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Farah and Farah, P.A.10 W. Adams Street Jacksonville, FL 32202 Phone: (800) 670-1464
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Bayer Healthcare is promoting a new birth control pill that promises to be an improvement over its former blockbuster, Yaz. If the thousands of product liability lawsuits filed against Yaz are any indication of what’s to come, that is not promising much.
The new pill is called Natazia. It contains a form of estrogen never before used in an oral contraceptive.
Bayer was known to make many far reaching promises in its ads for Yaz. After the birth control pill was marketed in 2006, it quickly became a best seller bringing Bayer $800 million in profits last year. The Jacksonville Yaz side effect attorneys at Farah & Farah are representing women in product liability cases who have been injured by the contraceptive’s dangerous side effects such as blood clots.
Like Natazia, Yaz was also a new chemical formulation and was promoted for multiple purposes. Brightly colored balloons in the commercial promised women would be able to say goodbye to headaches, a bad complexion, muscle aches, acne bloating, an increased appetite, and feeling anxious and moody. NPR quotes Ruth Day of Duke University, a professor who advises the FDA as saying that she has never seen an ad that makes such sweeping claims.
The FDA said the ads were misleading and the agency ordered Bayer to run a corrective commercial. But the original ad was effective.
And the side effects were profound. Women who took Yaz and a similar pill, Yasmin, suffered a 64% higher risk of blood clots than those women taking pills that were developed decades earlier, according to research published in the British Medical Journal. Bayer disagrees with the findings.
NPR reports that there are 2,700 women suing Bayer over Yaz. Not surprisingly, sales have dropped so Bayer is launching its new birth control pill.
Warning- Natazia has only been tested on 3,000 women pre-market and contains hormone combinations never used before. Does this sound familiar?

In China, when an executive of a major company is found to have a manufacturing problem that results in consumer deaths, the executive may turn to suicide. That’s not the case here in the U.S. where executives regularly flaunt health and safety regulations to the detriment of the public. Regulators at the U.S. Food and Drug Administration have generally been the passive tail being wagged by the corporate dog, but there seems to be a groundswell within the agency to change the way it does business.
High profile recalls are prompting the change, along with new leadership that has vowed it will not be business as usual and criminal charges may be in order.
CNN reports FDA Commissioner Margaret Hamburg wrote to Sen. Chuck Grassley, R-Iowa, in March to say that the agency intends to consider “the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officials accountable.”
For example, the recent series of pharmaceutical recalls of Tylenol and children’s cold and allergy over-the-counter medications, made by McNeil, a subsidiary of Johnson & Johnson, may be the first to fall under the ax.
The FDA would pursue criminal convictions for violations of the federal Food, Drug and Cosmetic Act against executives who knew or should have known about manufacturing problems that threaten public safety.
In the case of J & J, the children’s Tylenol plant in Pennsylvania was found to have multiple violations including bacterial contamination, an open roof, and inconsistent formulations. The plant is still closed. Many children reportedly were sickened.
The problem has been the “get government off our backs” attitude of industry and a compliant federal leadership. With corporations setting their own rules, FDA enforcement and inspections dropped. CNN reports there were 600 criminal prosecutions against companies in 1939. By 1989 that number had dropped to 16.
Things seem to be changing. In 2009, there were more than 1,742 drug recalls and 684 food recalls in 2010. Food recalls also come under the umbrella of the FDA.
The message is clear to industry – clean up your act or you could go to jail. A felony conviction could result in a $10,000 fine and up to three years in prison.
Since the FDA is funded by our tax dollars and it in charge of protecting the public, shouldn’t we have insisted on this all along?

