MEMORANDUM
LEGG, District Judge.
In this civil action removed to this Court by defendant Tambrands pursuant to 28 U.S.C. § 1441
et seq.,
the Court is called upon to decide the motions for partial summary judgement filed by defendant, Tam-brands, Inc. (“Tampax”) with respect to (i) federal preemption of plaintiffs failure to warn claim and (ii) punitive damages. For the reasons set forth below, the Court will, by separate order, GRANT both motions for partial summary judgement.
I.
FACTS AND PROCEDURE
Plaintiff Marie Sloman used tampons regularly for over ten years. (Sloman Dep. at 44). “On Thursday, April 12,1990, the Plaintiff (who was 27 years of age), began her monthly menstrual flow and utilized ‘tampax’ tampons for absorption of menstrual flow.” (Complaint If 5).
Plaintiff alleges that, on April 15,1990, she “developed signs and symptoms which included, but were not limited to, dull, aching pain, weakness, low back pain, fatigue, and diarrhea.” (Complaint ¶ 5). On Monday, April 16, 1990, plaintiffs condition worsened, and she was taken to Francis Scott Key Medical Center where she required emergency hospitalization for Toxic Shock Syndrome (“TSS”). As a consequence of TSS, both of plaintiffs legs were amputated below the knee. (Complaint ¶ 6). Plaintiff alleges that she developed TSS as a “direct and proximate result of using Defendant’s ‘tampax’ tampons” (Complaint ¶ 6) and that Tampax “failed to adequately, properly and fully warn her” of the dangers of TSS and thus caused her to contract TSS. (Complaint ¶ 26).
Plaintiff filed a five-count complaint in Baltimore City Circuit Court on August 7, 1992, stating claims against Tampax for (i) negligence; (ii) breach of express and implied warranty; (iii) strict product liability in tort; (iv) failure to warn; and (v) punitive damages.. The ease was removed to this Court on September 10, 1992.
II.
DISCUSSION
Defendant Tampax contends, and plaintiff concedes (Plaintiffs Opposition at 1), that the tampon labeling regulation promulgated by the Food and Drug Administration (“FDA”) expressly preempts plaintiffs state law failure to warn claims in Counts 1
, IV,
and V.
Defendant alleges, that because its warning label complied with federal regulations, plaintiff has no claim. Plaintiff counters that there are two material issues of disputed fact such that summary judgement can not be granted: (i) whether plaintiff has established a genuine issue concerning Tampax’s compliance with the federal regulation and (ii) whether plaintiffs claims concerning defendant’s advertisements are preempted by federal regulation.
Tampons are regulated as medical devices by the 1976 Medical Device Amendments, (21 U.S.C. § 360c) to the Federal Food, Drug & Cosmetics Act of 1938, which expressly preempts any different or additional state regulation of medical devices, including label regulations.
The Amendments and the regulations, specifically 21 C.F.R. § 801.430, expressly confer upon the FDA the exclusive authority to establish labeling standard for tampons.
A.
Compliance with Federal Regulations
Plaintiff is correct in her assertion that summary judgement is not automatically granted when federal law preempts state claims.
In the case at bar, defendant must demonstrate that, as a matter of law, its labels and inserts complied with the appropriate federal regulations for tampon safety warnings cited in footnote 4 of this opinion. The Court concludes that defendant successfully demonstrated that it, complied with the appropriate federal regulations.
“Since 1982, more than 25 billion Tampax tampons have been manufactured and sold without any suggestion by the FDA of lack of compliance.” (Clayton L. Thomas Aff. ¶ 6). At least four courts have granted summary judgment in favor of defendant on the issue of compliance after considering the precise warning at issue here. See
Lindquist v. Tambrands, Inc.,
721 F.Supp. 1058 (D.Minn.1989);
Comelison v. Tambrands, Inc.,
710 F.Supp. 706, 709 (D.Minn.1989);
Aase v. Tambrands, Inc.,
No. 68108, slip op. at 3 (Kootenai County, Idaho Aug. 24, 1989);
Jones v. Tambrands, Inc.,
No. C0870102 (N.D.Iowa, Dec. 5, 1988).
Tampax’s warning complies with each of the specific requirements established by the FDA. As mandated by 21 C.F.R. § 801-430(c), the tampon package includes an alert statement worded precisely as required by the regulation, and Tampax’s insert provides all the information about TSS required by 21 C.F.R. § 801.430(d). The Court therefore finds that there is no genuine issue of fact concerning Tampax’s compliance with federal labeling regulations.
Plaintiff asserts, however, that Tampax’s package warning does not comply with 21 U.S.C. § 352(c) because the label is not conspicuous, likely to be read, or likely to be understood.
In
Beecher v. Tambrands, Inc.,
Civ. No. 3-90-639 (D.Minn. Nov. 19, 1992), the court addressed this issue and held that the warning label and insert did not violate § 352(e). This Court agrees.
