Recently in Defective Drug Category

January 17, 2012

No More Free Lunch for Doctors Who Prescribe Yaz; But Desert Still Being Served in Florida

As a South Miami lawyer who sues doctors, I was very pleased to see that President Obama is making an effort to kill the conflict of interest that exists between patients and their doctors who receive money from drug and medical device manufacturers. Currently doctors who receive money from the same pharmaceutical companies that make the drugs they prescribe their patients are not required to disclose that fact.

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A recent report to Congress shows that drug and device manufactures have extensive financial relationships with doctors, medical schools and professional organization. Accordingly, there exist conflicts between what is in the best interest of drug makers and what is best for patients.

Some of the relationships between doctors and drug makers are all business; others are less obvious. But the evidence is clear that at least some interactions between doctors and drug reps leads to an increase in prescriptions of newer and more expensive drugs. In fact, a recent New York Times article reported that a quarter of U.S. doctors receive cash payments from drug makers and nearly two-thirds accept routine gifts. They also found that doctors who take cash from the makers of dangerous drugs Yaz and Yazmin practice medicine differently from those who do not and are more likely to prescribe medication in unapproved ways.

Under President Obama's new standard, sponsored by Senator Grassely of Iowa and Senator Kohl of Wisconsin in the 2010 health care bill, the reporting requirement will apply if the company produces any product covered by Medicare or Medicaid. This will affect more than 1,000 drug, device and distribution companies.

We agree that Congress should require all drug and medical device manufactures and distributors to report and disclose their financial relationships with doctors, physicians' groups and pharmacists. The recommendations should go further and include pharmacies, pharmacists, health insurance plans and hospitals. To keep doctors honest, they should also have to report all gifts, food, entertainment, golf outings, or anything of more than $1.00 value given to them on the side.

The information should be placed on a public website or app that is available to every consumer of health care in this country, both in English and Spanish. We believe this is an important step to protecting patients from greedy doctors and dangerous drug manufacturers.

Florida's doctors should not feel too bad about this new law, as Florida's First District Court of Appeal recently held that Florida's Medical Malpractice Statute §766.206 entitles doctors or hospitals to a dismissal of a medical malpractice case and to hold a claimant (patient) or claimant's attorney "personally liable for all attorney's fees and costs included during the investigation and evaluation of a potential medical malpractice claim if the exact requirements of the 'reasonable investigation' requirements of §766.201-766.212," which includes a review of the claim and a sworn written and notarized opinion by an expert witness.

What is even more frightening is that §766.206 provides that if the lawyer who mailed the notice does not do a "reasonable investigation" or filed the claim without first mailing a notice of intent, the court has to report that lawyer to the Florida Bar. If the lawyer is reported three or more times within a 5-year period the Florida Supreme Court shall be notified. This puts a heavy burden on a lawyer who represents injured new born babies in Florida to have both experience and knowledge of Florida's complex medical malpractice statutory scheme. In addition it provides doctors with one more shield to protect themselves from aggressive patients' advocates.

January 16, 2012

FDA turns a blind eye to Yaz and Yazmin's Dangers

The Yaz law suits have created a nightmare for its victims and the United States Food and Drug Administration (FDA) that is supposed to be safeguarding Americans taking this dangerous medication.

Last month an advisory panel for the FDA recommend that the benefits of Yaz, Yasmin, Beyaz and Safyral made with the synthetic progestin, drospirenone, outweighed the risk of developing a life threatening and dangerous blood clot. Apparently, three of the "FDA's advisers" are closely tied to Bayer AG, the maker of the drugs. For some reason, the FDA forgot to disclose this key fact.

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The Wall Street Journal, (WSJ) reported that the advisers are, Julia V. Johnson of the University of Massachusetts Medical School, Paula Hillard, an obstetrics professor at Stanford University School of Medicine and Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins. All of whom have done research for and funded by Bayer.

As a Miami Yaz claims attorney I don't understand how the FDA could even allow these three to vote on an issue that they are clearly partial to. According to the WSJ, the "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the FDA because he had publicly criticized the drugs' safety in newsletters published by the group. How is that fair?

This type of favoritism is another example of how our government conceals the dangers of products from consumers and allows dangerous medications to be consumed by an unsuspecting and trusting public. Is it any wonder that the general public has lost faith in its government, particularly when the powerful pharmaceutical to essentially serve as its own judge and jury? The FDA allows dangerous drugs to be marketed and tested on an a public who believe that the FDA does more than rubber stamp drugs before they are approved.

One need look no further than Chinese Drywall, the defective DePuy ASR and Pinnacle metal on metal hips replacement implants, Trans-vaginal mesh, Accutane, Avandia, Fosamax, that were all put on the market with inadequate warnings that ended up harming and in some cases killing people. Read a copy of the complaint we have filed on behalf of our client a Florida woman injured from taking Yaz.

