Montgomery Personal Injury Lawyer

Roof strength standard update on hold until Oct. 1

Scott Thomas — Fri, 05 Sep 2008 17:39:06 GMT

The National Highway Traffic Safety Administration (NHTSA) was scheduled to release its amended and upgraded federal standard on vehicle roof strength requirements July 1. However, after input from a U.S. Senate hearing on June 4 that featured testimony from groups such as the People Safe in Rollovers Foundation, and which called for the proposal to be significantly strengthened, the NHTSA has delayed its announcement of the final roof strength standard to Oct. 1.

The original NHTSA proposal would upgrade the Federal Motor Vehicle Saftey Standard No. 216, extending coverage to vehicles with gross weight ratings up to 10,000 pounds, and requiring a roof withstand an applied force equal to 2.5 times the vehicle's weight while still maintaining sufficient headroom for an average adult male.

The upgrade would for the first time regulate the roof strength of many SUVs and pickup trucks, many of which are currently exempt under a 6,000-pound standard. The current requirement for roof strength is that a roof withstand applied force equal to only 1.5 times the vehicle's weight.

However, despite the suggested increases, research and consumer groups objected to the NHTSA proposal, saying the suggested new standard is still not tough enough to protect drivers and passengers. They call for a standard that would increase roof strength to withstand at least 3.5 times the vehicle's weight.

Results of a 2008 study by the Insurance Institute for Highway Safety, a nonprofit research and communications organization, supports the call for a stronger standard. The study found that occupants in vehicles that meet the current strength requirements by a narrow margin have elevated injury risks compared to occupants in vehicles with stronger roofs. The IIHS estimates that a standard requiring roof strength to increase to a level of 3 or 3.5 times the vehicle's weight would save hundereds of lives each year.

Originally posted at InjuryBoard by Scott Thomas

Vytorin and cancer: real threat?

Tom Methvin — Wed, 03 Sep 2008 17:35:36 GMT

Vytorin, manufactured by Merck & Co. and Schering-Plough was introduced as the newest weapon in the fight against "bad" cholesterol. But last week the U.S. Food and Drug Administration dealt another blow that strengthens the argument that perhaps it's the drug that's bad, when it linked Vytorin use to an increased risk of cancer.

Vytorin, a combination of Merck's Zocor (simvastatin), and Schering-Plough's Zetia (ezetimibe), began taking hits in December 2007, when the FDA reported that the combination of Zetia and statin drugs, like Zocor, can increase the risk of liver damage and disease.

Then, in February 2008, the results of the drug manufacturers' ENHANCE study, which were delayed for two years after the study's April 2006 completion, pointed to the fact that Vytorin showed no significant benefit in slowing arterial plaque buildup. In fact, the study showed that patients taking Vytorin might actually have more plaque growth than patients taking only a simvastatin.

Now, in the worst news yet for the drug, the FDA issued a MedWatch alert Aug. 21 to inform healthcare professionals that the agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial of a possible link between Vytorin use and the increased risk of cancer and cancer death.

The FDA announced there are 3 months left until completion of the final SEAS study report, and that it would need an additional 6 months after receiving that data to evaluate the clinical data and other relevant information. In the meantime, they are advising patients to continue taking Vytorin and consult with their physician.

The announcement of the possible Vytorin-cancer link caused controversy, with some experts arguing that the results of the SEAS study are incomplete and may be a fluke. However, Dr. Jeffrey Drazen, editor of The New England Journal of Medicine, warned that the implications should not be "brushed aside," according to a report by USA Today released this morning.

Dr. Drazen, along with four other editors, including two statisticians, published an editorial in the NEJM skeptical abut the safety of Vytorin and saying that it has raised uncertainty among physicians and patients.

According to the USA Today article, researchers found evidence that patients who took Vytorin appear to have at least a 40 percent greater risk of dying from cancer than those who took a placebo.

The results of the SEAS trial, which involved 2,000 patients, are being compared to two other ezetimibe studies, SHARP and IMPROVE-IT, which are still ongoing, and which involve more than 10,000 patients combined.

Some researchers say that a definite answer about the connection between ezetimibe and cancer will not be known until those studies are complete in 2012, USA Today reports. However, other experts warn that it is just as impossible to rule out a link between the drug and cancer, according to the news report.

Originally posted at InjuryBoard by Tom Methvin

Eyes of the nation on Alabama AWP litigation

Jere Beasley — Tue, 02 Sep 2008 17:30:31 GMT

A landmark verdict was delivered in February 2008, when a state court jury awarded Alabama $215 million in its Average Wholesale Price (AWP) litigation / Medicaid Fraud litigation, against AstraZeneca PLC. Beasley Allen represented the State of Alabama.

