Jennifer Fuson's blog

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.

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.” 

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

Washington, DC—More than seventy-eight percent of all Consumer Product Safety Commission (CPSC) recalls in 2012 were products made by foreign manufactures.  Despite those numbers, foreign corporations are able to evade United States laws and safety standards because of the difficulty of holding them responsible in the U.S. court system. This creates an unfair market advantage for foreign corporations, who have little fear of being held accountable when their defective products injure and kill American consumers.

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.

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!

Take Justice Back highlights the story of Karen Bartlett, a victim of a dangerous generic drug

Washington, DC — Simply because Karen Bartlett’s prescription was filled with a generic drug, not a brand, her legal rights are now in doubt.  The U.S. Supreme Court will hear Karen's case, Mutual Pharmaceutical v. Bartlett, today about the legal responsibility generic manufacturer’s have for the safety of their drug.  Take Justice Back is highlighting her story and fight for accountability with a new online video of Karen sharing her story in her own words.  

Washington, DC—For the third time in a matter of minutes, Karen Bartlett puts drops in her eyes to substitute for the tears she no longer produces.  Legally blind, Karen's eyes are a noticeable injury from her Stevens-Johnson syndrome (SJS), a lifetime condition resulting from taking sulindac, a generic drug prescribed for shoulder pain.   

The U.S. Supreme Court will hear a case known as Mutual Pharmaceutical v. Bartlett on March 19, 2013.  It centers around a woman who suffered devastating side-effects after taking the generic drug sulindac for shoulder pain.

While the “fiscal cliff” negotiations continued in the wee hours, Congress did pass one piece of legislation that got very little national attention: legislation that would set standards for drywall.  It might seem trivial, but not for the thousands of homeowners who have lost their homes or suffered significant drops in their home values because of dangerous Chinese drywall that was used after hurricane Katrina created shortages in the South.