device . . . FDA believes that a performance standard is necessary to control the design, material composition, and mechanical properties of the device such as its flexibility rigidity, strength and surface finish." (52 C.F.R. 33697 (1987) (to be codified at 21 C.F.R. § 888.3560).
No such performance standards have yet been promulgated. However, the FDA has stated that performance standards will be necessary to control the design, material, composition and mechanical properties of the device. It is therefore clear that the FDA did not provide that the general controls under the statute and regulations would be sufficient to regulate the design of this type of device. Because the FDA has not yet developed such specific performance standards, plaintiff's causes of action regarding those factors are not preempted.
Defendants argue that "Congress has determined that the safety and effectiveness of medical devices can best be promoted through the development of uniform standards under the expertise of the FDA. To this end, Congress has decided that state law claims which would give rise to contrary requirements should be preempted." Defendants are correct. But the FDA has not yet promulgated the standards to regulate the safety and effectiveness of this type of device.
The First Circuit has recently held that general regulations such as those cited by defendants can preempt state tort claims, because they impose additional requirements. Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994), See also, Gile v. Optical Radiation Corp, 22 F.3d 540 (3rd Cir. 1994) (holding tort claims against investigational device preempted). The Mendes case concerned a Class III pacemaker which was approved as being substantially equivalent to a product on the market which had undergone premarket approval. The Mendes holding, in its broadest interpretation, calls into question all of the cases which have allowed some tort claims to survive preemption. Although it is very recent, Mendes has already been questioned. Oja v. Howmedica, 848 F. Supp. 905, 907 (D.Colo. 1994).
This court also declines to follow Mendes to the extent that its reasoning could apply to these Class II devices, and finds that the general provisions cited by defendants do not preempt plaintiff's tort claims. Holding otherwise would compel preemption even though the FDA has specifically stated that it will promulgate performance standards to control the design, material composition and mechanical properties of the device (52 Fed. Reg. 33697). The FDA did not intend that its general regulations would be the maximum requirements applicable to the Microloc device.
Finally, this court considers whether plaintiff has standing to allege claims for the alleged failure of the Microloc device to conform to FDA standards. Plaintiff asserts in this motion that his claims include those allegations. Defendants argue that there is no private right of action for such a claim. The courts appear to be split on this issue.
In Reiter v. Zimmer Inc., 830 F. Supp. 199, 204 (S.D.N.Y. 1993), the district court held that state tort claims with regard to Class III bone cement were preempted, but held that the plaintiff's claims that the product failed to comply with FDA manufacturing standards could proceed. In Stewart v. International Playtex, Inc., 672 F. Supp. 907, 909-10 (D.S.C. 1987), a district court granted summary judgment against state tort claims for inadequate labelling of tampons, but held that the plaintiff's claims that the product failed to comply with federal regulations survived.
However, other courts that have addressed the issue have held that there is no private cause of action for violation of the Food Drug and Cosmetics Act. See Gile v. Optical Radiation Corp., 22 F.3d at 544; Lewis v. Intermedics Intraocular, Inc., No. 93-0007, 1994 U.S. Dist. LEXIS 5158, at *2 (E.D. Lou. Apr. 20, 1994); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1022 n.5 (E.D. Mich. 1993); Brinkman v. Shiley, Inc., 732 F. Supp. 33, 35 (M.D. Pa. 1989) Aff'd without op., 902 F.2d 1558 (3rd Cir. 1989); and Pacific Trading Co. v. Wilson & Co., Inc., 547 F.2d 367, 370 (7th Cir. 1976).
The Food Drug and Cosmetics Act provides that "all such proceedings for the enforcement, or to restrain violations, of [the Act] shall be by and in the name of the United States." 21 U.S.C. § 337(a). The Act also allows states to bring certain limited causes of action. Given that language and the regulatory nature of the Act, and the fact that Congress has vested the power to enforce the regulatory scheme in the United States, this court concludes that there is no private right of action. See Pacific Trading, 547 F.2d at 370. Therefore, to the extent that plaintiff alleges causes of action that defendants failed to comply with the Act or the regulations, summary judgment should be granted in favor of defendants.
For the reasons set forth above:
(1) Defendants' motion for summary judgment on the ground of preemption is denied.
(2) Defendants' motion for summary judgment on the ground of no standing by plaintiff to bring a cause of action to enforce the Food Drug and Cosmetics Act is granted.
(3) The pretrial conference will be on November 3, 1994 at 3:00 p.m. o'clock.
(4) The trial will be on November 28, 1994.
IT IS SO ORDERED.
DATE: August 22, 1994
CHARLES A. LEGGE
UNITED STATES DISTRICT JUDGE