Baker v. St. Jude Medical, S.C., Inc.

• Decision Date: 30 June 2005
• Docket Number: No. 01-02-00802-CV.,01-02-00802-CV.
• Citation: 178 S.W.3d 127
• Parties: Keith BAKER, Individually, and Ian Baker, Individually and as Independent Executor of the Estate of Jean Baker, Deceased, Appellants, v. ST. JUDE MEDICAL, S.C., INC. and St. Jude Medical, Inc., Appellees.
• Court: Texas Supreme Court

178 S.W.3d 127

Keith BAKER, Individually, and Ian Baker, Individually and as Independent Executor of the Estate of Jean Baker, Deceased, Appellants, v. ST. JUDE MEDICAL, S.C., INC. and St. Jude Medical, Inc., Appellees.

No. 01-02-00802-CV.

Court of Appeals of Texas, Houston (1st Dist.).

June 30, 2005.

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James V. Pianelli, McGehee & Pianelli, L.L.P., Timothy D. Riley, Riley Law Firm, Houston, TX, for Appellants.

David M. Gunn, Joe W. Redden, Jr., Beck, Redden & Secrest, L.L.P., Houston, TX, for Appellees.

Panel consists of Chief Justice RADACK and Justices JENNINGS and HIGLEY.

OPINION

SHERRY RADACK, Chief Justice.

This appeal involves the issue of federal preemption of state law causes of action arising out of the implantation of an allegedly defective heart valve in the deceased, Jean Baker. Specifically, we must decide whether state common-law causes of action asserted by Baker's heirs against the valve manufacturer are preempted by the manufacturer's compliance with the Food and Drug Administration's premarket approval procedures for certain medical devices. Because we hold that state product-liability claims are preempted by federal law in this case, we affirm the summary judgment granted in the manufacturer's favor.

BACKGROUND

Legislative Background of Medical Devices Act

In 1976, in response to mounting consumer concern over, among other things, defective intrauterine devices, Congress passed the Medical Device Amendments (MDA) to allow the Food and Drug Administration (FDA) to regulate medical devices. The MDA creates three categories of medical devices. The most stringent FDA control is over Class III devices, which are devices that either "presen[t] a potential or unreasonable risk of illness or injury," or which are "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." See 21 U.S.C. § 360c(a)(1)(C)(ii)(I-II). It is undisputed that a heart valve is a Class III medical device.

Obtaining FDA Approval to Market Class III Devices

1. Full PMA Approval

Before marketing a Class III device, the manufacturer must either submit its product to the FDA for premarket approval (PMA) or qualify for one of two exceptions to the premarket approval process. To obtain PMA approval, the manufacturer must provide the FDA with "reasonable assurance" that the device is safe and effective. See 21 U.S.C. § 360e(d)(2). To do so, manufacturers submit detailed information regarding their device, which the FDA then reviews for an average of 1200 hours before approving or disapproving the device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 2247, 135 L.Ed.2d 700 (1996).

2. § 510(k) Exemption to PMA approval

In addition to the "rigorous" PMA process, there are two exemptions by which a manufacturer may gain the FDA's permission to market a device. Id. at 477-78, 116 S.Ct. at 2247. One of these exemptions permits devices that are "substantially equivalent" to devices existing in 1976¹ to be marketed and sold without full PMA approval. See 21 U.S.C. § 360j(g)(1). This review is known as a section 510(k) review (after the number of the section in the original act) and is "by no means comparable to the PMA process." Lohr, 518 U.S. at 479, 116 S.Ct. at 2247. As opposed to the PMA's average review time of 1200 hours, a § 510(k) review takes an average of only 20 hours to complete. Lohr, 518 U.S. at 478, 116 S.Ct. at 2247.

3. PMA Supplementation for Modifications to PMA — Approved Devices

If a manufacturer wants to modify a Class III device that already has PMA approval, the manufacturer may submit a PMA supplement, rather than obtain an entirely new PMA approval. See U.S. v. Prigmore, 243 F.3d 1, 5 (1st Cir.2001) (describing PMA supplement process). The PMA supplement "must contain scientific information that provides a basis for approval of the modified device." Id. (quoting 21 C.F.R. § 814.39(c)). The procedures for a PMA supplement are the same as those for an original PMA, although the FDA requires only that the manufacturer provide materials supporting the proposed modification. Worthy v. Collagen Corp., 967 S.W.2d 360, 364-65 (Tex.1998); Kemp v. Medtronic., Inc., 231 F.3d 216, 222 (6th Cir.2000).

