Thursday, July 03, 2008

No Injury Scorecard

Regular readers know that we’ve been keeping two “scorecards” – one for drug preemption, and one for device preemption. While we continue to update the drug preemption scorecard religiously, the device preemption scorecard is no longer necessary after Riegel settled the basic preemption issues – mostly in favor of our position.

Gluttons for (inflicting) punishment that we are, we’ve decided to create another scorecard to replace medical device preemption. What follows is a list – that we’ll keep current as best we can – of all drug and medical device decisions that have addressed claims brought by plaintiffs who have suffered no present injury. Cases in this scorecard will include both increased risk claims and claims involving intangible (as opposed to out of pocket) economic loss.

One difference, compared to our preemption scorecards, is that this one will be, in a sense, less complete. That’s because there is far more overlap in this area with decisions involving other products. Asbestos comes to mind with respect to increased risk claims. Automobile manufacturers have been common targets for claims of intangible economic loss.

We thought about including non-drug/device cases but, frankly, even we have our limits. To try to keep up with the law on an ongoing basis beyond drugs and medical devices would just be too much work.

So with that introduction, here’s our scorecard for drug and medical device decisions concerning no-injury claims. If you know of something we don’t have, by all means send us an email.
  1. Woodill v Parke Davis & Co., 374 N.E.2d 683 (Ill. App Jan. 27, 1978). Bystander emotional distress of parents of child injured by Pitocin was insufficient injury in the absence of an intentional tort. This decision was affirmed on other grounds. Woodill v Parke Davis & Co., 402 N.E.2d 194 (Ill. Feb. 22, 1980).
  2. Mink v University of Chicago, 460 F. Supp. 713 (N.D. Ill. Mar. 17, 1978). Increased risk/fear of cancer from exposure to DES is not sufficient injury.
  3. Payton v. Abbott Labs, 437 N.E.2d 171 (Mass. June. 22, 1982). Increased risk/fear of future serious disease from exposure to DES is not sufficient injury.
  4. Plummer v. Abbott Laboratories, 568 F. Supp. 920 (D.R.I. July 1, 1983). Fear of increased risk of cancer from exposure to DES is not sufficient injury.
  5. Colby v. E.R. Squibb & Sons, Inc., 589 F. Supp. 714 (D. Kan. July 9, 1984). Asymptomatic, undetectable cancer from exposure to DES is not sufficient injury.
  6. Rall v. Medtronic, Inc., 1986 WL 22271 (D. Nev. Oct. 15, 1986). Fear of increased risk of pacemaker lead failure is not sufficient injury.
  7. Hahn v. Sterling Drug, Inc., 805 F.2d 1480 (11th Cir. Dec. 16, 1986). Bystander emotional distress of parents of child injured by Campho-Phenique is insufficient injury under the “impact rule.” Hahn applied Georgia law.
  8. Hagepanos v. Shiley, Inc., 1988 WL 35752 (4th Cir. Apr. 18, 1988) (unpublished, in table at 846 F.2d 71). Increased risk/fear of heart valve failure is not sufficient injury. Hangepanos applied Maryland law.
  9. Taylor v. Medtronics, Inc., 861 F.2d 980 (6th Cir. Nov. 22, 1988). Risk of pacemaker lead failure is not sufficient injury where plaintiff’s lead never failed. Taylor applied Ohio law.
  10. Kent v. Shiley, Inc., 1989 WL 88307 (D. Or. Jan. 24, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Kent was affirmed in an unpublished opinion. Pryor v. Shiley, Inc., 1990 WL 159582 (9th Cir. Oct. 18, 1990) (in table at 916 F.2d 716).
  11. O’Brien v. Medtronic, Inc., 439 N.W.2d 151 (Wis. App. Mar. 14, 1989). Increased risk of pacemaker failure is not sufficient injury, even where plaintiff had medically unnecessary explant surgery. A further appeal was denied.
  12. Sill v. Shiley, Inc., 735 F. Supp. 337 (W.D. Mo. June 1, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Sill was affirmed without published opinion. Sill v. Shiley, Inc., 909 F.2d 508 (8th Cir. 1990).
  13. Brinkman v. Shiley, Inc., 732 F. Supp. 33 (M.D. Pa. June 7, 1989). Fear of increased risk of heart valve failure is not sufficient injury. Brinkman was affirmed without published opinion. Brinkman v. Shiley, Inc., 902 F.2d 1558 (3d Cir. Nov. 24, 1989).
  14. Khan v. Shiley Inc., 266 Cal. Rptr. 106 (Cal. App. Jan. 30, 1990). Increased risk/fear of heart valve failure is not sufficient injury, except in an action for fraud, which was allowed to proceed. A further appeal was denied.
  15. Spuhl v. Shiley, Inc., 795 S.W.2d 573 (Mo. App. Aug. 14, 1990). Fear of increased risk of heart valve failure is not sufficient injury. A further appeal was denied.
  16. Burk v. Sage Products, Inc., 747 F. Supp. 285 (E.D. Pa. Sept. 27, 1990). Fear of AIDS from needlestick was not sufficient injury, without proof of actual exposure.
  17. Lauterbach v. Shiley, Inc., 1991 WL 148137 (S.D. Tex. Mar. 29, 1991). Fear of increased risk of heart valve failure is not sufficient injury.
  18. Willett v. Baxter International, Inc., 929 F.2d 1094 (5th Cir. May 1, 1991). Fear of increased risk of heart valve failure is not sufficient injury. Willett applied Louisiana law.
  19. Murphy v. Shiley, Inc., 1991 WL 135505 (9th Cr. 1991) (unpublished, in table at 940 F.2d 668). Fear of increased risk of heart valve failure is not sufficient injury. Murphy applied Washington law).
  20. Bravman v. Baxter Healthcare Corp., 794 F. Supp. 96 (S.D.N.Y. May 18, 1992). Increased risk/fear of heart valve failure is not sufficient injury. Reversed in part, Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 74 (2d Cir. 1993), plaintiff could bring claim for excessive noise, but not for a failure that had not occurred.
  21. Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273 (Haw. Sept. 30. 1992). Where the plaintiff had medically indicated explant surgery, increased risk of heart valve failure was sufficient injury.
  22. Walus v. Pfizer, Inc., 812 F. Supp. 41 (D.N.J. Jan. 22, 1993). Fear of increased risk of heart valve failure is not sufficient injury.
  23. Mattaliano v. Shiley, Inc., 1993 WL 13145778 (D.N.J. Feb. 25, 1993). Fear of increased risk of heart valve failure is not sufficient injury.
  24. Nesom v. Tri Hawk International, 985 F.2d 208 (5th Cir. Mar. 8, 1993). Fear of future injury from tissue transplant not sufficient injury. Nesom applied Louisiana law.
  25. Angus v. Shiley Inc., 989 F.2d 142 (3d Cir. Mar. 29, 1993). Fear of increased risk of heart valve failure is not sufficient injury. Angus applied Pennsylvania law.
  26. Upjohn Co. v. Freeman, 885 S.W.2d 538 (Tex. App. Aug. 26, 1994). Loss of consortium claim is derivative and fails where spouse was not injured by use of Halcion. A further appeal was denied.
  27. Lareau v. Page, 39 F.3d 384 (1st Cir. Nov. 14, 1994). Consumer fraud claim for failure to warn of unrealized risk of brain tumor from exposure to Thorotrast is not sufficient injury. Lareau applied Massachusetts law.
  28. Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. Feb. 7, 1995). Where the plaintiff had medically indicated explant surgery, increased risk of heart valve failure was sufficient injury. Michael applied Pennsylvania law.
  29. Cameron v. American Dental Technologies, Inc., 1995 WL 599871 (E.D. Mich. June 8, 1995). Misrepresentation claim about capability of medical laser is barred by economic loss rule where there is no claim of physical injury.
  30. Martin v. American Medical Systems, Inc., 1995 WL 680630 (S.D. Ind. Oct. 25, 1995). Risk of penile implant failure is not sufficient injury to create a “case or controversy” that confers Article III standing to sue upon members of class that had not suffered failure, nor is it sufficient state-law injury.
  31. Pfizer, Inc. v. Farsian, 682 So.2d 405 (Ala. Aug. 30, 1996). Increased risk/fear of heart valve failure is not sufficient injury. Fraud case.
