Jacksonville Personal Injury Lawyer - FDA & Prescription Drugs - Most Commented

Grandmother Blames Gardasil In Granddaughter's Death

Eddie Farah — Sun, 20 Sep 2009 23:30:29 GMT

Jessie Ericzon was 17-years-old and about to graduate from high school.

Like many girls her age, she was given the first of the three-shot series of Gardasil, the Merck drug that is supposed to protect young girls from the human papillomavirus, or HPV, that causes two types of cervical cancer and two types of warts.

That was 19 months ago.

Jessie had no health problems, but after the second shot in September 2007 she started to get bad headaches, as well as muscle aches, and joint pain, says her grandmother, Denise Melton. Last February she got the third shot in the series, two days later she was dead.

Her grandmother said after the final shot Jessie said she had a headache and went to bed. That next morning her mother found her on the bathroom floor. "Without a shadow of a doubt, I know that Gardasil is what killed her," says Melton.

An autopsy was inconclusive.

Jessie is not alone. There have been at least 43 reports of deaths following the vaccine and the CDC and FDA have collected about 14,000 adverse events including muscle numbness and paralysis, also known as Guillian-Barre Syndrome, headaches, and fainting.

Let's not forget that Merck is the same company that brought us Vioxx, and knew or should have known that heart attack and strokes would result from the painkiller which was eventually taken off the market.

Even the American Cancer Society says that cervical cancer has declined by 74 percent between 1955 and 1992, largely due to the Pap test.

No one really knows if Gardsil works to prevent cervical cancer, but parents should know that about 80 percent of women are exposed to HPV over their lifetime and their natural immunities fight it off. They should also know that if their child is injured, they have no recourse through the courts. Merck enjoys immunity from liability, as to all vaccine makers.

Melton is going to take Jessie's death as far as she can. She has written to the governor and Congress. She has a license plate that says "One Less" in reference to the Merck campaign by the same name. What she wants one less of, is young woman or girls dying from the drug that is supposed to deliver a cure. #

Originally posted at InjuryBoard by Eddie Farah

Number of Yaz and Yasmin Lawsuits Growing

Eddie Farah — Fri, 13 Nov 2009 19:10:56 GMT

In 2007, Susan Galinis of San Francisco was the happy mother of 3-year-old twins, until doctors put her on the Yaz birth control pill. Four weeks and one day later she suffered a stroke.

Today it’s obvious to see part of her skull has been removed. Doctors had to operate to accommodate the brain swelling following her stroke. Her IQ is 77. She has chronic pain and no short-term memory. Her twins have gone to counselling to deal with the differnt mother who returned from the hospital after six months.

Galinas has sued Bayer HealthCare. Her doctors told her it was Yaz that caused her stroke.

Anne Marie Eakins, 34, a history teacher and mother of two is also suing. She developed blood clots in both lungs in 2007 after starting Yaz. That resulted in partial loss of her right lung.

Yaz is the newest sister to drug, Yasmin, both made by Bayer. Ocella birth control is the generic version that is sold by Teva Pharmaceuticals.

All three oral contraceptives are among the most widely used and involve a combination of ethinyl estradiol with a new type of progestin, drospirenone that has been inked to health problems including strokes, heart attacks, deep vein thrombosis, gallbladder disease, pulmonary embolisms, and death.

Our firm is taking in a number of cases by women who have been hurt by these oral contraceptives which should be taken off the market. With six new cases being filed around the country every day and class action lawsuits being launched around the country, it won't be long before the drug is taken off the market.

Until then, women have to suffer.

The go-to drugs for women under the age of 35 generated sales of about $1.8 billion for Bayer last year. A multi-million dollar ad campaign promises the pill is a quality of life treatment that will improve acne and severe premenstrual depression. Bayer had to spend $20 million correcting those ads after the FDA said the company went well beyond what the drug approval.

Bayer stands behind its oral contraceptives and plans to defend itself vigorously against the rising number of lawsuits filed by lawyers and the women they represent, to hopefully soon bring the marketing of these dangerous oral contraceptives to an end.

Originally posted at InjuryBoard by Eddie Farah

Foster Kids Put On Drugs At Alarming Rates

Eddie Farah — Sun, 31 May 2009 22:26:00 GMT

A new report by the state finds that hundreds of kids in foster care have been placed on psychiatric drugs by their caregivers in Northeast Florida. What’s especially shocking is that no one gave authority for these drugs to be used on the children, and most of the drugs are not even approved for use in children.

The Department of Children and Families (DCF) undertook a review of children put on powerful drugs for depression and ADHD after the death of Gabriel Myers, 7, in Fort Lauderdale. Gabriel was put on at least four different medications, some of which are known to contribute to suicidal thoughts. With the system, his parents, and caregivers along the way letting him down, the little boy killed himself in the shower of a foster home in Broward County. He had been in the foster care system less than one year but his life had been a living hell.

