Brooks v. Howmedica Inc., 00-1188

CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)
Citation273 F.3d 785
Docket NumberNo. 00-1188,00-1188
Parties(8th Cir. 2001) CAROL JEAN BROOKS, PLAINTIFF - 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., DEFENDANTS - APPELLEES. PRODUCT LIABILITY ADVISORY COUNCIL, INC., AMICUS ON BEHALF OF APPELLEES. Submitted:
Decision Date10 July 2001

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

Before Wollman, Chief Judge, Heaney, McMILLIAN, Bowman, Loken, Hansen, Morris Sheppard Arnold, Murphy, and Bye, Circuit Judges.

Murphy, Circuit Judge.

Carol Jean Brooks brought this action against the manufacturer of Simplex bone cement claiming damages for injury resulting from its failure to give adequate warnings about product dangers. The case was dismissed on summary judgment after the district court1 concluded that her claim was preempted by federal law, § 360k of the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et. seq. A panel of this court reversed with one judge dissenting, Brooks v. Howmedica, Inc., 236 F.3d 956 (8 th Cir. 2001), a petition for rehearing en banc was granted, and the panel opinion was vacated. After examining the record and considering Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), we affirm the judgment of the district court.

I.

Carol Jean Brooks is a licensed practical nurse whose work as a surgical technician included mixing bone cement. Bone cement is used to bond with a bone or prosthesis in replacements. Brooks began mixing bone cement during 1978 while she worked at St. Mary's Hospital in Duluth, Minnesota, but her principal exposure occurred after she moved to St. Luke's Hospital in cement or being present during its preparation approximately four times a week. By 1992 she was mixing bone cement or was close to the mixing process during approximately ten surgeries a week. Although Brooks is unable to identify the brand of bone cement used at St. Mary's, it is undisputed that St. Luke's used Simplex P Radiopaque bone cement (Simplex), which was manufactured and marketed by appellees (collectively Howmedica).2

Brooks began to cough at some time in 1989 or 1990. She went to see a doctor about it in 1991 when she was told she had asthma. An occupational health physician at St. Luke's Hospital also investigated possible causes for her cough, reviewed Howmedica's Material Safety Data Sheet, and talked with a Howmedica chemist, but that investigation did not link her cough to Simplex. St. Luke's restricted her exposure to a number of chemicals after an acute asthma attack in 1992; the restriction included methyl methacrylate which is an ingredient in Simplex. Brooks was later diagnosed to have occupational asthma caused by exposure to methyl methacrylate. Brooks has been unable to work since 1995.

Brooks brought a failure to warn claim against Howmedica, alleging that it had not provided "adequate warnings and instructions" for Simplex use and that as a result, she had contracted "severe asthma and associated respiratory complications." Howmedica asserted federal preemption and also denied that the Simplex label contained inadequate warnings and instructions or that it proximately caused Brooks' injury. St. Luke's Hospital intervened, seeking compensation from Howmedica for what it had paid Brooks in workers compensation benefits, costs, interest, disbursements, and attorney fees, but it is not involved in this appeal.

II.

Starting in the early 1970's Howmedica began to market bone cement in the United States under the trade mark Simplex. Bone cement is sold in two separately packaged components: methyl methacrylate monomer which is a colorless liquid and a powder mixture containing polymethyl methacrylate, methyl methacrylate styrene copolymer, and barium sulfate. The liquid and powder are mixed together in the operating room to form a pliable mass that later hardens into a cement like consistency. The mixing process releases vapors containing methyl methacrylate, which is classified as a hazardous chemical by the Occupational Safety and Health Administration.

It is undisputed that Simplex has been heavily regulated by the FDA since it entered the market when it was treated as a drug subject to the Federal Food, Drug, and Cosmetic Act of 1938 (1938 Act). The 1938 Act required Howmedica to submit a New Drug Application (NDA) before it could sell Simplex,3 see 21 U.S.C. § 355, and the NDA is a rigorous process. The NDA process required Howmedica to disclose details of animal studies, manufacturing and quality control procedures, the identification of possible side effects, results of clinical trials, summaries of surgical cases and post operative complications, long term toxicity, and carcinogenicity studies. The process also produced reports from the investigational use of Simplex by sixty seven physicians in 1,408 hip replacements which involved 2,800 preparations of the product. All these submissions were then studied and reviewed by a panel of FDA experts. Under the 1938 Act, Simplex could not be marketed without approval by the Secretary of Health and Human Services. See 21 U.S.C. § 360(c) (premarket approval process).

