Friday, February 20, 2009

4 years

The Georgia legislature passed a bill, effective February 16, 2005, which capped noneconomic damages in all medical malpractice cases. The stated legislative intent of the damage cap was twofold: 1) improving the quality of medical care in Georgia; and 2) increasing the number of physicians in Georgia.

After four years, what has been the practical effect of the cap? 1) The bill certainly has not improved the quality of medical care provided to Georgians. According to the Agency for Healthcare Research and Quality, U.S. Dept. of HHS, the quality of medical care in Georgia has declined since 2005. While there are numerous reasons for the decline in the quality of medical care provided to Georgians over the past four years, Georgia legislators now know what every healthcare advocate has known for the past three decades, preventing full accountability under the law reduces the deterrent of liability law. 2) Prior to the February of 2005, physicians licensed in Georgia increased by 7.79% in 2003 and by 5.89% in 2004. After the malpractice damages caps were passed, physicians licensed in Georgia increased by 4.96% in 2005, 6.69% in 2006, 5.91% in 2007, and 5.78% in 2008. The medical malpractice damage caps have had no effect on the number of physicians licensed in Georgia.

Thursday, February 19, 2009

Report: FDA lack of enforcement of testing standards "stunning in its contempt" for patients

According to a report released February 18 by the non-profit Project on Government Oversight, the recent failure of the Food and Drug Administration to enforce federally-mandated safety and quality standards with regard to medical devices places patients' lives in danger and raises “incalculable risks” to public safety. News of this report appears in Wednesday's Wall Street Journal (subscription required for full article) and was also reported by the Associated Press.

In particular, the report noted a dramatic decline in FDA inspections of plants producing medical devices such as coronary stents, pacemakers, defibrillators, and heart valves. According to the report, there were 33 such inspections in 2005, 7 in 2007, and just 1 in 2008. Without inspections, the FDA relies on manufacturers' assurances that they are following federal guidelines, which provides manufacturers significant protection from disciplinary action by the FDA as well as from prosecution. The FDA's lack of action is “stunning in its contempt for the protection of patients," the report concludes.

A 2006 internal FDA memo pointed out multiple instances in which medical device manufacturers had failed to comply with federal testing standards, and suggested increased governmental oversight. However, the FDA elected at that point not to increase its inspections of the production of those devices. "This decision . . . may result in an irreversible cascade of adverse consequences to the protection of the public," according to a letter submitted to Congress by the Society of Quality Assurance.

The FDA's lack of oversight of the medical industry is especially troublesome given the latest attempt by the Georgia legislature to provide blanket immunity from liability to the pharmaceutical industry in certain circumstances where a product has received FDA approval. In addition to this most recent report, the FDA's failure to fulfill its mandate to protect the public has been well documented.

Contributed by John D. Hadden
Turkheimer & Hadden, LLC

Friday, February 13, 2009

Legislative Days 17 and 18

Newspaper articles and blogs around the nation are starting to take interest in the Governor's tort deform legislation, SB 101 and SB 108. There is a great post on The PopTart examining this legislative effort and what happened in Michigan, the only state to pass a similar bill to SB 101. The bill didn't bring jobs to Michigan-- and it didn't stop jobs from leaving the state either. All it did was bar a citizen in Michigan who was injured or killed by a pharmaceutical company from seeking justice in a fair court of law.

On Thursday, the Senate Health and Human Services Committee heard testimony and voted on SB 133, an expansion of the Georgia Health Share Volunteers in Medicine Act. This bill would allow nurses, doctors, dentists, etc. to all receive payment in a health clinic and still be immune from liability as long as the patients are poor and receive the care for free.

I understand wanting to reward medical professionals for working in a safety-net clinic. In fact, the GTLA team came up with many ways to reward such a professional. But the committee didn't seem interested in alternatives.

In order to reward a doctor, why must we punish the patient?

Fundamentally, it just seems wrong. Stripping people just above the federal poverty of the Constitutional Rights is unjust.

We will be back in session next Tuesday for Day 19...

Tuesday, February 10, 2009

Legislative Day 16 of the Georgia General Assembly

This week the legislature will only be in session Tuesday- Thursday. A resolution was passed today setting the schedule through Day 35. Day 35 will land on March 25. They will be in session for 3 days of the week until then. Mondays will be a big day for committee meetings and Fridays will primarily be budget days.

Day 36 will be in late June.