  32. Vitolo v. Dow Corning Corp., 651 N.Y.S.2d 104 (N.Y. App. Div. Dec. 9, 1996). Prescriber’s claim for economic harm from negative publicity about breast implants he implanted isnot sufficient injury in tort or warranty.
  33. In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863 (D. Minn. Nov. 13, 1998). Increased risk of breast implant failure is not sufficient injury. Minnesota Breast Implant applied Arizona law.
  34. Wiggins v. Boston Scientific Corp., 1999 WL 94615 (E.D. Pa. Jan. 7, 1999). Asymptomatic presence of broken piece of guide wire in plaintiff’s body is not sufficient injury. Reconsideration denied, Wiggins v. Boston Scientific Corp., 1999 WL 200672 (E.D. Pa. Apr. 8, 1999).
  35. Petito v. A.H. Robins Co., 750 So.2d 103 (Fla. App. Dec. 22, 1999). Uninjured users of fen-phen may pursue claims for medical monitoring. A further appeal was denied.
  36. McGeehan v. Becton-Dickinson & Co., 2000 WL 33128993 (Pa. C.P. Dec. 18, 2000). Where employers paid all expenses of needlestick plaintiffs no injury supports medical monitoring claim.
  37. Fetick v. American Cyanamid Co., 38 S.W.3d 415 (Mo. Mar. 6, 2001). Prescribing physician’s mental suffering in fraud case involving alleged risks of oral polio vaccine, where plaintiff was not physically injured and was not suing on behalf of injured patient, is not sufficient injury.
  38. Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315 (5th Cir. Feb. 15, 2002). Increased risk of injury from Duract is not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under Texas law not presented.
  39. Cartiglia v. Johnson & Johnson Co., 2002 WL 1009473 (N.J. Super. Law Div. Apr. 24, 2002). Consumer fraud claims of patients using Propulsid who suffered no physical injury and did not allege paying for the drug alleged insufficient injury.
  40. In re Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D. La. June 4, 2002). Medical monitoring and restitution claims by persons not injured by Propulsid stated sufficient injury to create a “case or controversy” that confers Article III standing to sue. State-law injury issues not addressed.
  41. Wood v. Wyeth-Ayerst Laboratories, Division of American Home Products, 82 S.W.3d 849 (Ky. Aug. 22, 2002). Increased risk of heart disease from exposure to Fenfluramine not sufficient injury. No cause of action for medical monitoring.
  42. Nishi v. Ethicon, Inc., 2003 WL 917978 (N.D. Cal. Feb. 26, 2003). Unfair competition claim for restitution brought by plaintiff not suffering any out of pocket loss from contaminated sutures is not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Nor does plaintiff have standing to represent the general public.
  43. Friedman v. Merck & Co., 131 Cal. Rptr.2d 885 (Cal. App. Mar. 26, 2003). Risk of emotional injury from vegan’s exposure to animal products in tuberculosis test is not sufficient injury. A further appeal was denied.
  44. In re St. Jude Medical, Inc. Silzone Heart Valves Products Liability Litigation, 2003 WL 1589527 (D. Minn. Mar. 27, 2003). Subclinical injuries from implantation of Silzone heart valves are sufficient to create a “case or controversy” that confers Article III standing to sue. Reversed on other grounds, In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. Oct. 12, 2005) (class action should not have been certified).
  45. Tedford v. Warner-Lambert Co., 327 F.3d 423 (5th Cir. Apr. 7, 2003). Increased risk/fear of future injury from Rezulin is not sufficient injury. Tedford applied Texas law.
  46. Desiano v. Warner-Lambert Co., 326 F.3d 339 (2d Cir. Apr. 18, 2003). Consumer fraud claims that plaintiffs purchased higher priced Rezulin over available lower priced alternatives allege sufficient injury. Desiano applied New Jersey law.
  47. Searfoss v. Johnson & Johnson, 2003 WL 23785715 (Pa. C.P. May 29, 2003). Asymptomatic heart condition from exposure to Propulsid is not sufficient injury. Affirmed by uncitable memorandum opinion, Searfoss v. Johnson & Johnson, 2004 WL 792789 (Pa. Super. Jan. 8. 2004) (in table at 847 A.2d 766).
  48. In re West Virginia Rezulin Litigation, 585 S.E.2d 52 (W. Va. July 3, 2003). Uninjured users of Rezulin may pursue claims for medical monitoring.
