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Prince v. B.F. Ascher Company2/17/2004
the dosage ranges used as a nasal decongestant. 41 Fed. Reg. 38,402 (1976); see also 59 Fed. Reg. 43,386 (1994).
The FDA mandates the specific language as to directions for use and warnings that must appear on all Benzedrex® containers. See 59 Fed. Reg. 43,396 (1994) Comment 13; and 59 Fed. Reg. 43,404 (1994) Comment 25. When the FDA published its Tentative Final Monograph for Nasal decongestants it specifically addressed the issue that "certain OTC nasal decongestant products containing propylhexedrine have the capability of producing a 'high' and therefore have a potential for abuse." 50 Fed. Reg. 2,226 (1984) Comment 12. Acknowledging the reported instances of abuse "among individuals, most of whom had a history of drug abuse, who knowingly misused the drug," the FDA concluded " he agency believes that propylhexedrine should be available as an inhalant nasal decongestant because it is safe and effective, when used as instructed in the labeling." Id. at 2,227. In establishing the required warnings of OTC inhalant products, the FDA considered and rejected a warning that stated "Caution: Not for use by mouth," agreeing with a comment that such a warning could potentially incite abuse by stimulating the imagination of consumers and noting that the mandated dosage and directions "clearly indicate that these inhalants are to be used intranasally." 50 Fed. Reg. 2,234 (1985) Comment 29.
The Benzedrex® label reads as follows:
DIRECTIONS: This product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine. Adults and children (6-12 years) with adult supervision: 2 inhalations in each nostril not more often than every 2 hours. Children under 6: consult a physician. This inhaler is effective for a minimum of 3 months after first use. Keep inhaler tightly closed.
DO NOT EXCEED RECOMMENDED DOSAGE. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection. Do not use this product for more than three days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a physician. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Ill effects may result if taken internally. In case of accidental overdose or ingestion of contents, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
At deposition, Prince admitted the warning on Benzedrex® package conveys the product may be poisonous if ingested.
During his initial years of propylhexedrine abuse, Ballard would dismantle the Benzedrex® inhaler's plastic tube and swallow the cotton pledget inside, which contained the FDA-approved mixture of propylhexedrine, menthol, and lavender oil. Sometime in the late 1970's or early 1980's, Ballard's step-son showed him how to create a solution using water and a syringe to extract the propylhexedrine from the cotton pledget, which solution Ballard would inject directly into his bloodstream using a hypodermic needle. This method caused a more immediate "high" while avoiding the foul taste associated with swallowing the cotton pledget. Ballard continued to abuse propylhexedrine in this way throughout the 1980's and 1990's until the date of his death, injecting the extracted contents of as many as three to five Benzedrex® inhalers a day.
Prince maintains Ballard's addiction did not cause him to suffer any identifiable injury until his death. In support of this claim, she notes Ballar
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