Atlanta Injury Lawyer Blog

As you know, Governor Sonny Perdue has proposed legislation that would grant any Georgia corporation that manufactures drugs complete immunity from any civil liability if that company's drug harms a user as long as the FDA had approved it. This is a slap in the face of all Georgians and we need to tell the Governor we are not going to put up with it. Can you imagine the insanity of this proposal in light of the FDA debacle in Blakely, Georgia with the Peanut Corporation of America and the salmonella outbreak? Obviously, the FDA is a joke and can't protect us from peanut butter, much less from dangerous pharmaceuticals. This is the same FDA that missed 12 prior positive tests for salmonella at the Peanut Corporation of American plant before the salmonella outbreak.

The Governor's office made some feeble attempt to justify this slap in the face of Georgians yesterday and to distinguish the horrible peanut situation from his proposed FDA legislation: “The ‘F’ in FDA is much different than the ‘D’ in FDA. Our legislation is specifically targeted at drugs and medical devices that go through a rigorous approval process, which is totally unrelated to the FDA’s food regulation process,” said Perdue spokesman Bert Brantley. (The entire article is reprinted below).

Can you believe he said that? This sort of hyper-technical and meaningless distinction is tantamount to the Governor's treating Georgians like second class citizens. We deserve better. Use this link to tell Governor Perdue enough is enough, and when it comes to the safety of Georgians' food and drugs, we deserve grades of "A's" and "B's", not "F's" and "D's." Give Governor Perdue's proposed "get out of jail free" card for corporate wrongdoers an "F."

How peanut butter might gum up a Perdue bill

Thursday, January 29, 2009, 01:47 PM
The Atlanta Journal-Constitution

The state Capitol can be a highly insulated bubble, but reality occasionally imposes itself.

Two years ago, the massacre at Virginia Tech threw a wrench into legislation backed by the National Rifle Association to permit employees to keep guns in cars parked on company lots.
peanut.jpg

We may be witnessing something similar right now. Even if you live in a bubble, you know about that peanut-butter factory in Blakely:

A federal report released Wednesday on the salmonella outbreak fueled outrage and calls for a criminal probe into the South Georgia plant that officials said made the peanut butter that is linked to the food crisis. Georgia legislators vowed to sharpen laws regulating food-processing plants as federal officials announced an expanded product recall.

The report from the U.S. Food and Drug Administration detailed how the Blakely peanut butter plant failed to control contamination and retested tainted products before shipping them to market.

Two weeks ago, Gov. Sonny Perdue announced he would introduce legislation that would protect drug companies and medical device manufacturers in Georgia from lawsuits over products approved by the FDA.

Said Perdue:

“As we continue to attract new investment in biotechnology, we can secure our position as a leader in this industry by enacting laws that respect the role of the federal Food and Drug Administration as the regulator of the safety of drugs and medical devices.”

The governor’s legislation hasn’t manifested itself yet. But litigators who oppose the measure are practicing their lines, and the Blakely peanut-butter factory has quickly become a major part of the script.

“If the Food and Drug Administration can’t protect citizens and consumers from peanut butter, do we really want them to be the only line of defense for drugs and medical devices?” asked Bill Clark, director of political affairs for the Georgia Trial Lawyers Association.

We asked Lt. Gov. Casey Cagle this morning if the Blakely incident might sour the mood of the Capitol toward the governor’s bill.

Too soon to tell, Cagle said. He’d like to see the legislation.

But a spokesman for the governor said Perdue’s bill is to peanut butter what apples are to oranges.

“The ‘F’ in FDA is much different than the ‘D’ in FDA. Our legislation is specifically targeted at drugs and medical devices that go through a rigorous approval process, which is totally unrelated to the FDA’s food regulation process,” said Perdue spokesman Bert Brantley.

Further, Brantley said, the governor’s measure would protect companies from complaints against design defects of drugs and medical devices, not manufacturing defects. “If a drug manufacturer had salmonella in their factory and people got that from the taking the drug, this bill would not protect them,” he said.

The salmonella-tainted peanut butter poisoning cases nationwide are frightening and horriffic-over 500 individuals sickened from it so far and eight deaths. From peanut butter! And this is peanut butter that was supposed to have been checked by the Federal Government, in the form of the FDA (Food & Drug Administration) and through State Government, in the form of the Georgia Department of Agriculture, both of which have, obviously, failed Georgians and all United States citizens. Both of these government entities have failed miserably at their missions, protecting consumers. The FDA Inspection Reports read like an absolute horror story. The culprit corporation, Peanut Corporation of American, located in Blakely, Georgia, had numerous batches of peanut butter test positive for salmonella, but instead of immediately halting production, they shipped off the same batches to be tested by other laboratories that, for some unknown reason, failed to detect the strains of salmonella that were obviously present. Then the Peanut Corporation of American knowingly shipped out tons of peanut butter that had salmonella in them, that ultimately killed and sickened hundreds of people. What unbelievable reckless conduct! And by the way, where was the Georgia Department of Agriculture in all this??

The list of tainted products that you should not consume, apparently, grows with each day. I urge you to check the list of affected foods and do not consume any of them or give any of them to your pets.

And now, here in Georgia, the Governor has the audacity to introduce a bill into the Georgia General Assembly that would immunize any Georgia corporation whose product had been approved by the FDA. The proposed law by Governor Perdue currently would apply to Georgia pharmaceutical companies. That means any Georgian harmed by a pharmaceutical would have no recourse against the corporation that harmed him/her if the FDA had simply approved the product. Now I ask you, if the FDA obviously can't keep Georgians safe from peanut butter, how could it possibly keep Georgians safe from pharmaceuticals that kill or harm users? It can't, obviously, but our dear Governor would have his own Georgian citizens treated like second class citizens.