So much is dependent on the Federal Stimulus Bill. I suppose we all will be waiting to see what happens.
From the Daily-Citizen:

The Georgia General Session may be extended until June.

Lawmakers agreed to meet three days a week — Tuesday through Thursday, with committee hearings on Mondays and Fridays — until March 25. They plan to recess then and come back into session in June and try to finish the 2010 budget before the start of the next fiscal year on July 1.

Legislators want to learn if any funds from the federal stimulus bill are headed the state's way.

Friday, February 6, 2009

Legislative Days 14 and 15

Yesterday the Governor's so-called "tort reform" package made it into the Hopper. The press releases sent by GTLA are in the posts below.

Today, the bills were read for the first time and assigned to committee. Both pieces went to the Senate Special Judiciary Committee. The author, Senator Bill Cowsert and co-signer Senator Judson Hill are both on the committee. The Chairman of the Senate Special Judiciary Committee, Senator John Wiles, also signed the bill.

It wasn't until later today that the Governor released his press release regarding these bills. He still argues that these bills would be good for business.

Michigan, the only state to pass a bill like SB 101, did not reap business rewards. Not only did their bill fail to bring new business into the state, Michigan actually lost business and jobs.

Thursday, February 5, 2009

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

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

Atlanta, GA-- With the introduction of SB 101, 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 Phenix 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."

“SB 101 gives negligent companies, who hurt or harm citizens of this state a ‘Get out of Jail Free’ card for the real world,” said Childers. “It’s clear to me where the Governor’s priorities are. He’d rather grant favors to big corporations than ensure the Constitutional Rights of the people of Georgia. Let’s hope the Legislature doesn’t agree.”


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

MEDIA RELEASE: Enacting ‘Victim Pays’ would be like taking away David’s Slingshot

SB 108 would allow intimidation and fear to rule our court of law

Atlanta, GA—SB 108, a component of Governor Perdue’s so-called “tort reform” package, seeks to enact a ‘Victim Pays’ provision in Georgia law. Current law dictates that each party in a lawsuit pays its own attorney fees unless specific authority is granted by statute or contract allowing for the assessment of those fees against the other party. This provision is known as the ‘American Rule.’ This uniquely American method distinguishes our Civil Justice System from that of much of Europe which still operates under ‘The English Rule.’

The American Civil Justice System was based on the premise that individuals and small businesses, regardless of their financial means, have the right to seek justice for wrongdoing in a court of law that views each party as completely equal. As our Civil Justice System has matured, the American Rule has been championed as a unique equalizer — it does not discourage a person of little-to-no means from pursuing a meritorious claim — whereas ‘Victim Pays’ acts as a deterrent to individuals harmed through no fault of their own by the negligence of others.

“Governor Perdue has used the term ‘Loser Pays’ to label this provision. Yet nothing could be further from the truth” said Fred Orr, President of the Georgia Trial Lawyers Association. “This provision only affects one party in the suit — the plaintiff. If a large corporate defendant loses a claim, they will never have to pay for the victim’s legal fees under this bill, despite how baseless their defenses were.”

“SB 108 as it is written will harm middle class Georgians and small businesses the most,” said Atlanta attorney Darren Penn. “The very rich can afford legal fees and poor plaintiffs, as a practical matter, will not have to pay either. But, your traditional ‘mom and pop’ businesses and regular middle class Georgians could be bankrupted by the steep fees corporate defense attorneys charge.”

Besides creating real fear and intimidation for Georgians who wish to file suit, SB 108 fails to do much else that isn’t already covered by Georgia law. Besides having sanctions against “frivolous” lawsuits in both state and federal courts already in place, our current ‘American Rule’ operates under a contingency fee system — a natural deterrent against claims with little-to-no merit. Under the contingency fee system, the plaintiff’s lawyer carefully reviews a potential case to decide if he or she will take the case. The attorney fronts the entire cost of pursuing the case out of his or her own pocket — receiving no payment from the client. Both the client and the attorney only get paid if they win in court. In the business world, such expenditures are called ‘research and development.” Just as no business is going to spend money researching and developing a product they know to be worthless, no wise attorney would risk their money and their practice by pursuing a “frivolous” claim in court. The personal financial risk would be too high. SB 108 does nothing to improve that situation and is not needed.