A newlywed couple was in a single-vehicle crash Saturday, August 21, that left the husband dead and the wife seriously injured, a St. Petersburg Times article reported.
The accident happened in Brooksville, Florida, just before noon. Daryl and Tiffany Snyder were driving their 2003 Chevrolet S-10 pickup truck eastbound on Powell Road. It was raining. The truck began to rotate counter-clockwise before it ran off the road and onto the shoulder, according to the Florida Highway Patrol.
That is where it struck a tree. Daryl, 20, was not wearing a seat belt and was ejected from the driver’s seat. Tiffany, 21, was wearing a seat belt, but received serious injuries. She was taken to Brooksville Regional Hospital.
The couple married in Brooksville on July 30.
Our sincere condolences go out to the family of Mr. Snyder. As is often the case with the comments following these stories, some insensitive people speculate he may have been drinking, but others insist he did not drink. The FHP says it was raining and the road was slick where the accident happened.
Seat Belt Usage
Florida drivers are doing a better job buckling up these days. Whether it is the new law that makes it mandatory, or the Click It or Ticket Campaign, for the first time, Florida drivers have a statewide seat belt use record of 85.2%.
The national seat belt use for 2009 is 84%.
Defective Product
The other possibility is that his seat belt could have been defective. Often this is a cause of injuries and death that is overlooked, as the assumption is that the seat belt will always work. When it does not, because the latch came undone, or the webbing broke, an individual can be ejected in an accident and suffer devastating head and brain injuries.
If you suspect part of your car may have failed and you suffered injuries as a result, the Florida auto product liability attorneys at Farah & Farah will be honored to consult with you on your accident.

Mazda has issued a recall of its 2007-2009 Mazda 3 and Mazda 5’s because of a steering problem.
The National Highway Traffic Safety Administration (NHTSA) says the loss to power assist in the steering can increase the risk of a crash. Mazda says the problem occurs when rust forms inside the high-pressure pipe on the power steering system and particles enter the power steering pump, causing it to shut down, reports the New York Times.
In the U.S., 215,000 vehicles will be recalled one year after Mazda began fixing a similar problem in vehicles in Japan.
Mazda says it was not receiving a large number of complaints in the U.S., so it adopted a “wait-and-see” attitude and instead issued a technical bulletin to dealers to tell them how to fix the problem.
However, the problems did not go away in the U.S. and last year the NHTSA received 33 complaints about power steering. It then began a safety investigation.
The problem with this wait-and-see attitude is that under law, automakers are supposed to alert federal auto regulators within five days after they know they have a problem. A failure to do so is what brought Toyota a record $16.4 million fine when it delayed reporting for four months concerning the sticky pedal defect.
Mazda could be facing the maximum fine for failing to promptly recall vehicles – $15 million. The Motor Vehicle Safety Act of 2010 is threatening with an even bigger stick – allowing the government to fine automakers up to $300 million for failing to promptly notifying the appropriate agency of a problem with a defective automobile.
No surprise, automakers are fighting that provision.
Florida auto product recall attorneys would like to remind you to be safe and if you experience this problem in your Mazda vehicle, contact your dealer to have it repaired right away.

The Centers for Disease Control and Prevention (CDC) is investigating a multi-state outbreak of two types of Salmonella – Baildon and Hartford. Both of these types of salmonella serotypes are rare. DNA is used to type the bacteria. Since mid-April, at least 155 people who have purchased food from Taco Bell locations in 21 states have become infected with Salmonella Hartford or Baildon, including one case in Georgia for each type of contamination.
Symptoms began between May 11, 2010 and July 19, 2010 and the median age is 47 years. Seventy-four percent of patients are female. Among the 68 patients with available hospitalization information, 27 (40%) were hospitalized, reports the CDC with no deaths reported.
When CDC investigators and public health officials talked to those affected they found one thing in common – indications are that eating at Taco Bell was associated with the illness. Although no specific food or ingredient has been identified as the culprit, symptoms have shown up at 22 different Taco Bell restaurants.
The company, owned by Yum Brands, should know better. In 2000, contaminated green onions were determined to be the source of food poisoning. In 2006, it was E. coli from lettuce that sickened many who ate at Taco Bell.
Symptoms of Salmonella poisoning usually begin up to 72 hours after consuming contaminated food. Fever, diarrhea, cramps, and vomiting can result. Reiter’s syndrome, which is a form of arthritis, meningitis, sepsis and death can result in some of the vulnerable population.
In the case of Taco Bell, it could be found legally responsible or liable to compensate those who have experienced a loss of income, medical expenses, and pain and suffering, among other damages. A Jacksonville personal injury attorney can help you understand your rights.

