Savannah DMAA lawsuit news February 2012

A class action claims Florida-based BPI Sports' bodybuilding and dietary supplements "contain a dangerous amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects."
 
 BPI's best selling products include '1.M.R' powder and tablets, 'RoxyLean ECA' and 'Rx6' (collectively, the 'products.') These products are purported dietary supplements which are marketed for use as bodybuilding and weight loss supplements. 1.M.R is marketed as a pre-workout bodybuilding supplement. RoxyLean and Rx6 are marketed as 'fat burning' weight loss supplements.

"DMAA was patented by Eli Lilly & Company in 1944 and later marketed, beginning in 1971, under the trademark 'Forthane' for use as a nasal decongestant and as a treatment for hypertrophied or hyperplasic oral tissues. DMAA is a vasoconstrictor and central nervous system stimulant which is on the World Anti-Doping Agency ('WADA') and Major League Baseball ('MLB') lists of banned substances. The sale of DMAA is totally prohibited in Canada and New Zealand. Recently, DMAA has gained popularity with young people as a designer drug used in 'party pills.'

     "BPI failed to inform consumers that DMAA is a dangerous central nervous system stimulant which is banned by WADA, MLB, Canada and New Zealand, and that using the products can cause consumers to test positive for an illegal substance and/or amphetamine use., says the lawsuit.

     Here are the defendants: BPI Sports LLC, BPI Sports Holdings Inc., Brian Pharma II LLC, and BPI principals Derek Ettinger and James Grage.

     

Savannah DMAA Supplement Lawsuit News 2/6/2012

The Department of Defense temporary halted the sales of products containing 1,3-dimethylamylamine (DMAA) within military facilities after recent reports showed two soldier deaths and additional adverse health effects in other service members may be related to use of the dietary supplements.



The Department of Defense's moratorium will remain in effect pending further review of relevant scientific evidence and reported events.

The Assistant Secretary of Defense for Health Affairs Jonathan Woodson asked the surgeons general of the military services to conduct a review of available scientific evidence and adverse event reports (AERs) to better understand any potential relationship between DMAA and these events.

DMAA has been cited in a class action lawsuit claims bodybuilding and supplements from Florida-based BPI Sports contained undisclosed 1,3-dimethylamylamine (DMAA), an amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects, according to the suit.



The plaintiffs seek restitution and class damages for consumer law violations, unfair competition, false and misleading advertising, breach of express warranty and breach of implied warranty.
DMAA is banned by several athletic organizations, including the World Anti-Doping Agency and Major League Baseball. It is illegal to sell in many countries, including Canada and New Zealand. The lawsuit says the ingredient is supposedly derived from the oil of the geranium plant. DMAA, also known as Methylhexanamine and Geranainine, is a vasoconstrictor and central nervous system stimulant.

 http://www.naturalproductsinsider.com/news/2011/11/lawsuit-claims-supplement-contained-dmaa.aspx

.FDA Issues Warning About Lymphoma Drug Brentuximab

The US Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).

Two new cases of progressive multifocal leukoencephalopathy (PML), which is a rare but serious brain infection, have been reported. Because of the seriousness of PML, which can result in death, a new boxed warning highlighting this risk has been added to the drug label, according to the FDA.

In addition, a contraindication was added, warning against the use of brentuximab with the cancer drug bleomycin because of the increased risk for pulmonary toxicity.

Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.

The signs and symptoms of PML can develop over the course of several weeks or months. They can include changes in mood or usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech, or walking; and decreased strength or weakness on one side of the body, the FDA says.

Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.

Brentuximab generated much excitement among experts when study results were presented at the American Society of Hematology annual meeting in 2010. Some of the responses seen in refractory lymphoma were described as "amazing." The new drug is the first to be approved by the FDA for Hodgkin's lymphoma in more than 30 years, the company said.

Lawyers: Why I follow (some of) you on Twitter

Image via CrunchBase

Ours is a personal injury practice with a national approach. In our offices, we not only have attorneys licensed in three states, but we litigate across the country.

On Twitter for one of our accounts we have taken a deliberate approach to following certain types of attorneys. We have compiled a list of lawyers by state and by specialty. For specialties, I follow attorneys in these areas: Criminal law, family law, estates, transactional, and immigration. I don't spend much time seeking out or searching for IP lawyers (unless they are interesting) or construction.

Why do I follow in those areas at all? Because our office now is actively involved in litigation in multiple Multi District Litigation matters involving unsafe/recalled products across the country. We are not limited to the south in our practice, and of the many people we represent, on average (we keep records) we have current clients asking about 30-50 times a month law questions other areas of law we don't practice, as well as in states we are not licensed in. 

So, if you wonder why one of us decides to follow you now some of you know.








