What Do A Former Major League Umpire, A Kindergartner, and A Former Quality Assurance Tech for the Medical Device Industry Have in Common?

Washington, DC—On Tuesday, March 31, 2009, victims harmed by dangerous medical devices and their families will be in Washington, DC, to meet with members of Congress about The Medical Device Safety Act (MDSA), legislation that would restore the right of thousands of Americans who have suffered or even died because of defective medical devices, like heart defibrillators, artificial valves, and prosthetic knees and hips, to seek justice through the civil justice system. 

Last year, the Supreme Court ruled in Riegel v. Medtronic that manufacturers of class III medical devices that have been approved by the FDA’s pre-market approval process are essentially immune from liability.  The Riegel decision is the subject of the MDSA that would restore injured patients’ right to seek justice in the courts when medical devices have failed, and in some instances, have even been recalled.  This legislation follows the Supreme Court’s decision earlier this year in Wyeth v. Levine that held federal law does not preempt state-law claims with regard to drug warning labels.

“Medtronic was aware the device was failing at abnormally high rates but continued to market it as alleged in lawsuits filed against the company,” according to Wendy Fleishman, an attorney with Lieff Cabraser Heimann & Bernstein, LLP, who has clients affected by medical devices.  “Medtronic put profits ahead of patient safety.  It should not receive the benefit of a judicial doctrine granting the company immunity.” 

Below are just three of the faces of the patients that have been harmed by medical devices. 

For more stories click here http://www.afj.org/faces_of_preemption.pdf.

Avery DeGroh, of McHenry, Illinois, or was born with a hereditary heart defect that put her at risk for arrhythmia.  When she was only two years old, her doctor recommended that, as a precaution, she have a defibrillator implanted in her chest.  At three years old,  she was playing in her basement when her implanted defibrillator began shocking her.  Terrified and unsure what was happening, Avery began to scream that monsters were attacking her.  A representative from Medtronic was present at the hospital and confirmed that Avery’s lead had fractured and she had been shocked nine times. Avery’s parents, Molly and Alex, decided to have the Sprint Fidelis lead replaced with a St. Jude model, as they were distrustful of Medtronic and wary of another lead fracture. Because they were implanting a St. Jude, Medtronic told them that the company would not cover the cost of the defective lead replacement. As a result, Molly and Alex are still struggling to pay off the medical bills from the replacement surgery.

Mark Hirschbeck of Ansonia, Connecticut, spent 15 years as an umpire for Major League Baseball.  He had umpired in both the 1998 and 2001 World Series, in four National League Division Series (1996, '97, '99, '02) and two American League Division Series (2000, '01).  The game had taken a toll on his body, and in 2003 Mark needed hip replacement surgery.  His doctors had assured him he would be able to return to baseball the following year.  Six weeks after the surgery, Mark experienced ongoing pain in his right hip.  Further examination showed, through no fault of his own, Mark’s ceramic hip had fractured.  Mark’s doctor testified in a deposition that the hip should have lasted 15 years; instead it lasted just six weeks.   Mark needed another surgery to replace the fractured hip.  During that surgery, Mark contracted a staph infection.  In the end, Mark had to undergo five hip surgeries to replace the hip and clean out the infection.  Mark no longer works in baseball.  He enjoys life with his four children, but still misses his former Major League Baseball career.

Leonard “Len” Stavish of Bear Creek, Pennsylvania, is 69 years old. He was a Sergeant First Class in the Medical Corp of the USA Army and has had a 33 year career in Medical Device Design and Process Engineering with global responsibilities for major companies in the life sciences industry.  In 2004, he was diagnosed with congestive heart failure and a defibrillator was implanted.  Less then two years later, the lead to his defibrillator fractured and shocked him 47 times over a five-hour period before it was able to be turned off.  He had surgery to replace the lead, unfortunately, that lead was recalled, and Len had to have a second replacement surgery.  Len now has Post Traumatic Stress Disorder sometimes experiencing nightmares and phantom shocks because of  the trauma from undergoing 47 shocks, a similar experience to being electrocuted 47 different times.