Wednesday, February 25, 2009


Preemption's March Through Georgia

Viewed from the perspective of Michigan, where we have had a full FDA preemption shield law for fourteen years, it is fascinating to watch the struggle over such a law in Georgia. In some ways, it is like watching an old slow motion.

Still, 2009 is not the same as 1995. We are living in the post-Vioxx era and with a very different consciousness (post Enron, etc.) about corporate corruption, FDA's inadequacies, and public trust in the industry. Polls show that beginning in 1997, when DTC advertising on television fully blossomed, the public's view of the industry has plummeted. While that has leveled off some in the past couple of years, it is not clear that the overall trend has changed. In the meantime, as all here know, the industry itself is up against much larger challenges re: the pipeline, patent expiration, etc., all in the context of the wider economic collapse.

Below some excerpts from a piece on the efforts in Georgia to pass a full FDA shield law. As of yesterday (Tuesday), the relevant state senate committee already voted against the legislation. It's Chair, however, is one of two supporters. And he invited reintroduction of the bill before the current legislative term runs out.

A link is not available, so a few excerpts instead....Don't miss the reflections of Rep. Seth Harp. And even Medtronic indirectly shows up at the end...

Monday, February 23, 2009

Senators weigh drug-maker bill

By Andy Peters, Staff Reporter

(Zachary D. Porter/Daily Report)

Sen. Seth Harp said the FDA's seal of approval “doesn't work anymore.”
Gov. Sonny Perdue's legislative proposal to grant legal protections to Georgia companies whose products have Food and Drug Administration approval came under heavy fire last week from a Republican lawmaker.

But two attorneys who represent pharmaceutical and medical-device manufacturing companies in products-liability litigation told state senators that Perdue's legislation is needed to preserve the FDA as the arbiter of what products can be sold to the public.

Both exchanges came on Thursday afternoon during a meeting of the Senate Economic Development Committee, which is considering Senate Bill 101. Sponsored by Perdue's legislative floor leaders, the bill would bar suits against Georgia pharmaceutical and medical-device makers that sell FDA-approved products.....

The lawmaker that criticized the proposal sponsored by his fellow Republicans, Sen. B. Seth Harp Jr. of Midland, said that in his previous career as a pharmacist he became aware of a bronchitis drug that caused severe liver problems in some patients. However, the drug, called telithromycin and marketed under the name Ketek, had received FDA approval, Harp said.

“Ketek helped bronchitis, but it tore up your liver,” said Harp, a member of the panel.

A December 2006 FDA report identified cases of acute liver failure in patients who took telithromycin and also identified four deaths among patients who had taken the drug, according to a copy of the report.

“How can we give these companies carte blanche to kill people if their products have FDA approval?” Harp said.
The bill's lead sponsor, Sen. William S. Cowsert, R-Athens, responded that companies that go through “all the hoops required by the FDA” should be immune from being sued.....

In order to qualify for the immunity from litigation, a company must have its U.S. “corporate headquarters, principal place of research and development or manufacturing, or a research and development facility in this state,” according to the terms of the legislation. Or, the company must employ “more than 200 Georgia residents for manufacturing or research and development purposes.”

“That's why this bill is in the economic development committee, we're trying to encourage these companies to come here,” Cowsert said......

Some other opponents of the bill called the committee's attention to a recent amicus brief filed by medical doctors in a drug-safety case pending in the U.S. Supreme Court. In the case, Wyeth v. Levine, a group of eight physicians wrote that “the FDA is in no position to ensure the safety of prescription drugs. Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public.”....

University of Georgia law professor Thomas A. Eaton, who has reviewed the legislation, said that the legislation may violate the commerce clause of the U.S. Constitution.

The bill, he said, is “giving a competitive advantage to companies with a Georgia presence.” He did not speak at the Senate committee meeting.

Ironically, Eaton added, “The only people who will be barred from bringing suits are Georgians. . ... I don't understand why Georgians would seek to put other Georgians at a disadvantage to seek compensation for injuries.”

Another of the bill's supporters, Greenberg Traurig litigation partner Thomas J. Mazziotti, said that the bill would prevent giving too much power to a jury in deciding what drugs are safe.

“I would be concerned that 12 people on a jury, who have deliberated for a couple of hours, would render a verdict for a patient that would be second-guessing the work of engineers and physicians who have spent 1,500 hours reviewing a drug's safety,” said Mazziotti, who said he's represented Medtronic Inc. in medical-device product-liability litigation.......

[plus ca change...Ed.]


  1. Damn Scary! All a drug maker has to do is set-up an R & D facility with 201 employees and, bada bing, they’re immune from liability.

    The mob would love a deal like this.

    Is the plan to dot the U.S. with these buildings?

    When is somebody going to do something about the corruption in pharma and FDA?

  2. Sal - You got it. Just round up the extended family and you're all set.

    Too bad we didn't think of that in Michigan. We could have at least kept the jobs of a few hundred people even if everyone else got shafted.

    Go, Bulldogs!

  3. Sal, stay out of Texas.

    Texas lawmakers and the attorney general are cracking down on drug cartels. Click on "Glad" to hear the rest of the story.


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