This Bill, If Passed, Would Restore An Injured Patient's Right To Sue A Medical Device Manufacturer By Reversing Riegel v. Medtronic Ruling

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 18, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346).

This June 18 hearing has been titled "Medical Devices: Are Current Regulations Doing Enough for Patients?"  It is my understanding that this hearing is intended to be a follow-up to the Health Subcommittee's May 12, 2009 hearing on H.R. 1346. 

At this June 18 hearing I hope the idea of keeping medical device patients safe by maintaining "complementary" systems, i.e., the FDA and our civil court system, is stressed and understood.  In order to insure that our medical devices are effective and safe we need both a rigorous FDA device-approval process and court access when a defective device harms a patient.

Unfortunately, as a result of the United State Supreme Court's decision in the Riegel v. Medtronic case — which was handed down in the first part of 2008 — injured patients are currently barred from going into the court system and holding medical device manufacturers legally accountable for an injury caused by a defective device, e.g., Sprint Fidelis lead wire malfunction victims.

From my perspective, this current situation is not fair to injured patients and that is why we need Congress to pass the Medical Device Safety Act of 2009 into law.  Simply put, this bill would prevent medical device manufacturer from receiving total immunity as regards any patient injury claim simply by pointing to the FDA's prior approval of its device.  Instead, if passed, the Medical Device Safety Act would allow an injured patient to recover legal compensation when her injury was caused by a defective medical device.

What do you think about this issue of whether the federal preemption doctrine should be applied so as to prevent injured patients from suing a medical device manufacturer?