Miller v. Alza Corp..

• Decision Date: 17 December 2010
• Docket Number: Case No. 3:08–cv–402.
• Citation: 759 F.Supp.2d 929
• Parties: William MILLER, as Administrator of the Estate of Cornell Phillips, Plaintiff,v.ALZA CORPORATION, et al., Defendants.
• Court: U.S. District Court — Southern District of Ohio

759 F.Supp.2d 929

William MILLER, as Administrator of the Estate of Cornell Phillips, Plaintiff,

v.ALZA CORPORATION, et al., Defendants.

Case No. 3:08–cv–402.

United States District Court, S.D. Ohio, Western Division.

Dec. 17, 2010.

Charles Wade Miller, Heygood, Orr & Pearson, Dallas, TX, James Craig Orr, Jr., Mark Mathew Kitrick, Kitrick & Lewis Co. LPA, Columbus, OH, for Plaintiff.Ernest W. Auciello, Jr., Rita A. Maimbourg, Tariq M. Naeem, Tucker Ellis & West LLP, Cleveland, OH, for Defendants.

DECISION AND ENTRY GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT IN PART AND DENYING IN PART (Doc. 19)

TIMOTHY S. BLACK, District Judge.

This civil case is presently before the Court on the Motion of Defendants, ALZA Corporation (“ALZA”) and Sandoz, Inc. (“Sandoz”), requesting summary judgment on all of Plaintiff's claims pursuant to Fed.R.Civ.P. 56. (Doc. 19). Plaintiff filed a Response to Defendants' Motion (Doc. 46) and Defendants filed a Reply Memorandum. (Doc. 48). The matter is now ripe for decision.

I. FACTS

This case concerns the death of 51 year-old Cornell Phillips. At the time of his death, Phillips was using a fentanyl patch manufactured by Defendant ALZA and distributed by Defendant Sandoz. Fentanyl patches are prescription pain patches designed to deliver fentanyl through a user's skin.¹ (Doc. 21–1). Fentanyl is a very powerful narcotic drug that is used to treat persistent moderate to severe chronic pain. (Doc. 21–1). Fentanyl is 80 times more potent than morphine by weight and “has a very narrow therapeutic band, meaning the difference between a therapeutic [and] a lethal dose is small[.]” (Doc. 46–4).

The patches Phillips wore at the time of his death contain fentanyl gel in a reservoir between a layer of impermeable polyester backing and a semi-permeable layer of ethyl-acetate vinyl (“EVA”) film. (Doc. 21–1). The semi-permeable layer is placed on the patient's skin, and, following application, patches are intended to continuously deliver the requisite dose of fentanyl to the patient's bloodstream over a 72–hour period. ( Id.) However, Plaintiff alleges that the reservoir design fentanyl patches Phillips wore at the time of his death were known by Defendants to leak as a result of seal integrity defects. (Doc. 1). Further, Plaintiff alleges that, despite proper use, non-leaking reservoir design fentanyl patches were known to “produce levels of fentanyl in patients above the intended and designed level.” (Doc. 1).

Before his death, Phillips suffered from chronic pain due to several medical conditions, including chronic intestinal pain and osteoarthritis. (Doc. 32). In 2006, Phillips developed a malignant tumor in his nasopharynx ² and was diagnosed with nasopharyngeal carcinoma. ( Id.) During radiation treatment for this cancer, Phillips began to suffer from mucositis, which caused him significant pain. ( Id.) Phillips rated the pain as a 9 on a scale of 10, and described the pain as “swallowing cut glass.” ( Id.)

In June 2006, Phillips was referred to Dr. E. Ronald Hale after being diagnosed with nasopharyngeal cancer. During the course of treatment, Dr. Hale prescribed Phillips a 25 micrograms per hour (“mcg/hr”) fentanyl patch for pain on approximately July 25, 2006. ( Id.) In August 2006, Dr. Hale increased the dose of the fentanyl patch to 50 mcg/hr by instructing Phillips to use two 25 mcg/hr patches simultaneously. ( Id.) Phillips' dosage was thereafter increased to 75 mcg/hr, and later increased again to 100 mcg/hr. ( Id.) According to Dr. Hale, on or about October 22, 2006, Phillips' hematology doctor, Dr. Abuerreish, increased the dosage to 125 mcg/hr. ( Id.)

On November 6, 2006, Phillips was taken to the Miami Valley Hospital after calling 911. (Doc. 42). He died later that afternoon after attempts to revive him failed. Following his death, Phillips was examined by the Montgomery County, Ohio coroner's office. (Doc. 21–4). Toxicology tests revealed that Phillips had a postmortem fentanyl blood level of 13 ng/mL, well above the expected level from the dosage Phillips used at the time of his death. ( Id.) After a complete autopsy, Dr. Russell L. Uptegrove, M.D., Forensic Pathologist Deputy Corner of Montgomery County, Ohio, concluded that Phillips died as a result of “fentanyl intoxication.” ( Id.)

