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Pediatric Formula - A Case Study

nteral formulas are nutritional medical foods that are not regulated by the FDA to the same extent as prescription medications. Despite this classification, enteral formulas are typically prescribed by licensed physicians to infants, children and elderly persons suffering a variety of gastrointestinal disease and conditions. In 2000, Apria Healthcare, the largest home health agency in the country and, Nestle USA, one of the largest corporations in the world entered into a business venture whereby all of Apria’s home health clients receiving enteral fomulas prescribed by their physicians would be converted to a Nestle enteral formula product that was allegedly similar and suitable for the patient’s particular medical condition. The purpose of this business alignment was to permit Nestle to capture an additional 30,000,000 in enteral formula market share and for Apria to obtain preferential pricing such that their existing client sales would become significantly more profitable.

Apria and Nestlé’s Nationwide Conversion Program employed the use of dieticians hired by Nestle who would be permitted access to Apria’s confidential client medical information. The dieticians would contact the prescribing physician to attempt to convince them that the Nestle product was the same or better than the enteral formula taken by their patients. In the conversion process, careless misrepresentations were made to physicians to induce them to authorize or order a conversion to a Nestle product for their patients.

One of Nestlé’s products, Peptamen Junior was an enteral formula that contained hydrolyzed whey, a common milk protein that had been broken down. Peptamen Junior was typically prescribed for pediatric patients suffering from gastrointestinal conditions, but was not classified or considered as a hypoallergenic product suitable for use in patient’s suffering from whey allergey. Neocate One Plus was a hypoallergenic pediatric enteral formula containing wholly free amino acids that was designed, manufactured and marketed to pediatric patients who had serious allergies to whey and other proteins. Despite the obvious and significant differences in the intended use and ingredients between Peptamen Junior and Neoctae One Plus, Nestle sought to directly market its product against Neocate One Plus without regard to whether it was dangerous for use by patients suffering whey allergy.

As a part of the Conversion Program, Nestlé’s dietician contacted the physician of a young disabled child suffering from multiple medical conditions that was taking Neocate One Plus because of his whey protein allergy. Despite knowledge of the different intended uses between Neocate One Plus and Nestlé’s Peptamen Junior, Nestle falsely represented that Peptamen Junior was “the same” as Neocate One Plus. The false representations induced the physician to authorize a substitution to the Nestle product. Tragically, within seconds of ingesting Nestlé’s Peptamen Junior, the young disabled child died in his father’s arms from of a massive allergic reaction.

I represented the family in a wrongful death suit against the Apria and Nestle asserting claims for strict tort liability-marketing defect, breach of express and implied warranties and fraud. Although Nestle defended the case by claiming an honest mistake, our discovery efforts revealed the sinister nature of Nestlé’s corporate policies. Nestlé’s corporate knowledge concerning the serious danger of allowing a pediatric patient that was allergic to whey protein to ingest Peptamen Junior and their marketing plan against Neocate One Plus came to light leaving Nestle unable to offer any serious defense to their actions. The claims against Nestle and Apria were settled for a confidential amount shortly before trial.

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