Thursday, February 05, 2009

Consumers At Risk with Proposed Georgia Legislation

From the GTLA: Governor Perdue wants to place the safety of Georgia’s citizens in the hands of a mismanaged federal bureaucracy

Georgia lawmakers introduced SB 101. Senate Bill 101 would grant new protections from product-liability suits to Georgia companies whose products have Food and Drug Administration approval.

In essence SB 101 seeks to rely on the federal Food and Drug Administration (FDA) amidst grave controversy while giving large pharmaceutical companies who harm Georgians a “Get out of Jail Free” card

Governor Perdue suggests that a federal bureaucracy embroiled in heavy controversy, the FDA, should have all the power in deciding the safety of pharmaceuticals and medical devices. SB 101 bars any Georgia citizen from bringing a products liability claim against a pharmaceutical corporation so long as it is headquartered or has 200 employees in Georgia and the product in question, either a drug or a medical device, is FDA approved.

“Vioxx was an FDA approved drug that harmed at least 139,000 people. If there were to be a drug or medical device made here in Georgia that injured or killed people like Vioxx did, Georgia residents would have absolutely no recourse. A person in Phoenix City, Alabama could pursue justice; a person in Columbus could not,” said Fred Orr, President of the Georgia Trial Lawyers Association. “The Governor believes SB 101 will bring corporations to Georgia. But I don’t think we want the kind of business this legislation would attract as this bill says, “Move to Georgia! You can harm or kill our citizens and you will not be held accountable!”

The Governor stated early in the session that FDA approval “should mean something” and that it should protect corporations from lawsuits.

“The FDA can’t protect us from peanut butter. How can we possibly rely on the FDA to protect us from dangerous drugs and medical devices?” said Orr. “If a pharmaceutical corporation manufactures a drug or medical device that seriously harms or kills an innocent person, that corporation should not, under any circumstance, be shielded from accountability. The Governor has simply gone too far with this proposal.”

On February 2, 2009 President Obama had harsh words for the FDA and he urged Congress to conduct a complete review of the FDA after the agency failed to protect the public from contaminated peanut butter. At this time the contaminated peanut butter has killed 8 people and sickened over 500 people.

In addition to the agency’s failure to protect the public from peanut butter, as recently as the last month, the FDA has been at the center of three other nationally publicized controversies concerning alleged corruption, mismanagement, and claims of serious financial conflicts of interest. First the federal Government Accountability Office (GAO) released a report revealing that the FDA has failed to comply with a congressional mandate set nineteen years ago that requires manufacturers of medical devices to provide proof of rigorous testing and safety analysis to the FDA for all Tier 3 medical devices (classified as those devices that are implanted or that a person relies on for life) prior to approval.

Second, a group of FDA scientists went public with their allegations of corruption, mismanagement and coercion within the FDA. The scientists stated that the scientific review process for medical devices “has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” They allege that managers at the FDA lacked scientific knowledge and clinical expertise regarding medical devices and that they have ignored the experts and scientists within the FDA. The authors stated that they had been ordered to modify their findings and evaluations of medical devices—allowing for the approval of products that may not be safe.

And third, the Inspector General of the Department of Health and Human Services (HHS) issued a report uncovering a troublesome conflict of interest inherent in the FDA approval system. The FDA failed to collect information on financial ties between those that perform clinical tests and the pharmaceutical companies that manufacture the product being tested in an alarming 42% of the cases. HHS claims that such financial ties may compromise the safety of the people in the clinical trials and the authenticity and integrity of the final research data.

“The scientists working at the FDA think that Americans are in danger. Other governmental entities report that the FDA is inept at keeping the American public safe. Yet Governor Perdue inexplicably thinks we should trust a corrupt federal bureaucracy to keep Georgians safe,” said Andy Childers, an Atlanta attorney.

National leaders in medicine don’t think that FDA approval is enough to keep people safe either. In a friend-of-the-court brief filed in association with the case of Wyeth v Levine, multiple editors of the New England Journal of Medicine stated, “The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety." The doctors went on to say that without civil lawsuits and the discovery they produce, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

NOTE: For more information on the FDA approval process and other Government reports, please contact Rebecca DeHart at GTLA.

The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgians