Regulatory

AAJ Opposes CMS Proposed Rulemaking on Medicare Repayment System

Washington, DC—The American Association for Justice (AAJ) submitted comments to the Centers for Medicare and Medicaid Services (CMS) in opposition to the proposed rulemaking on future medical requirements in the Medicare Secondary Payer (MSP) system.   MSP is a process to ensure Medicare is reimbursed for medical bills that are the responsibility of another party – such as an insurer or negligent party.

AAJ: Protect Consumers From Secretive Forced Arbitration

AAJ filed two sets of comments on a forthcoming study encouraging the Consumer Financial Protection Bureau (CFPB) to fully examine the devastating impact forced arbitration has on the rights of American consumers.

AAJ President Gary M. Paul stated in the comments:

“Corporations’ broad utilization of pre-dispute mandatory arbitration clauses greatly reduces the ability of consumers to enforce their rights and in effect nullifies the protections incorporated in land mark consumer protection laws.”

Preview: June’s Trial Magazine

Drugs and devices are major areas of focus and concern among AAJ members—and the June issue of Trial, AAJ’s flagship magazine for attorneys and the legal community, looks into the latest on key drug and device litigation topics, including:

IOM finds FDA Drug Monitoring Deficiencies

The Institute of Medicine (IOM) released a report Tuesday recommending that the U.S. Food and Drug Administration (FDA) review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues. The IOM also recommended that the FDA create a comprehensive, publicly available document that reflects risks as they crop up throughout the "lifecycle" of the drug.

NYT Calls for Action to Ensure Generic Drug Patients' Rights

Over the weekend, the New York Times called on Congress and the U.S. Food and Drug Administration (FDA) to address the lack of accountability generic manufacturers have when it comes to monitoring the safety of their drugs. They stated:

“This outrageous denial of a patient’s right to recover fair damages makes it imperative that Congress or the Food and Drug Administration fashion a remedy.”

FDA Must Protect Patients from Defective Generic Drugs

In a letter sent to Public Citizen today the FDA has asked for more time to consider Public Citizen’s petition calling for a regulation change that would force generic manufacturers to update their labels. AAJ sent comments supporting the petition urging the FDA to ensure patients’ rights are protected when they are injured by defective generic drugs.

AAJ President Gary M. Paul stated:

AAJ Calls for Transparency of Medical Industry Payments

AAJ submitted comments today to the Centers for Medicare and Medicaid Services (CMS) calling for more transparency of payments made to doctors and hospitals by drug and device manufacturers. Financial relationships between drug and device manufacturers and physicians/hospitals can create an untenable conflict of interest and impact negatively on patient safety.

Congress must address device manufacturer immunity to keep patients safe

Tomorrow Congress will hear from the FDA, the medical device industry and health care professionals on the current medical device approval process. The House Energy and Commerce Committee, Subcommittee on Health is holding a hearing entitled “Reauthorization of Medical Device User Fee Act (MDUFA): What It Means for Jobs, Innovation and Patients.”

Public Pressure Leads to Carlyle Dropping Forced Arbitration Clause

The American Association for Justice (AAJ) has long fought to prohibit corporations from avoiding accountability by hiding forced arbitration clauses in the fine print of consumer and employee contracts.  When Bloomberg broke the story that Carlyle was attempting to take away investors’ rights by including a forced arbitration clause in its proposed IPO filing, AAJ raised concerns with the SEC and brought awareness to the issue.

The media coverage that followed and the news on Friday that Carlyle dropped the forced arbitration clause shows that now more than ever, "the public cares and public scrutiny matters." 

Lawmakers Call Out Carlyle for Denying Investors’ Legal Rights

Members of Congress are calling out Carlyle for including a forced arbitration clause in its proposed IPO filing that would ban shareholder class proceedings, severely limiting the ability of investors to hold the company publicly accountable for fraud, misconduct, or negligence.