The story of Gabriel is heartbreaking and cries out for change. DCF has just issued an audit sparked by Myers’ death.

It shows in Northeast Florida - 205 kids in Duval, Clay, and Nassau counties were found to be on at least one psychotropic drug. In St. Johns, Putnam, Flagler, and Volusia counties 136 kids are medicated and 76 are on drugs in Baker, Union, Bradford, Gilchrist, Alachua and Levy counties, reports the Florida Times Union.

Under Florida law, parental consent must be granted in writing before children in foster care can be given psychotropic drugs to modify behavior. Oversight by a psychiatrist is required, along with court orders. DCF will now aggressively seek out those parents to get consent in about 16 percent of the cases where no permission was given.

What’s interesting in the report is that kids who stayed with family members were only placed on medication about 4 percent of the time, while those with strangers or in group homes were on medication up to 30 percent of the time, especially teenagers. Grandma will put up with far more than an hourly employee. Let’s home more kids can stay with family members.

And DCF appears to be improving its handling of information, setting up a Web site with full information which is the first step to healing a long-term festering wound. That’s a far cry from the days of deny and cover-up which placed Florida among the worst foster care systems in the country. #

Originally posted at InjuryBoard by Eddie Farah

Patients Need To Be Aware of Medtronic Infuse Use In The Neck

Eddie Farah — Sat, 17 Jan 2009 23:49:00 GMT

Medtronic is facing more trouble over its Infuse Bone Graft.

A Texas woman is reportedly preparing a lawsuit blaming off-label use of Infuse for injuries she suffered after cervical spine surgery. Mary Selke claims that bone formed in her neck and it made it difficult for her to breathe and swallow resulting in more surgery, this time of an emergency nature.

Her physician will also reportedly provide testimony that Medtronic promoted use of the product off-label directly to physicians.

Each year, an estimated half million people undergo spinal surgery to repair and stabilize the spine after experiencing damaged discs or to remedy the condition of scoliosis.

“Infuse Bone Graft” is a biologically engineered liquid that is used to promote bone growth in spine-repair surgery. It’s become a best seller for Medtronic Inc. of Minneapolis, estimated to have brought in $815 million in the fiscal year that ended April 2008, according to the Wall Street Journal.

Infuse is not approved to be used in the neck, but doctors are free to use a medical device off-label at their own discretion.

The family of Shirley Nisbet sued after the California woman died in August 2008. Nisbet had spinal-fusion surgery using Infuse in her neck. After her surgery, the suit says, Ms. Nisbet went into respiratory arrest and a coma and was kept alive by artificial means until she died. That off-label use is being investigated by the U.S. Department of Justice.

Medtronic is supposed to report adverse events to the agency, but a spokesman for the Kaiser Hospital in California, where Ms. Nisbet had her surgery, said it did not report the death to Medtronic because it didn’t consider the product to be the cause of death.

The Minneapolis Firefighters’ Relief Association also filed a class-action shareholder lawsuit against Medtronic in December alleging that the company kept secret that most of its revenue came from off-label use of Infuse and that the device as causing complications.

Litigation may be the only way we get a true picture of the damage done by aggressive marketing to physicians of the off-label use of Infuse.

Meanwhile, it is up to patients to be aware of the serious complications that follow Medtronic’s Infuse, used off-label, in spine surgery in the neck. #

Originally posted at InjuryBoard by Eddie Farah

Florida Laid Off Workers Can't Afford Cobra

Eddie Farah — Fri, 09 Jan 2009 12:31:04 GMT

You lose your job and your medical benefits. At least there is COBRA to get you through. That’s the health insurance you can obtain up to 18 months after you lose your job. You must pay for, but at least it keeps you covered.

A new study says that Florida is one of nine states where the cost of COBRA exceeds unemployment benefits – in other words you must dip into your savings at a time you have no job, if you want to afford COBRA health insurance.

For example, COBRA premiums cost an average of $1,037 a month for a family. The unemployment insurance pays $1,013. Do the math.

The report is issued by Families USA and comes from the U.S. Department of Labor.

This is sobering news at a time that the nation’s unemployment rate is 7.2 percent, the highest reported in 15 years.

“COBRA health coverage is great in theory and lousy in reality,” Families USA Executive Director Ron Pollack said during a press conference Friday morning. “For the vast majority of workers who are laid off, they and their families are likely to join the ranks of the uninsured.”

In 41 states, COBRA premiums cost more than three-fourths of unemployment benefits.