What could be worse behind the wheel than a drunk driver? How about a drunk driver also on caffeine? The drink in question is called Four Loko and if you haven’t heard of it, likely your college student or teen acquaintances have. It’s one of a handful of drinks aimed at mixing two types of highs at once.
Four Loko has an alcohol content of 12 percent. Consider that a beer has half or one-third of that. The 23.5 ounce colorful can also has a load of sugar. Similar drinks go by the name of Liquid Charge, Rockstar 21, and Torque.
In Florida, the drink made headlines recently when a 20-year-old driver was found to have mixed Four Loko with liquor and marijuana before driving through a red light in St. Petersburg, killing a family of four.
Popular Among the Young
The Food and Drug Administration (FDA) believes about 26 percent of college students have consumed these high-alcohol, high-caffeine drinks and it is considering a ban.
Last November, the FDA sent letters to 27 manufacturers asking for some explanation as to why the drinks should not be banned. While caffeine alone is considered safe and alcohol is lawful under certain circumstances, mixing alcohol and caffeine together in a product for sale is not legal unless it receives FDA approval.
So far, 19 of the drink makers have responded to the FDA. They may have an argument in that caffeine is added to some soft drinks in low concentrations of less than 200 parts per million.
Four Loko is made by Drink Four Brewing Company of Milwaukee and distributed by Phusion Projects. The company does not disclose the caffeine count, but similar energy drinks such as Monster contain 160 mg of caffeine, Amp contains 143 mg, Xenergy has 200 mg.
An eight ounce cup of coffee contains about 100 mg of caffeine.
Congress is involved as well and wants to know how the caffeinated alcohol drinks can be marketed in a way similar to energy drinks, with colorful large cans and on social media sites to customers who are under the drinking age of 21.
A company spokesman tells TBO.com that they work hard to make sure the product is sold to adults over the age of 21.
Fearing product liability lawsuits, Anheuser-Busch and MillerCoors stopped producing caffeinated alcohol drinks after attorney generals in several states accused them of marketing to underage drinkers. Smaller companies have since filled the niche.

Almost 4,000 product liability lawsuits have been settled between drug maker, AstraZeneca Plc, the maker of the antipsychotic drug, Seroquel, and consumers who claim that use of the drug caused weight gain and diabetes. Cases have been heard in state court while others have been consolidated in U.S. District Court in the Middle District of Florida in Orlando.
The settlements were reached through mediation and will be kept confidential. In March, AstraZeneca announced in a regulatory filing that more than 10,000 cases had been filed involving 22,500 plaintiffs who claimed the drug caused diabetes. Some of those cases had been dismissed over a lack of evidence.
The lawsuits claim that London-based AstraZeneca knew about the side effects of significant weight gain and diabetes but failed to include a warning in the drug’s label.
Even a 2003 study published in the American Journal of Psychiatry echoed the finding that Seroquel was linked to an increased risk of diabetes.
So far AstraZeneca has spent about $688 million defending Seroquel-related cases, reports Bloomberg. On average, plaintiff cases had been settled for about $10,000 each, which is an insignificant amount for a drug injury.
In a parallel action, the FDA is pursuing the company for failing to mention a link to diabetes in its promotional materials. Pharmalot reports the FDA sent a letter on July 29 to the company saying the risks were omitted while the efficacy of Seroquel’s slow release XR was overstated by promising patients would experience remission with the drug. In April, AstraZeneca paid the federal government $520 million to settle charges that it improperly marketed Seroquel for unapproved uses.
If you or a loved one has taken Seroquel and experienced side effects, you may have a product liability action against the drug maker for a failure to warn. Contact the experienced Florida defective drug attorneys at Farah and Farah for a consultation on your case.