Ms. Sloman claims that Tambrands violated § 352(e) by placing the TSS alert statement on the back instead of on the front of its Tampax box.
(See
Plaintiffs Opposition at 4). The FDA, however, expressly declined to require that the alert statement appear on any particular panel of the box.
(See
47 Fed.Reg.
26,987
(1982) (“FDA has concluded that there is no need to require that the alert statement appear in any specific location, thus providing flexibility to manufacturers.”). Therefore, Tampax did not violate FDA reg
ulations by placing the TSS alert statement on the back of its box.
Plaintiffs contention that, because the bulk of the alert statement is provided in an insert it is inconspicuous is also inaccurate. The FDA permits manufacturers to include this information in a package insert rather than on the exterior of the package.
See
21 C.F.R. § 801.430(c).
Free access — add to your briefcase to read the full text and ask questions with AI
MEMORANDUM
LEGG, District Judge.
In this civil action removed to this Court by defendant Tambrands pursuant to 28 U.S.C. § 1441
et seq.,
the Court is called upon to decide the motions for partial summary judgement filed by defendant, Tam-brands, Inc. (“Tampax”) with respect to (i) federal preemption of plaintiffs failure to warn claim and (ii) punitive damages. For the reasons set forth below, the Court will, by separate order, GRANT both motions for partial summary judgement.
I.
FACTS AND PROCEDURE
Plaintiff Marie Sloman used tampons regularly for over ten years. (Sloman Dep. at 44). “On Thursday, April 12,1990, the Plaintiff (who was 27 years of age), began her monthly menstrual flow and utilized ‘tampax’ tampons for absorption of menstrual flow.” (Complaint If 5).
Plaintiff alleges that, on April 15,1990, she “developed signs and symptoms which included, but were not limited to, dull, aching pain, weakness, low back pain, fatigue, and diarrhea.” (Complaint ¶ 5). On Monday, April 16, 1990, plaintiffs condition worsened, and she was taken to Francis Scott Key Medical Center where she required emergency hospitalization for Toxic Shock Syndrome (“TSS”). As a consequence of TSS, both of plaintiffs legs were amputated below the knee. (Complaint ¶ 6). Plaintiff alleges that she developed TSS as a “direct and proximate result of using Defendant’s ‘tampax’ tampons” (Complaint ¶ 6) and that Tampax “failed to adequately, properly and fully warn her” of the dangers of TSS and thus caused her to contract TSS. (Complaint ¶ 26).
Plaintiff filed a five-count complaint in Baltimore City Circuit Court on August 7, 1992, stating claims against Tampax for (i) negligence; (ii) breach of express and implied warranty; (iii) strict product liability in tort; (iv) failure to warn; and (v) punitive damages.. The ease was removed to this Court on September 10, 1992.
II.
DISCUSSION
Defendant Tampax contends, and plaintiff concedes (Plaintiffs Opposition at 1), that the tampon labeling regulation promulgated by the Food and Drug Administration (“FDA”) expressly preempts plaintiffs state law failure to warn claims in Counts 1
, IV,
and V.
Defendant alleges, that because its warning label complied with federal regulations, plaintiff has no claim. Plaintiff counters that there are two material issues of disputed fact such that summary judgement can not be granted: (i) whether plaintiff has established a genuine issue concerning Tampax’s compliance with the federal regulation and (ii) whether plaintiffs claims concerning defendant’s advertisements are preempted by federal regulation.
Tampons are regulated as medical devices by the 1976 Medical Device Amendments, (21 U.S.C. § 360c) to the Federal Food, Drug & Cosmetics Act of 1938, which expressly preempts any different or additional state regulation of medical devices, including label regulations.
The Amendments and the regulations, specifically 21 C.F.R. § 801.430, expressly confer upon the FDA the exclusive authority to establish labeling standard for tampons.
A.
Compliance with Federal Regulations
Plaintiff is correct in her assertion that summary judgement is not automatically granted when federal law preempts state claims.
In the case at bar, defendant must demonstrate that, as a matter of law, its labels and inserts complied with the appropriate federal regulations for tampon safety warnings cited in footnote 4 of this opinion. The Court concludes that defendant successfully demonstrated that it, complied with the appropriate federal regulations.
“Since 1982, more than 25 billion Tampax tampons have been manufactured and sold without any suggestion by the FDA of lack of compliance.” (Clayton L. Thomas Aff. ¶ 6). At least four courts have granted summary judgment in favor of defendant on the issue of compliance after considering the precise warning at issue here. See
Lindquist v. Tambrands, Inc.,
721 F.Supp. 1058 (D.Minn.1989);
Comelison v. Tambrands, Inc.,
710 F.Supp. 706, 709 (D.Minn.1989);
Aase v. Tambrands, Inc.,
No. 68108, slip op. at 3 (Kootenai County, Idaho Aug. 24, 1989);
Jones v. Tambrands, Inc.,
No. C0870102 (N.D.Iowa, Dec. 5, 1988).