The rising cost of health care is the drum beat we hear every day which will have to be addressed by a new administration.

On a personal level, we can all do our part by trying to stay healthy, and not just avoiding disease.

Originally posted at InjuryBoard by Eddie Farah

"Sicko" Coming Soon to a Theatre Near You

Eddie Farah — Tue, 22 May 2007 18:02:40 GMT

More than 2,000 movie goers at the Cannes Film Festival applauded loudly at the first showing of Michal Moore's newest film, "Sicko," all about the perils of our country's modern healthcare system.

Expect it in theatres in June.

So far the reviews are mixed between hilarious and very sad.
The latter is a good summary of our healthcare system which is likely responsible for more deaths than we like to admit through infections, mis-diagnosis, delayed treatment, drug overdoses and incompetent doctors. In fact, a recent study found that among the largest industrialized nations, the U.S. spends the most on healthcare and has the poorest outcomes in terms of access, patient safety, efficiency and equity.

Moore found that our federal regulators were not laughing at his film. On his website, he doesn't understand how they may have seen a preview, since it's been a guarded secret, but the Treasury Department has been investigating Moore for allegedly breaking a trade embargo with Cuba, where he went to shoot a segment on 911 ground zero workers getting medical care. Moore's lawyers told him it was possible he could face a fine, jail time or the film could be seized.

I mean, folks, I have just about had it. Investigating ME because I'm trying to help some 9/11 rescue workers our government has abandoned? Once again, up is down and black is white. There are only two people in need of an investigation and a trial, and the desire for this across America is so widespread you don't even need to see the one's smirk or hear the other's sneer to know who I am talking about

Never shy at self promotion, "Sicko" will pack a punch at the box office.

Originally posted at InjuryBoard by Eddie Farah

Georgia Lures Industry With Promises Of Curtailing Civil Rights

Eddie Farah — Fri, 13 Feb 2009 01:32:50 GMT

This is reminiscent of what’s put Michigan on the map as the friendliest state for drug and device makers.

In Michigan, drug companies enjoy immunity from prosecution. Imagine if you or I enjoyed such protection. Now Georgia is trying to entice the pharmaceutical and medical device industry to the state with a promise of protection. Senate Bill 101 was introduced last week into the Georgia General Assembly.

What does it promise? Immunity from civil lawsuits, in some cases, over products that have the Food and Drug Administration seal of approval. If the FDA says it’s okay, citizens lose their right to find justice and win compensation, even if it can be proven that the drug or device maker was reckless and had a callous disregard for the safety of the public.

Georgia Gov. Sonny Perdue was the backer of the bill. In a statement he said, “This legislation will make plain that the threat of meritless litigation is not a viable business strategy in Georgia.”

I thought the Governor was supposed to represent the people, not just business strategies.

Court is a viable option if one of my family members suffers irreparable harm and we are out a million dollars in medical bills. It’s a viable option if a loved one is killed by a product that was approved by the FDA, and yes, there have been a few.

And let’s not forget that the FDA doesn’t even test drugs – it relies on the honesty of the pharmaceutical and device industry to submit all relevant studies to the safety and efficacy of a drug/ device. We have found out too late that selective editing goes on by some companies before the FDA sees data.

Even former FDA commissioners have agreed that the system is far from perfect and cannot be relied upon to assure the safety of the public.

To assume the FDA has fully vetted each and every drug is not dealing with a full deck.

No doubt this legislation would be a lovely welcoming gift for scientists visiting Atlanta in May for a large biotechnology convention.

Just ask the residents of Michigan, harmed by Vioxx, Fen-pfen, and Trasylol - among about 20 other drugs withdrawn since 2000 - how this sort of legislation has worked out for them. #

Originally posted at InjuryBoard by Eddie Farah

Private Medical Records Found In Garbage Sent To TV Station

Eddie Farah — Thu, 01 Jan 2009 00:38:13 GMT

We might never have known this happened, except someone decided to send the medical records they found in the garbage to First Coast News, the NBC/ABC affiliate in Jacksonville.

What they found were pages upon pages of un-shredded medical documents from pediatric and adolescent psychiatrist, Dr. Angali Pathak’s office.

In all, the records of 37 patients ended up in the newsroom along with names, prescription information addresses, social security numbers, phone numbers, and birth dates - basically anything someone would need to steal your identity or to find out your most personal secrets.

These records are supposed to remain private. One patient told the news station, “They ended up at your news station, to you, and they could have ended up anywhere.”

The doctor’s office told First Coast News that sometimes the shredder gets clogged, but they have no idea how the documents escaped the office intact.

Privacy laws have been broken and this represents an abuse of privacy on the part of the doctor and staff members who are supposed to be professionals.