Following on the heels of that verdict, Beasley Allen represented the state in the second of the AWP Medicaid fraud cases to go to trial, against two companies: GlaxoSmithKline and Novartis, in July 2008. After only five and a half hours of deliberation, the jury returned a verdict in favor of the state, holding the pharmaceutical companies responsible for $114 million in compensatory damage, the 13^th largest jury verdict in the U.S. so far this year.

These verdicts represented a significant win for the state in terms of dollars, of course, but the real impact of these cases is on the state's ongoing AWP litigation, which involves a total of 75 drug manufacturers. There are 69 companies still facing fraud charges.

And, perhaps even more important, the impact of these verdicts reaches beyond Alabama. There is AWP Medicaid Fraud litigation pending across the nation, with 22 states with pending AWP suits against the same 72 pharmaceutical companies involved in Alabama's litigation. There also is an AWP federal court multi-district litigation (MDL) pending in Boston.

What is AWP Litigation?

The basis of the AWP Litigation involves prices charged by pharmaceutical companies when selling drugs to individuals and agencies such as Medicaid. When a patient fills a prescription at a pharmacy, the patient's health plan reimburses the pharmacy for the cost of the drug based on the drug's AWP - average wholesale price. The AWP is a figure reported by the pharmaceutical company that is supposed to be associated with the average price at which pharmacies buy their drugs.

In this AWP Litigation, the states allege the drug companies falsified pricing information, charging Medicaid much higher rates for drugs than they charged retailers, some by as much as 1,000 percent.

False and inflated AWP figures for drugs provide greater financial incentives for pharmacies to buy and sell the drugs. Manipulating the average prices also provides higher sales revenue for the pharmaceutical companies, greater volume and market share for the drug companies and dramatically steeper drug costs for Medicaid and the State Health Plan.

Compensatory damages in the remaining cases in Alabama alone would total more than $1 billion, and punitive damages could be an additional $3 billion or more.

Originally posted at InjuryBoard by Jere Beasley

Getting ready for Gustav

Wendi Lewis — Thu, 28 Aug 2008 15:58:15 GMT

There's an unwelcome guest heading to the Gulf Coast this Labor Day holiday weekend, as Hurricane Gustav makes tracks past Jamaica and into the Gulf of Mexico. He's just a tropical storm right now, but the National Weather Service National Hurricane Center expects him to strengthen to hurricane strength as he approaches the Cayman Islands and continue to grow in the Gulf.

Because hurricane tracking is not an exact science, best guess currently has the entire Gulf Coast area from Texas to Florida on alert. A big storm doesn't just affect those who live along the beaches, either. Strong winds and flooding rains will move inland still carrying a good deal of force. Residents of states in the line of fire, like Alabama, are bracing for impact and preparing for a worst-case scenario.

In Fall 2007, the Alabama Department of Public Health unveiled a disaster preparedness campaign that helps provide planning information that will get people ahead of the game in the event of an emergency. Called the Get 10 campaign, the program promotes the 10 items everyone should prepare as a disaster readiness kit, and provides additional information and resources for emergency situations.

If you live in Alabama or another Gulf Coast state preparing for Gustav, this information can help you get ready. With landfall expected sometime Monday or Tuesday, the time to act is now. The 10 items recommended by ADPH are:

1. water
2. food
3. can opener
4. medications
5. first aid
6. flashlight
7. radio
8. clothes
9. personal care items (toiletries)
10. important documents

The Get 10 web site has additional information about preparing each of these items. Additionally, they recommend these 5 important things to do to be ready in the case of an emergency:

1. Stay informed. Learn about the emergency alert system and weather alerts.
2. Learn about basic injury and disease prevention.
3. Look for the most current information on emergency preparedness.
4. Create a family preparedness plan and emergency supply kit (the 10 items listed above)
5. Become familiar with the emergency plans of your community, school, caregivers and workplace.

Even if you do not live in an area that may be affected this weekend by Hurricane Gustav, these are good tips for any emergency. Be prepared, and be safe.

Originally posted at InjuryBoard by Wendi Lewis

Physicians say litigation helps ensure drug safety

Wendi Lewis — Mon, 18 Aug 2008 10:27:03 GMT

Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often "overwhelmed" by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a "key defense mechanism" to protect consumers by insuring drug safety and providing a method to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, "the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug's manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA's judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine's position, the AP report states.

Originally posted at InjuryBoard by Wendi Lewis

Loachapoka Motorcycle Accident Kills One

Shannon Weidemann — Wed, 23 Jul 2008 16:30:00 GMT

One person was killed and another injured in a motorcycle accident in Loachapoka. A car and motorcycle collided at Lee Road 4 and Lee Road 188. The motorcycle driver was killed after being thrown from his bike.

