Lakie v. Smithkline Beecham, Civil No. 93-0561 (HHG).

• Decision Date: 05 March 1997
• Docket Number: Civil No. 93-0561 (HHG).
• Citation: 965 F.Supp. 49
• Parties: Betsy LAKIE, Plaintiff, v. SMITHKLINE BEECHAM, et al., Defendants.
• Court: U.S. District Court — District of Columbia

Page 49

965 F.Supp. 49

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

Civil No. 93-0561 (HHG).

United States District Court, District of Columbia.

March 5, 1997.

COPYRIGHT MATERIAL OMITTED

Harvey S. Williams, Washington, DC, Michael G. Phelan, Cantor, Arkema & Edmonds, Richmond, VA, for Plaintiff.

Daniel W. Whitney, Howell, Gately, Whitney & Carter, Towson, MD, for Defendant SmithKline Beecham.

Opinion

HAROLD H. GREENE, District Judge.

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.¹

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.² 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, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (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, 111 S.Ct. 2419, 2434-2435, 115 L.Ed.2d 447 (1991). The nonmoving 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, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (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, 106 S.Ct. at 2510.

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.³

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, ___ U.S. ___, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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 Court⁴ 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." Id. at ___, 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 preempted by the [MDA]," unless the FDA specifically preempts them by regulation, the state cause of action is based on a state law that is device specific and different from or additional to federal requirements, or the state tort claim has the effect of establishing a substantive requirement for a specific device. Id. at ___, 116 S.Ct. at 2259.

The plurality noted that "[t]he presence of a damages remedy does not amount to the additional or different `requirement' that is necessary under the statute ..." when the duties these remedies enforce parallel federal requirements. Id. at ___, 116 S.Ct. at 2255. Thus state common law of general applicability is preempted only if the FDA has promulgated a specific federal requirement applicable to a particular device. Id. To interpret this section otherwise, the Court observed, would give the MDA the "perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation...." Id. at ___, 116 S.Ct. at 2251.

With these parameters in mind, the Court will deny the defendant's motion for summary judgment with respect to plaintiff's state law claims. Orafix Special was classified as a Class III device in 1987. 21 C.F.R. § 872.3500. However, Orafix Special was not subject to any specific FDA requirements regarding the product's benzene content. Thus this is not a case where "the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case ... and implemented that conclusion via a specific mandate on manufacturers or producers." ___ U.S. at ___, 116 S.Ct. at 2258. See, e.g., Papike v. Tambrands Inc., 107 F.3d 737, 741 (9th Cir.1997) (holding state law claims against tampon manufacturers preempted because FDA regulations mandated the "specific substantive content" of warnings regarding toxic shock syndrome).

Defendant reads Lohr as applying only to products which have received their market clearance through the 510(k) process. Defendant argues that a crucial basis for the Supreme Court's decision was the truncated nature of the "substantial equivalence" 510(k) process, which by definition is not as complete or rigorous as the PMA process. Since Orafix Special was commercially distributed before the enactment of the MDA in 1976, it was subject to the classification process set forth in 21 C.F.R. § 860.7. As a result, defendant contends Lohr does not apply.

In effect, defendant asks the Court to hold that the FDA's PMA process amounts to a "specific" federal requirement. Neither Lohr nor the MDA compel such a result. As the Ninth Circuit recognized, all Class III devices must undergo PMA and classification procedures before being sold in interstate commerce. Kennedy v. Collagen Corp., 67 F.3d 1453, 1459 (9th Cir.1995), (citing 21 U.S.C. § 360(e); 21 C.F.R. § 814.1), ...