September 7, 2011

Fosamax's Serious Side Effects

More than four million women in the United States currently take Fosamax. It was first approved by the FDA to treat postmenopausal osteoporosis, Paget's disease and later a pre-osteoporosis condition called, ostepenia. Since Fosamax's patent expired three years ago the generic version (bisphosphonates) has been widely marketed.

Our Fosamax claim office is monitoring the upcoming two FDA advisory panels who will decide whether women taking the drug should take a "drug holiday" because of the increasing evidence that Fosamax side effects may outweigh the drug's benefits.


After 16 years on the market the concern is focused on how long-term (more than 3-5 year) use of the drug proves may actually cause bones to weaken. There have been an alarming number of women who have suffered sudden bone fractures and bone death. Currently, Merck is facing over 1000 law suits from patients claiming jaw bone injuries and 535 claims of broken femurs (legs) and other bones. Of the four cases that have already gone to jury, Merck won three and is appealing the fourth that resulted in a verdict of $8 million.

Fosamax is marketed as Alendronate (Fosamax, Fosamax Plus D) Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa). As a Florida Fosamax injury lawyer I recommend that, before you consider taking Fosamax or if you are presently taking the drug, ask your doctor to examine your mouth and see a dentist. It is vital that you maintain good mouth care during Fosamax treatement. In addition, if you have developed any unusual pain in your leg, hip or groin, immediately notify your physician.

Our Fosamax injury lawyers hope that the FDA will order stronger labeling and warnings on Fosaxmax and the generic drugs as well as outright banning its long term use in patients where the benefit is outweighed by the risk.

July 28, 2011

Zoloft Found to Cause Birth Defects

Our Zoloft Injury law firm is investigating law suit against the manufacturer of the medication, Zoloft, for causing birth defects.

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When we learned that Zoloft has been linked to children who have suffered birth defects as a result of their mothers having been prescribed and taken the medication. Zoloft is a selective serotonin re-uptake inhibitor or an SSRI typically prescribed for depression, anxiety disorders and some personality disorders.

The FDA released a public health warning in 2006 advising patients who take Zoloft about the increased risk of birth defects which include: heart and lung defects, club foot, undescended Testes, spina bifida and others. Read the warning here.

Our Florida defective pharmaceutical drug attorneys are currently accepting inquiries and investigating claims on behalf of injured children whose mothers were prescribed and took Zoloft. Clinical studies have also shown that Zoloft has also been associated with suicide in a small number of children, teenagers, and young adults who took Zoloft.

Our Miami injury law firm focuses on assisting the victims of cruise ship injuries, car accidents and medical malpractice, we also devote a substantial amount of effort to assist those injured by dangerous and defective medications.

June 24, 2011

GENERIC OR NAME BRAND--NOT JUST A QUESTION OF PRICE ANYMORE

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Bruce Shemrock
Trial Lawyer, Aronfeld Trial Lawyers

As a law firm that sues drug companies we were surprised to discover the U.S. Supreme Court ruled on June 23, 2011 that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects. In the case they heard, the generic drug manufacturers argued that federal law barred these suits because the U.S. Food and Drug Administration (FDA) approved the subject name brand drugs, and that federal law requires generics to have the same labels as the name brand.

However, in 2009, the Supreme Court ruled that drug regulations do not protect pharmaceutical companies from being sued in state courts over drug labeling and failure to warn consumers of possible side effects. In this year's ruling, the Court agreed with the generic drug manufacturers that, because of the federal labeling law, they had no choice but to put the same labels on their products as the name brand drug manufacturers. Generic drug companies are therefore protected from responsibility for failure to warn of possible side effects if such warnings do not appear on the name brand drug label.

Some argue that this will change the face of drug dispensing. Consumers with good insurance or the ability to pay may now choose to take the name brand to get the extra protection of the possibility of suit should something go wrong. Others opine that prices of generic drugs may fall due to this new-found protection from lawsuits.

Our Florida defective product lawyers advise our friends and clients, to now carefully consider the question, "Is generic okay?" when you have prescriptions filled. Are you willing to forfeit your right to a claim should something go wrong for the sake of saving a few dollars? Theoretically, you could have a viable claim for injuries and a perfect right to assert your claim for injury in court, but such claim is completely barred by this ruling if the drug that injured you was generic.

May 25, 2011

Thinking of Having Spinal Fusion Surgery? Think again.

A recent study published in the North American Spine Society's Spine Journal revealed that a bone growth protein manufactured by Medtronic used in spinal fusions has been linked to an increased risk of male sterility. Our Florida back injury lawyers are particularly concerned because of the growing number of injured men who elect to have fusions after suffering traumatic spine injuries. About 80,000 patients per year undergo spinal fusions in the United States alone. Many of our clients who have sustained back injuries from a car wreck, slip and fall or cruise ship accident have considered having spinal fusion surgery.

