Brooks v. Howmedia, Inc.

• Decision Date: 18 October 2000
• Docket Number: No. 00-1188,00-1188
• Parties: (8th Cir. 2001) CAROL JEAN BROOKS, APPELLANT, ST. LUKE'S HOSPITAL, INTERVENOR BELOW, v. HOWMEDICA, INC., A DELAWARE CORPORATION, DIVISION OF PFIZER HOSPITAL PRODUCTS GROUP, INC.; PFIZER, INC.; HOWMEDICA INTERNATIONAL, LTD., APPELLEES. Submitted:
• Court: U.S. Court of Appeals — Eighth Circuit

Page 956

236 F.3d 956 (8th Cir. 2001)

CAROL JEAN BROOKS, APPELLANT, ST. LUKE'S HOSPITAL, INTERVENOR BELOW, v. HOWMEDICA, INC., A DELAWARE CORPORATION, DIVISION OF PFIZER HOSPITAL PRODUCTS GROUP, INC.; PFIZER, INC.; HOWMEDICA INTERNATIONAL, LTD., APPELLEES.

No. 00-1188

UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT

Submitted: October 18, 2000

Filed: January 10, 2001

Appeal from the United States District Court for the District of Minnesota

[Copyrighted Material Omitted]

Before Murphy, Heaney, and Bye, Circuit Judges.

Bye, Circuit Judge.

This appeal requires us to assess the preemptive power of the Medical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539 (codified in various sections of 21 U.S.C. and 26 U.S.C.), in view of the Supreme Court's recent decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

BACKGROUND

In the late 1960s, defendants Howmedica, Inc., Pfizer, Inc. and Howmedica International, Ltd. (together, "Howmedica") developed a product called "surgical Simplex (r) P Radiopaque bone cement" ("Simplex"). Surgeons employ Simplex in a variety of orthopedic procedures, including joint, hip, knee, shoulder and elbow replacement surgeries, and the repair of bone fractures.

Simplex consists of two components: a colorless liquid and a powder. Prior to surgery, the liquid and powder ingredients are mixed together, forming an amorphous mass. That mass quickly hardens into a cement-like substance that bonds tissues and bones. The mixing process releases a potentially harmful chemical byproduct, methyl methacrylate vapors. Nurses and surgical technicians who mix the Simplex components often inhale those methyl methacrylate vapors.

Howmedica submitted Simplex to the Food and Drug Administration (FDA) for marketing approval on February 8, 1971. Howmedica provided the FDA with a wealth of safety information concerning Simplex: details of animal studies; manufacturing and quality control procedures; identification of possible side effects; results of clinical trials; summaries of surgical cases and post-operative complications; long-term carcinogenicity and toxicity studies; and the results of investigational use by 67 physicians in 1508 hip replacements involving 2800 preparations of the bone-cement.

The FDA subjected Simplex to the New Drug Application (NDA) process. As part of the NDA process, the FDA scrutinized Howmedica's proposed labeling and packaging for Simplex. The FDA reviewed, and in many instances rewrote, language to be included on Simplex's package (and its insert) explaining how to use the bone cement. FDA doctors met with Howmedica representatives on several occasions to discuss the content of Simplex's label and inserts. The FDA also informed Howmedica that Simplex would not be approved until the FDA had seen the actual printed labels and the final Simplex package insert. Each Simplex label, and every word included in the package insert, was scrutinized by FDA doctors and representatives.

The FDA formally approved Simplex for marketing on October 7, 1971. In subsequent years, the FDA required modifications to Simplex's labels and package inserts. In 1973, in response to a rat-study, the FDA recommended revising the warning section of the label; Howmedica revised the label accordingly. In 1976, doctors released a study observing operating room personnel's response to Simplex. In response to that study, the FDA required Howmedica to send out a "Dear Doctor" letter, cautioning physicians to use Simplex carefully, and referring doctors to the package insert warnings.

In 1965, Carol Brooks began work as a licensed practical nurse in Duluth, Minnesota. Between 1978 and 1981, she worked at St. Mary's Hospital in Duluth. At St. Mary's, Brooks regularly mixed bone cement for use in surgical procedures. In late 1983, Brooks left St. Mary's and joined the staff at St. Luke's Hospital in Duluth.

Brooks worked almost exclusively in the orthopedic surgery department at St. Luke's. During her first year on the job, she mixed bone cement for an average of four cases per week. Brooks's bone cement mixing duties increased steadily thereafter. In 1992, she assisted surgeons in approximately 10 operations per week requiring the use of bone cement. In virtually all such operations, Brooks mixed the bone cement herself, or she was positioned nearby as another nurse mixed the cement.

