Dow v. Baxter Healthcare Corp., Civ. A. No. 94-30099-MAP.

• Decision Date: 21 September 1995
• Docket Number: Civ. A. No. 94-30099-MAP.
• Citation: 899 F. Supp. 822
• Parties: Anna Mae DOW, et al. v. BAXTER HEALTHCARE CORPORATION.
• Court: U.S. District Court — District of Massachusetts

899 F. Supp. 822

Anna Mae DOW, et al. v. BAXTER HEALTHCARE CORPORATION.

Civ. A. No. 94-30099-MAP.

United States District Court, D. Massachusetts.

September 21, 1995.

Pamela Manson, Ely & King, Springfield, MA, for plaintiffs.

Joseph J. Leghorn, Ellen Rosenberg, Lydia A. Clougherty, Warner & Stackpole, Boston, MA, for defendant.

MEMORANDUM REGARDING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

PONSOR, District Judge.

This is a product liability action arising from injuries allegedly sustained by the plaintiff Anna Mae Dow as a result of the use of a defective foley catheter during surgery. The catheter in question was manufactured by the defendant Baxter Healthcare Corporation ("Baxter"). Co-plaintiff Roger W. Dow, plaintiff Anna Mae's husband, asserts a claim for loss of consortium.

The defendant moved for summary judgment on all counts of the complaint, contending that the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 360(c) et seq., preempts all of plaintiffs' causes of action. This motion was referred to Magistrate Judge Neiman, who recommended that it be allowed with regard to plaintiff's claims of negligent manufacture and distribution, breach of implied warranties and breach of express warranty. Judge Neiman recommended that the defendant's motion be denied with respect to plaintiffs' claims for negligent design, violation of Mass.Gen.L. ch. 93A and loss of consortium. The court will adopt the Report and Recommendation, except with regard to plaintiff's claim for breach of warranty, as to which the defendant's motion will be denied, for the following reasons.

First, a recent First Circuit decision, Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1st Cir.1995), provides clear authority for the magistrate judge's recommendation that the defendant's motion for summary judgment be allowed as to the plaintiff's claims for negligent manufacture, negligent distribution and breach of express warranty.

Second, the Talbott decision at n. 3 also presents strong inferential support for the magistrate judge's recommendation that the motion for summary judgment as to the negligent design claim be denied. Here, the catheter in question "had not gone through the pre-market approval process, but instead was marketed under § 510(k) as `substantially equivalent' to an existing device." At 31, n. 3. This consideration drastically undercuts defendant's preemption argument. See Lohr v. Medtronic, 56 F.3d 1335 (11th Cir. 1995), cited in Talbott. This court agrees with the case of Parenteau v. Johnson & Johnson Orthopedics, Inc., 856 F.Supp. 61 (D.N.H.1994) that "preemption does not apply when the FDA has issued no regulations or other requirements specific to the particular device." Id., at 63, quoting King v. Collagen Corp., 983 F.2d 1130, 1134 (1st Cir.1993).

Third, having denied the motion for summary judgment with regard to negligent design, the court must decline to adopt the magistrate judge's recommendation with regard to the claim for breach of warranty based upon defective design. The Supreme Judicial Court has made it clear that proof of negligence necessarily implies proof of a breach of warranty. Colter v. Barber-Greene Co., 403 Mass. 50, 62, 525 N.E.2d 1305 (1988). This proposition is well recognized in the First Circuit. Kotler v. American Tobacco Co., 926 F.2d 1217 and 1229-1230 (1st Cir.1990); Allen v. Chance Mfg. Co., Inc., 873 F.2d 465, 466, n. 2 (1st Cir. 1989). Thus, if plaintiffs can prove negligent design, they will necessarily have proved a breach of warranty. It follows from this that the claims under ch. 93A and for loss of consortium are also viable.

For the foregoing reasons, the court hereby adopts the magistrate judge's recommendation in part. Defendant's Motion for Summary Judgment is ALLOWED with regard to plaintiff's claims for negligent manufacture and distribution and breach of express warranty. The Motion for Summary Judgment is DENIED with regard to claims for negligent design, breach of warranty based upon negligent design, violation of Mass.Gen.L. ch. 93A and loss of consortium.

The clerk will contact counsel with a date for a conference to establish a schedule for completion of all pretrial proceedings and trial.

A separate order will issue.

REPORT AND RECOMMENDATION REGARDING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT (Docket No. 21)

NEIMAN, United States Magistrate Judge.