Plaintiff, William Miller, administrator of Phillips' estate, filed this wrongful death action asserting statutory product liability causes of action, including: (1) a manufacturing defect claim pursuant to O.R.C. § 2307.74; (2) a marketing defect claim pursuant to O.R.C. § 2307.76; (3) a design defect claim pursuant to O.R.C. § 2307.75; and (4) a failure to conform to representations claim pursuant to O.R.C. § 2307.77. (Doc. 1). Plaintiff also sets forth claims of negligence, negligent misrepresentation, breach of the implied warranty of fitness, breach of express warranty and a claim titled “deliberate, intentional, reckless and/or malicious conduct.” ( Id.) In addition to compensatory damages, Plaintiff's prays for punitive damages.

II. STANDARD OF REVIEW

A motion for summary judgment should be granted if the evidence submitted to the Court demonstrates that there is no genuine issue as to any material fact and that the movant is entitled to summary judgment as a matter of law. Fed.R.Civ.P. 56; see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

“Summary judgment is only appropriate ‘if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.’ ” Keweenaw Bay Indian Comm. v. Rising, 477 F.3d 881, 886 (6th Cir.2007) (quoting Fed.R.Civ.P. 56(c)). “Weighing of the evidence or making credibility determinations are prohibited at summary judgment—rather, all facts must be viewed in the light most favorable to the non-moving party.” Id.

Once “a motion for summary judgment is properly made and supported, an opposing party may not rely merely on allegations or denials in its own pleading; rather, its response must—by affidavits or as otherwise provided in this rule—set out specific facts showing a genuine issue for trial.” Fed.R.Civ.P. 56(e)(2).

III. ANALYSIS

Defendants move for summary judgment on all claims asserted by Plaintiff. With regard to Plaintiff's product liability claims, Defendants assert: (A) that Plaintiff's failure to warn/inadequate warning claims must fail because the prescribing doctor unequivocally testified that he would have still prescribed the fentanyl patch despite the warnings advocated by Plaintiff, and because Plaintiff have no proper expert testimony regarding the adequacy of the warnings; (B) Plaintiff's design defect claim must fail because an allegedly leaking patch is not a design defect, and, regardless, Ohio law shields drug manufacturers from design defect claims if they warn of the dangerous aspect of the drug; (C) Plaintiff's manufacturing defect claim must fail because there is no evidence, either direct or circumstantial, sufficient to show that any patch used by Phillips actually leaked; and (D) Plaintiff's failure to conform to representations claim must fail because Plaintiff does not identify representations to which the patches failed to conform.

Defendants also move for summary judgment on Plaintiff's claims of negligence, negligent misrepresentation, breach of warranty claims, claims alleging misrepresentations to the U.S. Food and Drug Administration (“FDA”), and Plaintiff's request for punitive damages.

A. FAILURE TO WARN

Plaintiff's failure to warn claim is premised on the assertion that Defendants failed to warn of the risk of overdose “by leaking or otherwise[.]” (Doc. 1). Defendants challenge Plaintiff's failure to warn claim, arguing that: (1) there is no genuine issue of fact regarding the lack of causation because Dr. Hale would have prescribed despite the warnings advocated by Plaintiff; and (2) Plaintiff's proposed warnings experts are not physicians and cannot testify regarding the adequacy of prescription drug warnings.

Pursuant to O.R.C. § 2307.76, inadequate warnings or instructions render a product defective if:

at the time of marketing if, when it left the control of its manufacturer, both of the following applied:

(a) The manufacturer knew or, in the exercise of reasonable care, should have known about a risk that is associated with the product and that allegedly caused harm for which the claimant seeks to recover compensatory damages;

(b) The manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the product would cause harm of the type for which the claimant seeks to recover compensatory damages and in light of the likely seriousness of that harm.

To prove a “failure to warn” claim, plaintiffs must prove: “(1) a duty to warn against reasonably foreseeable risks; (2) breach of this duty; and (3) an injury that is proximately caused by the breach.” Graham v. Am. Cyanamid Co., 350 F.3d 496, 514 (6th Cir.2003).

With regard to prescription drugs, a manufacturer's duty is discharged “if the manufacturer adequately warns the patient's doctor of those risks.” Id. (citing O.R.C. § 2307.76(C)). Further, “[w]hen a plaintiff alleges that the warning given to a prescribing physician is inadequate, the plaintiff must prove his claim through expert medical testimony.” Id.

1. Warnings Advocated by Plaintiff

Initially, the Court finds it necessary to identify the warnings Plaintiff argues should have been given to fully, properly and adequately warn of foreseeable risks. In this regard, Plaintiff cites the opinions of: (1) James C. Morrison (Doc. 46–34), a purported expert in FDA drug...