Source: https://law.justia.com/cases/federal/appellate-courts/F3/56/703/624280/
Timestamp: 2019-05-20 11:27:58
Document Index: 751228656

Matched Legal Cases: ['§ 360', '§ 360', 'art. 2315', '§ 1292', 'art. 2315', 'art. 1']

Prod.liab.rep. (cch) P 14,261edward A. Lewis, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.louis Angelle, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.joseph Ferrara, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.joseph Caronia, Etc., Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.christopher Bordenave, Jr., Etc., et al., Plaintiffs-appellees, v. Intermedics Intraocular, Inc., Defendant-appellant, 56 F.3d 703 (5th Cir. 1995) :: Justia
Justia › US Law › Case Law › Federal Courts › Courts of Appeals › Fifth Circuit › 1995 › Prod.liab.rep. (cch) P 14,261edward A. Lewis, Plaintiff-appellee, v. Intermedics Intraocular, Inc.,...
Prod.liab.rep. (cch) P 14,261edward A. Lewis, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.louis Angelle, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.joseph Ferrara, Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.joseph Caronia, Etc., Plaintiff-appellee, v. Intermedics Intraocular, Inc., Defendant-appellant.christopher Bordenave, Jr., Etc., et al., Plaintiffs-appellees, v. Intermedics Intraocular, Inc., Defendant-appellant, 56 F.3d 703 (5th Cir. 1995)
US Court of Appeals for the Fifth Circuit - 56 F.3d 703 (5th Cir. 1995)
July 6, 1995. Order Granting Partial Rehearingand Modifying OpinionAug. 24, 1995
Congress enacted the Medical Device Amendments of 1976 (MDA) in order to vest regulatory power over medical devices in the Food and Drug Administration (FDA). The MDA established three categories of medical devices, each with different pre-marketing requirements, based upon the degree of risk to the public health and safety. The intraocular lenses in question are classified as Class III devices under the MDA. Class III devices receive the most rigorous level of scrutiny by the FDA. Usually, manufacturers of Class III devices must submit an extensive application for pre-market approval before such devices can be marketed. However, the Investigational Device Exemption (IDE), 21 U.S.C. § 360j(g), allows the FDA to exempt qualified devices from the requirements of the MDA. Thus, under the IDE a device may be marketed even though its safety and effectiveness have not been proven to the FDA. The FDA granted such an IDE to intraocular lenses and adopted federal regulations governing their clinical investigation. Pursuant to the federal regulations, intraocular lenses were to be tested on cataract patients who gave their informed consent for the lenses to be tested.
Intermedics filed a motion for summary judgment, contending that all of plaintiffs' state tort claims regarding the safety and effectiveness of the lenses are preempted by the MDA. See 21 U.S.C. § 360k(a) and 21 C.F.R. Sec. 808.1(b). Plaintiffs opposed the motion, arguing that Congressional intent with respect to the IDE was not to preempt state tort law claims, but to encourage discovery and development of useful medical devices and to protect the public health. The FDA did not provide remedies for the public in the event of injury; therefore, plaintiff contends there is no federal preemption of remedies for damages caused by intraocular lenses.
The district court dismissed all of plaintiffs' state tort claims except those relating to the duty to obtain informed consent, because it concluded that federal law preempts any state law claim relating to the safety and effectiveness of the lenses. In so doing, the court relied upon a case from the Seventh Circuit involving the issue of such federal pre-emption in the field of intraocular lenses, Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.), cert. denied, --- U.S. ----, 113 S. Ct. 327, 121 L. Ed. 2d 246 (1992). In Slater, the plaintiff alleged injury to his eye caused by the implantation and removal of a defective anterior-chamber intraocular lens. The plaintiff alleged negligence relating to the testing, safety, and effectiveness of the lens, inadequate clinical testing, defective design, failure to warn, strict products liability, and breach of implied warranty.
Intermedics subsequently urged the court to reconsider its ruling as to the informed consent claim in light of the Third Circuit's decision in Gile v. Optical Radiation Corp., 22 F.3d 540 (3d Cir.), cert. denied, --- U.S. ----, 115 S. Ct. 429, 130 L. Ed. 2d 342 (1994). In Gile, the court addressed the question of whether a patient who had received an intraocular lens had a cause of action against the manufacturer based on an alleged failure to obtain informed consent. Our colleagues of the Third Circuit disallowed the claim because the plaintiff could not provide any support for her contention that she was entitled to bring an informed consent claim against the manufacturer under state law. The district court in the case at bar distinguished Gile and refused to dismiss the informed consent claim because it found that authority for plaintiffs' informed consent claims could be found in Louisiana Civil Code art. 2315. The district court allowed Intermedics to take an interlocutory appeal pertaining to the issue of whether federal law preempts plaintiffs' state law informed consent claims. See 28 U.S.C. § 1292(b).
However, we cannot take such an easy path in our resolution of this pre-LPLA case. The LPLA does not apply retroactively to causes of action which accrued prior to the effective date of the Act. Brown v. R.J. Reynolds Tobacco Co., 52 F.3d 524, 527 (5th Cir. 1995); Cates v. Sears, Roebuck & Co., 928 F.2d 679, 683 (5th Cir. 1991). The plaintiffs' claims for failure to obtain informed consent would have "accrued" at the time the manufacturer allegedly failed to obtain informed consent. In this case, that appears to have been prior to 1988 for all plaintiffs. Thus, the LPLA does not appear to be applicable.
However, notwithstanding the very general language in art. 2315, the Louisiana legislature has spoken specifically on the issue of informed consent in another statute. Louisiana Revised Statutes 40:1299.40 outlines the procedures by which patients in Louisiana are to be informed of the risks of medical treatment and also governs tort suits against a "physician or other health care provider" for failure to obtain informed consent. The Louisiana Uniform Consent Law, La.R.S. 40:1299.40 clearly does not apply to manufacturers. Although plaintiffs might argue that Intermedics might qualify as some "other health care provider" under the statute, the 1990 amendments to the statute and the case law do not support such a view. The statute was amended in 1990 to make it clear that only a physician or health care provider who will actually perform the procedure is required to obtain informed consent. Davis v. St. Charles Gen. Hosp., 598 So. 2d 1244 (La.App. 4th Cir. 1992), was decided based upon the law as it was worded prior to the 1990 amendment, just as this case will be. Davis held that a referring physician had no duty to obtain informed consent. If a referring physician has no duty, a fortiori, a manufacturer has no duty under state law. Thus, there can be no recovery against a manufacturer under the Uniform Consent Statute.
(Opinion July 6, 1995, 5th Cir. 1995, 56 F.3d 703)
In Louisiana, case law is not considered positive law. See La.Civ.C. art. 1. Even jurisprudence from within this civilian jurisdiction is not considered binding authority on other Louisiana courts, because Louisiana does not recognize stare decisis. A fortiori, common law concepts developed through the case law in other jurisdictions would not be binding on Louisiana courts. See Principal Health Care of La., Inc. v. Lewer, 38 F.3d 240, 245, n. 5 (5th Cir. 1994)