Tampax’s warning complies with each of the specific requirements established by the FDA. As mandated by 21 C.F.R. § 801-430(c), the tampon package includes an alert statement worded precisely as required by the regulation, and Tampax’s insert provides all the information about TSS required by 21 C.F.R. § 801.430(d). The Court therefore finds that there is no genuine issue of fact concerning Tampax’s compliance with federal labeling regulations.
Plaintiff asserts, however, that Tampax’s package warning does not comply with 21 U.S.C. § 352(c) because the label is not conspicuous, likely to be read, or likely to be understood.
In
Beecher v. Tambrands, Inc.,
Civ. No. 3-90-639 (D.Minn. Nov. 19, 1992), the court addressed this issue and held that the warning label and insert did not violate § 352(e). This Court agrees.
Ms. Sloman claims that Tambrands violated § 352(e) by placing the TSS alert statement on the back instead of on the front of its Tampax box.
(See
Plaintiffs Opposition at 4). The FDA, however, expressly declined to require that the alert statement appear on any particular panel of the box.
(See
47 Fed.Reg.
26,987
(1982) (“FDA has concluded that there is no need to require that the alert statement appear in any specific location, thus providing flexibility to manufacturers.”). Therefore, Tampax did not violate FDA reg
ulations by placing the TSS alert statement on the back of its box.
Plaintiffs contention that, because the bulk of the alert statement is provided in an insert it is inconspicuous is also inaccurate. The FDA permits manufacturers to include this information in a package insert rather than on the exterior of the package.
See
21 C.F.R. § 801.430(c). Plaintiff also claims that the alert statement violates § 352(c) because the insert states “If you are using TAMPAX tampons for the first time, please read these directions carefully.” Because Marie Sloman was not a first time user, she argues that this statement would have induced her to ignore the alert statement provided. This statement, however, appears on the opposite side of the insert from the TSS alert statement and the insert is folded so that the consumer sees the alert statement first. (Clayton L. Thomas Aff. ¶ 9). Thus, plaintiffs claim has no merit.
Plaintiff also alleges that she was not specifically warned “that toxic shock syndrome is something that one has to worry about beyond her first use of the product.” (Plaintiffs Opposition at 5). The FDA regulations, however, do not require this type of warning and a state law requiring this type of warning would be preempted by federal law because 21 U.S.C. § 360k provides that:
no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement which is different from, or in addition to, any requirement available under this chapter to the device.
Finally, plaintiff claims that the word “Attention” before the TSS warning on the Tampax package is not strong enough to alert consumers.
(See
Kenneth Laugherty Aff. ¶ 3). FDA regulation 21 C.F.R. § 801.430(c) explicitly states, however, that the word “Attention” should be placed before the warning. Therefore, once again, Tampax complied with FDA requirements.
Viewing the evidence in a light most favorable to the plaintiff, the Court finds that no question of fact exists concerning Tampax’s compliance with federal regulations. Tampax’s warning met each of the specific requirements established by the FDA. The Court has examined the package and insert in light of plaintiffs arguments and concludes that the warnings “so correspond in meaning and clarity with the FDA specifications” as to preclude a finding that defendant did not comply with the regulation.
Meyer v. International Playtex, Inc.,
724 F.Supp. 288, 294 (D.N.J.1988). The Court therefore finds that there is no genuine issue of fact concerning Tampax’s compliance with federal labeling regulations.
B.
Defendant’s Advertisements
Plaintiff also argues that federal preemption would not apply to a “failure to warn in advertising” claim because the FDA does not specifically regulate advertisements. This theory of recovery, however, was not pled by plaintiff in her complaint. Moreover, even if this theory had been pled by plaintiff, she admits in her Opposition that there is no Maryland authority to buttress her contention.
(See
Plaintiffs Opposition at 8). Therefore, the Court concludes that plaintiffs claim for failure to warn in advertising lacks merit.
Thus, the Court finds that no question of fact exists concerning Tampax’s warnings or advertisements and therefore will grant summary judgement in favor of defendant regarding Count IV and those portions of Count I that rely upon an alleged failure to warn.
C.
Punitive Damages
— Count
V
Defendant also moves for partial summary judgement on the issue of punitive damage. Since plaintiffs punitive damage claim is based on her allegation that defendant’s warning was inadequate, which this Court has determined lacks merit, the Court concludes that plaintiff is not entitled to punitive damages.
D.
Conclusion
The Court will grant defendant’s motions for partial summary judgement with respect to the portion of Count I that is based on federal preemption of state claims, as well as Counts IV and V of plaintiffs complaint.