U.S. Supreme Court: A Victory for Consumers

The Supreme Court on Wednesday issued its decision in the much-watched case of Wyeth v. Levine—the underlying lawsuit that inspired it is based on a fairly simple idea: Diana Levine was severely injured when she was given Wyeth’s Phenergan by a physician’s assistant who was attempting to inject the drug directly into the vein but instead either got it into the artery or injected it in such a way that it leaked out of the vein (”perivascular extravasation”) and mixed with arterial blood.

The Court held that the labeling approval by the FDA does not preempt state laws or shield companies from legal damages as part of liability claims.


From the opinion, the Supreme Court noted what many saw as a practical reality about the FDA:

"The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for post marketing drug safety work are especially inadequate and that resource limitations have hobbled the agency’s ability to improve and expand this essential component of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Post market Decision-making and Oversight Process 5 (GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf."

"The FDA lacks a clear and effective process for making decisions about, and providing management oversight of, post market safety issues."

Mcdonald's Coffee Case

THE MCDONALD'S SCALDING COFFEE CASE- Have you seen the real facts?

Stella Liebeck of Albuquerque , New Mexico , was in the passenger seat of her grandson's car when she was severely burned by McDonald's coffee in February 1992. Liebeck, now 81, ordered coffee that was served in a styrofoam cup at the drive-through window of a local McDonald's.

After receiving the order, the grandson pulled his car forward and stopped momentarily so that Liebeck could add cream and sugar to her coffee. (Critics of civil justice, who have pounced on this case, often charge that Liebeck was driving the car or that the vehicle was in motion when she spilled the coffee; neither is true.) Liebeck placed the cup between her knees and attempted to remove the plastic lid from the cup. As she removed the lid, the entire contents of the cup spilled into her lap.

The sweatpants Liebeck was wearing absorbed the coffee and held it next to her skin. A vascular surgeon determined that Liebeck suffered full thickness burns (or third-degree burns) over 6 percent of her body, including her inner thighs, perineum, buttocks, and genital and groin areas. She was hospitalized for eight days, during which time she underwent skin grafting. Liebeck, who also underwent debridement treatments, sought to settle her claim for $20,000, but McDonald's refused.

During discovery, McDonald's produced documents showing more than 700 claims by people burned by its coffee between 1982 and 1992. Some claims involved third-degree burns substantially similar to Liebeck's. This history documented McDonald's knowledge about the extent and nature of this hazard.

McDonald's also said during discovery that, based on a consultant's advice, it held its coffee at between 180 and 190 degrees fahrenheit to maintain optimum taste. He admitted that he had not evaluated the safety ramifications at this temperature. Other establishments sell coffee at substantially lower temperatures, and coffee served at home is generally 135 to 140 degrees.

Further, McDonald's quality assurance manager testified that the company actively enforces a requirement that coffee be held in the pot at 185 degrees, plus or minus five degrees. He also testified that a burn hazard exists with any food substance served at 140 degree or above, and that McDonald's coffee, at the temperature at which it was poured into styrofoam cups, was not fit for consumption because it would burn the mouth and throat. The quality assurance manager admitted that burns would occur, but testified that McDonald's had no intention of reducing the "holding temperature" of its coffee.

Plaintiff's expert, a scholar in thermodynamics as applied to human skin burns, testified that liquids, at 180 degrees, will cause a full thickness burn to human skin in two to seven seconds. Other testimony showed that as the temperature decreases toward 155 degrees, the extent of the burn relative to that temperature decreases exponentially. Thus, if Liebeck's spill had involved coffee at 155 degrees, the liquid would have cooled and given her time to avoid a serious burn.

McDonald's asserted that customers buy coffee on their way to work or home, intending to consume it there. However, the company's own research showed that customers intend to consume the coffee immediately while driving. McDonald's also argued that consumers know coffee is hot and that its customers want it that way. The company admitted its customers were unaware that they could suffer third- degree burns from the coffee and that a statement on the side of the cup was not a "warning" but a "reminder" since the location of the writing would not warn customers of the hazard.

The jury awarded Liebeck $200,000 in compensatory damages. This amount was reduced to $160,000 because the jury found Liebeck 20 percent at fault in the spill. The jury also awarded Liebeck $2.7 million in punitive damages, which equals about two days of McDonald's coffee sales.

Post-verdict investigation found that the temperature of coffee at the local Albuquerque McDonald's had dropped to 158 degrees fahrenheit. The trial court subsequently reduced the punitive award to $480,000 -- or three times compensatory damages -- even though the judge called McDonald's conduct reckless, callous and willful. Subsequent to remittitur, the parties entered a post-verdict settlement.

Legislative Days 25 and 26

The biggest news over these past two legislative days had to be the death of HB 200 on the House Floor. HB 200 would have allowed for the failure to wear a seatbelt to be admissible in civil cases. Together, GTLA and the Georgia Chamber of Commerce worked to hammer out a compromise that both parties could support.

The bill was introduced from the well and questions were answered. Representatives began to question why a victim in a car accident would be revictimized in a court of law. Momentum began to build against the bill.

The Speaker of the House called for the vote and the bill failed 15-143.

SB 108, the Victim Pays provision of the Governor's Tort Reform Package passed the Senate Special Judiciary Committee as well. The orgiginal language was replaced with the language found in HB 414. SB 108 no longer contains the Victim Pays provision, but it does allow for a Stay of Discovery.

FDA Only Investigates 96 of 188,000+ Food Processing Plants

I know what you are thinking - that stat simply cannot be correct. The FDA, the entity created to guard the gates for the public when it comes to food, product, and device safety, has only investigated about 100 food processing plants of the nearly 200,000 food processing plants that in some manner bring food into our homes?

It is. That's .0005% of all such facilities.

The FDA is badly broken. The only thing more discouraging (if that is possible) than the numbers cited above? Some folks think the FDA is doing a bang up job. If the FDA guards the public, who is guarding the guards?

Read more here.

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.

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

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...

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.

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.