Drug maker, pharmacy say Fentanyl case should be removed or dismissed

By Kelly Holleran | Jun 2, 2009

BLUEFIELD -- A drug manufacturer and a pharmacy are alleging a case in which a deceased woman's sister claims she died due to a defective fentanyl patch should be removed to federal court if it is not dismissed.

Katherine Browning filed a complaint in McDowell Circuit Court against ALZA Corporation and Sandoz, makers of the allegedly defective fentanyl patch, and Fruth Pharmacy, the store that sold the patch, before the companies removed the complaint to federal court.

The complaint is nearly identical to a case filed in McDowell Circuit Court against ALZA, Sandoz and Citizens Drug Store. In that complaint, Jackie Deskins says his wife died because extra Fentanyl leaked through the patch and into her skin.

In both complaints, ALZA and Sandoz say the pharmacies, which were the only non-diverse defendants, were added as defendants so the plaintiffs would have an opportunity to file the case in circuit court instead of federal court.

"The action implicates the growing concern of federal courts over plaintiffs' attempts to defeat diversity jurisdiction by fraudulently joining non-diverse pharmacy defendants in actions where the real targets -- the diverse pharmaceutical/manufacturer defendants -- are entitled to a federal forum," the suit states.

However, Browning's claim against Fruth are barred because, under West Virginia code, pharmacists and their stores are not responsible for drugs sold to patients in an unaltered condition, ALZA and Sandoz claim.
If Fruth is excluded as a defendant, there is complete diversity of jurisdiction between the defendants and the plaintiff, and the complaint can be removed to federal court.

In her original complaint, Browning says her sister, Susan Cobb, died after she applied a 75 mcg Sandoz patch to her skin. Cobb's doctor, Jeffrey Trump, prescribed her the medication, which she filled in March 2007. Cobb was found dead on March 26, 2007, according to the complaint.

The patch Cobb used was designed by ALZA and consisted of a reservoir design that utilized multiple layers. In such a design, a layer of a gel that includes the drug fentanyl is sandwiched in between two of the patch's other layers.

"Fentanyl is an extremely dangerous drug that is at least 80 times stronger than morphine," the suit states. "Fentanyl is classified as a Schedule II controlled substance by the FDA and is generally used to relieve pain."

When placed on the body, the patch delivers fentanyl through a patient's skin. The fentanyl is supposed to be released into the patient at a certain rate and produce a certain level of fentanyl in the blood, according to records.

However, the patch that Cobb was using leaked extra amounts of fentanyl into her skin, Browning claims.

In fact, ALZA recalled numerous lots of patches in 2004 and twice in 2008 because of leaking defects, Browning claims.

"Prior to and at the time of the manufacture of the Cobb Patch, the Patch Defendants knew or should have known that they were producing defective patches that were killing patients and/or injuring patients," the suit states. "Despite the foregoing, the Patch Defendants, with reckless and/or intentional disregard for the safety of patients, continued and continue to this day to manufacture fentanyl patches which kill patients because of the massive revenue being generated by their sale."

Instead of manufacturing a patch using the reservoir design, ALZA should have utilized a matrix design, which is safer and cannot leak fentanyl, Browning contends.

Although ALZA admits it did recall patches twice in 2004 and in 2008, it denies it recalled them because of leaking defects.

Browning included Fruth as a defendant because it failed to provide adequate warnings about the patch.

Because Browning is seeking a judgment of more than $75,000 and because diversity of citizenship exists between her, ALZA and Sandoz, the companies have removed the case to federal court.

Browning is seeking unspecified punitive, exemplary and actual damages, plus pre- and post-judgment interest, costs and other relief to which she may be entitled.

Sandoz and ALZA are asking the court to dismiss the complaint with prejudice and to grant them other relief it deems just.

Sandoz and ALZA say Cobb's death could have been caused by her own conduct or by another event.

"The injuries and damages allegedly suffered in this action, which are denied, were due to an allergic, idiosyncratic, or idiopathic reaction to the product at issue in this case, or by an unforeseeable illness, unavoidable accident, or preexisting condition, without any negligence or culpable conduct by Sandoz," Sandoz's answer to the complaint states.

In addition, Sandoz and ALZA complied with all state and federal statutes and the company did not breach any warranties, so Browning's claims against the company are barred, the company's answer states.

Fruth says it should not be named as a defendant in the suit and has denied requests for admission.

"Defendant asserts all of the affirmative defenses contained within Rule 8(c) of the West Virginia Rules of Civil Procedure as if fully set forth herein, including statute of limitations," Fruth's answer states.

Kathryn R. Bayless of The Bayless Law Firm in Princeton will be representing Browning.

David B. Thomas and Debra C. Price of Allen, Guthrie and Thomas in Charleston will be representing ALZA and Sandoz.

Brian E. Bigelow of The Law Offices of Stephen E. Flesher in Beckley will be representing Fruth.

U.S. Federal Court case number: 1:09-0440

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