Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

January 9, 2013

Manufacturer's motion to dismiss parent's claims alleging the warning label on infant formula was inadequate denied by district court

By Danielle H. Capilla, JD

Parents whose infant suffered from a Cronobacter sakazakii (C.sak) infection are able to continue with their claims against two powdered infant formula (PIF) manufacturers for failure to warn, but their claims for derivative loss of consortium were dismissed (Burks v. Abbott Laboratories, January 8, 2012, Tunheim, J). The parents raised reasonable questions for a jury to decide regarding whether or not the warning on the infant formula fed to their daughter adequately warned of a dangerous characteristic of PIF consumption, namely that it has been historically linked to C. sak outbreaks. Their derivative loss of consortium claims were dismissed based on the statute of limitations. Earlier litigation in the case determined the case would be governed by Louisiana law, specifically the Louisiana Products Liability Act (LPLA).

Background. Abbott Laboratories (Abbott) and Mead & Johnson Company (Mead) both manufactured PIF that was fed to a full term healthy infant, in the first few weeks of her life. The formula fed to the infant was either purchased by her parents or given to them in an unsolicited mailing from Abbott. The formula was mixed with bottled water and delivered to the parent's home. When E.B. was approximately two weeks old she was diagnosed by a local emergency room physician with C.sak meningitis. The parents later learned that although rare, C.sak outbreaks are frequently isolated to PIF, and that the World Health Organization has held three expert panels to discuss the risks of PIF and identify ways to make it safer. After the infant's diagnosis, the FDA tested the remaining PIF from the parent's house as well as other samples from the same batch of formula, but was unable to identify C.sak in any of the samples. Both formulas fed to the infant featured labels that indicated that PIF is not sterile and great care should be taken in preparation, dilution, use and storage of the formula. The labels also indicated that the formula might not be safe for infants who are susceptible to infection (such as premature infants), but made no reference regarding the safety of PIF for full term, healthy infants. The parents argued that full term infants at less than four weeks of age do not have fully developed enteric immunity and that the label should include a warning about this category of infants.

Failure to warn. The LPLA requires a manufacturer to provide an adequate warning on all products; products without adequate warning are considered unreasonably dangerous. Abbott and Mead both argued that they had no obligation to warn consumers of the "remote risk" of C. sak. However, the LPLA does not provide an exception to its adequate warning requirements for remote risks, and as such, the remoteness of the risk is a factor for the jury to weigh when it determines whether the manufacturers exercised reasonable care to provide an adequate warning. Abbott and Mead also argued that the parents cannot establish that either of their PIFs caused infant's illness. The parents argued that the doctrine of alternative liability allows their claims regarding the failure to warn to proceed. The court found that the doctrine of alternative liability, while not discussed by the LPLA, is widely accepted and supported by sensible rationale. The manufacturer's motion to dismiss was denied.

Loss of consortium. The parents filed derivative loss of consortium claims after Louisiana's one year statute of limitations for tort actions had expired. Although they argued that Minnesota recognizes the "escape clause" which gives room for filing if the statute of limitations in another state is substantially different from their state, the court found that the escape clause should rarely be employed. The parents were unable to present evidence that the facts of this case warranted the use of the escape clause, namely they were unable to show that Louisiana's one year statute of limitations deprived them of their fair opportunity to sue. The parent's claims of loss of consortium were dismissed.

Expert testimony. Abbott and Mead also moved to exclude a variety of the parent's expert witnesses. The first witness, Dr. Goldhaber, was presented as a "warnings and labelings" expert who opined in earlier testimony that the warning labels on the PIF was inadequate because they did not refer to C. sak and its consequences, or the risk factors for a healthy, full term infant. The court found that Dr. Goldhaber's experience and expertise resulted in reliable and useful opinions regarding the effectiveness of the provided warnings and alternative warnings, but must be confined to a discussion on the type of risk the average consumer would comprehend in the absence of a warning, and not to a discussion on the scope of risk posed by an item. The manufacturers also moved to exclude a variety of causation experts whom opined that it is more likely than not that the infant's illness was caused by PIF contaminated with C. sak. Based on the allowable doctrine of alternative liability, the motion to exclude these experts was denied.

The case number is 08-3414 (JRT/JSM).

Stephen C. Rathke, Kate G. Westad, Nicholas A. Dolejsi (Lommen, Abdo, Cole, King & Stageberg, PA), for Rockland Burks and Adrienne Lawrence, plaintiffs. June K. Ghezzi (Jones Day), William J. Tipping, Sara H. Daggett (Gaskins, Bennett, Birrell, Schupp, LLP), for Abbott Laboratories, defendant. Anthony J. Anscombe (Sedgwick LLP), Frederick W. Morris (Leonard Street and Deinard, PA), for Mead Johnson & Company, defendants.

Abbott Laboratories. Mead Johnson & Company.

MainStory: TopStory LabelingNews FoodSafetyNews MinnesotaNews LouisanaNews

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.