Petix v. Kabi Pharmacia Ophthalmics, Inc.

Citations: 884 F. Supp. 92; 1995 U.S. Dist. LEXIS 9375; 1995 WL 244606Docket: 1:92-cv-00503

Court: District Court, W.D. New York; March 31, 1995; Federal District Court

SummaryOriginalCytator Case TreatmentBackward CitatorAnalysis

EnglishEspañolSimplified EnglishEspañol Fácil

Plaintiff Jennie Petix brought a diversity action against Defendants Kabi Pharmacia Ophthalmics, Inc. and Intermedics, Inc. in the United States District Court for the Western District of New York, alleging negligence and strict products liability related to the implantation of an intraocular lens following cataract surgery. The Defendants filed a motion for summary judgment asserting that federal law preempted the Plaintiff’s claims. The Plaintiff opposed the motion, and oral arguments were held. The court ultimately granted the Defendants' motion for summary judgment.

The facts established that the Defendants had marketed the Pharmacia Intermedics Ophthalmics model 024 intraocular lens, which received pre-market approval from the FDA as a Class III medical device, requiring extensive clinical investigation. Petix underwent surgery on January 16, 1984, after being informed about the clinical study associated with the lens implantation, which included a one-year observation period to evaluate safety and efficacy. She consented to participate in this study, understanding that her surgery results would be reported to the FDA and that confidentiality could not be guaranteed.

The informed consent form signed by Petix on January 5, 1984, clarified that surgical results were not guaranteed and outlined potential complications associated with lens implantations. Dr. Sirkin performed the surgery on January 16, 1984, implanting an Intermedics Model 024 intraocular lens in Petix's right eye, which initially succeeded. After the surgery, Dr. Sirkin completed a Lens Accountability Form detailing the patient's information and the lens type to the manufacturer, Indermedics Intraocular, Inc. Post-market studies later indicated that complications could arise from the lens beyond the one-year follow-up period, leading to recommendations from the medical community for discontinuation of such lenses. In May 1987, Intermedics voluntarily withdrew the Model 024 lens from the market for marketing reasons. Following this withdrawal, Petix experienced significant visual deterioration, leading to a diagnosis of pseudophakos bulbous keratopathy and eventual blindness in her right eye. In July 1990, she underwent lens extraction as part of a corneal transplant, and by the time of the current motion, she was scheduled to have her right eye removed. Petix was never informed of the lens's market withdrawal or the complications associated with closed-loop anterior chamber intraocular lenses.

In legal proceedings, summary judgment may be granted when the moving party shows no genuine issues of material fact exist and is entitled to judgment as a matter of law. The burden is on the moving party to demonstrate this absence of genuine issues, and any ambiguity in the record must be resolved in favor of the nonmoving party. Defendants argue for dismissal based on federal preemption from the Medical Device Amendments to the Food, Drug, and Cosmetic Act, which is acknowledged by Plaintiff for the period between lens implantation and its market withdrawal. However, Plaintiff asserts that post-withdrawal, Defendants had a duty to warn of known hazards, and under New York law, manufacturers have a continuing obligation to inform users about defective products.

Plaintiff argues that common-law duties fall outside the preemptive scope of the Medical Device Amendments (MDA), making her claims viable. The Supremacy Clause establishes that federal law prevails over conflicting state law, with potential preemption occurring when Congress explicitly states its intent or when compliance with both federal and state laws is impossible. The burden of proof for preemption lies with the party asserting it, demonstrating clear congressional intent or conflict with federal law. The MDA, enacted in 1976, aimed to regulate the medical device market in response to public safety concerns, granting the FDA authority to ensure device safety and effectiveness. Section 360k(a) of the MDA prohibits states from establishing requirements that differ from or add to federal standards regarding device safety or effectiveness. The FDA’s regulations further clarify these provisions, emphasizing the limitations on state regulations concerning medical devices.

After May 29, 1976, states and their political subdivisions cannot impose legal requirements on medical devices intended for human use that differ from or add to federal regulations regarding safety and effectiveness, as outlined in 21 C.F.R. 808.1(b). The FDA stipulates that state or local requirements are only preempted when the FDA has established specific regulations for a device, which would render any differing state requirements incompatible (21 C.F.R. 808.1(d)). Although the statute includes preemption language, there is no legislative history indicating Congress intended to limit state tort actions. The court in Bravman noted that agency regulations include court decisions in the definition of state requirements. The Supreme Court in Cipollone v. Liggett Group affirmed that state law requirements encompass both statutory and common law obligations. 

