Recent Developments in Health Law

In April 1991, the FDA issued a final rule requiring the filing of a premarket approval application prior to the commercial distribution of a silicone breast implant (56 Fed. Reg. 14,621 (1991)). As a result, silicone gel implant manufacturers withdrew their products from the market; none submitted to the rigorous premarket approval process. In April 1992, the FDA further restricted the use of silicone implants to clinical trials and reconstructive surgery.

No foreign manufacturers are included in the settlement. Additionally, the settlement agreement has brought claims that the agreement is unfair to potential foreign plaintiffs because, while the preregistration process only affects the amounts that American claimants can receive, foreign claimants are precluded from recovery unless they register. The Eleventh Circuit Court of Appeals is presently considering the merits of this issue.

It is estimated that over 12,000 women opted out of the settlement, with more than 60 percent of them residing in Texas, a jurisdiction that has recently seen several favorable plaintiffs' verdicts.

1994 WL 578353 at 7.

Feldman Paul , “Prop. 187 Sponsors Blame Foes for Illegal Immigrants' Fears Over Seeking Health Care,” Los Angeles Times, Nov. 26, 1994, at 33A.

Daily Report for Executives, “Health Care, California Votes to Deny Health Care to Illegal Immigrants,” Nov. 10, 1994, at A216.

“Fearful Aliens in California Staying Away from Clinics,” New York Times, Nov. 12, 1994, at 9.

Romney Lee Marquis Julie , “Activists Cite Boy's Death as First Prop. 187 Casualty,” Los Angeles Times, Nov. 23, 1994, at 1A.

See Daily Report, supra note 2, at 9.

Romney Marquis , supra note 4.

Plyler v. Doe, 457 U.S. 202 (1982).

Id. at 221.

Id. at 210–11.

Id. at 216–17, 225.

Feldman Paul Connell Rich , “Wilson Acts to Enforce Parts of Prop. 187,” Los Angeles Times, Nov. 10, 1994, at 1A.

Plyler v. Doe, supra note 9, at 227.

Id. at 225–26

Feldman , supra note 1, at 33A.

See League of United Latin American Citizens v. Wilson (CD. Cal. 94-7569-MRP); Gregorio T. v. Wilson (C.D. Cal. 94–7652); and Children Who Want To Go To School v. Wilson (CD. Cal. 94-7570).

“California: Federal Court Blocks Most of California Proposition,” B. Health Law Rep., 3 (1994): 49.

See Daily Report, supra note 2, at 9.

See McDonnell Patrick , “Health Clinics Report Declines After Prop. 187,” Los Angeles Times, Nov. 26, 1994, at 1A.

National Organization for Women v. Operation Rescue, 37 F.3d 646, 648–49 (D.C. Cir. 1994).

Id at 649.

On January 26, 1990, a district court issued a permanent injunction; subsequently, on July 31, 1990, it issued a revised permanent injunction. In 1993, various health care facilities successfully sought enforcement of the permanent injunction. See National Organization for Women v. Operation Rescue, 747 F. Supp. 760, 661 (D. D.C. 1990); and National Organization for Women v. Operation Rescue, 816 F. Supp. 729, 736–37 (D. D.C. 1993).

National Organization for Women v. Operation Rescue, 37 F.3d 646, 649 (1994).

Id. at 654.

Madsen v. Women's Health Center, Inc., 114 S. Ct. 2516, 2528 (1994). See also Smith Paul C. , “Madsen v. Women's Health Center, Inc.,” J. L. Med, & Ethics, 22 (1994): 292–93.

National Organization for Women v. Operation Rescue, 37 F.3d 646, 655 (1994).

Madsen, 114 S. Ct. at 2526.

National Organization for Women, 37 F.3d at 655 (quoting Madsen, 114 S. Ct. at 2526).

Lloyd Corp. v. Tanner, 407 U.S. 551, 568 (1972).

Id at 656, 649, 655.

Brandenburg v. Ohio, 395 U.S. 444, 447 (1969).

Madsen, 114 S. Ct. at 2524 (quoting Califano v. Yamasaki, 442 U.S. 682, 702 (1979)).

National Organization for Women v. Operation Rescue, 37 F.3d at 657–58.

Id at 658.