Tell Governor Perdue enough is enough. If you don't want yourself or your loved ones to be harmed by dangerous products, including dangerous pharmaceuticals, please call or write the Governor's office and tell Governor Perdue you don't like being treated like a second class citizen and you don't want Georgia corporations to get away with murder just because the (meaningless) FDA has approved the product. This has got to stop.

I want to continue to use my blog to warn Georgia consumers of dangerous medications when it becomes apparent that a particular drug either is more dangerous than it is helpful, or that the side effects of a drug are so severe that it calls into question using the drug in the first place. Such may be the case with the drugs Cipro and Levaquin, both common antibiotics. If you are taking Cipro or Levaquin, this warrants discussion with your physician who is prescribing it.

Apparently, despite the risk, these drugs remain popular in the medical community to prescribe for infections. Many patients are not even aware of the risks associated with them, and many doctors are not telling their patients of the risks. It shouldn't be this way. Physicians should be telling their patients when they prescribe a drug all known possible side effects and give their patients as much information as possible when prescribing any drug.

FDA Warning: Cipro May Rupture Tendons
Agency Issues 'Black Box' Warning for Antibiotics Known as Fluroquinolones
By Todd Zwillich
WebMD Health News
Reviewed by Louise Chang, MD
July 8, 2008 -- Federal regulators are ordering new warnings on Cipro and similar antibiotics because of increased risk of tendinitis and tendon rupture.
The new warnings apply to fluoroquinolones, a class of antibiotics that includes the popular drug Cipro. The FDA has told companies that the drugs must now carry "black box" warnings alerting doctors and patients that the drugs can increase risk of tendinitis and tendon rupture in some patients.
Fluoroquinolones have carried similar warnings for years, but officials say they continue to receive reports of safety problems. A "black box" warning is the FDA's sternest warning.
"We have seen continuing reports of tendon rupture so we are trying to increase awareness," says Edward Cox, MD, director of the FDA's Office of Antimicrobial Products.
The warning applies to drugs of the fluoroquinolone class, including Cipro, Cipro XR, Proquin XR, Levaquin, Floxin, Noroxin, Avelox, Factive, and marketed generics.
Renata Albrecht, MD, who heads the FDA's Division of Special Pathogen and Transplant Products, estimates that spontaneous ruptures occur in about one in 100,000 people. The agency says taking the drugs appears to triple or quadruple the risk.
Most of the tendinitis and tendon ruptures affect the Achilles tendon, behind the ankle. But the agency has also received reports of tendinitis and ruptures in the shoulder and hand. Tendons connect muscle to bone.
Officials also say they are adding new warnings cautioning that patients over 60, those taking corticosteroids, and those who've undergone heart, lung, or kidney transplants are also at increased risk of tendon rupture or tendinitis if they take fluoroquinolones.
Researchers don't know exactly what fluoroquinolones do that promotes tendon rupturing. Theories suggest the drug may impede collagen formation or interrupt blood supply in joints, Albrecht says.
She says patients taking the drugs should tell their doctors immediately if they experience soreness or inflammation in muscles or tendons and that they should not exercise affected joints.
A consumer watchdog group sued the FDA in January asking for the new warnings. The agency has received more than 400 reports of tendon ruptures in fluoroquinolone patients since 1997, according to Public Citizen's Health Research Group, which filed the suit.
FDA officials would not confirm the number of reports of ruptures it has received, citing the ongoing litigation.
"There are several hundred, I would say," says Ann McMahon, MD, acting director of FDA's Division of Adverse Event Analysis II.

A South Carolina jury recently returned a verdict for a woman who was wrongfully accused by Target of attempting to pay for an item of merchandise with an allegedly counterfeit $100 bill. Target violated its own procedures by sending out email with surveillance photos of the plaintiff attached. After suspecting the plaintiff was trying to use a counterfeit bill, Target then took it upon itself to notify 31 other businesses about her, telling them to keep an eye out for the plaintiff in their stores. The Secret Service then visited the plaintiff and determined her $100 bill was legitimate! The stress of the investigation and the false accusations made against her reputation caused the plaintiff to lose 40 pounds.

Do American corporations simply have no common sense any more?

Cantrell v. Target Corp., U.S.D.C. (S.C.), October 22, 2008

Did you know there is compelling evidence that links inflammatory bowel disease (IBD) to the use of Accutane, an acne drug? If you or a loved one has ever taken Accutane, you need to be aware of this causal link, especially if you begin to show signs of IBD.

A jury in New Jersey recently handed down verdicts of $13 Million in three cases in which the plaintiffs allege the use of Accutane for acne caused IBD againt the drug manufacturer, Hoffman-La Roche. Plaintiffs argued the drug company should have placed stronger warnings on the label of the drug warning users that use of Accutance can cause IBD. The three plaintiffs in the New Jersey case all took Accutance in their teens for acne. Soon thereafter, they developed IBD, causing one to have to undergo surgery to remove his colon. They all face a greater risk now of colon cancer.

Do these side effects sound worth the risk to clear up some acne? No, of course not. And had the plaintiffs known about them they never would have used the drug. The drug manufacturer, though, knew about this side effect and failed to warn appropriately about it. Hoffman-La Roche still claims there is no causal connection between Accutane and IBD, regardless of the jury's opinion. Not shocking...a drug manufacturer failing to accept responsibility for what it has done. It also faces a host of other upcoming civil jury trials on this drug.

I want to get this information out to Georgia citizens, though, before they have the same thing happen to them as the young men in New Jersey. Please use extreme caution!