“SB 108 is a procedural “gotcha” that will discourage attempts to resolve technical deficiencies in legitimate claims and will encourage gamesmanship and manipulation of the legal system by corporate defendants, rather than facilitating appropriate resolution of disputes between parties,” stated Penn. “Enacting SB 108 is like taking away David’s slingshot. The party with more money, more power and more control will have the ability to scare David into not taking a shot at all, even when David has a righteous cause.”


Wednesday, February 4, 2009

Day 13 of the Legislative Session

The Governor's so-called "tort reform" bills made it to the Senate Hopper today.

SB 101 provides complete immunity for pharmaceutical companies located within Georgia who manufacture drugs and medical devices-- even if the drugs and devices kill Georgia's citizens-- as long as those drugs and medical devices are approved by the FDA.

SB 108 would enact a Victim Pays provision in Georgia. It would require that a person, who was harmed through no fault of their own and then files suit to seek justice, pay the attorneys' fees of the defendant if the person's case were dismissed for any variety of reasons at the beginning of the process.

GTLA is opposed to both provisions.

Tuesday, February 3, 2009

Days 11 and 12 of the Legislative Session

This week has certainly picked up speed. Committees are in full swing and there are several pieces of legislation being passed by both Chambers.

On Tuesday, Senator Don Thomas' SB 5, seatbelts in pick-up trucks, passed the Senate Judiciary Committee.

Also on Tuesday, the AJC printed a "Pro" and a "Con" guest column regarding the Governor's tort reform package. Interestingly, the Pro was not written by a person in Georgia, but rather the Director of the American Justice Partnership, Dan Pero, of Lansing Michigan.

So the Macon Telegraph printed a supporting piece written by someone in San Francisco. And the AJC has printed a supporting piece written by someone in Michigan.

It seems evident, at this point, that there are some national interests pushing the Governor's legislation.

GTLA's President, Fred Orr, responded to Mr. Pero's column with the following Letter to the Editor:

In a guest column printed on 2/3/09, Dan Pero, President of the American Justice Partnership (AJP), commends our Governor for proposing new ‘tort reform’ measures while he distorts the truth about the intention and effect of the legislation.

The AJP was created by the National Manufacturers Association (NMA) to enact tort reform at the state level. It’s a front group for big business and corporate greed. Mr. Pero doesn’t even live in Georgia, he lives in Michigan—a state that passed similar legislation in 1995 under Governor John Engler, who is now the President of NAM.

Mr. Pero fails to report that Michigan, after passing similar legislation, is facing a disastrous economic crisis. Also, he misrepresents the Georgia Trial Lawyers Association’s (GTLA) position. GTLA opposes the Governor’s so-called “tort reform” package because large corporations do not deserve special rights— period.

The citizens of Georgia know what’s best for Georgia. We don’t need some talking head in Michigan, a ‘tort reform’ front group, or a corrupted federal bureaucracy to tell us what to do. Let’s keep the rhetoric out of the debate and instead focus on what the Constitution provides for—a government that protects the rights of its people, not the financial interests of a few.

Fred Orr
President of the Georgia Trial Lawyers Association

Hypocrisy of attacks on consumers

The efforts being made by tort reformers to make it harder for citizens to stand up for their rights is part of a larger attack on the health and safety of all consumers. Consumers are under attack by large business interests, and tort reform is just one battleground. Others are in the health care and financial arenas. In order to see the hypocrisy of these 'reformers,' it is necessary to look no further than the AJC.

For example, an AJC article last week reported that both of Georgia's Senators were among the 32 Republicans who just voted against the bill to expand health insurance coverage to 4 million children who are presently uninsured. The estimated cost of that legislation is $32 billion over the next 4-1/2 years, or around $7 billion per year. Yet in the same issue of the AJC, it was reported in another article that banking executives had paid themselves $18 billion in bonuses over the past year -- using funds from the massive financial industry bailout that was supported by the same Georgia Senators. What is more important, $7 billion to provide health care for 4 million American, or $18 billion to make rich bankers even richer?

The week before, the AJC reported that a four-year study by the GAO revealed woeful deficiencies in the FDA's review process for approval of medical devices. The article stated that 228 medical devices had been approved by the FDA without adequate review, and reported that “the FDA acknowledged the problem.” But in the same issue of the AJC, there was an editorial by columnist Jim Wooten supporting Governor Perdue's proposal to immunize companies from lawsuits over deaths and injuries caused by FDA-approved drugs and medical devices which may be dangerous despite being rubber-stamped by FDA bureaucrats. Peanuts, anyone?