       

Yaz News for Savannah and South Georgia for December 2011

Image via Wikipedia

After hours of circular debate about the safety of this family of oral contraceptives, 15 of the FDA's 26 expert advisors voted that the benefits of these birth control pills outweigh the risk of dangerous blood clots.

But that's no tub-thumping victory for Bayer. It created this family of contraceptives, which now includes Beyaz and Safyral. They contain a hormone called drospirenonethat's found in none of the other two dozen or so birth control pills available to American women.

And many who voted in favor of Bayer's drugs expressed serious reservations because of the risks. "I voted yes, but it was a difficult vote," said Sean Hennessy of the University of Pennsylvania. "I think the drug probably ought to be rarely used."

Underscoring those doubts, 21 of the 26 panelists voted for strengthening the warnings on labels of Bayer's contraceptives to reflect the findings of seven studies that the company's team had spent much of the day trying to discredit.

One of the seven was a 835,000-woman study commissioned by the FDA; it found about a two-fold increase in blood clots for Bayer's pills compared to competitors' products.

Nobody's completely satisfied with the quality of the evidence on the safety of Bayer's contraceptives containing drospirenone.

But many pointed out that the studies Bayer relies on most to argue for the drugs' safety were paid for by the company. Bayer makes a bundle on its contraceptives, although U.S. sales have fallen sharply since doubts began to be raised in 2009.

Savannah Attorney makes his case to the City

Image by bjepson via Flickr

Attorney Howard Spiva was supposed to be speaking to City Council at a Thursday morning workshop about whether the city was failing to properly trim and maintain trees and whether that was putting the city at risk for increased injury claims.

Spiva represents Shanta Greene, 29, who filed a claim against the city after she lost her right leg and suffered other crushing injuries in July 2010. A massive tree branch fell and impaled her in the passenger side of a pickup as it headed along Bee Road at 42nd Street. Spiva began his presentation showing television coverage of the accident and her recovery.

“Once I saw the outline, I knew I had been bamboozled,” Johnson said. “What we got was a full-fledged court presentation ... designed to sensationalize the injury and invoke sympathy. I hope that I have not jeopardized the city’s position.”

Spiva says he told city officials from the beginning he wanted to talk about an injury claim. He asked council to direct its attorney and Risk Management staff to negotiate a settlement rather than risk losing a jury verdict that could cost the city substantially more.

Greene has had more than 40 surgeries. Spiva said she has incurred more than $760,000 in medical expenses and seeks at least $2 million more for future medical costs and loss of income. The city has denied her claim.

“Either meet to mediate,” Spiva said, “or we file suit and the war begins.”

When Greene later was wheeled into the room, council members were clearly uncertain about whether to acknowledge her. Alderwoman Mary Osborne shook Greene’s hand and spoke to her, and others eventually mumbled condolences. Johnson turned away in his chair, which, Greene said, offended her.

“I went in there as the victim” she said. “I felt like the enemy. (The mayor) just turned around like I was nothing. And I voted for him.”

With cameras trained on him while asked about it later, Johnson was dignified, but clearly angered by the implication he had no sympathy for Greene.

“Of course I feel sympathy for her,” he snapped. “She has suffered a catastrophic injury that has changed her life forever. The conflict I felt was how do I express sympathy for her while still maintaining responsibility for this city and its purse strings?”

Johnson tried to call a halt about halfway through Spiva’s presentation, saying he wanted to seek an opinion from City Attorney James Blackburn. The presentation was far different than he anticipated, he said.

On Blackburn’s advice, and with Spiva demanding the right to continue, Johnson allowed the last part of Spiva’s presentation. In it, Spiva showed city records that he says proves the city had prior knowledge of the rot and damage to the tree. City records also show, he said, the city had been called out previously to deal with rotting limbs from the tree.

Cooper Lens and Avaira Lens Recall Georgia and Florida

Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.

CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company’s Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.

The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.

As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.

Dozens of Avaira Toric users reported problems ranging from hazy vision and pain to severe injuries, including torn corneas, which required emergency medical treatment. Company officials were accused of issuing a “stealth recall” in August that left many consumers unaware of the problem.

Company officials noted that no product lines other than Avaira Toric and Avaira Sphere use silicone oil to manufacture the products. The firm expects to set aside a reserve of $9 million for the costs of the expanded recall. All told, the company expects to spend $23.2 million on the Avaira recalls, according to the press release.

Consumers with problems or questions related to the recalls should contact the company at 1-855-526-6737. The firm says it has reached out to affected consumers to ensure their safety.

Defective Contact Lens Lawsuit

If you or a loved one have suffered or been injured by defective CooperVision Avaira Contact Lenses you may be entitled to compensation and justice. Call Us 404-451-7781