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LAKIE v. BEECHAM

March 5, 1997

BETSY LAKIE, Plaintiff,
v.
SMITHKLINE BEECHAM, et al., Defendants.


HAROLD H. GREENE, United States District Judge


The opinion of the court was delivered by: GREENE

In this case, plaintiff claims to have suffered personal injuries as a result of her use of a denture adhesive, Orafix Special, sold and distributed by the defendants, SmithKline Beecham (SKB) and Norcliff-Thayer. *fn1"

 I

 Facts

 Mrs. Lakie is 68 years old. According to plaintiff, she began using Orafix Special in the spring of 1985. As a denture adhesive, Orafix Special is intended to be applied to the base of the denture before the denture is placed in the mouth. 21 C.F.R. § 872.3500(a). Plaintiff claims that she applied Orafix Special to the roof of her mouth at least every day, for most of the time twice a day. She stopped late in 1990 after learning that the product was being recalled by the Federal Drug Administration ("FDA") for benzene contamination.

 In February of 1989 plaintiff was diagnosed with macrocytic anemia. She consulted Dr. Paul Swerdlow, a hematologist, in October of 1990. He diagnosed her condition as myelodysplastic syndrome ("MDS") 5 q-minus, a bone marrow disorder accompanied by a deletion in the long or "q" arm of the fifth chromosome. Her symptoms include a reduction in white blood cells (leukopenia), platelet levels (thrombocytopenia), and lymphocytes (lymphocytopenia).

 MDS 5 q-minus is an extremely rare form of MDS -- the incidence is estimated at 1 in 100,000 or perhaps as low as 1 in 1,000,000. In most cases its cause is unknown but it can occur spontaneously without exposure to a toxin. It is more common in women than in men, and occurs most frequently in people 60 or older. MDS can transform into leukemia and, in some cases, lead to death.

 In her complaint plaintiff alleges claims of negligence, strict liability, breach of express and implied warranty, fraud, and failure to comply with FDA regulations. The defendant has filed two motions for summary judgment, which the plaintiff has opposed. *fn2" For the following reasons, both motions will be denied.

 II

 Summary Judgment

 Summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c). For purposes of summary judgment, "the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986) (emphasis in original). In determining this, a court must draw all justifiable inferences in favor of the non-moving party. Masson v. New Yorker Magazine, Inc., 501 U.S. 496, 520, 115 L. Ed. 2d 447, 111 S. Ct. 2419 (1991). The non-moving party "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986). Only if there are no genuine issues of material fact and the movant is entitled to judgment as a matter of law may the Court grant summary judgment. Liberty Lobby, 477 U.S. at 248.

 III

 Preemption

 The defendant first moves for summary judgment as to each count in the complaint on the basis that plaintiff's state law claims are preempted by the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 321-394. Congress enacted the MDA in 1976 in order to regulate the safety and effectiveness of medical devices in the wake of injuries caused by the Dalkon Shield. See Robert S. Adler and Richard A. Mann, 59 Mo. L. Rev. 895, 910-11 (Fall 1994). Under the MDA and its implementing regulations, the FDA is required to classify each medical device intended for human use into one of three classes based on the level of risk the medical device presents. 21 U.S.C. § 360c(b)(1). Those that "present[] a potential unreasonable risk of illness or injury" are assigned to Class III. 21 U.S.C. § 360c(a)(1)(C).

 Because Class III devices present the greatest risks, they are subject to premarket approval ("PMA") requirements. Each manufacturer is required to submit to the FDA extensive information which provides reasonable assurance of the safety and effectiveness of the medical device. Id. The PMA process is quite rigorous and time consuming; had Congress required that each device be submitted to this process thousands of devices would have had to be removed from the market at the time the MDA became law. To avoid this problem, Congress allowed companies to market a medical device "substantially equivalent" to a device already on the market if the companies submit to the FDA a so-called 510(k) notification. *fn3"

 The MDA also contains a provision which preempts additional or inconsistent state requirements concerning the manufacture of medical devices. This section provides:

 
Except as provided in subsection (b) of this section, 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 --
 
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
 
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

 21 U.S.C. § 360k(a).

 Defendant claims that section 360(k) expressly preempts not only state statutes and regulations, but also state common law actions which by providing for the award of damages effectively establish requirements for medical devices different from or in addition to those imposed by the FDCA regulatory scheme.

  The Supreme Court recently addressed this precise issue. In Medtronic, Inc. v. Lohr, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996), the Court considered whether section 360k(a) applied to bar a claim for defective design of a Class III device which was exempt from the PMA process under section 510(k). A divided Court *fn4" held that Congress did not intend to bar state common law causes of action for injuries resulting from defective medical devices. The plurality held that, in enacting section 360k(a) Congress was "primarily concerned with the problem of specific, conflicting State statutes and regulations rather than the general duties enforced by common-law actions." 116 S. Ct. at 2252. This includes state law claims for negligent or defective design and inadequate labeling. In fact the Supreme Court stated that "few, if any, common-law duties have been pre-empted by the [MDA]," unless the FDA specifically preempts them by ...


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