Sowell v. Bausch & Lomb, Inc.

• Citation: 230 A.D.2d 77,656 N.Y.S.2d 16
• Parties: , Prod.Liab.Rep. (CCH) P 15,001 Cynthia SOWELL, Plaintiff-Respondent, v. BAUSCH & LOMB, INC., Defendant-Appellant, and Cohen Fashion Optical, Inc., Defendant-Respondent, and "John Doe", et al., Defendants.
• Decision Date: 10 April 1997
• Court: New York Supreme Court Appellate Division

Page 16

656 N.Y.S.2d 16

230 A.D.2d 77, Prod.Liab.Rep. (CCH) P 15,001

Cynthia SOWELL, Plaintiff-Respondent, v. BAUSCH & LOMB, INC., Defendant-Appellant and Cohen Fashion Optical, Inc., Defendant-Respondent and "John Doe", et al., Defendants.

Supreme Court, Appellate Division First Department.

April 10, 1997.

Stephen C. Glasser, of counsel (Thomas M. Gannon on the brief, Sullivan & Liapakis, P.C., attorneys) for plaintiff-respondent.

Harry P. Sacks, of counsel (Steven J. Brill on the brief, Sack Montgomery, P.C., attorneys) for defendant-appellant.

Cynthia L. Marks, of counsel (Dale A. Hunte on brief, Brody & Fabiani, attorneys) for defendant-respondent.

Before SULLIVAN, J.P., and MILONAS, ELLERIN, NARDELLI and WILLIAMS, JJ.

ELLERIN, Justice.

The issue before us on this appeal is whether plaintiff's State law tort claims are preempted by Federal law.

The plaintiff, Cynthia Sowell, alleges that she sustained serious physical injury to her eyes due to the use of extended wear contact lenses which were manufactured by defendant-appellant Bausch & Lomb and were prescribed and sold to her by defendant Cohen Fashion Optical. Plaintiff has asserted four causes of action against Bausch & Lomb, i.e., negligence in the design, manufacture, production, testing, examination, inspection, distribution and delivery of the device; breach of express warranties; breach of implied warranties; and a strict products liability claim alleging that the product was defective and unreasonably dangerous. Bausch & Lomb moved for summary judgment dismissing the complaint on the ground that all of plaintiff's causes of action were barred by Federal preemption. The IAS court denied this motion, and Bausch & Lomb now appeals.

The sale and distribution of medical devices such as the contact lenses here in issue are governed by that portion of the Federal Food, Drug and Cosmetic Act of 1938 known as the Medical Device Amendments of 1976 ["MDA"] (21 U.S.C. § 360c et seq.). The statutory scheme separates medical devices into three categories. Class I medical devices are those which pose little or no threat to public health and are subject only to "general controls" related to their manufacture (see, 21 U.S.C. § 360c[a][1][A]; 21 C.F.R. § 860.3[c][1] ). They include devices such as tongue depressors. Class II medical devices, such as tampons and oxygen masks, are those which pose some risk of injury. In addition to the above mentioned general controls, they are also subject to "special controls", including performance standards, use guidelines and post-market surveillance programs (see, 21 US.C. § 360c(a)(1)(B); 21 C.F.R. § 860.3(c)(2)).

It is undisputed that the device involved herein, extended wear contact lenses, constitutes a Class III medical device, i.e., one which presents a "potential[ly] unreasonable risk of illness or injury" or which is "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" (21 U.S.C. § 360c[a][1][C][ii]; 21 C.F.R. § 860.3[c][3] ). The general rule applicable to distributors of Class III medical devices requires them to obtain premarket approval ["PMA"] of the device before marketing it (21 U.S.C. § 360c[e]; 21 C.F.R. § 814.1[c], 860.3[c][3] ). Before a PMA will be granted, the Federal Food and Drug Administration ["FDA"] conducts a "rigorous" review of the product, involving the submission by manufacturers of "detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission" (Medtronic v. Lohr, 518 U.S. 470, ----, 116 S.Ct. 2240, 2247, 135 L.Ed.2d 700, citing Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987)). ¹ In addition, significant post-market regulation may be imposed upon Class III devices going far beyond the relatively unintrusive post-market surveillance required of Class II devices and the FDA retains the right to withdraw the PMA if it subsequently determines that a device previously approved is unsafe or ineffective (21 U.S.C. § 360e[e] ).