In Slater v. Optical Radiation Corp., the court dismissed a plaintiff's claims against a manufacturer of an intraocular lens due to express preemption by federal law. The court highlighted that the FDA's investigational device exemption (IDE) regulations provided extensive rules for the use of intraocular lenses, which preempted state law claims related to safety and effectiveness. The Seventh Circuit upheld this decision, stating that imposing additional state tort law requirements regarding the lenses was prohibited under the Medical Device Amendments (MDA) preemption provision.

In Slater, 961 F.2d at 1333, the court limited the scope of preemption to state sanctions for compliance with federal regulations on the safety and efficacy of experimental lenses. In Hunsaker v. Surgidev Corp., 818 F. Supp. 744 (M.D. Pa. 1992), the court analyzed the preemptive effect of the Investigational Device Exemption (IDE), the Medical Device Amendments (MDA), and the Federal Food, Drug, and Cosmetic Act (FDCA) on state tort claims concerning intraocular lenses. Following a plaintiff's cataract surgery and subsequent vision loss after implantation of the defendant's lens, the court determined that Congress intended to promote investigational use of these devices through the IDE. The court noted a critical distinction between devices approved for sale and those approved for investigation, highlighting a conflict between federal and state law regarding safety standards. Consequently, the court ruled that the plaintiff's negligence and strict liability claims were preempted, as they pertained to areas regulated by Congress.

In a related case, Hamilton v. Surgidev Corp., 1993 WL 533994 (E.D. La. 1993), similar preemption principles were affirmed for claims related to the safety and effectiveness of intraocular lenses. Petix raised claims of negligence in design and testing, as well as failure to warn about health hazards, all focused on the lens's safety and effectiveness. Given federal preemption established by the MDA and relevant case law, the court found Petix's claims preempted. Petix conceded that her claims were preempted from 1984 until the lens's market withdrawal in 1987 but argued that the defendant had a duty to warn post-withdrawal upon discovering product dangers. The court did not find any genuine issue of material fact regarding the lens's regulatory status after its market withdrawal.

Congress did not intend to rescind the protection for manufacturers under FDA regulations when a product is withdrawn from the market due to poor performance. The Investigational Device Exemption (IDE) is designed to promote the development of medical devices while safeguarding public health. The Medical Device Amendments (MDA) aim to grant researchers the freedom to innovate without the threat of tort litigation. The case of Kemp v. Pfizer illustrates this principle; despite a heart valve being withdrawn from the market after it caused complications, the court upheld that preemption by the MDA applied because it had received FDA pre-market approval. The court emphasized that removing liability after a product is withdrawn would discourage manufacturers from developing new devices, undermining Congress' purpose. The argument that individuals could sue manufacturers for unsuccessful devices conflicts with the MDA's intent, which is to allow the development of medical products without the burden of state tort law claims for those that fail. Additionally, the FDA regulations require strict compliance for obtaining an IDE, and imposing liability would contradict Congress' objectives. Section 360h of Title 21 of the United States Code further addresses notification and remedies related to the MDA.

Notification provisions require the Secretary to inform the public if a device poses an unreasonable risk to health, as per 21 U.S.C. 360h(a). However, the statute and related regulations do not mandate manufacturers to notify the public when recalling an exempt device that had an Investigational Device Exemption (IDE). Consequently, any state law duty to warn would impose additional requirements beyond federal regulations and is preempted by federal law, as established in Cipollone. The court rules that Petix's state law claim regarding the failure to warn about the withdrawn intraocular lens from 1987 is preempted. Petix argues that defendants did not follow FDA notification requirements and intentionally bypassed the process when withdrawing the lens. However, she has not provided evidence or authority to support this claim. Even if defendants failed to comply with FDA requirements, state law claims cannot enforce compliance with federal procedures, as noted in Papas v. Upjohn Co. The scope of preemption under the Medical Device Amendments (MDA) is broad enough to cover Petix's claims, warranting dismissal. The court acknowledges that informing patients about the withdrawal of a medical device could be beneficial for personal medical evaluations but emphasizes that this issue falls under the FDA's regulatory authority. The court grants the defendants' motion for summary judgment.