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Theresa Huck v. Trimark Physicians Group

April 24, 2013


Appeal from the Iowa District Court for Sac County, Gary L. McMinimee, Judge.

The opinion of the court was delivered by: Vogel, P.J.

Plaintiff appeals multiple district court orders granting summary judgment and dismissing its claims. AFFIRMED.

Heard by Vogel, P.J., and Vaitheswaran and Bower, JJ.

Plaintiff, Theresa Huck, ingested a drug which later caused her serious negative side effects. She appeals from various district court rulings, all of which resulted in judgments for the defendant brand name and generic drug companies.*fn1 Because we find all of her claims to be either not preserved, controlled by Iowa law, or preempted by federal law, we affirm.

I. Background Facts and Proceedings

From February 11, 2004, until March, 2006, Huck was prescribed Reglan,*fn2

a drug first approved by the Food and Drug Administration, (FDA) in 1980. Her physician*fn3 relied upon information published by the brand name manufacturer in the Physician's Desk Reference, containing the manufacturer's labeling for the drug. The 2002 FDA labeling, approved at the time Huck began taking metoclopramide, contained a warning about possible side effects, including developing tardive dyskinesia*fn4 or irreversible movement disorder. The warning included that tardive dyskinesia was expected to occur in one in every five-hundred patients. Huck never ingested Reglan, the brand named drug, as her pharmacy filled the prescription using the generic form, metoclopramide, manufactured by PLIVA.

In July 2004, approximately five months after Huck began taking the drug, the FDA approved the additional label warning language requested by Schwarz*fn5

to indicate in bold print in two different locations, "Therapy should not exceed 12 weeks in duration." While this new language appeared in the label approved by the FDA for Reglan, the generic manufacturer did not provide the updated label, or communicate the new information it contained to Huck or her physician. On June 27, 2008, the FDA reviewers evaluated the onset of "Drug-Induced Movement Disorders" and recommended heightened warnings about the prolonged use of the drug. On February 26, 2009, the FDA imposed the following warning, "prolong treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia."

While the symptoms of tardive dyskinesia had been occurring in Huck for some time, she was not diagnosed with the disease until about June 6, 2006. She filed suit on May 27, 2008, alleging strict liability, negligence, misrepresentation, fraud, and breach of warranties against the "manufacturers." In her petition she did not distinguish between the Brand Defendants and PLIVA. On March 2, 2009, the district court granted the Brand Defendants' motion for summary judgment, finding they were entitled to dismissal because they "did not manufacture or sell the generic metoclopramide ingested by [Huck]." This motion was unresisted by Huck, no post dismissal motions were filed, and the ruling was not immediately appealed.

On December 14, 2010, PLIVA, the only remaining defendant, moved the district court for a stay of all deadlines and to continue the scheduled trial date as a result of the Supreme Court of the United States' grant of certiorari in the case of PLIVA, Inc. v. Mensing,131 S.Ct. 2567 (2011). After the Supreme Court handed down its decision in Mensing, PLIVA moved for summary judgment,*fn6 asserting all of Huck's claims were preempted by federal law. As a result of her interpretation of the Mensing decision, Huck filed a "motion for relief" from the March 2, 2009 judgment that dismissed the Brand Defendants. On January 9, 2012, the district court granted PLIVA's motion for summary judgment and denied Huck's motion for relief. After a denied motion for reconsideration, Huck appeals.

II. Standard of Review

We review a district court decision to grant or deny a motion for summary judgment for correction of errors at law. Kolarik v. Cory Int'l Corp., 721 N.W.2d 159, 162 (Iowa 2006). We examine the record to determine whether a material fact is in dispute and, if not, whether the district court properly applied the law. Robinson v. Fremont Cnty., 744 N.W.2d 323, 325 (Iowa 2008). Summary judgment is proper when the plaintiff's claim lacks evidence to ...

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