On November 13th, Cook County Circuit Court Judge Diane J. Larsen declared the 2005 Illinois medical malpractice “reform” statute, which capped noneconomic damages, violated the Illinois Constitution. The ruling came in the case of Lebron v. Gottlieb Memorial Hospital, which had been designated as the lead case for challenges to the law. The decision constituted a major victory for the Center for Constitutional Litigation (CCL). CCL President Robert S. Peck argued the case. Joining him on the briefs were CCL attorney Francine Hochberg, as well as Jeffrey M. Goldberg of Jeffrey M. Goldberg Law Offices and Todd Smith and Devon Bruce of Power, Rogers and Smith, P.C., all of Chicago and AAJ members.

The Plaintiffs had moved for judgment on the pleadings on their constitutional claims. The Defendants in Lebron, represented by former U.S. Solicitor General Theodore Olson, had cross-moved for a declaration that the law was constitutional, while also challenging the Plaintiffs’ standing to raise the law’s constitutionality.

Judge Larsen ruled in favor of the plaintiffs on all issues. She found the “catastrophic nature of the injuries pled in the complaint” were sufficient to confer standing. She also held that the cap on damages “operates as a legislative remittitur which ‘disregards the jury’s careful deliberative process in determining damages that will fairly compensate injured plaintiffs who have proven their causes of action’” and thus violates separation of powers. The cap limited noneconomic damages against doctors to $500,000 and against private hospitals to $1,000,000.

Judge Larsen found it unnecessary to consider the plaintiffs’ other constitutional arguments, because their first argument on separation of powers was sufficient to dispose of the constitutional question. In so ruling, she relied on the Illinois Supreme Court’s decision in Best v. Taylor Machine Works (1997), which invalidated a previous non-economic damage cap. Because the 2005 law contained an inseverability clause, Judge Larsen held the entire act unconstitutional, including provisions for periodic payments, restrictions on expert testimony, requirements for a certificate of merit, and an evidentiary protection against admissions of liability. CCL President Peck called the victory was “gratifying.” He noted that, like every state constitution, the “Illinois Constitution gives the state legislature no power to render a judicial judgment and no right to take away the jury’s authority to determine the proper compensation when liability is proven.”

Illinois Trial Lawyers Association President Bruce Kohen praised the decision as “an important victory for the rule of law and constitutional government over the rule of special interests.” He added that “today’s ruling provides further confirmation that, despite the power and influence of the insurance lobby, laws that violate the state’s Constitution will not stand.”

The Defendants are expected to appeal, and the Illinois Supreme Court could hear the matter as early as next summer.

The Center for Constitutional Litigation (CCL) is a law firm that focuses its practice on access to justice issues. The American Association for Justice often retains CCL to assist state trial lawyers in challenging laws that impede that access.

FDA’s oversight of drug trials is dangerously lax, report says

The FDA’s oversight of volunteers in clinical drug trials is sorely lacking, according to a report from the Office of the Inspector General (OIG) for the Department of Health and Human Services, and the agency is overly reliant on voluntary compliance from drug companies even when the companies’ violations of FDA policy are flagrant. The report by Inspector General Daniel Levinson, released in September, was prepared in response to congressional inquiries.

Its findings depict an agency that is disorganized, plagued with poor record-keeping, and unable to monitor subjects in clinical trials with any rigor or thoroughness. Millions of people take part in these trials and, the report suggests, their safety could be compromised.

The study set out to determine how well the FDA’s Bioresearch Monitoring (BiMo) Program protects participants in trials paid for by drug and device manufacturers who are seeking FDA approval for their products. The OIG examined FDA inspections of company-financed trials that occurred from fiscal year 2000 to fiscal year 2005.

One of the key problems, the study found, is that the agency does not maintain a registry of institutional review boards (IRBs)—committees made up of medical experts with responsibility for overseeing subject safety in research trials and ensuring that researchers adhere to strict ethical guidelines. The FDA inspected very few IRBs, although “IRBs are important because their primary purpose is to ensure that clinical investigators take appropriate steps to protect the rights and welfare of human subjects,” the report found.

Another problem is the apparent lack of coordination among the agency’s three centers that regulate medical products—the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiologic Health—which leads to inconsistency in inspections. “Uncertainty of timing and lack of coordination impede FDA’s ability to conduct [bioresearch monitoring] inspections,” Levinson wrote.
Among the study’s key findings:

Most (75 percent) of the inspections were so-called surveillance inspections, meaning they focused on the trials’ clinical results, not on the well-being of the human subjects.

The OIG also expressed concern about the FDA’s reliance on voluntary compliance and low rates of follow-up after discovering violations of agency policy. The FDA issues three levels of response to violations: NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). The study found that in 70 percent of the OAI cases, the Center for Drug Evaluation and Research downgraded the inspectors’ findings to VAI status. And of 348 OAIs, only 26 companies were disqualified from conducting further clinical trials.

The study recommended that the FDA establish a database of all ongoing trials and a complete registry of research-ethics boards, and that it maintain better records of its trial inspections. Levinson also stressed that the agency should exert more authority over those involved in designing and running the studies.

“FDA should consider seeking additional authority that covers all of the stakeholders in the management and conduct of clinical trials,” he wrote. “In particular, FDA should consider seeking authority to include the colleagues and subordinates of a clinical investigator if they participate in the conduct of a clinical trial.”