I. INTRODUCTION

This action arose out of personal injuries that Plaintiff Anna Mae Dow claims she sustained as a result of the use of a foley catheter during an exploratory laparotomy. The catheter was manufactured by Defendant Baxter Healthcare Corporation ("Baxter"). Plaintiff Roger W. Dow, Anna Mae's husband, asserts a claim for loss of consortium. Baxter has moved for summary judgment on all counts of the Dows' complaint pursuant to Federal Rule of Civil Procedure 56. Baxter's motion has been referred to the Court for a report and recommendation pursuant to Rule 3 of the Rules for United States Magistrates in the United States District Court for the District of Massachusetts. 28 U.S.C. § 636(b)(1)(B). The Court recommends granting Baxter's motion in part and denying it in part for the reasons set forth below.

II. FACTUAL AND PROCEDURAL BACKGROUND

A. Factual Background of Present Action

Ms. Dow was admitted to the Cooley Dickinson Hospital in Northampton, Massachusetts, for an exploratory laparotomy on February 26, 1991. During the procedure, doctors inserted a foley catheter into Ms. Dow that was designed, manufactured, and distributed by Baxter. The catheter could not be removed following surgery because the balloon failed to deflate. After conventional methods were unsuccessful in deflating the balloon and removing the catheter, a cystoscopy was performed on March 2, 1992. In her complaint, Ms. Dow alleges severe bladder and urological problems dating back to the cystoscopy.

Specifically, Ms. Dow asserts claims of (1) negligent design, manufacture, and distribution of the foley catheter (Count I); (2) breach of the implied warranties of merchantability and fitness for a particular purpose (Count II); (3) breach of an express warranty (Count III); and (4) violation of Massachusetts General Laws Chapter 93A (Count V). Plaintiff Roger W. Dow is asserting a claim for loss of consortium (Count IV). In response, Baxter claims that the Medical Devise Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 360c, et seq. pre-empts all of Plaintiffs' claims and does not independently provide any remedy.

B. The MDA And Its Implementing Regulations

Congress enacted the MDA in 1976. The MDA is a system of regulation for all medical devices which directs the Food and Drug Administration ("FDA") to classify each medical device intended for human use. 21 U.S.C. § 360c(a)(1). The three classifications the FDA utilizes establish an ascending order of controls and oversight. Class I is comprised of devices (e.g., tongue depressions) which require only the most general of controls. Class II (e.g., tampons) includes devices which require compliance with both general controls and applicable performance standards promulgated by the FDA. The performance standards include annual registration, labeling requirements, prohibitions against misbranding and adulteration, and good manufacturing practices. 21 U.S.C. § 360c; 21 U.S.C. § 360k; 21 C.F.R. § 860.3(c)(1)-(2). The FDA has classified the foley catheter, at issue here, as a Class II medical device. 21 C.F.R. § 876.5130. Finally, Class III includes devices (e.g., pacemakers) which pose potential unreasonable risks of injury. The controls exercised over Class II devices are insufficient to determine safety or effectiveness of Class III devices. Accordingly, Class III devices must be generally approved prior to being marketed. See 21 U.S.C. § 360e and § 360c(a)(2)(C).

C. The FDA's 510(k) Approval Process

Section 510(k) of the MDA governs "substantially equivalent" devices. 21 U.S.C. § 360(k). Each class of devices undergoes substantially the same 510(k) process. 21 C.F.R. §§ 807.87, 807.92, and 807.93. The process applies to any device which the manufacturer submits as, and the FDA finds to be "substantially equivalent" in design and function to a "predicate device", i.e., a device which was on the market prior to the effective date of the MDA or was lawfully sold as a substantially equivalent device. 21 U.S.C. § 360c(f) and (i); 21 C.F.R. § 814.80. FDA regulations govern the form and substance of the information required for a submission under Section 510(k), including proposed labeling. 21 C.F.R. §§ 807.87 and 807.92. The FDA may request additional information in an effort to determine whether the device is substantially equivalent to a predicate device. 21 C.F.R. § 807.100. The process has been described as follows:

Under section 510(k), devices that are shown to be substantially equivalent to a device on the market before the MDA was passed (a "predicate" device) can gain approval without submitting to the type of premarket approval required for a new device. At least ninety days before marketing its device, a manufacturer must submit to the FDA information that the device has the same intended use as a pre-Amendment device and that it has the same technological characteristics. Alternatively, a device may satisfy the 510(k) process even if it has different technological characteristics, as long as these characteristics do not raise different questions of safety and effectiveness from the predicate device. If a device meets the equivalence requirement, it can enter the marketplace without further scrutiny.

Gail H. Javitt, I've Got You Under My Skin And I Can't Get Redress: An Analysis of Recent Case Law Addressing Preemption of Manufacturer Liability for Class III Medical Devices, 49 Food & Drug L.J. 553, 571 (1994) (footnotes excluded) ("Javitt, I've Got You Under My Skin"). The FDA's substantial equivalence...