Not a Lexis Advance subscriber? Try it out for free.


U.S. High Court Won’t Hear Arguments That Punitives Are Preempted In Drug Cases

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on Oct. 7 refused to hear arguments by Novartis Pharmaceuticals Corp. that federal drug regulations and high court precedent preempt the awarding of state law punitive damages in an Aredia/Zometa jaw injury case (Novartis Pharmaceuticals Corporation v. Herbert Fussman, et al., No. 12-1339, U.S. Sup. [ subscribers may access Supreme Court briefs for this case]). 

A jury in the U.S. District Court for the Middle District of North Carolina in 2010 awarded Herbert Fussman $1.25 million in compensatory and punitive damages.  Novartis appealed, arguing that the U.S. Supreme Court’s drug preemption ruling in Wyeth v. Levine (U.S. 555 [2009] [enhanced opinion available to subscribers]) allowed only compensatory damages and was silent about punitive damages.

 The Fourth Circuit U.S. Court of Appeals affirmed the verdict, and Novartis in May petitioned the Supreme Court for a writ of certiorari

Exclusive Federal Authority 

Novartis argued that the Food and Drug Administration’s exclusive authority to punish violations of federal law governing the marketing of prescription drugs preempts state tort law and the imposition of punitive damages. 

The company also argued that punitive damages impermissibly penalize drug manufacturers under state law for exercising their federal right to market a prescription drug. 

Finally, Novartis argued that the Fourth Circuit erred in holding that Levine does not prohibit the awarding of punitive damages. 

Plaintiff’s Injuries 

In 2001, Rita Fussman was prescribed Aredia and later Zometa, both injectable bisphosphonate drugs made by Novartis, after her breast cancer returned and metastasized to her bones.  Aredia and Zometa are prescribed to prevent cancer-related bone loss. 

In 2002, Fussman had two teeth extracted and claimed to have developed osteonecrosis of the jaw (ONJ). 

In 2006, Fussman and her husband, Herbert, sued Novartis in the District Court, alleging that Novartis knew about the risk of ONJ but failed to adequately warn about the risk.  The case was transferred to the Aredia/Zometa multidistrict litigation in the Middle District of Tennessee and was then remanded for trial. 

Rita Fussman died during the litigation. 

Damages Awarded 

In 2010, a jury awarded $287,000 in compensatory damages and $1 for loss of consortium.  It also awarded $12.6 million in punitive damages. 

Applying North Carolina’s punitive damages law limiting damages to three times the compensatory damages, the court entered judgment for $1.25 million. 

Novartis is represented by Joe G. Hollingsworth, Katharine R. Latimer, Bruce J. Berger and Eric G. Lasker of Hollingsworth in Washington. 

Herbert Fussman is represented by John J. Vecchione of John J. Vecchione Law PLLC in Fairfax, Va.  

Amicus curiae Washington Legal Foundation is represented by Cory L. Andrews of the Washington Legal Foundation in Washington and Jeffrey S. Bucholtz of King & Spalding in Washington. 

For all of your legal news needs, please visit subscribers may search all Mealey Publications.

Non-subscribers may search for Mealey Publications stories and documents at or visit

Mealey's is now available in eBook format!

For more information about LexisNexis products and solutions, connect with us through our corporate site.