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American Federation of State County and Municipal v. Ortho-Mcneil-Janssen Pharmaceuticals

March 12, 2012


The opinion of the court was delivered by: Rufe, J.


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"), Sandoz, Inc., and ALZA Corporation. Defendants have moved for summary judgment, which Plaintiffs oppose. Because Plaintiffs have not established that they in fact suffered any injury, the motion will be granted.


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." *fn1

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. *fn2 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." *fn3 The federal Food and Drug Administration classified this action as a Class II voluntary recall to remove a "defective product from the market" where the product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." *fn4

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 provided telephone numbers for patients to call "for assistance with this recall." *fn5

The "Dear Pharmacist" letter noted that "[i]t is expected that most patients and their caregivers would have learned of this recall via the media, following [the press release]." *fn6 Neither of these letters stated that patients should discard undamaged patches, and the record before the Court does not reveal whether any patients called for assistance, or whether any physicians or pharmacists advised patients to discard or return the patches.

Plaintiffs filed suit, seeking damages from Defendants for alleged violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law ("UTPCPL"), *fn7 breach of express and implied warranties, and unjust enrichment because, as third-party payors, Plaintiffs "have paid or will pay expenses related to the purchase of and reimbursement for supplies of 25 mcg/hour fentanyl patches [for their members] that were unusable, worthless, and had to be discarded." *fn8 Defendants filed a motion to dismiss, and this Court dismissed the two warranty claims but allowed the UTPCPL and unjust enrichment claims to proceed to discovery. *fn9 The parties thus have had the opportunity to develop the record, and Defendants now move for summary judgment on the remaining claims.


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." *fn10 A fact is "material" if it could affect the outcome of the suit, given the applicable substantive law. *fn11 A dispute about a material fact is "genuine" if the evidence presented "is such that a reasonable jury could return a verdict for the nonmoving party." *fn12

A party moving for summary judgment has the initial burden of supporting its motion by reference to admissible evidence *fn13 showing the absence of a genuine dispute of a material fact or showing that there is insufficient admissible evidence to support the fact. *fn14 Once this burden has been met, "the non-moving party must rebut the motion with facts in the record and cannot rest solely on assertions made in the pleadings, legal memoranda, or oral argument." *fn15 In considering a summary judgment motion, the Court does not weigh the evidence or make ...

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