Notwithstanding this rigorous and detailed statutory scheme, the large majority of Class III devices currently on the market have never received premarket approval from the FDA because of two exceptions to the requirements of the Act. First, devices that were already on the market at the time of the passage of the MDA were "grandfathered" in without the necessity of a PMA review until such time as the FDA chooses to initiate and complete a PMA (see, 21 U.S.C. § 360e[b][1][A]; 21 C.F.R. § 814.1[c][1] ). Moreover, an exception from the PMA process also exists for products which are found by the FDA to be "substantially equivalent" to devices already on the market prior to the effective date of the MDA (see, 21 U.S.C. § 360e[b][1][B] ). In such cases, a much less extensive premarket notification process (also known as a " § 510[k] review", after the number of the section in the original Act), which generally requires no more than 20 hours to complete, is permitted to establish such substantial equivalence (Medtronic v. Lohr, supra, at 2240, 116 S.Ct. at 2247). Once it is established, the marketer is only required to comply with the aforementioned general controls, which are applicable to all three classes of medical devices, and which include FDA regulations setting forth "good manufacturing practices", i.e., general requirements for most of the steps involved in every device's manufacture (21 C.F.R. § 820.20 et seq.) and FDA labeling regulations, which require various types of warnings to be affixed to devices (21 C.F.R. § 801.109). ²

In this case, since the device sought to be marketed by Bausch & Lomb, i.e., extended wear contact lenses, was not substantially equivalent to a device already on the market and therefore not eligible for the less rigorous premarket notification process, Bausch & Lomb was required, under 21 U.S.C. § 360e, to submit a full PMA application.

There is no dispute that Bausch & Lomb's PMA application underwent a comprehensive review requiring the submission by Bausch & Lomb of extensive, detailed information regarding the contact lenses and their manufacture. In response to that application, Bausch & Lomb was advised, on July 25, 1983, that the application had been granted. In addition, Bausch & Lomb was advised of various conditions to the approval of the marketing of the lenses, including that the sale and distribution of the lenses were to be restricted to prescription use, that Bausch & Lomb was to continue clinical studies on patients and submit the data to the Food and Drug Administration ["FDA"] and that Bausch & Lomb could not make any changes in the design, manufacturing, labeling, packaging, quality control methods, suppliers or distributors, unless it submitted a supplemental PMA application to the FDA for approval. Bausch & Lomb was also required to submit to the FDA reports on any adverse reactions or defects involving the lenses, in addition to periodic reports indicating new information about the lenses, such as scientific literature.

Since the MDA include no provision for a private cause of action by a person injured by a medical device, when plaintiff brought this action, arguing that the contact lenses had caused injury to her eyes, her claims were necessarily limited to State law causes of action and, as indicated, sought recovery based on negligence, breach of express and implied warranties and strict products liability. In response, Bausch & Lomb asserted as a defense that, since the lenses had received a PMA prior to their entering the market, all of plaintiff's State causes of action were preempted by Federal law.

Although Federal law is the "supreme Law of the Land" (U.S. Const. Art. VI, cl. 2) and will render "without effect" State law that is in conflict with it (McCulloch v. Maryland, 4 Wheat. 316, 17 U.S. 316, 4 L.Ed. 579), all preemption analysis "start[s] with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress" (Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447). In the absence of an express declaration by Congress, preemption will only be found "if that law actually conflicts with federal law, .... or if federal law so thoroughly occupies a legislative field 'as to make reasonable the inference that Congress left no room for the States to supplement it' " [citations omitted]. (Cipollone, supra, at 516, 112 S.Ct. at 2617).

Bausch & Lomb's argument that, in spite of the absence of a Federal private right of action, plaintiff's State causes of action were preempted, is based on the preemption provisions of 21 U.S.C. § 360k(a), which provides, in pertinent part:

[N]o 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 Act 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 Act.

While this appeal was pending, the Supreme Court of the United States, in Medtronic v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700, dealt with the related issue of whether the fact that a Class III medical device (in that case a pacemaker lead) had gone through the premarket notification process necessary to establish substantial equivalence to a device already on the market meant that State tort law was preempted. The Court recognized the ambiguity of § 360k(a)...