Plaintiff Has Standing in Defective Device Lawsuit

Pursuant to Rule 12(b) of the Federal Rules of Civil Procedure, St. Jude moved for dismissal of the complaint, asserting Sutton lacked standing to pursue his action and that he failed to state a claim upon which relief could be granted. The district court found Sutton's alleged injury “purely hypothetical” because he did not provide the court with “any information from which to assess his allegedly increased risk of harm from implantation of the aortic connector.” Sutton v. St. Jude Med. Inc., 292 F. Supp. 2d 1005, 1008-09 (W.D. Tenn. 2003). The thrust of the district court's decision was that Sutton failed to establish a sufficient risk of harm associated with the device to survive dismissal for lack of standing.

The Sixth Circuit's Analysis

The appellate court noted that in order to satisfy the standing requirements of Article III of the Constitution, Sutton had to meet three prerequisites. First, he had to demonstrate that he had suffered an “injury in fact” that could be characterized as both concrete and particularized and actual or imminent; second, that the injury was fairly traceable to the challenged action of St. Jude; and, third, that it was likely, as opposed to merely speculative, that the injury would be redressed by a favorable decision. (These Article III standing requirements apply also to class actions, with the added requirement that as class representative, Sutton was required to allege an individual, personal injury in order to seek relief on behalf of himself or any other member of the class. See O'Shea v. Littleton, 414 U.S. 488 (1974)).

There was little dispute as to the second and third requirements for standing under Article III, as any harm caused by the device was definitely traceable to St. Jude and the injury could be at least partially redressed by the creation of a medical monitoring fund or payment for removal of the defective devices. Thus, the primary question before the court was whether Sutton could show a constitutionally cognizable “injury in fact.”

Sutton made three main factual allegations in his complaint, that: 1) the device was defective and unreasonably dangerous; 2) implantation of the device put Sutton and class members at a substantially greater risk for developing restenosis and occlusion of the bypass graft; and 3) this increased risk necessitated both current and future medical testing and monitoring. These allegations the district court found “purely hypothetical.” It based its opinion in part on the Sixth Circuit's holding in Taylor v. Medtronics Inc., 861 F2d 980 (6th Cir. 1988), in which the appellate court affirmed judgment as a matter of law for a defendant on a products liability claim after finding that the evidence showed that the plaintiff's particular pacemaker was not defective, even though there was a high incidence of defects in that model of pacemaker. The district court's reliance on Taylor here was misplaced, said the Sixth Circuit, as that case was not about standing, but about the merits. The Taylor court's grant of summary judgment was upheld not because the plaintiff's failure to show her actual pacemaker was defective deprived her of standing, but because her claim was not meritorious.

In Sutton, the court held, the district court incorrectly attempted to evaluate the merits of Sutton's contention that he was entitled to medical monitoring costs during the threshold standing inquiry. In the Sixth Circuit's eyes, Sutton had alleged sufficient facts, when accepted as true, to suggest an increased risk of future harm resulting from being implanted with St. Jude's device. Whether Sutton was likely to prevail on the merits was not a proper consideration at the phase of trial in which standing was contested. Thus, dismissal was not warranted on the basis of a lack of standing.

The States Differ

The case was remanded to the district court, where the question will be whether Tennessee law allows for recovery for medical monitoring when there is no current physical injury. As the Sixth Circuit noted in its opinion, “Tennessee law is murky on the issue.”

Most states allow plaintiffs who can show possible future harm to recover for medical monitoring in at least some circumstances. For example, such recovery is sometimes allowed in Colorado, the District of Columbia, Kansas, Kentucky, New York, Pennsylvania, Utah and Washington. See Cook v. Rockwell Intern. Corp., 755 F. Supp. 1468 (D. Colo. 1991) (district court concluding that Colorado Supreme Court would recognize a tort claim for medical monitoring); Friends For All Children Inc. v. Lockheed Aircraft Corp., 241 U.S. App. D.C. 83 (D.C. Cir. 1984) (holding District of Columbia recognizes a cause of action for medical monitoring without manifestation of physical injury); Burton v. R.J. Reynolds Tobacco Co., 884 F. Supp. 1515 (D. Kan. 1995) (stating that a claim is recognized in Kansas only if the plaintiff has not yet suffered injuries; otherwise, medical monitoring is merely a component of damages); Bocook v. Ashland Oil Inc., 819 F. Supp. 530 (S.D. W. Va. 1993) (applying Kentucky law and finding that a plaintiff who could present evidence of need for medical monitoring did not need to prove “a demonstrable physical injury”); Gibbs v. E.I. DuPont DE Nemours & Co. Inc., 876 F. Supp. 475 (W.D.N.Y. 1995) (holding that New York recognizes “a claim for medical monitoring in the absence of a physical injury); In re Paoli R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir. 1994) (Pennsylvania) (setting out a four-step test for when medical monitoring is appropriate and finding that physical injury is not necessary), cert. denied, 115 S. Ct. 1253 (1995); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970 (Utah 1993) (holding medical monitoring available to those who have ingested, inhaled, injected or otherwise absorbed a toxic substance that results in an increased risk of serious injury and medical testing will provide a substantial benefit); In re Hanford Nuclear Reserv. Litig., 780 F. Supp. 1551 (E.D. Wash. 1991) (holding Washington takes same view as Pennsylvania regarding medical surveillance, see Paoli, supra).

