California Supreme Court Refuses to Review Appeals Court Ruling that Brand-Name Drug Manufacturer Can Be Liable for Injuries the Patient Sustained while Taking Generic Version of the Drug

February 10, 2009

By Jamie K. Wolszon –    

On January 21, 2009, the California Supreme Court decided that it would not review a remarkable California appeals court decision that a brand-name drug manufacturer could be liable for an adverse event the plaintiff suffered as a result of taking a generic version of the drug, if the physician foreseeably relied upon the brand-name drug company’s labeling.  We previously reported on the First Appellate District in the Court of Appeal in the State of California decision.

Wyeth submitted a petition in Conte v. Wyeth, Inc., et. al. requesting that the California Supreme Court review the appeals court decision. The California Supreme Court does not automatically review appeals court decisions in civil cases:  Parties seeking review file petitions for review with the court.  The California Supreme Court did not provide any explanation of its decision to deny the petition, although it did note that Justice Marvin Baxter wanted to grant the petition.

The Washington Legal Foundation (“WLF”), a group well known in food and drug law circles for challenging FDA’s policies regarding the dissemination of information pertaining to off-label information, filed an amicus brief urging the California Supreme Court to hear the case.  WLF argued in its brief that the appeals court holding represented a radical departure from the long-standing legal principle that a manufacturer only can be liable under products liability law if it makes the drug that injured the plaintiff.

WLF also argued in its brief that allowing the appeals court ruling to stand would discourage generic drug makers’ from ensuring that their labeling contain sufficient safety information.  FDA regulations call on generic drug manufacturers, as well as innovator drug makers, to ask FDA to change the label if new information comes to light. 
WLF stated in a litigation update about the case that it expects other plaintiff attorneys will try to use a similar theory in future cases.  The group added that it will look for opportunities to defeat the theory as it arises in other cases. 

The controversial appellate court ruling that was the subject of the petition for review held: “that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer’s product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug.” 
The appellate court also found that the plaintiff created a sufficient factual dispute as to whether the plaintiff’s physician relied on the information submitted by Wyeth to the Physician’s Desk Reference (“PDR”) for its drug REGLAN (metoclopramide) to defeat a motion for summary judgment.  The plaintiff claimed that the information Wyeth submitted to the PDR did not adequately warn about the adverse effects that could occur from taking the drug for more than 12 weeks at a time, that the physician relied on that information, and as a result, the plaintiff suffered injury. 

The trial court, reversed by the appellate court, had granted Wyeth’s motion for summary judgment on the grounds that a brand-name drug manufacturer does not owe a duty of care to the plaintiff who only took the generic version of the drug, and that the plaintiff could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth. 

Now that the California Supreme Court has refused to hear the case, the case will return to the trial court.

Categories: Drug Development