PENNSYLVANIA RECORD

A Philadelphia judge has filed an opinion outlining why he feels an appeals court should

uphold an earlier trial court ruling that dismissed a complaint against a pharmaceutical company stemming from a West Coast incident that involved injuries sustained in a vehicle crash while the plaintiff was on a generic version of the sleep drug Ambien.

Stephen M. Madden filed suit in the Philadelphia Court of Common Pleas back on Oct. 4, 2010, against Teva Pharmaceuticals and Sanofi-Aventis LLC.

Teva makes the generic version of the drug Ambien, which is used to treat insomnia, while Sanofi-Aventis is responsible for placing warning labels on the medication.

Background information on the case shows Madden was prescribed 10 mg of Ambien by a Washington state doctor on Sept. 20, 2008, following knee replacement surgery.

The plaintiff filled the prescription at a Walgreens pharmacy in Redding, Calif. on Oct. 1, 2008, the record shows.

The pharmacist provided Redding with the generic version of Ambien, which is called Zolpidem.

At about midnight on Oct. 3 of that year, Madden ended up driving his vehicle off of the road and into a ditch in Redding.

He ultimately crashed the vehicle into a tree and electrical pole, which caused Madden to be ejected from the vehicle and sustain various injuries, including head trauma, multiple severe facial fractures, a skull fracture with traumatic head injury, brain swelling, spinal injuries and other ills, the case background shows.

Madden remained hospitalized until he was transferred to a rehabilitation facility in December 2008.

Madden, who has no recollection of the crash, remains confined to a convalescent home in Sylmar, Calif.

Madden’s subsequent lawsuit alleges that he suffered from a condition known as “sleep-driving,” which is a term that refers to driving while not fully awake, and which can occur after taking a sedative-hypnotic such as Ambien.

Madden claims in his suit that sleep-driving is a known risk associated with Ambien and its generic equivalent.

On Jan. 4, 2011, exactly three months after Madden filed his complaint, Philadelphia Common Pleas Court Judge Allan Tereshko sustained Sanofi’s preliminary objections and dismissed any and all claims against the company that is responsible for the warning labels on the generic version of Ambien.

On June 20 of this year, Madden appealed the judge’s decision, arguing that the court erred in concluding that Washington State law applies to the present litigation, and that the court erred in declining to hold Sanofi responsible for the labeling of the generic version of Ambien.

Madden had filed his complaint in Pennsylvania, but made several claims against Sanofi based on events that occurred in both Washington and California.

Tereshko, in his Oct. 1 opinion outlining his request for the earlier court decision to be held up on appeal, says that based on Madden’s allegations, the decision to prescribe the drug was made in Washington, the prescription was written in Washington and any warnings to the doctor would have been received in Washington.

“Therefore, any claims of negligence or negligent misrepresentation would be based on a representation to the prescribing physician in Washington …,” Tereshko wrote. “Accordingly, Washington has an interest in having its law applied to determine whether or not such allegations amount to a cognizable claim. Washington also has a general interest in ensuring that its law is applied to products liability claims involving alleged representations within its borders.

Tereshko further wrote that permitting the “significant expansion” of liability sought by Madden in this case would be in direct contrast to the Washington Product Liability Act, which was designed to address a liability insurance crisis that could threaten the availability of socially beneficial products and services.

Under Madden’s theory of liability, Sanofi would become what Tereshko calls a “functional insurer” for its competitor’s products that it does not manufacture or sell.

“Ultimatley, Washington has the greater interest in having its law applied to Plaintiff’s claims against Sanofi,” the opinion states.

Tereshko wrote that considering the contacts and interest of the other states involved, such as Pennsylvania, (the forum state), New Jersey, (the state where Sanofi is based), and California, (the plaintiff’s home state), the trial court properly concluded that Washington law should apply.

And under the Washington Product Liability Act, Sanofi cannot be held liable for the plaintiff’s injuries, the court determined, since the WPLA provides the exclusive remedy for product liability claims in Washington State.

“The WPLA subsumes virtually all prior causes of action, including negligence and negligent misrepresentation,” the opinion states. “Consequently, Plaintiff’s claims can only be brought, if they can be brought at all, under the WPLA.”

And under the WPLA, the opinion states, product liability claims can only be brought against a product’s manufacturer or seller.

“Sanofi was not the manufacturer or seller of the product at issue in this case,” Tereshko wrote. “Accordingly, Plaintiff cannot assert a legally sufficient claim against Sanofi under Washington law. As such, the Court properly dismissed Plaintiff’s claims against Sanofi.”