Even people who don’t like lawyers or lawsuits have to appreciate what they sometimes can yield. When the plaintiff deposes the other side, in this case Toyota, it can find out all sorts of things that the company would rather keep secret, and that is good for the public interest.
In a class action filed in federal court in California, documents from inside Toyota reveal the automaker has been aware of the problem of sudden acceleration of its vehicles for at least six years, according to a Consumer Affairs report. From the news reports earlier this year and last about the cars suddenly accelerating and taking off with the driver, you would think from Toyota’s response that it had never before heard or known of such a problem.
The documents include a statement from a Toyota technician who looked at a case of unintended acceleration in 2003. He urged Toyota to take immediate action, calling the problem of a runaway car “extremely dangerous.” He also expressed fear that more cases could occur if Toyota did not intervene.
It was the August 2009 death of California Highway Patrolman Mark Saylor and his entire family in a runaway Lexus in San Diego six years later that awakened the public to the potential dangers of Toyota.
Toyota has responded by blaming over-sized floor mats placed too near the accelerator pedal in issuing a recall of 2007/2008 Lexus ES 350 and 2007/2008 Camry. Last November, Toyota said it would reshape the accelerator pedal on 3.8 million vehicles and the recall expanded in January.
Toyota says it has not found anything wrong with the electronics of the vehicles which many suspect is a defective product that commandeers the Toyota vehicles, giving the victims of sudden acceleration the feeling that they have no control over the vehicle.
If you or a family member has experienced unintended acceleration in a Toyota vehicle, the experienced Florida product recall attorneys at Farah and Farah would like to hear your story to help you find a solution.

Miracle Mineral Solution (MMS) is a liquid nutritional supplement that promises to treat diseases from the common cold to cancer. MMS is sold over the internet and online auctions by various independent distributors. Also known as “Miracle Mineral Supplement,” the Food and Drug Administration (FDA) has issued a warning to consumers not to take the product because it contains industrial bleach.
The bleach has been known to cause serious harm to consumers. The FDA has received several reports of injuries including life-threatening low blood pressure, dehydration, vomiting and severe nausea.
The MMS label tells consumers to mix the liquid, which is a 28 percent sodium chlorite solution, with some acidic drink such as orange juice. Instead of providing healthy benefits, the liquid produces chlorine dioxide. That is the same sort of bleach used commercially to strip textiles and in water treatment plants. Consuming quantities of this type of bleach can also cause nausea, vomiting, diarrhea, and dehydration.
Consumers are directed by the FDA to dispose of MMS and to report adverse events to the MedWatch program at www.fda.gov/medwatch/report.htm Or 800-FDA-1088. Consult with a physician if you experience any side effects.
Besides the obvious dangers, the FDA reports in a news release that there is no evidence MMS can treat a common cold, cancer, HIV, hepatitis, swine flu virus, or any other condition MMS claims to treat.
Under Florida law, manufacturers, sellers and distributors of products that pose a danger to users may be held responsible for a defective design or manufacture of a product under products liability or negligence law. If you or a loved one has purchased this product, and have been harmed you may have a product liability action against the manufacturer and you should contact a Florida product liability attorney right away.
The federal agency is also considering civil or criminal enforcement actions to protect the public.

This is bad news for kids. Perdue Farms has recalled about 92,000 pounds of frozen chicken nuggets, according to The Washington Post. The Great Value Fully Cooked Chicken Nuggets sold at Wal-Mart stores nationwide, are thought to be contaminated with plastic particles. Consumers were the first to find the blue plastic. There is no word where the plastic came from.
Perdue Farms, Inc. is located in Perry, Georgia.
The U.S. Agriculture Department’s Food Safety and Inspection Service (FSIS) issued the recall notice in a news release on July 19. Here is how the label reads on the recalled items:
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1-pound, 13-ounce bag of “GREAT VALUE Fully Cooked Chicken Nuggets.” Each bag bears the establishment number “P-33944” as well as a case code of “89008 A0160” on the backside of the packaging. There is also a “BEST IF USED BY” date of June 9, 2011.
FSIS says it has not received any reports of injury but if you find the blue plastic and/or consume it, contact a physician. Consumers should also look for this recalled food product in their freezer.
This is a Class II recall which means there is a “remote probability of adverse health consequences from the use of the product.” Class I is a recall issued for the most dangerous products that have the potential to lead to death. A Class III recall means the product will not cause any adverse health consequences.
Plastic in food sold to the public is a defective product and could be subject to a product liability lawsuit if a consumer is harmed. Consumers who want to contact Purdue directly should call Luis Luna, Vice President of Corporate Communications, at (410) 341-2533. Consumers with questions about the recall should contact Perdue Consumer Relations at (877) 727-3447. Consumers who have been harmed by a defective product should call the Florida product liability attorneys at Farah & Farah.
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