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.

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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.