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Spine fusion surgery is when two bones in the back are permanently joined together to prevent them from moving. Fusions are usually performed with other back surgical procedures such as discectomies, laminectomis or foraminotomies, which remove the discs between the spine before fusion. Some surgeons opt for grafts, which uses bones taken from the patient or a cadaver to hold the bones together.

The Medtronic product in question is called, "Infuse," and was approved by the FDA in 2002. The results of the study show that only men have an increased risk of sterility. Our Broward County defective medical device lawyers recommend that men who are considering having children consult with their orthopedic surgeons regarding the risks and benefits of using the Medronic product and the availability of alternative surgical techniques.

May 9, 2011

Can Advil Cause Total Kidney Failure? Yes!

As a Florida medical malpractice and defective drug and medicine lawyer, I was surprised when a client of ours was recently diagnosed with acute kidney failure related to her use of a common over-the-counter non-prescription pain medication. Apparently, non-steroidal anti-inflammatory drugs (NSAIDs) have been found to induce two different kinds of kidney injuries.

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Our Miami injury lawyers recommend that if you are pregnant, have high blood pressure, asthma or a history of liver or kidney disease to tell your physician before taking Aspirin, Motrin, Advil, Naproxen, Aleve or Relafen. The greatest risk is when a patient is seeing multiple physicians and there is no coordination of care. It is highly possible that one doctor can be unaware of what another doctor of a different specialty is doing while treating an unrelated condition.

Lastly, do not underestimate the dangers of NSAIDs simply because they are available over the counter without a prescription.

April 17, 2011

Emergency Urgent Recall By FDA for Breast Incision Pad

As a Florida defective drug device lawyer, I was concerned by the FDA's Class 1 recall of of Axxent Flexishield Mini pads. The pad was designed for use in breast cancer patients who received one dose of radiation after undergoing cancer surgery.

The pads were supposed to shield healthy tissue, but instead have left breast and chest muscles peppered with hundreds of particles of tungsten. While the long-term effects of tungsten are unknown, their presence will interfere with mammogram readings that are especially important for women who have had breast cancer and are concerned with recurrence.

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The device is made by Hoag. Lawsuits for Axxent pads are being filed by women who have been exposed and have tungsten particles. Some of the affected women are now considering mastectomies to rid themselves of the particles.

Continue reading "Emergency Urgent Recall By FDA for Breast Incision Pad" »

April 15, 2011

Taking Fosamax? FDA Warns of Sudden Broken Legs

Our Florida Fosamax injury law firm advises that all women currently taking Fosamax medication to immediately consult their doctors. There are an alarming number of reports of women taking Fosamax suddenly breaking their legs for no apparent reason.


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Fosmax and the following drugs Actonel (risedronate sodium) tablets, Actonel with Calcium (risedronate sodium with calcium carbonate tablets), Atelvia (risedronate sodium) delayed-release tablets, Boniva (ibandronate sodium) tablets, Fosamax (alendronate sodium) tablets and oral solution, Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets, Reclast (zoledronic acid) Injections are now required to have clear warning labels regarding low-energy, or low trauma fractures of the femoral shaft (leg bone).

As a Fosamax medication attorney, I suggest discussing this drug with any elderly female friends and relatives as they may be unaware of the current crisis and the FDA's warnings.

April 10, 2011

DePuy Hip Replacement Device Claims

Our De Puy Hip Injury law firm is helping patients who were implanted with a DePuy hip replacement devices that have been recently recalled. We allege that the company knew about problems with its products for years before they were finally recalled.

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DePuy Orthopaedics and Johnson & Johnson, recalled the ASR XL Acetabular System and ASR Hip Resurfacing Systems in 2010 because these products were than twice as likely to fail as similar hip replacement implants.

The FDA received over 400 reports of DePuy hip replacement devices problems. In England 13% of patients with the acetabular system and 12% patients with the resurfacing system required follow up surgery to fix these implants. Yet, according to DePuy only 5% of hip implants should need to be replaced within five years. The Australian National Joint Replacement Registry recalled DePuy hips in 2009.

Our De Puy Hip failure lawfirm recommends that If you have a DePuy Hip Implant device contact your physician for an immediate evaluation.

February 25, 2011

U.S. Supreme Court Takes Justice Away From Vaccine Victims

As a Florida prescription drug lawyer, I was astonished by the U.S. Supreme Court's latest ruling in the case of Hannah Bruesewitz, who received a vaccine known as D.T.P. as an infant in 1992. The vaccine supposedly protects against diphtheria, tetanus and pertussis, and whooping cough. Since being vaccinated, she suffers from seizures and developmental problems.