  49. Albertson v. Wyeth Inc., 63 Pa. D. & C.4th 514 (Pa. C.P. July 8, 2003). Uninjured users of fen-phen may pursue claims for medical monitoring.
  50. N.J. Citizen Action v. Schering-Plough Corp., 842 A.2d 174 (N.J. App. Div. July 15, 2003). Consumer fraud claims that plaintiffs purchased Claritin at artificially increased prices do not allege sufficient injury. A further appeal was denied.
  51. Williams v. Purdue Pharma Co., 297 F. Supp.2d 171 (D.D.C. Dec. 31, 2003). Consumer fraud claims that plaintiffs purchased Oxycontin at artificially increased prices do not allege sufficient injury.
  52. Heindel v. Pfizer Inc., 381 F. Supp.2d 364 (D.N.J. June 7, 2004). Consumer fraud and warranty claims that plaintiffs purchased Celebrex or Vioxx at artificially increased prices do not allege sufficient injury. The drugs were effective for their indicated use. Heindel applied New Jersey and Pennsylvania law. Pennsylvania claims are also barred by the economic loss rule.
  53. Lewis v. Bayer AG, 70 Pa. D. & C.4th 52 (Pa. C.P. Nov. 18, 2004). Uninjured users of Baycol may pursue claims for medical monitoring.
  54. Sutton v. St. Jude Medical S.C., Inc., 419 F.3d 568 (6th Cir. Aug. 23, 2005). Increased risk of aortic connector failure is sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under Tennessee law is not presented.
  55. Taylor v. Pharmacia-Upjohn Co., 2005 WL 3502052 (S.D. Miss. Dec. 19, 2005). Fear of increased risk of cancer from exposure to Depo-Provera is not sufficient injury where significant exposure is not established.
  56. Buckland v. Threshold Enterprises, Inc., 2006 WL 5574742 (Cal. Super. June 19, 2006). Having lawyer spend money to buy product on plaintiff's behalf held insufficient injury under consumer fraud statute.
  57. Conway v. A.I. DuPont Hospital for Children, 2007 WL 560502 (E.D. Pa. Feb. 14, 2007). Medical monitoring claim for future out of pocket expenses incurred as a result of implantation of stent is viable without present injury.
  58. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 484 F. Supp.2d 973 (D. Minn. Apr. 16, 2007). Claims of third party payers that purchased implantable defibrillators based upon misconduct directed to prescribing physicians are not sufficient injury to create a “case or controversy” that confers Article III standing to sue. Question of sufficiency of injury under state law is not presented. Reconsideration granted, in part, to change dismissal to “without prejudice.” In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 2028137 (D. Minn. May 9, 2007).
  59. Prohias v. Pfizer, Inc., 485 F. Supp.2d 1329 (S.D. Fla. Apr. 24, 2007). Consumer fraud claims that plaintiffs purchased Lipitor at artificially increased prices do not allege sufficient injury. The drug was effective for its indicated use.
  60. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289 (D. Minn. June 12, 2007). Where the plaintiff had medically indicated explant surgery, increased risk of defibrillator failure is sufficient injury. The case applied California law.
  61. In re Bextra & Celebrex Marketing, Sales Practices & Product Liability Litigation, 2007 WL 2028408 (N.D. Cal. July 10, 2007). Consumer fraud claims that plaintiffs purchased higher priced Bextra and Celebrex over available lower priced alternatives allege sufficient injury.
  62. International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076 (N.J. Sept. 6, 2007). Consumer fraud claims that plaintiffs purchased Vioxx at artificially increased prices do not allege sufficient injury.
  63. Simonet v. SmithKline Beecham Corp., 506 F. Supp.2d 77 (D.P.R. Aug. 3, 2007). Tort claims that Paxil did not function as intended and was therefore ineffective are barred by economic loss rule where plaintiff suffered no physical injury.
  64. Lorenzi v. Pfizer, Inc., 519 F. Supp.2d 742 (N.D. Ohio Oct. 24, 2007). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  65. Parker v. Howmedica Osteonics Corp., 2008 WL 141628 (D.N.J. Jan 14, 2008). Consumer fraud claims for possible future costs of medical care not yet incurred due to implantation of total hip replacement do not allege sufficient injury.