Factual Background

In 1982, the FDA approved St. Jude's initial PMA application for a mechanical heart valve. During the following years, St. Jude made several improvements to the valve, which were approved through a series of PMA supplements. One of these improvements incorporated a rotating sewing cuff, which eliminated the need for surgery to position the valve before sewing it in place.

In an effort to combat endocarditis, a life-threatening infection of the heart muscle,² St. Jude notified the FDA that it planned to develop a mechanical heart valve with an infection-resistant, sterile, silver coating on the sewing cuff. In May 1997, after an FDA-required animal test was completed, St. Jude submitted a PMA supplement to add the Silzone³ coating to its already approved heart valve.

In March 1998, the FDA approved St. Jude's PMA supplement. As part of its approval, the FDA imposed several post-approval requirements, including how the valve could be marketed. Specifically, the FDA prohibited St. Jude from making any claims about the efficacy of the Silzone coating in preventing endocarditis. St. Jude began marketing the Silzone valve accordingly.

St. Jude, however, continued to participate in studies to determine the efficacy of the Silzone coating in preventing endocarditis. One of these studies was the Artificial Valve Endocarditis Reduction Trial (AVERT). On January 21, 2000, approximately one month before Baker's death, an independent board reviewing the AVERT data concluded that patients with the Silzone valve were more likely to experience a post-operative complication known as a paravalvular leak. Approximately 2% of the patients with the Silzone valve experienced such leaks, as opposed to .25% of patients with conventional valves.

The same day that it became aware of the conclusions of the AVERT monitoring board, St. Jude began a voluntary recall of all non-implanted Silzone valves, and so informed the FDA. In response, the FDA, in a letter from Edwin Dee to St. Jude, stated, "We agree with your firm's decision to recall [the Silzone valve] . . . We have reviewed your action and conclude that it meets the formal definition of a `Recall.' This is significant, as your action is an alternative to a Food and Drug Administration legal action to remove the defective products from the market."⁴ It is undisputed, however, that the FDA never formally withdrew its PMA approval of the valve, and that the valve had FDA approval on the date it was implanted in Baker.

The decedent in this case, Jean Baker, a 66-year-old woman, had undergone open heart valve-replacement surgery in November 1999. A Silzone-coated heart valve, manufactured by St. Jude, was implanted in Baker to replace her own deteriorating mitral heart valve. In February 2000, approximately one month after St. Jude issued its voluntary recall of the valves, Baker died.

Baker's two sons, Ian Baker and Keith Baker, filed this wrongful death suit against St. Jude based on theories of negligence, product liability, breach of warrant under the Deceptive Trade Practices Act, malice, and fraud. St. Jude filed a motion for summary judgment, contending that the appellee's state court claims were preempted by the FDA's federal regulation over the valves at issue. The trial court agreed, and granted St. Jude's motion for summary judgment.

ANALYSIS

Standard of Review for Summary Judgments

We will uphold a summary judgment only if the record establishes that there is no genuine issue of material fact, and that the movant is entitled to judgment as a matter of law on a ground set forth in the motion. See Tex.R. CIV. P. 166a(c); Cathey v. Booth, 900 S.W.2d 339, 341 (Tex.1995). In reviewing the summary judgment, we indulge every reasonable inference in favor of the non-movant, resolve any doubts in its favor, and take as true all evidence favorable to it. Pace v. Jordan, 999 S.W.2d 615, 619 (Tex.App.-Houston [1st Dist.] 1999, pet. denied).

Preemptive Effect of PMA Approval

1. Can a State-Court Action be a Prohibited State "Requirement"?

State laws that conflict with federal laws are preempted under the Supremacy Clause of the Constitution. U.S. Const. Art. VI, cl. 2. Congressional intent to preempt state law can either be expressly stated in statutory language or implied in the structure and purpose of federal law. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992). The MDA contains an express preemption provision, which provides as follows:

[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 requirements 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].

21 U.S.C. § 360k (emphasis added). The initial issue, thus, is whether a state tort lawsuit can ever be a state "requirement," prohibited by § 360k.

The Supreme Court considered this issue in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). In Lohr, the Supreme Court held that state-tort claims were not preempted if a medical device received FDA approval through the § 510(k) notification process. The majority noted that, under § 510(k) approval process, the FDA makes no endorsement as to a product's safety, but concludes only that it is "substantially equivalent" to a device already on the market. The Court concluded that because a § 510(k) approval by...