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The case turned on whether a 1986 law that created a vaccine victim compensation fund protects vaccine manufacturers from law suits. In the majority opinion Justice Scalia opined that the compensation fund was a "social bargain" to give vaccine manufacturers peace of mind to "avoid costly tort litigation and the occasional disproportionate jury verdict" and dismissed Hannah's case along with the rights of any other injured child.

The effect of this ruling creates a safety issue for our children as vaccine manufacturers are now virtually immune from being held accountable for failing to make technological advancements when designing or distributing their vaccines. Thank you, Justice Scalia, for taking away the rights of injured children and protecting Wyeth and other vaccine manufacturers.

December 22, 2010

The Danger of Over-the-Counter Medication For Children

I am a parent of two kids and a Florida prescription drug attorney and I am amazed at how literally incomprehensible the labeling and dosage information is on many non-prescription pediatric drugs.
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A recent study by JAMA (The Journal of the American Medical Association) found that 52 medicines were sold without a measuring device in the package and nearly all had inconsistencies between the dosing directions and the devices, missing or superfluous markings or obscure measuring units (grams or cubic centimeters). Of course, the FDA does little to help. Rather than demanding standardized labels and dosages, they established a voluntary guideline.

Our Miami children's injury law firm recommends that parents administering medication to children should carefully read instructions and understand measurements. For example, realize that a tablespoon is four teaspoons and always use a standardized measuring device.

November 11, 2010

Fosamax and other Osteoporosis Drug Dangers

As a Fosamax injury law firm, we are watching a New York jury trial against Merck, the drug's manufacturer very closely. Fosamax is a drug taken by millions of American women who suffer from osteoporosis and was approved by the FDA in 1990.

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On October 12, 2010, the FDA issued a safety update for Fosamax, Fosamax Plus D, Actonel, Acontel with Calcium, Voniva, Ateliva and Reclast, finding patients who takethe drugs have an increased risk of developing broken legs and other bones

In the New York case, Merck is utilizing the classic finger-pointing defense by blaming the steroid and arthritis drugs that the claimant took. So far the score is 1-1: Merck landed a defense verdict against a claimant but lost to a plaintiff who was awarded $8 million by a jury. The judge later reduced that plaintiff's verdict to $1.5 million.

As a Fosamax claims lawyer, I recommend people taking Fosamax, or any other drug containing bisphosphonate, to immediately see their doctors, especially if they are feeling any pain or discomfort in their hip or thigh. They should also report any side effects to the FDA's Medwatch program or call 1-888-463-6332. If you have taken Fosamax, or the other named medications, you should also consult with an experience drug injury lawyer regarding your legal rights.

November 5, 2010

Hip Implant Claims

More than two years after the FDA first received complaints about the defective hip implants made by Johnson and Johnson's DePuy Orthopeadics they have finally been recalled. As a Florida defective hip implant lawyer, I am astonished that it took so long.

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This is nothing new for Johnson and Johnson, the proud makers of the recalled Liquid Children's Tylenol, Acuvue contact lenses and an illegally marketed and unapproved medical device called the Corail Hip System.

The recalled hip implants are the ASR XL Acetabular System (hip socket replacement) and the ASR Hip Resurfacing Systyem (placement of a metal cap on the ball of the femur).

Our Miami Hip Implant Lawyers advise our clients who are considering a hip replacement surgery to seriously consider options other than the DePuy products. Those patients who have undergone hip replacement surgery using a DePuy replacement product should immediately contact their surgeon for an evaluation.

October 23, 2010

Increased Risk of Complications Associated With Synthetic Vaginal Mesh

As a defective medical device lawyer, I recently noted an American Journal of Obstetrics and Gynecology study finding an increased risk of complications with woman who were operated on using synthetic vaginal mesh to treat vaginal prolapse.

Vaginal prolapse is a condition where the uterus, rectum, bladder, urethra, small bowel, or the vagina itself falls out of their normal positions. The mesh is used to to provide support to the bladder or uterus for sexually active women following a hysterectomy or complicated child birth. The surgical procedure is called a Sacral Colpopexy.

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Two years ago, in October 2008, the FDA issued a warning to doctors finding serious complications associated with the use of synthetic mesh. However, like most defective medical devices, it remains on the market.

Our Florida vaginal mesh complication lawyers advise you to reconsider the use of synthetic vaginal mesh if you are considering having surgery to correct vaginal prolapse. If you have undergone a sacral colpopexy surgery where synthetic vaginal mesh was used, please be especially vigilant for adverse affects such as erosion, infection and complications associated with the bowel or bladder. If you suffer from any adverse affects seek immediate medical attention and contact our defective mesh attorneys for a free initial consultation regarding your legal rights.