  66. Sarrazine v. Louis Garzone Funeral Home, 2008 WL 204986 (Pa. C.P. Jan. 14, 2008), aff'd mem., 959 A.2d 982 (Pa. Super. 2008). Fear of infection from allograft is not sufficient injury absent proof of actual exposure to infectious agent.
  67. Aberbach v. Biomedical Tissue Services, Ltd., 854 N.Y.S.2d 143 (N.Y. App. Div. Feb. 26, 2008). “Potential” for infection by bone paste is not sufficient injury.
  68. Clark v. Pfizer, Inc., 2008 Phila. Ct. Com. Pl. Lexis 74 (Pa. C.P. Mar. 14, 2008). Tort claims of purchasers of Neurontin for off-label uses are not barred by economic loss rule.
  69. Sinclair v. Merck & Co., 948 A.2d 587 (N.J. June 4, 2008). Uninjured users of Vioxx may not pursue claims for medical monitoring.
  70. Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314 (N.D. Fla. July 10, 2008). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  71. Clayworth v. Pfizer, Inc., 83 Cal. Rptr.3d 45 (Cal. App. July 25, 2008). Pharmacies that passed on any artificially high drug charges to their customers did not sustain any cognizable injury for antitrust or consumer protection purposes.
  72. Oliver v. Pharmacia & Upjohn Co., C.A. No. 06-5737 §B(2), 2008 WL 4691626 (E.D. La. Oct. 6, 2008). Asymptomatic loss of bone mineral density from exposure to Depo-Provera is not sufficient injury.
  73. Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009). Plaintiff had no cognizable harm from purchase of a recalled drug that was neither ineffective nor caused the plaintiff harm. Plaintiff has no claim at all concerning other drugs she never purchased.
  74. Degelmann v. Advanced Medical Optics, Inc., 2010 WL 55874 (N.D. Cal. Jan. 4, 2010).  Plaintiffs lack Article III standing to sue for consumer fraud under California statute.  They never heard of the risk of the product before a recall, stopped using the product before the recall, do not claim for suffering the risk, used the product normally, and it behaved as expected.  They cannot claim to have lost any money, as they would have bought another brand had they not bought this one.
  75. Mitchell v. Proctor & Gamble, 2010 WL 728222 (S.D. Ohio March 1, 2010).  Mere allegation of increased risk, without allegation of actual causation, of damages is insufficient to plead compensable injury under Twombly/Iqbal.
  76. Watkins v. Omni Life Science Inc., ___ F. Supp.2d ___, 2010 WL 809820, slip op. (D. Mass. March 9, 2010).  Fear of/increased risk of hip implant failure is not sufficient injury, nor is loss of the benefit of the bargain where the implant remains intact.
  77. Cohen v. Guidant Corp., No. 2:05-cv-08070-R, slip op. (C.D. Cal. Feb. 15, 2011), fear of future injury is not compensable in California.
  78. In re McNeil Consumer Healthcare Marketing & Sales Practices Litigation, 2011 WL 2802854 (E.D. Pa. July 15, 2011).  Plaintiffs lack Article III standing to sue for economic injuries from various recalled products.  Plaintiffs do not allege that they bought any particular product or that they were injured by any particular recall.  Injuries to others are insufficient.
  79. Barker v. Carefusion 303 Inc., No. 1:11-cv-00938-TWP-DKL, slip op. (S.D. Ind. Nov. 28, 2012).  Pure bystander emotional distress from witnessing injury to another is not "physical injury" as required by the Indiana product liability statute.
  80. Carter v. Alcon Laboratories, 2014 U.S. Dist. Lexis 32381 (E.D. Mo. March 13, 2014).  Plaintiffs alleging consumer protection violations from single use medications allegedlycontaining excessive product for a single use failed to allege any cognizable injury.  The defendant had a legal right to charge the same amount for a smaller-sized amount of product.
  81. Travelers Indemnity Co. v. Cephalon, Inc., C.A. No. 12-4191, 2014 U.S. Dist. Lexis 95075 (E.D. Pa. July 14, 2014).  Third party payers lack Article III standing to sue for economic losses absent evidence that the product is unsafe or ineffective.  Getting the product that was paid for, even if more expensive than alternatives, is not injury.

1 comment:

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