United States District Court, Central District of Illinois, Springfield Division
March 8, 1991
BRANDI NICOLE DECK, A MINOR, BY RITA DECK HER MOTHER AND NEXT FRIEND, AND RITA DECK, INDIVIDUALLY, PLAINTIFFS,
TERRY MCBRIEN AND SULLIVAN DRUGS, INC., DEFENDANTS.
The opinion of the court was delivered by: Richard Mills, District Judge:
On July 10, 1986, Rita Deck purchased the prescription drug
Asendin from Sullivan Drugs, Inc. and Terry McBrien, a
pharmacist employed by Sullivan. The drug was not dispensed in
a child-proof container as required by federal law.
One month later, on August 15, Rita's 2 1/2 year old
daughter, Brandi, ingested the drug and, as a result, sustained
severe and permanent injuries.
The Decks have brought this action under the Consumer Product
Safety Act, 15 U.S.C. § 2072, seeking $6,000,000 in damages
against the Defendants. Defendants have moved to dismiss on the
basis that § 2072 does not provide for a private cause of
action in this case and thus jurisdiction is improper. The
motion to dismiss raises a novel question under the Consumer
Product Safety Act which was not addressed by two courts which
allowed recovery in similar cases. See Baas v. Hoye,
766 F.2d 1190 (8th Cir. 1985); Wahba v. H & N Prescription Center, Inc.,
539 F. Supp. 352 (E.D.N.Y. 1982).
In short, we hold that the Consumer Product Safety Commission
must by rule designate prescription drugs for regulation before
the act can apply.
In resolving this issue we must examine the Consumer Product
Safety Act, 15 U.S.C. § 2051 et seq., the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. § 301 et seq., and the Poison
Act, 15 U.S.C. § 1471 et seq., as well as regulations issued
pursuant to these acts by the Consumer Product Safety
We begin with the statute at issue. Section 2072(a) of the
Consumer Product Safety Act provides:
Any person who shall sustain injury by reason of
any knowing (including willful) violation of a
consumer product safety rule, or any other rule or
order issued by the Commission may sue any person
who knowingly (including willfully) violated any
such rule or order in any district court of the
United States in the district in which the
defendant resides or is found or has an agent,
shall recover damages sustained, and may, if the
court determines it to be in the interest of
justice, recover the costs of suit, including
reasonable attorneys' fees. . . .
15 U.S.C. § 2072(a). By its terms § 2072 is limited to
providing a private cause of action for violation of a consumer
product safety rule or other rule or order of the Commission;
the statute does not provide a private cause of action for
violation of the act itself. Drake v. Honeywell, Inc.,
797 F.2d 603, 606 (8th Cir. 1986).
The Consumer Product Safety Act was passed by Congress in
1972 for the purpose of, inter alia, protecting "the public
against unreasonable risks of injury associated with consumer
products." 15 U.S.C. § 2051(b)(1). The act expressly excludes
"drugs, devices, or cosmetics" from the definition of consumer
product found in § 2052. See id. § 2052(a)(1)(H). In addition,
the term "consumer product safety rule" is defined as a
"consumer product safety standard" or "a rule under this
chapter declaring a consumer product a banned hazardous
product." Id. § 2052(a)(2).
Therefore, by its own terms, the act does not regulate
prescription drugs. Plaintiffs argue that their private cause
of action under the act exists because § 2072(a) provides a
cause of action for violation of a consumer product safety rule
(which does not apply) and any other rule or order of the
Commission. One such "rule or order" requires that prescription
drugs be dispensed only in "special" (i.e. child-proof)
packaging. 16 C.F.R. § 1700.14(a)(10).
Prior to the enactment of the Consumer Product Safety Act and
the creation of the Commission in 1972 several specific
regulatory statutes were in existence, including the Poison
Prevention Packaging Act of 1970, 15 U.S.C. § 1471 et seq. The
Senate Report accompanying the Consumer Product Safety Act
explains that these pre-existing regulatory statutes were
brought under the jurisdiction of the Commission rather than
repealed in favor of the more general Consumer Product Safety
Act, both because the existing legislation represented explicit
findings by Congress as to specific consumer hazards and to
avoid duplicative regulatory action under the new act when the
old acts had been operating efficiently in their areas of
concern. S.Rep. No. 92-835, 92d Cong., 2d Sess., reprinted in
1972 U.S.Code Cong. & Admin. News, at 4573, 4592.
The Consumer Product Safety Act provides that
A risk of injury which is associated with a
consumer product and which could be eliminated or
reduced to a sufficient extent by action under . .