In 1989, Brooks began to cough frequently at work. Her persistent cough worsened and, in 1991, she was diagnosed with asthma. Brooks's doctor attempted to find the cause of her asthma, but he could not pin down its precise etiology. Brooks's doctor even phoned Howmedica to inquire about Simplex's components. Though the doctor was unable to conclude that Simplex was the cause of Brooks's asthma, he restricted her exposure to Simplex at work. In 1992, Brooks suffered an acute asthma attack at work, and was thereafter restricted from exposure to Simplex. Brooks left work in 1995, unable to do her job. She has been diagnosed with occupational asthma. Her doctors now attribute its cause to her repeated exposure to methyl methacrylate vapors, a Simplex byproduct.

On March 19, 1997, after her illness prevented her from working, Brooks commenced a products liability action against Howmedica. In particular, Brooks contended that Howmedica had negligently failed to warn her of the danger of contracting occupational asthma by inhaling methyl methacrylate vapors during the process of mixing the liquid and powder components of Simplex. In addition, Brooks claimed that Howmedica failed to comply with FDA labeling regulations. After more than a year of discovery, Howmedica moved for summary judgment. Both sides filed affidavits, many of which explained the medical and technical issues in the case. The district court ultimately granted Howmedica's motion, and entered judgment adverse to Brooks. Brooks now appeals from that judgment.

DISCUSSION

We review de novo a district court's grant of summary judgment by applying the same standard as the district court. See Treanor v. MCI Telecomm. Corp., 200 F.3d 570, 573 (8th Cir. 2000). Summary judgment is appropriate when the evidence --viewed in the light most favorable to the nonmoving party -- demonstrates that there are no disputed issues of material fact and the moving party is entitled to judgment as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

A. Brooks's Failure-to-Warn Claim

Brooks alleged that Howmedica failed to warn her of the risk of contracting asthma through repeated exposure to methyl methacrylate vapors. The district court ruled that Howmedica was entitled to summary judgment because Brooks's state-law failure-to-warn claim was preempted by federal law. We reverse.

The MDA contains an express preemption provision that governs federal preemption of state law with respect to medical devices:

[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 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).

The Supreme Court recently analyzed the meaning and scope of 360k preemption in Lohr. The plaintiff in Lohr suffered a complete heart block that required emergency surgery after her Medtronic pacemaker failed. She filed suit against Medtronic alleging products liability causes of action stemming from the failure of the company's Model 4011 pacemaker lead. After considering the nature and scope of 360k preemption, the Supreme Court held that none of Lohr's Florida law causes of action were preempted.

Lohr clarified several aspects of 360k preemption, but the Court's fractured holding has troubled the lower federal courts. See, e.g., Kemp v. Medtronic, Inc., 231 F.3d 216, 224 (6th Cir. Nov. 1, 2000) ("The various courts of appeals that have confronted issues of preemption arising under the MDA have struggled mightily with Lohr's language in the effort to discern its holding."). Justice Stevens favored very narrow preemption; he wrote a plurality opinion for four Justices. See Lohr, 518 U.S. at 474-503 (Stevens, J., joined by Kennedy, Souter and Ginsburg, JJ.). Justice O'Connor favored far broader federal preemption, and wrote a partial concurrence and partial dissent for four Justices. See id. at 509-14 (O'Connor, J., joined by the Chief Justice, and Scalia and Thomas, JJ.). Justice Breyer agreed with portions of both opinions, and with Justice Stevens's overall result, but wrote a separate opinion. See id. at 503-508 (Breyer, J.). From this, then, we must divine the Supreme Court's intentions.

All nine Justices agreed that 360k's reference to state "requirements" included common law tort actions. See Lohr, 518 U.S. at 486-91 (Stevens, J.), 504-505 (Breyer, J.), 510 (O'Connor, J.). Justices Stevens and Breyer then parted company from Justice O'Connor's foursome. Justices Stevens and Breyer argued that courts' interpretation of 360k should be "informed by" the FDA's own regulations explaining 360k. See id. at 495-97 (Stevens, J.), 505-507 (Breyer, J.). Justice O'Connor bitterly dissented from the Court's decision to look to the FDA's preemption regulations for guidance. See id. at 509 (O'Connor, J.) (decrying the decision as "bewildering and seemingly without guiding principle"). Notwithstanding Justice O'Connor's opinion for four Justices, however, a majority ¹ of the Court sought assistance from FDA regulations in interpreting 360k's preemptive force.

The FDA preemption regulation provides that "state requirements are pre-empted 'only' when the FDA has established 'specific counterpart regulations or . . . other specific requirements applicable to a particular device.'" Id. at 498 (quoting 21...