In the News

Unequal Harm: Disproportionate Damage to Women from Drugs and Devices

Michelle Garcia of Miami never thought a simple doctor’s office procedure for birth control would result in the removal of both of her fallopian tubes.  Yet last year Michelle underwent surgery to remove Essure, a medical device marketed as a “surgery-free permanent” birth control procedure. It was supposed to be Michelle’s easy solution for birth control for life; instead, it was her worst nightmare, requiring surgery to remove the coils and both damaged fallopian tubes.

Women suffer disproportionately from faulty drugs and medical devices, and Michelle is just one example.  As part of National Women’s Health Week, the American Association for Justice (AAJ) has released “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices,” an analysis detailing a history of a few of the many products that have harmed women over the years.

Ranbaxy Settlement Shows Need for Generic Drug Accountability

As if we needed another example of the need to hold generic drug makers accountable to the same standard as brand names, there is this disturbing story from The New York Times. A drug maker named Ranbaxy was churning out generic versions of a number of common drugs, including the epilepsy drug, gabapentin.  But in 2007, it admitted to the Food and Drug Administration that certain batches of the drug had tested positive for “unknown impurities.” 

Bipartisan Bill Addresses Foreign Corporate Liability in U.S.

78% of 2012 CPSC Recalls from Foreign Makers According to Analysis

Demand that Schwab Drop Forced Arbitration

Public Citizen is running an important petition against Charles Schwab & Co., Inc. for its use of forced arbitration in contracts.  If you are a private investor doing business with Schwab, you should consider registering your complaint by signing this petition.   

CISPA Limits Incentives for Corporate Responsibly

The U.S. House of Representatives passed the Cyber Intelligence Sharing and Protection Act (CISPA), H.R. 624, last week and the bill is set to be taken up by the Senate quickly.  

While there is across-the-board agreement on the need to update the nation’s cybersecurity laws, CISPA contains broad provisions that eliminate the ability of harmed individuals and business to hold corporations accountable that have acted recklessly or negligently after receiving cyber threat information. 

Legal Rights in Question with FDA Action on Metal Hips

Taxpayers and patients could pay the price for faulty metal-on-metal hips when the U.S. Food and Drug Administration (FDA) reclassifies several metal-on-metal hips, requiring manufacturers to complete a premarket approval application (PMA) or product development protocol (PDP) in order to receive the agency’s approval.  The reclassification may put patients’ legal rights in question.

Take Action to Protect your Medicine Cabinet!

Generic drugs make up 80% of all prescriptions filled in the United States, and roughly 53 billion dollars in sales.  Despite that, the U.S. Supreme Court recently held in Pliva v. Mensing that generic drug manufacturers have no responsibility to update their warning labels when they learn of new side-effects.  As a result, generic drug makers cannot be held accountable, even if their drug injures or even kills someone. The Supreme Court left it to Congress to change the law.  

Read the real story of Camille Baruch to learn how the access of justice has been denied for generic drug patients.  

Congress needs to amend the law to allow both generic and brand manufacturers to be responsible for their drugs’ safety.  Send a message to your member of Congress today!

What Justice for Victims of Oklahoma Dentist?

As some 7,000 patients of a Tulsa dentist now face the real possibility that they have been exposed to HIV or hepatitis in his care, they also face harsh limits on their access to accountability and justice. 

WSJ LTE: Accountability for Generic Drugs

The Wall Street Journal ran my Letter to the Editor calling for accountability in the generic drug market over the weekend.  Currently, patients injured by generic drugs do not have access to the civil justice system in order to hold the negligent manufacturer accountable.  The civil justice system is a proven incentive to help improve consumer safety.  An excerpt from the letter can be found below, and the full text can be found online here

Accountability motivates drug makers to both produce safe products and monitor for new side effects after their drugs are approved and enter the marketplace. Generics make up 80% of the prescription drug market, and yet cannot be held responsible and are not subject to the same safety requirements as brand-name manufacturers.

Both generic and brand-drug manufacturers should have the same responsibility to monitor the safety and disclose information about the risks of their drugs.

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