. the Poison Prevention Packaging Act of 1970 . .
. may be regulated under [the Consumer Product
Safety Act] only if the Commission by rule finds
that it is in the public interest to regulate such
risk of injury under [the Consumer Product Safety
Act]. (emphasis ours)
15 U.S.C. § 2079(d). The Commission has identified several
products which it regulates under the Consumer Product Safety
Act rather than the pre-existing statutes; however,
prescription drugs are not included among those identified
products. See 16 C.F.R. § 1145 et seq.
In Riegel Textile Corp. v. Celanese Corp., 493 F. Supp. 511
(S.D.N.Y. 1980) a manufacturer of children's sleepwear brought
suit under § 2072 against a fiber manufacturer who had supplied
material which was later declared a "banned hazardous
substance" by the Commission. The Commission, in ordering the
proceeded under regulations issued pursuant to the Federal
Hazardous Substances Act (one of the pre-existing statutes)
rather then the Consumer Product Safety Act. The district court
held that a cause of action under § 2072 does not arise in the
absence of valid regulatory action by the Commission under the
Consumer Product Safety Act. Because the Commission proceeded
pursuant to the Hazardous Substances Act, rather than issuing
an order under § 2079 transferring regulatory authority over
the product to the Consumer Product Safety Act, no regulation
under the Consumer Product Safety Act was at issue and thus no
cause of action under § 2072 existed.
No implied private right of action exists under either the
Federal Food, Drug, and Cosmetic Act, Pacific Trading Co. v.
Wilson & Company, Inc., 547 F.2d 367 (7th Cir. 1976), or the
Poison Prevention Packaging Act of 1970. Doane v. Metal Bluing
Products, Inc., 568 F. Supp. 744, 746 (N.D.N.Y. 1983). Thus,
Plaintiffs' case turns upon whether a cause of action exists by
applying the regulations issued pursuant to the Poison
Prevention Packaging Act through the Consumer Product Safety
Act. As previously mentioned, Plaintiffs rely upon two cases
allowing recovery in similar situations.
In Wahba v. H & N Prescription Center, Inc., 539 F. Supp. 352
(E.D.N.Y. 1982) the plaintiffs brought an action pursuant to §
2072 against a pharmacy that dispensed the drug Lomotil in a
non-child-proof container resulting in the death of their two
year old son. The district court, without discussing whether a
cause of action could be maintained under § 2072 for violation
of the regulations issued pursuant to the Poison Prevention
Packaging Act, held that § 2072 did not allow for the recovery
of punitive damages and struck plaintiffs' prayer for punitive
Similarly, in Baas v. Hoye, 766 F.2d 1190 (8th Cir. 1985) the
plaintiffs brought an action pursuant to § 2072 following the
death of their daughter from ingestion of Tedral SA which had
been dispensed in a non-child-proof container. Among the issues
presented to the circuit court was whether the pharmacy had
violated a consumer product safety rule. However, rather than
contending that drugs were not consumer products as defined by
§ 2052, the pharmacy argued that Tedral SA was not a drug which
was required to be dispensed only in a child-proof container.
The circuit court, without discussing the exclusion of drugs
from the definition of "consumer product" merely stated that
the United States Pharmacopeia listed Tedral SA as a
prescription drug and thus it should have been dispensed in a
Neither Wahba nor Baas apparently considered the question of
whether a cause of action could be maintained under § 2072 for
violation of the regulations requiring prescription drugs to be
dispensed only in child-proof containers. As discussed earlier,
the Commission has not acted pursuant to § 2079(d) to regulate
prescription drugs under the Consumer Product Safety Act and
thus we must conclude that no cause of action exists under §
2072. Therefore, Defendants' motion to dismiss must be allowed.
IT IS THEREFORE ORDERED THAT Defendants' motion to dismiss
(d/e 6) is ALLOWED. Counts I and II of Plaintiffs' complaint
are dismissed WITH PREJUDICE. Counts III and IV, premised on
state law, are DISMISSED WITHOUT PREJUDICE for lack of pendent
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