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Miller v. Janssen Pharmaceutica Products

April 30, 2007

DENNIS MILLER, PLAINTIFF,
v.
JANSSEN PHARMACEUTICA PRODUCTS, L.P. AND ALZA CORPORATION, DEFENDANTS.



The opinion of the court was delivered by: Herndon, District Judge

MEMORANDUM and ORDER

I. Introduction and Background

Now before the Court is Plaintiff's motion for class certification (Doc. 81). Naturally, Defendants oppose the motion (Doc. 87). On April 19, 2007, the Court heard argument on Plaintiff's motion and took the matter under advisement. Based on the record, the oral argument, and the applicable case law, the Court denies Plaintiff's motion for class certification.

On November 29, 2006, Dennis Miller, on behalf of himself and all others similarly situated, filed a Second Amended Class Action Complaint against Janssen Pharmaceutica Products, L.P. ("Janssen"), and Alza Corporation ("Alza") for product liability-strict liability (Count I); product liability-negligence (Count II); breach of express warranty (Count III); breach of implied warranty (Count IV); violation of all states' consumer protection statutes (Count V) and unjust enrichment (Count VI) (Doc. 78). Plaintiff is a "user of the DURAGESIC 75 MCG (fentanyl transdermal system) CII patch ("Duragesic patch")" (Doc. 78, ¶ 2). Plaintiff seeks class certification "on behalf of all persons who have purchased, and/or use or used the Duragesic patch." (Doc. 78, ¶ 2). Plaintiff alleges that "Defendants, through distributors, have injured and defrauded consumers by manufacturing, distributing and selling Duragesic patches that are faulty, either in design or production, whereby they deliver too much or too little medication and thus, caused Plaintiff and the class personal and economic injury." (Doc. 78, ¶ 2). Plaintiff alleges that he "has been damaged by overexposure to the medication and by symptoms related withdrawal due to the involuntary overdose." (Doc. 78, ¶ 9). Plaintiff also alleges that Janssen, a pharmaceutical company, sold and distributed the Duragesic patch and that Alza, a pharmaceutical and medical systems company, manufactured the Duragesic patch. (Doc. 78, ¶, ¶ 10-12).

Plaintiff moves this Court to certify the following nationwide class: All prescription users, other than Defendants, of the Duragesic 75 mcg/hr patch, lot numbers 0327192, 0327193, 0327294, 0327295, or 0330362 (the "Recalled Lots"), who either suffered opiate overdoes or opiate withdrawal, but not death, during their use of the Recalled Lots of the Duragesic 75 mcg/hr patches.*fn1

Plaintiff contends that the proposed class meets the requirements of Fed.R.Civ.P. 23(a)( and 23(b)(3).

II. Facts

Alza manufactured and Janssen marketed and distributed the Duragesic pain patch. The patch is a prescription pain patch used to treat moderate to severe chronic pain. It is a transdermal system that is adhered to a patient's skin and continually releases a rate controlled medication over a period of time- 72 hours. The medication contained in the patch is called fentanyl, which is an opiod. Fentanyl is contained in a gel mixture inside each patch and passes from a reservoir within the patch through the patient's skin. It comes in five strengths: 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr. It is similar in appearance to an oblong, oversized Band-AidTM. Fentanyl is intended only for patients who already receiving and have become tolerant to some other form of opioid pain relief therapy.

The Duragesic 75 is manufactured using the Bodolay One Form Fill and Seal Machine ("Bodolay 1"). The patch is constructed of a three-layer laminate comprised of ethylene-vinyl acetate ("EVA") rate controlling membrane, a silicone adhesive, and a protective liner, with the fentanyl stored in a drug reservoir in between the rate controlling membrane and a backing. The Duragesic lots in question each number roughly 500,000 patches per lot. All defective lots contained the same "fold-over defect" which caused the patches to leak their active ingredient, fentanyl, when applied to the patient. Each lot's defects were attributed to the same "root cause" which caused the same type and number of defects that Defendants later recalled.

Around February 12, 2004, Alza began receiving a substantial increase in complaints over a two-week period concerning Duragesic 75, Lot # 0327192 patches. This lot was on the market for one month. Alza determined that the patches were defective in that the patch seals contained breaches that were identical in location and size. All complaints had the same root cause, a "fold-over" defect. The backing film on the patch was not positioned correctly on the Bodolay 1 pull wheels. Alza also determined that the fold-over defect was unique to the Duragesic 75 due to the width of the unused material along the edge of the patch.

From this defect there could either be increased or decreased exposure of the opiate fentanyl. The consequences of an increased exposure of fentanyl include hypoventilation, dyspnea, apnea, respiratory depression, death, arrhythmia, bardycardia, somnolence, confusion, abnormal coordination, nausea and vomiting. The symptoms of not enough fentanyl are severe withdrawal symptoms (because the patients are often opioid tolerant). They also experience breakthrough pain and classic opiate withdrawal symptoms such as nausea, vomiting, shivering, anxiety, diarrhea, increased respiratory rate, hypertension or tachycardia. Further, the patients do not recognize these symptoms as withdrawal because they are wearing the patch.

On February 14, 2004, Alza initiated a Class I Recall for Lot # 0327192. Notification of the recall affecting Lot # 0327192 was sent to physicians, hospitals, pharmacies, distributors, medical associations, and retail pharmacy associations in all 50 states, the District of Columbia and Puerto Rico on February 16, 2004. By March 5, 2004, Alza found 67 reports that indicated patch leakage for Lot # 0327192. In a March 12, 2004 Memo, Alza stated that it knew of similar fold over defects in Lot #0372294 and potentially in Lots 0372193 and 0372295. On or about April 5, 2004, Alza recalled the other lots. That same day, an expanded recall notice was sent to physicians, hospitals, pharmacies, distributors, medical associations, and retail pharmacy associations in all 50 states, the District of Columbia and Puerto Rico.

Alza manufactured these patches between August 2003 and March 2004. Alza determined that they defectively manufactured anywhere from .72% to 5% (totaling 18,000 to 125,000) of the patches throughout the United States. However, the precise number was not known.

The FDA investigated the Alza plant in Vacaville, California, the Bodolay 1, the defective patches sent in from complaining users, interviewed employees and reviewed data on the patches from February 20, 2004 to June 16, 2004. The FDA issued an Establishment Inspection Report and a 483 Inspectional Observations ("483'). The 483 provided seven inculpatory findings regarding ...


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