The NDA included review by the FDA of the proposed design and content for all Simplex labels, including labels for a vial, a pouch, two internal boxes, an outer box, and a package insert. Howmedica employees met with members of the FDA on several occasions to discuss its application, including the product labels. The FDA reviewed every word that appeared on Simplex labels, and the FDA drafted the language that was used in the package insert. That package insert included the following warning:

As the liquid monomer is highly volatile and flammable, the operative room should be provided with adequate air circulation. Caution should be exercised during the mixing of the two components to prevent excessive exposure to the concentrated vapors of the monomer which may produce irritation of the respiratory tract, eyes, and possibly the liver.

The vial containing the liquid component and the box with the powder both referred the user to the package insert for information regarding dosage and administration.

Simplex was approved by the FDA for use in total hip replacement surgeries in 1971. The FDA wrote "[w]e have completed the review of this application and have concluded that the drug is safe and effective for use as recommended in the submitted labeling. Accordingly, the application is approved."

These review requirements were affected by the 1976 Medical Device Amendments (MDA) to the 1938 Act. The MDA created three classes of medical devices, categorized by the risk to the public and the degree of regulation required. Class I devices present no unreasonable risk of illness or injury and are subject only to "general controls." 21 U.S.C. § 360c(a)(1)(A). Class II devices present greater risk than those in Class I, and they must comply with federal performance regulations called "special controls" but may be marketed without advance approval. Id. at § 360c(a)(1)(B). Class III devices carry "a potential unreasonable risk of illness or injury," or are used for "supporting or sustaining human life," or are seen to be "of substantial importance in preventing impairment of human health." Id. at § 360c(a)(1)(C). Class III devices are highly regulated and must receive premarket approval (PMA) from the FDA before they may be sold. Id. at § 360e(a).4

Devices such as Simplex, which had been treated as drugs prior to the amendments to the 1938 Act, were automatically reclassified by the MDA as Class III medical devices.5 21 U.S.C. § 360j(l)(1). The statute provided that these devices were deemed to have PMA approval if they had gone through the NDA approval process. Id. at § 360j(l)(3)(A). Beginning in 1976 Simplex was accordingly treated as a Class III medical device with PMA approval.

Under both the 1938 Act and the MDA, the FDA has continuing authority and responsibility to control the content of any information or warnings Howmedica provides Simplex users. Howmedica was required to provide the FDA with regular reports of any new information learned about Simplex. See 21 U.S.C. § 355(k); 21 C.F.R. §§ 314.80, 314.81, 814.84 (2000). The company was not permitted to make any changes to the product label affecting the safety or effectiveness of the device without submitting a supplemental PMA, but it could temporarily "add or strengthen" warnings during the time the FDA had any supplement under consideration. 21 C.F.R. § 814.39(a), (d) (2000).

Howmedica learned that some individuals exposed to Simplex had developed contact dermatitis, and in 1973 it requested permission from the FDA to insert the following language into its warnings: "The liquid component is a powerful lipid solvent, and may also act as a sensitizer in certain individuals." After its consideration of the request, the FDA decided to direct Howmedica to revise its package insert to include this additional language:

The liquid component is a powerful lipid solvent. It has caused contact dermatitis in susceptible individuals. Wearing of a second pair of surgical gloves and strict adherence to the mixing instructions may diminish the possibility of hypersensitivity reactions. The compound should not be allowed to come into direct contact with sensitive tissues or be absorbed by the body.

In 1975, the FDA required bone cement manufacturers to participate in a review of the inhalation toxicity of methyl methacrylate vapors, and the Simplex warnings were reexamined. After a number of discussions, the FDA required Simplex to modify the package insert warnings concerning vapor inhalation as follows:

As the liquid monomer is highly volatile and flammable, the operating room should be provided with adequate...

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