Cal. Oct. 3, 2013) – In Eidson, the court rejected the plaintiff’s argument that specific FDA requirements for the device did not apply because the FDA had granted premarket approval to the Infuse Bone Graft used in conjunction with the LT Cage, but the Infuse Bone Graft was used during the plaintiff’s surgery without the LT Cage.
  • Gavin v. Medtronic, Inc., 2013 WL 3791612, *11 (E.D. La. July 19, 2013) – The court rejected the plaintiff’s argument that “the PMA was granted on the Device [the Infuse Bone Graft used with the LT Cage] and does not apply to the INFUSE Bone Graft component of the Device.”
  • Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, *12 (D.N.J. Mar. 18, 2013) – “[A]lthough the patella and femoral components of the RP Knee were initially [cleared] through the 510(k) process, the RP Knee as a whole received PMA.  As a result, the patella and femoral components still underwent the PMA process as components of the RP Knee.  Consequently, Plaintiff has not shown a genuine issue of material fact regarding preemption.”
  • Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 471 (D. Mass. 2012) – Duggan involved insulin delivery system that combined an insulin monitor with a screen display and an insulin pump.  The device as a whole was granted PMA approval, but prior to that the insulin pump had received 510(k) clearance.  The court explained that once PMA approval is granted for a device, “all claims relating to all components of the device are preempted,” even if the component at issue had previously been marketed through the 510(k) clearance process.
  • Gross v. Stryker Corp., 858 F. Supp. 2d 466, 487 (W.D. Pa. 2012) – In Gross, the court explained that “a device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption” and refused to view the acetabular shell of the Trident artificial hip system separately from the rest of the device.
  • Bentzley v. Medtronic, Inc., 827 F. Supp. 2d 443, 452 (E.D. Pa. 2011) – Bentzley involved insulin delivery system that combined an insulin monitor with a screen display and an insulin pump.  The device as a whole was granted PMA approval, but prior to that the insulin pump had received 510(k) clearance.  The court stated, “Plaintiff’s contention that, in considering a preemption issue, the Court must break a medical device into its component parts, is without legal support.”
  • Wilhite v. Howmedica Osteonics Corp., 833 F. Supp. 2d 753, 762 (N.D. Ohio 2011) – In a case involving a ceramic hip prosthesis, one component of which had originally received 510(k) clearance, the court held that “components of medical devices will not be separately considered when the device as a whole underwent the PMA process and received approval.”
  • Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010) – In a case involving a ceramic hip prosthesis, preemption applied because the device had received PMA approval, even though the allegedly defective component had previously been cleared through the 510(k) process.
  • Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010) – In a case involving a ceramic hip prosthesis, preemption applied because the device had received PMA approval, even though the allegedly defective component had previously been cleared through the 510(k) process.
  • Lewkut v. Stryker Corp., 724 F. Supp. 2d 648 (S.D. Tex. 2010) – In a case involving a ceramic hip prosthesis, preemption applied because the device had received PMA approval, even though the allegedly defective component had previously been cleared through the 510(k) process.
  • Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009) – In a case involving a ceramic hip prosthesis, preemption applied because the device had received PMA approval, even though the allegedly defective component had previously been cleared through the 510(k) process.
  • Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) – Riley involved a stent coated with a drug to prevent clotting.  The court held that “[i]t makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components.”