In other jurisdictions, like Delaware, Virginia and West Virginia, plaintiffs cannot recover for medical monitoring until they have manifested some physical injury. See Mergenthaler v. Asbestos Corp., 480 A2d 647 (Del. 1984) (holding asbestos-exposure plaintiffs must show physical injury before the defendants must bear expenses for medical surveillance); Ball v. Joy Technologies Inc., 958 F2d 36 (4th Cir. 1991) (holding that West Virginia and Virginia require that the plaintiffs demonstrate that they are suffering from a present, physical injury before they are entitled to recover medical surveillance costs), cert. denied, 502 U.S. 1033 (1992).

Whatever the ultimate outcome of Sutton, the Sixth Circuit's change of focus away from the merits of the case to the fundamental question of standing under Article III of the Constitution puts a different twist on the approach needed when seeking dismissal of suits that ask for medical monitoring.

A patient implanted with a medical device is vulnerable to injury if that device is defective, even long after the operation and recovery phases have passed. Some courts have recognized a right to certain types of recovery when there is a prospect of future injury, but others have not. In the recent case of Sutton v. St. Jude Medical S.C. Inc., 2005 U.S. App. LEXIS 18013 (6th Cir. 9/23/05), the U.S. Court of Appeals for the Sixth Circuit was asked to answer a related threshold question of first impression in a medical monitoring case: Does an increased risk of harm requiring current medical monitoring serve as a sufficient injury in fact to confer standing to sue?

Fear Caused By Defective Heart Device

In Sutton, plaintiff Michael Sutton, who had a heart condition, brought suit on behalf of a proposed class of persons who underwent cardiac bypass surgery that employed a medical device called the Symmetry Bypass System Connector (the device), manufactured, designed and distributed by St. Jude Medical, S.C. Inc., and St. Jude Medical Inc. (collectively St. Jude). Heart surgeons use this device during cardiac bypass surgery to attach saphenous vein grafts to the aortic surface of the heart without sutures. Sutton claimed that the device had “led to severe and disabling medical conditions resulting from collapse and scarring of the graft” in “numerous patients,” necessitating removal of the device and/or monitoring for further harm, including death. He alleged that St. Jude failed to use reasonable care and was negligent in designing the device, and further, that the device was defective, unreasonably dangerous and sold and marketed without proper warnings. Sutton complained that St. Jude had been made aware of the device's problem through incident reports, but continued to market it despite this knowledge. Sutton himself has as yet suffered no injury.

Pursuant to Rule 12(b) of the Federal Rules of Civil Procedure, St. Jude moved for dismissal of the complaint, asserting Sutton lacked standing to pursue his action and that he failed to state a claim upon which relief could be granted. The district court found Sutton's alleged injury “purely hypothetical” because he did not provide the court with “any information from which to assess his allegedly increased risk of harm from implantation of the aortic connector.” Sutton v. St. Jude Med. Inc. , 292 F. Supp. 2d 1005, 1008-09 (W.D. Tenn. 2003). The thrust of the district court's decision was that Sutton failed to establish a sufficient risk of harm associated with the device to survive dismissal for lack of standing.

The Sixth Circuit's Analysis

The appellate court noted that in order to satisfy the standing requirements of Article III of the Constitution, Sutton had to meet three prerequisites. First, he had to demonstrate that he had suffered an “injury in fact” that could be characterized as both concrete and particularized and actual or imminent; second, that the injury was fairly traceable to the challenged action of St. Jude; and, third, that it was likely, as opposed to merely speculative, that the injury would be redressed by a favorable decision. (These Article III standing requirements apply also to class actions, with the added requirement that as class representative, Sutton was required to allege an individual, personal injury in order to seek relief on behalf of himself or any other member of the class. See O'Shea v. Littleton , 414 U.S. 488 (1974)).

There was little dispute as to the second and third requirements for standing under Article III, as any harm caused by the device was definitely traceable to St. Jude and the injury could be at least partially redressed by the creation of a medical monitoring fund or payment for removal of the defective devices. Thus, the primary question before the court was whether Sutton could show a constitutionally cognizable “injury in fact.”

