Drugs

WLF Seeks Reversal of Decision Allowing RICO Against Rx Firms

In a move to curb lower federal courts from hearing Racketeer Influenced and Corrupt Organizations Act (RICO) cases against pharmaceutical manufacturers for alleged inaccuracies in their marketing concerning the safety and efficacy of their prescription drugs, the Washington Legal Foundation (WLF) has filed a brief with the U.S. Supreme Court urging it to reverse a lower court’s decision that could see third-party payers branding pharmaceutical companies as “racketeers” in order to take advantage of RICO’s treble-damages provision. The WLF brief in GlaxoSmithKline LLC v. Allied Services Division Welfare Fund argues that a plaintiff cannot demonstrate the requisite “proximate cause,” demanded of all RICO plaintiffs, if the “theory of causation is too attenuated; e.g., if any damages are dependent on the actions of intermediaries not under the defendant’s control.”

The case involves an effort by several third-party health insurance payers (TPPs) to recover payments they made to their customers as reimbursement for the cost of GlaxoSmithKline’s diabetes drug Avandia that was prescribed by their doctors. WLF argues that the TPPs cannot satisfy RICO’s proximate-cause requirement because they lack a direct relationship with the drug manufacturer. The TPPs contend that GlaxoSmithKline fraudulently concealed medical studies indicating that using Avandia increased heart attack risk. Had the true facts been known, they say doctors would have written fewer Avandia prescriptions and thus the TPPs’ reimbursement expenses would have decreased.

The WLF brief contends that any damages suffered by the TPPs depended on the independent actions of physicians who may or may not have relied on the manufacturer’s alleged misrepresentations when they chose to prescribe Avandia for their patients. In a release, WLF chief counsel Richard Samp said: “The reflexive invocation of RICO by civil litigants engaged in garden-variety commercial disputes does violence to the statute’s original purpose and burdens our federal judicial system. RICO was enacted to fight organized crime, not to enrich the plaintiffs’ bar. The Supreme Court needs to step in and halt the abuse.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome