American Federation of State County & Municipal Employees, District Council 47 Health & Welfare Fund v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
American Federation of State County & Municipal Employees, District Council 47 Health & Welfare Fund v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Opinion of the Court
MEMORANDUM OPINION AND ORDER
Plaintiffs American Federation of State, County and Municipal Employees (“AFSCME”) District Council 47 Health and Welfare Fund, and Philadelphia Firefighters Union (“PFU”) Local No. 22 Health and Welfare Fund bring this action against Defendants Ortho-McNeil-Jannsen Pharmaceuticals, Inc. (“OMJ”), San-
I. Factual and Procedural Background
In December 2008, Plaintiffs, the Health and Welfare Funds of AFSCME District Council 47 and PFU Local No. 22, filed this putative class action on behalf of themselves and similarly situated third-party payors. Plaintiffs provide medical coverage, including prescription drug coverage, to their members and their members’ dependents. Defendants OMJ and Sandoz market and distribute the fentanyl transdermal system patch (“fentanyl patch”), which is manufactured by Defendant ALZA, an affiliate of OMJ. The fentanyl patch is a Schedule II narcotic, available only through a doctor’s prescription, designed to deliver a steady, controlled dosage (measured in micrograms per hour (“mcg/hour”)) of a powerful medication that provides relief for severe and chronic pain. ALZA contracted with OMJ and Sandoz to manufacture and supply fentanyl patches throughout the United States. OMJ distributes the patches under the brand name Duragesic and Sandoz distributes the patches as a generic equivalent. The package insert for the fentanyl patches instructs prescribing physicians to advise patients that the fentanyl patch “should not be used if the seal is broken, or if the patch is cut, damaged, or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal.”
On February 12, 2008, OMJ announced a recall of 25 mcg/hour fentanyl patches stamped with expiration dates on or before December 31, 2009. The official press release stated that the patches were “being recalled as a precaution from wholesalers and pharmacies” and that:
[The 25mcg/hr fentanyl patches] being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal .... Anyone who has [the 25mcg/hr] patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.2
The press release provided telephone numbers that “anyone with ... patches being recalled” should call and noted that “[p]atients using fentanyl patches who have medical questions should contact their health-care providers.”
The same month it issued the press release, OMJ sent “Dear Physician” and “Dear Pharmacist” letters repeating much of the same information in the press release. The “Dear Physician” letter provid: ed telephone numbers for patients to call “for assistance with this recall.”
Plaintiffs filed suit, seeking damages from Defendants for alleged violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law (“UTPCPL”),
II. Standard of Review
Under Federal Rule of Civil Procedure 56(c), a court may grant summary judgment only “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”
A party moving for summary judgment has the initial burden of supporting its motion by reference to admissible evidence
III. Discussion
Plaintiffs cannot prevail in this case unless they are able to establish that they have been injured; without a showing of injury, Plaintiffs lack standing to prosecute this action in federal court and cannot recover under the asserted UTPCPL and unjust enrichment claims.
Standing, as is relevant in this case, includes three elements: “(1) an injury in fact (i.e., a concrete and particularized invasion of a legally protected interest); (2) causation (i.e., a fairly traceable connection between the alleged injury in fact and the alleged conduct of the defendant); and (3) redressability (i.e., it is likely and not merely speculative that the plaintiffs injury will be remedied by the relief plaintiff seeks in bringing suit).”
Plaintiffs also must be able to show they suffered a loss in order to proceed with UTPCPL and unjust enrichment claims. To prevail on a claim under the UTPCPL, a statute that prohibits “[u]nfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce,”
Plaintiffs argue that all of the patches were “worthless and unusable to Plaintiffs due to the risk of exposure to a fatal narcotic overdose from merely opening their pouches.”
The wrongs [Plaintiffs] allege — failure to warn and sale of a defective product— are products liability claims. Yet, the damages they assert — benefit of the bargain, out of pocket expenditures — are contract law damages. The plaintiffs apparently believe that if they keep oscillating between tort and contract law claims, they can obscure the fact that they have asserted no concrete injury.27
Plaintiffs here contend that they need not establish a defective product because their claims are not products liability claims but are instead “based on Defendants’ uniform misrepresentations in their fentanyl patch labeling and their gross failure to assure their patches actually delivered the drug in the dose and duration claimed in the labeling.”
IV. Conclusion
Plaintiffs have proved unable to support the allegations in their Complaint with evidence of actual injury. Defendants’ motion for summary judgment therefore will be granted.
. Exh. l-B to Defs.’ Mot. Summ. J. (emphasis omitted).
. Exh. 1-A to Defs.' Mot. Summ. J.
. Id.
. Exh. 1 — C to Defs.’ Mot. Srarnn. J.
. Exh. 1-G to Plffs.’ Opp.
. Exh. 1-H to Plffs.' Opp.
. 73 Pa. Stat. §§ 201-1 ef seq.
. Compl. ¶¶ 21, 23.
. Mem. Opin. and Order of March 11, 2010.
. Fed.R.Civ.P. 56(a).
. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
. Id.
. See Callahan v. A.E.V., Inc., 182 F.3d 237, 252 n. 11 (3d Cir. 1999).
. See Fed.R.Civ.P. 56(c).
. Berckeley Inv. Grp. Ltd. v. Colkitt, 455 F.3d 195, 201 (3d Cir. 2006).
. Anderson, 477 U.S. at 255, 106 S.Ct. 2505.
. Freeman v. Corzine, 629 F.3d 146, 153 (3d Cir. 2010) (quoting Common Cause of Pa. v. Pennsylvania, 558 F.3d 249, 258 (3d Cir. 2009)) (all internal quotations omitted).
. Id. (internal quotations omitted).
. 73 Pa. Stat. § 201-2. Although Plaintiffs' Complaint specifically alleges a claim under the UTPCPL, Plaintiffs argue in their opposition to the motion for summary judgment that the New Jersey Consumer Fraud Act, N.J. Stat. Ann. §§ 56:8-1 et seq., applies to Plaintiffs’ consumer fraud claims pursuant to choice-of-law principles. Plffs.' Opp. at 7 n. 34. Assuming without deciding that Plaintiffs could plead under one state's statute but proceed under another's, the New Jersey statute requires Plaintiffs to establish unlawful conduct, an ascertainable loss that is actual, not hypothetical, and that the loss was caused by the unlawful conduct. Zafarana v. Pfizer, Inc., 724 F.Supp.2d 545, 556 (E.D.Pa. 2010) (applying New Jersey law). The Court's analysis would not change under New Jersey law.
. Hunt v. U.S. Tobacco Co., 538 F.3d 217 (3d Cir. 2008); Toy v. Metro. Life Ins. Co., 593 Pa. 20, 928 A.2d 186, 202 (2007).
. Mitchell v. Moore, 729 A.2d 1200, 1203 (Pa.Super.Ct. 1999).
. Zafarana, 724 F.Supp.2d at 560-61 (applying Pennsylvania law) (citations omitted). If New Jersey law were to apply to unjust enrichment (although it appears Plaintiffs still rely on Pennsylvania law for this claim), then the Court notes that there is no separate tort cause of action for unjust enrichment in New Jersey; instead, unjust enrichment provides the underlying logic for several torts, and also provides the basis for establishing quasi-contract liability. Castro v. NYT Television, 370 N.J.Super. 282, 851 A.2d 88, 98 (N.J.Super.Ct.App.Div. 2004), cited in Zafarana, 724 F.Supp.2d at 556-57. Under New Jersey law, unjust enrichment requires that the defendant
. In their statement of undisputed material facts, Defendants state that "Plaintiffs admitted they have no evidence that any of their plan participants ever discarded any of [the patches at issue] without using them.” Defs.’ Stat. Undis. Mat. Facts at ¶ 16. Plaintiffs did not counter the substance of this statement, but responded that "Plaintiffs maintain that this statement is not pertinent, let alone material, because they are not required to present evidence that their plan participants discarded recalled patches to establish their consumer fraud and unjust enrichment claims.” Plffs.’ Resp. Defs.’ Stat. Undis. Mat. Facts at ¶ 16.
. Defendants include in their statement of undisputed material facts that ”[t]he risk of serious harm was remote in part because the Cut Reservoir Defect was immediately obvious, such that individuals could avoid contact with a cut patch.” Defs.' Stat. Undis. Mat. Facts at ¶ 8. Plaintiffs "dispute this statement because although Defendants’ internal document refers to the obvious appearance of the defect, patches with cut reservoirs were not, in fact, immediately obvious to Defendants, whose failed quality control measures allowed patches with cut reservoirs to be introduced into the marketplace.” Plffs.’ Resp. Defs.' Stat. Undis. Mat. Facts at ¶ 8. Plaintiffs have not produced any evidence to counter Defendants’ assertion that the defect is visible once the outer pouch is opened.
. There is a question as to how many patches were damaged. Defendants point to evidence of few complaints to argue that the problem was not wide spread. Plaintiffs contend that Defendants destroyed the recalled patches while this litigation was pending, which prevented Plaintiffs and their experts from examining the patches to determine how many were damaged, and argue that this constituted spoliation of evidence. Plffs.' Opp. at 12-14. The Court need not resolve this dispute because the question is not whether a particular percentage of patches were damaged (as there is no evidence that all patches were damaged) but whether Plaintiffs paid for any damaged patches.
. Plffs.’ Opp. at 16.
. Rivera v. Wyeth-Ayerst Labs., 283 F.3d 315, 320-21 (5th Cir. 2002). The court in Rivera distinguished the case upon which the Plaintiffs in this case rely, Coghlan v. Wellcraft Marine Corp., 240 F.3d 449 (5th Cir. 2001), noting that the decision in Coghlan (which concerned a suit over a boat promised to be all fiberglass that was partly made of wood), "explicitly distinguishes valid, contract law suits from the 'no-injury products liability law suit' plaintiffs bring.” Rivera, 283 F.3d at 320.
. Plffs.' Opp. at 7.
. Rivera, 283 F.3d at 320.
. Plffs.’ Opp. at 9.
. O’Neil v. Simplicity, Inc., 574 F.3d 501, 503 (8th Cir. 2009).
. Plffs.' Opp. at 10.
. There are presumably logistical and business reasons why Defendants would not attempt to sort the usable patches from the unusable, and the destruction of the patches cannot serve as a substitute for evidence of harm to Plaintiffs.
Reference
- Full Case Name
- AMERICAN FEDERATION OF STATE COUNTY AND MUNICIPAL EMPLOYEES, DISTRICT COUNCIL 47 HEALTH AND WELFARE FUND v. ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.
- Cited By
- 2 cases
- Status
- Published