Pallone Statement at Health Hearing on Medical Device Safety Act of 2009

Washington, D.C. --- U.S. Rep. Frank Pallone Jr., Chairman of the House Energy and Commerce Subcommittee on Health, gave the following opening statement at a subcommittee hearing this morning on H.R. 1346, the Medical Device Safety Act of 2009.

"Good morning. Today the Subcommittee is meeting to review HR 1346, the 'Medical Device Safety Act of 2009.' We have made huge advances in medicine over the last few decades. New and emerging technologies hold promises that our great grandparents could never have imagined. Many illnesses that were once a death sentence are now preventable, curable or at least manageable through modern medical treatments.

"However, though these medical advancements offer huge benefits, they also present a certain amount of risk. For example, there have been recent stories of patients who have suffered serious injuries from defective FDA-approved devices, like implantable cardiac defibrillators and pacemakers.

"A young girl from my home state of New Jersey is one of the victims affected by a faulty medical device. Last year, this 14-year-old girl felt a very strong pain through her body that she described as "a horse trampling me." Eventually, she realized that her implantable cardiac defibrillator was shocking her; and it continued to do so 18 times.

"When the paramedics arrived at the scene, they found this little girl lying on the floor, begging for someone to remove the device from her body. She spent the next four days at a children's hospital waiting to have the surgery to remove the device. Though the faulty device is no longer inside her body, she still suffers from significant anxiety triggered by the slightest heart palpitation or any beeping sound she hears. The medical costs this family now bears as a result of the surgery and side effects are tremendous.

"Unfortunately, as we will hear today, this little girl and her family have no opportunity for legal recourse. And she is not alone in this problem.

"In February 2008, the U.S. Supreme Court deliberated the Riegel vs. Medtronic case and made a decision that, in effect, relieved medical device companies from the responsibility of ensuring the safety of their products. The Supreme Court ruled that patients could not receive compensation for their injuries, medical expenses, and lost wages caused by defective premarket approval (PMA) devices or inadequate safety warnings.

"This decision ignores congressional intent and is contrary to how the Medical Device Amendments (MDA) has been interpreted since the legislation was passed in 1976. For the past 30 years, federal regulation through the FDA, together with tort liability, played crucial roles in protecting consumers from risky devices.

"Already, this decision has had a devastating impact on patients who have been harmed by defective medical devices. For example, a federal judge in Minnesota threw out more than 1,400 lawsuits filed by patients who had defective heart defibrillator wires or "leads" implanted, many of whom died as a result. The judge based his decision on the Riegel case and noted that the only way to remedy the situation was for Congress to step in.

"It is crucially important that all the major stakeholders involved in manufacturing medical devices, make patient safety their main priority. We must be certain that we are taking every step necessary to ensure that the technologies designed to save lives are not placing people in danger. Much of the data used by the FDA in premarket approvals for both drugs and devices is limited in the number of individuals who are monitored, as well as in the timeframes they are collected. These studies are vital in making safety and efficacy determinations, while at the same time getting life-saving treatments to patients in a timely fashion.

"However, the Institute of Medicine has recommended that the risks and benefits of these treatment options should be monitored throughout their entire life cycle. This means that the manufacturer has a responsibility for the safety of their product for as long as it is being used by patients, not just during pre-approval trials.

"Until last year, the state court system provided an additional incentive for companies to actually follow this recommendation. Unfortunately, the Riegel vs. Medtronic case and its effects have removed that incentive, and provided medical device companies with blanket immunity. The Court premised its decision on the theory that FDA approval adequately protects patients from unsafe medical devices. That theory however, has proven false time and again.

"This is why I, along with the Chairman of the Energy and Commerce Committee Rep. Henry Waxman, introduced the Medical Device Safety Act of 2009, the bill we are examining today. This bill protects patients from dangerous and defective devices by correcting the Court's flawed interpretation of the Medical Device Amendments of 1976 (MDA). The legislation explicitly clarifies that state product liability lawsuits are preserved and puts safety first by eliminating the blanket immunity that medical device companies currently enjoy.

"Fortunately, there is precedent for this as the Supreme Court just a few months ago ruled in favor of a plaintiff in a case against a drug company. In this case, the Court upheld congressional intent and placed the responsibility for making a safe product squarely within the company’s purview. It is crucial that we act now to provide patients in need of a medical device with that same certainty."