Archive for January, 2011

After A.G., a minor, had two benign moles removed in 2004, his doctor gave him a prescription for ibuprofen. His parents, the Gaetas, bought an over-the-counter generic ibuprofen manufactured by Perrigo Pharmaceuticals (“Perrigo”). Later, A.G. developed a high fever and had to be rushed to the hospital and treated for liver failure. A.G. needed a liver transplant less than two weeks after the mole surgery and later had dead tissue from his fingers and toes amputated. Doctors determined that the ibuprofen had clashed with the anesthetic Halothane, which had been administered during the mole-removal surgery. Halothane is hepatotoxic or known to cause liver failure in some circumstances.

The Gaetas sued Perrigo and other manufacturers of generic ibuprofen, alleging defective design, defective marketing, breach of express and implied warranties, negligence and gross negligence, and deceit by concealment. The Gaetas claimed that Perrigo failed to warn doctors and consumers that ibuprofen could cause liver injury if mixed with other drugs. In response, Perrigo argued that the Gaetas’ state-law failure-to-warn claims were preempted by the labeling and marketing regulations of the Food and Drug Administration (“FDA”) governing generic drugs. The trial court agreed, concluding that since federal law required generic drugmakers to conform to the approved labeling of brand-name drugs, Perrigo could not have changed its labeling without violating federal law.

The Gaetas appealed the decision to the Ninth Circuit Court of Appeals. While the appeal was pending, the United States Supreme Court issued its opinion in Wyeth v. Levine, holding that approval of medication by the FDA does not shield a manufacturer of brand-name medications from liability under state law. After Levine, the Gaetas won a limited remand from the Ninth Circuit so that the trial court could reconsider its decision with the Supreme Court ruling in mind. The trial court denied the motion for reconsideration, however, and ruled that the high court’s decision only applied to brand-name drug manufacturers.

The Gaetas again appealed the trial court’s decision. With its holding, the Ninth Circuit joins the Fifth and Eighth Circuits in applying Levine to generic drugs as well. The court noted that (1) manufacturers are primarily responsible for warning consumers about possible drug dangers because they have better access to information about their products than the FDA, and (2) there is nothing in Levine that limits this responsibility to brand-name drug manufacturers. The court stated that both sets of manufacturers must take specific steps when they learn of new risks associated with their products. Finally, the court concluded that compliance with both state and federal law was not “impossible.” Accordingly, the court remanded the case to the trial court for further proceedings.

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Hansen v. Republic R-III School District, No. 10-1514.

Larry Hansen’s son is a ninth-grade student in the Republic R-III School District (“Republic”) and has been diagnosed with conduct disorder, bipolar disorder, and attention deficit hyperactivity disorder (“ADHD”). Hansen has (1) been suspended numerous times for threatening classmates and teachers, (2) made suicidal comments on multiple occasions, (3) consistently performed poorly in his classes and standardized tests. At the end of his fifth-grade year, Hansen’s father initiated proceedings under the Individuals with Disabilities Education Act (“IDEA”) for special education services for Hansen. After an eligibility evaluation, Republic determined that Hansen did not qualify. Hansen’s father challenged the decision through an administrative due process hearing, and the Due Process Panel agreed with Republic, noting that Hansen did not qualify for special education services under the IDEA as a matter of law.

Hansen’s father then sought judicial review of the panel’s decision. The district court agreed with Hansen’s father that Hansen was disabled as defined by the IDEA and, thus, eligible for special education services. Republic subsequently appealed the matter to the Eighth Circuit Court of Appeals, arguing that Hansen did not meet the statutory definition of a “child with a disability.”

The Eighth Circuit noted that the IDEA provides thirteen categories of eligibility, including “emotional disturbance” and “other health impairment.” The Code of Federal Regulations (“CFR”) defines “emotional disturbance” as a condition exhibiting at least one of the five listed characteristic “over a long period of time and to a marked degree that adversely affects a child’s educational performance.” The CFR’s definition precludes children who are only “socially maladjusted” and fail to exhibit at least one of the five provided characteristics. Republic contends that Hansen is socially maladjusted rather than emotional disturbed, as Hansen’s father alleges. The court agreed with Hansen’s father, stating that “consistently struggled to pass his classes, failed the standardized test . . . for advancement to the seventh grade, and suffered academically because of his diagnosed bipolar disorder.”

The court then explained that Hansen met the eligibility requirement for “other health impairment” under the IDEA. The CFR defines “other health impairment” as “having limited strength, vitality, or alertness . . . that—(i) Is due to chronic or acute health problems such as [ADHD] . . . and (ii) Adversely affects a child’s educational performance.” The court found that there was overwhelming evidence that Hansen suffered from ADHD and that his educational performance was affected by it.

Accordingly, the court held that Hansen meets the statutory definition of a “child with a disability” under the IDEA and affirmed the district court’s ruling.

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Ester Salinas spent a decade researching the area surrounding the Hayes-Sammons pesticide plant in Mission, Texas. She found that hundreds of children in the area were stillborn, while many others were born with birth defects. Pat Townsend was city manager in 2000, and he ordered the site to be tested by a toxicologist Ester Salinas recommended. He then obtained permission to have a second expert do additional testing, which angered Ester Salinas. At a 2003 Mission city council meeting, Ester Salinas said Townsend "was instrumental in inflicting human suffer[ing] and severe property damage." Two years later at another council meeting, Ester Salinas said, "Justice Day will come and some of you will be judged for the way you have stolen and lied and killed." In a televised interview in 2008, Ester Salinas said, "So we have to go to court to fight because even the mayor in La Joya told me that Norberto Salinas [the current mayor of Mission] went to talk to him to say that they were going to kill me." Mission residents also testified that Ester Salinas called Norberto Salinas a drug dealer and politically corrupt.

Norberto Salinas and Townsend sued Ester Salinas for slander, and the trial court ruled in their favor, awarding $10,000 to Townsend and $30,000 to Norberto Salinas. On appeal, the Texas Court of Appeals found that the statements about Townsend were not slanderous:

Public officials, particularly those in policymaking positions such as mayor, are prone to receiving hyperbolic criticism precisely because of the power they wield. Our only concern is whether her remarks would be reasonably understood by an ordinary listener as having charged Townsend with criminal behavior. They would not.

After dismissing the $10,000 award to Townsend, the court affirmed the remaining slander claims.

For the full story, click here.

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