HIPAA standards require that documents containing personal information be shredded. The requirements were set up to protect patients against any identity and information theft and their right to privacy.

HIPAA stands for Health Insurance Portability and Accountability Act. Enacted in 1996, HIPAA was designed to protect consumers so they do not lose insurance coverage when they change jobs and to reduce health care costs through standardized electronic transmission of transactions.

A HIPAA violation can carry fines of up to $250,000 and jail time of up to 10 years.

Privacy was a priority of HIPAA and you don’t want to mess with federal law by this type of violation.

It remains to be seen what will happen, but this sort of news probably has every doctor's office in Jacksonville sharpening their shredders or buying new ones. Thankfully, someone was smart enough to send these private records to a place where the information could be used in a helpful and not exploitative way. #

Originally posted at InjuryBoard by Eddie Farah

JAMA Favors Consumers In Upcoming Levine Pre-emption Case

Eddie Farah — Mon, 27 Oct 2008 23:22:24 GMT

Coming up next week before the U.S. Supreme Court is an issue that affects all Americans who take any kind of prescription drug from time to time – that would be virtually all of us.

The case before the court on November 3 is Wyeth v. Levine and the decision will help clarify one of the fiercest battles between consumers and corporations to date, known as federal pre-emption.

Now a prestigious medical journal is taking the side of consumers, which puts them squarely against the pharmaceutical industry, which is a rare position for doctors.

Background on the case - Diana Levine, 62, is rushed to a Vermont emergency room with a migraine. She was given demerol for the pain and a Wyeth drug Phenergan, for the nausea. Levine wishes she had opted for the nausea.

Wyeth’s label doesn’t warn against administering the drug through something called an IV push. The drug turned her arm gangrenous then she lost most of her right arm below the elbow, a terrible tragedy for a musician.

Wyeth was sued by Levine who won in court almost $7 million. Wyeth said, wait a minute in its brief (Wyeth brief)and appealed. Levine won that too.

Now Wyeth it taking the issue to the highest court in the land hoping to have a favorable outcome arguing essentially that a federal authority which approved the drug's label pre-empts a state lawsuit.

The endorsement from the medical community comes from the editors of the Journal of the American Medical Association (JAMA).

They say, in a nutshell that the government cannot possibly protect the public from the potential downsides of drugs that enter the market. Some have not had sufficient testing, while some have had negative test results withheld from regulators. The FDA can’t possibly screen for every dangerous drug.

What’s most interesting is the doctors and editors credit the power of a subpoena and an order to produce documentation as the most likely way to find out what is really happening behind the boardroom doors of pharmaceutical giants.

“Thus, tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings.”

Without information gathered in court, much of the behaviors by drug companies would stay hidden.

As the Diana Levine case goes, so likely will the pendulum swing – either toward consumer rights in court, or the rights of corporations to hide behind a blanket immunity.

Originally posted at InjuryBoard by Eddie Farah

Compulsive Gambling and Mirapex Verdict $8.2 Million

Eddie Farah — Sat, 02 Aug 2008 13:33:08 GMT

A drug given to treat Parkinson’s disease and restless leg syndrome is the focus of a number of trials underway in the District Court of Minneapolis. More than 200 plaintiffs are taking their case forward. But first, three cases will be heard back-to-back to determine the disposition of the remaining cases, including whether there should be a class settlement.

The cases have been consolidated against the drug Mirapex. So far it’s not good news for drug makers Pfizer and Boehringer Ingelheim. This week a federal jury agreed the drug contributes to compulsive gambling and awarded a man $8.2 million.

Many people responding to the story think this is a joke. But it’s not. Compulsive behavior can not only bankrupt you, but destroy marriages and lives. Drug makers denied they knew about the potential side effects, but attorneys for the plaintiffs have shown that the drug makers had knowledge of these compulsive side effects back into the 1990s. Apparently the jury agreed.

Mirapex was approved in 1997, but a warning of compulsive behavior was not issued until 2005. All the while, thousands if not millions of patients, trying to relieve the tremors of Parkinson’s began compulsive behavior. Not only gambling, but shopping, eating, many repetitive behaviors.

More than 10 million prescriptions have been written for Mirapex.

The drug makers blame the compulsive behavior on the patients.

Requip is also in the same class as Mirapex- so-called “dopamine agonists” that stimulate the brain’s movement and coordination centers by overactivating the brain’s pleasure centers. When you stop the drug, the behaviors stop.

With so many people involved in behavior they cannot stop, and no clue that theirs may be a drug-induced state, the drug makers deserve all the scrutiny these trials are now bringing.

They are being charged with liability for design, manufacturing and warning; breach of warranty; and negligence.

Originally posted at InjuryBoard by Eddie Farah