Sutton made three main factual allegations in his complaint, that: 1) the device was defective and unreasonably dangerous; 2) implantation of the device put Sutton and class members at a substantially greater risk for developing restenosis and occlusion of the bypass graft; and 3) this increased risk necessitated both current and future medical testing and monitoring. These allegations the district court found “purely hypothetical.” It based its opinion in part on the Sixth Circuit's holding in Taylor v. Medtronics Inc. , 861 F2d 980 (6th Cir. 1988), in which the appellate court affirmed judgment as a matter of law for a defendant on a products liability claim after finding that the evidence showed that the plaintiff's particular pacemaker was not defective, even though there was a high incidence of defects in that model of pacemaker. The district court's reliance on Taylor here was misplaced, said the Sixth Circuit, as that case was not about standing, but about the merits. The Taylor court's grant of summary judgment was upheld not because the plaintiff's failure to show her actual pacemaker was defective deprived her of standing, but because her claim was not meritorious.

In Sutton, the court held, the district court incorrectly attempted to evaluate the merits of Sutton's contention that he was entitled to medical monitoring costs during the threshold standing inquiry. In the Sixth Circuit's eyes, Sutton had alleged sufficient facts, when accepted as true, to suggest an increased risk of future harm resulting from being implanted with St. Jude's device. Whether Sutton was likely to prevail on the merits was not a proper consideration at the phase of trial in which standing was contested. Thus, dismissal was not warranted on the basis of a lack of standing.

The States Differ

The case was remanded to the district court, where the question will be whether Tennessee law allows for recovery for medical monitoring when there is no current physical injury. As the Sixth Circuit noted in its opinion, “Tennessee law is murky on the issue.”

Most states allow plaintiffs who can show possible future harm to recover for medical monitoring in at least some circumstances. For example, such recovery is sometimes allowed in Colorado, the District of Columbia, Kansas, Kentucky, New York, Pennsylvania, Utah and Washington. See Cook v. Rockwell Intern. Corp. , 755 F. Supp. 1468 (D. Colo. 1991) (district court concluding that Colorado Supreme Court would recognize a tort claim for medical monitoring); Friends For All Children Inc. v. Lockheed Aircraft Corp. , 241 U.S. App. D.C. 83 (D.C. Cir. 1984) (holding District of Columbia recognizes a cause of action for medical monitoring without manifestation of physical injury); Burton v. R.J. Reynolds Tobacco Co. , 884 F. Supp. 1515 (D. Kan. 1995) (stating that a claim is recognized in Kansas only if the plaintiff has not yet suffered injuries; otherwise, medical monitoring is merely a component of damages); Bocook v. Ashland Oil Inc. , 819 F. Supp. 530 (S.D. W. Va. 1993) (applying Kentucky law and finding that a plaintiff who could present evidence of need for medical monitoring did not need to prove “a demonstrable physical injury”); Gibbs v. E.I. DuPont DE Nemours & Co. Inc. , 876 F. Supp. 475 (W.D.N.Y. 1995) (holding that New York recognizes “a claim for medical monitoring in the absence of a physical injury); In re Paoli R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir. 1994) (Pennsylvania) (setting out a four-step test for when medical monitoring is appropriate and finding that physical injury is not necessary), cert. denied, 115 S. Ct. 1253 (1995); Hansen v. Mountain Fuel Supply Co. , 858 P.2d 970 (Utah 1993) (holding medical monitoring available to those who have ingested, inhaled, injected or otherwise absorbed a toxic substance that results in an increased risk of serious injury and medical testing will provide a substantial benefit); In re Hanford Nuclear Reserv. Litig., 780 F. Supp. 1551 (E.D. Wash. 1991) (holding Washington takes same view as Pennsylvania regarding medical surveillance, see Paoli, supra).

In other jurisdictions, like Delaware, Virginia and West Virginia, plaintiffs cannot recover for medical monitoring until they have manifested some physical injury. See Mergenthaler v. Asbestos Corp. , 480 A2d 647 (Del. 1984) (holding asbestos-exposure plaintiffs must show physical injury before the defendants must bear expenses for medical surveillance); Ball v. Joy Technologies Inc. , 958 F2d 36 (4th Cir. 1991) (holding that West Virginia and Virginia require that the plaintiffs demonstrate that they are suffering from a present, physical injury before they are entitled to recover medical surveillance costs), cert. denied, 502 U.S. 1033 (1992).

Whatever the ultimate outcome of Sutton, the Sixth Circuit's change of focus away from the merits of the case to the fundamental question of standing under Article III of the Constitution puts a different twist on the approach needed when seeking dismissal of suits that ask for medical monitoring.