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FDA Preemption is Sound Public Policy


Courts in Texas have decided to defer to the U.S. Food & Drug Administration regarding labeling and safety decisions. This public policy makes sense. It gives product manufacturers clarity on the process they must adhere to when developing and marketing prescription medications and medical devices. This clarity then promotes predictability and greater efficiency. It also makes sense when you consider the fact that the FDA is the main regulator of prescription drug companies, so if there is a problem with labeling or the safety of a drug, the FDA is best equipped to handle it.

This policy rationale underpinned the North District Texas Court’s decision in Anderson v. Abbott Labs., Case No. 3:11-cv-01825-L (N.D. Tex. Sept. 30, 2012). The case involved a plaintiff filing a claim against the manufacturer of a popular TNF blocking medication known as Humira. This medication was approved by the FDA to treat rheumatoid arthritis and other autoimmune conditions. The plaintiffs were the parents of a child who went to a doctor who prescribed Humira for the off-label treatment of psoriasis. The parents alleged that the medication caused their child to develop pediatric leukemia.

Shortly after the child was prescribed Humira, the FDA began investigating a possible link between Humira and pediatric leukemia. The investigation led to the FDA requiring a warning on the Humira label alerting patients to an increased risk of adolescent leukemia. 

Texas Law to the Rescue  

According to Texas Civil Practice & Remedies Code §82.007(a), an FDA-approved warning is adequate as a matter of law. Basically, this means it is not something that may be decided by a jury. There are some limited exceptions to this statute. For example, under § 82.007(b)(1), this preemption is negated if a manufacturer withholds material information from the FDA.

The court wasn’t buying it. They rejected the claim that the Humira label on the plaintiff’s medication did not include the most current FDA warning. The court highlighted the fact that the plaintiffs cited no authority to substantiate the argument that the FDA’s early communication about the investigation into pediatric leukemia was sufficient for the company to immediately institute a new warning label. The court therefore determined that the presumption afforded to the FDA-approved prescription drug label was adequate as a matter of law.

The plaintiffs then tried to argue that FDA preemption didn’t apply because there was evidence to “off-label” promotion. According to § 82.007(b)(3), a plaintiff may rebut the FDA presumption when there is evidence of the following:

  • The manufacturer recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the FDA;
  • The product was used as recommended, promoted, or advertised; and
  • The plaintiff’s harm was causally related to the recommended, promoted, or advertised use of the pharmaceutical product.

The court declared that this statute means that there must be evidence that a manufacturer promoted the drug off-label to the prescribing doctor and that the promotion caused the doctor to prescribe it.

The plaintiffs did not satisfy this legal standard and therefore had their complaint dismissed with prejudice. 

Contact a Brownsville Product Liability Defense Lawyer

If your company is being sued for alleged product liability, now is the time to retain aggressive and skilled legal representation. The law firm of Colvin, Saenz, Rodriguez & Kennamer, L.L.P. in Brownsville is here to assist your company in virtually any legal issue you may be confronting. Contact our office today to schedule a meeting.




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