The victim

who appeared to be wearing a helmet, was thrown approximately 275 feet from his motorcycle from the the point of impact, the coroner said. He was traveling north on Lee Road 188 when he struck Bishop's southbound vehicle.

The victim died at the scene. The driver of the car was injured and taken to East Alabama Medical Center to be treated for injuries. Alabama State Troopers are investigating the accident and believe that speed may have been a factor. The victim was from Auburn.

Originally posted at InjuryBoard by Shannon Weidemann

Limestone County Motorcycle Accident Kills Man

Shannon Weidemann — Mon, 14 Jul 2008 21:28:12 GMT

A 57-year-old man was killed in a motorcycle accident last week in Limestone County, Alabama. He was a resident of Cullen and had just purchased the motorcycle that day. He was driving on an Interstate 65 offramp at the time of the accident.

According to Alabama State Trooper reports, the accident occurred at approximately 4:15 p.m. at the southbound Interstate 65 on-ramp from Interstate 565.

"He was coming off of the ramp, lost control of the motorcycle, hit the guard rail and was ejected from the motorcycle," West said.

He was wearing a motorcycle helmet. He fell about 20 feet after leaving the motorcycle. He died at the scene of the accident. The Alabama State Troopers are still investigating the accident. No other vehicles were involved.

Originally posted at InjuryBoard by Shannon Weidemann

Salmonella Focus Moves Away from Tomatoes

Shannon Weidemann — Wed, 09 Jul 2008 07:00:00 GMT

The large outbreak of Saintpaul Salmonella cases around the country was originally blamed on raw tomatoes. Investigators from the FDA and CDC have been unable to confirm that with testing of over 1,700 samples. Now they are looking into the possibility that the culprit may be another ingredient in fresh salsa.

Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention say it is premature to declare jalape�os the lead suspect and still list it with tomatoes, cilantro and serrano peppers as one of the common salsa ingredients under investigation. Officials have also stepped up testing of cilantro and serrano peppers, but "there is no specific 'prime suspect,' " FDA spokeswoman Stephanie Kwisnek said.

Over 900 people in 40 states have confirmed cases of salmonella poisoning. There may be more cases that were not reported. Salmonella causes diarrhea, vomiting, abdominal pains and fever. It is rarely fatal. Jalape�os are a top suspect because they have a longer growing season than tomatoes do and a bush may be picked several times over a long period. They also have a very long shelf life when refrigerated. The FDA has not issued a warning for jalape�os, cilantro or serrano peppers.

Originally posted at InjuryBoard by Shannon Weidemann

Macon County Car Accident Injures Six

Shannon Weidemann — Mon, 07 Jul 2008 16:53:00 GMT

A holiday weekend car accident on Interstate 85 in Macon County injured six people on Sunday. They were all in a single vehicle headed north when the accident occured. No other vehicles were involved in the accident.

State Troopers say the driver lost control and ran into the median. All six people were in the same vehicle. Two of them were "seriously" injured, but their wounds do not appear to be life threatening.

Two of the victims were airlifted to a local hospital to be treated for their injuries. It is unknown what caused the car accident. Alabama State Troopers are still investigating the accident and no charges have been filed. The interstate was closed in both directions while the victims were being tended to and the accident scene was cleaned up.

Originally posted at InjuryBoard by Shannon Weidemann

Alabama gives pharmaceutical companies 30 days to settle

Wendi Lewis — Thu, 03 Jul 2008 15:47:45 GMT

Alabama Attorney General Troy King has put 69 pharmaceutical companies accused of defrauding Alabama's Medicaid system on notice they have 30 days to settle or be brought to trial. The deadline was announced to the public this morning by Jere Beasley, founding shareholder of Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., headquartered in Montgomery, Ala.

Beasley Allen represents the State of Alabama in a series of cases against a total of 72 pharmaceutical companies. Three of the companies already have gone to trial, one in February and two in June, with juries in both trials finding in favor of the State, awarding a total of $329 million. There are 69 companies left facing charges of fraud. The State alleges the drug companies falsified pricing information, charging Medicaid much higher rates for drugs than they charged retailers, some by as much as 1,000 percent.

In addition to Alabama, 22 other states have filed lawsuits against the 72 pharmaceutical companies, alleging similar Medicaid fraud.

Representatives from AARP and Alabama Arise spoke out in favor of the State's action against the drug companies, saying the issue is a matter of life and death, because Medicaid fraud impacts the ability of agencies that rely on the system to effectively serve Alabama's elderly and low-income citizens.

A video of the full news conference is available for viewing online.

Originally posted at InjuryBoard by Wendi Lewis