Practice Area: Drug Recall

Drug Recall and Pharmaceutical Injury Lawsuits

Relying upon the expertise and skill developed from years of successfully resolving pharmaceutical and product liability cases, Fleming and Associates has taken an aggressive and active approach to handling these cases. F&A has filed cases in state and federal courts across the country on behalf of clients who have suffered kidney failure, and in some cases death, as a result of recalled drugs and pharmaceutical injury.

Trasylol Lawsuit

Who is Responsible? What Can I Do? Trasylol Side Effects

If you or a loved one have recently undergone heart surgery, you may have been administered a drug called Trasylol, also called Aprotinin, which is administered to reduce blood loss during the procedure. If you or a loved one suffered from kidney failure, stroke or heart attack after having cardiac surgery, it is possible that Trasylol was the culprit.

Recent studies have reported that Trasylol significantly increases the risk of kidney failure, stroke and heart failure in patients administered the drug. The first of these studies, published in the New England Journal of Medicine in January of 2006, reported that Trasylol doubled the risk of kidney failure post operatively and also significantly raised the chance of stroke, heart failure, and heart attack. The study also found that two cheaper alternative drugs were equally as effective as Trasylol, without the dangerous side effects

In order to assess these risks more fully, the Food and Drug Administration (FDA) initiated hearings on whether the drug label for Trasylol should be expanded to include these risks. In September of 2006, the FDA decided no label changes were necessary.

Less than one week later, the FDA was alerted that Bayer, the manufacturer of Trasylol, had withheld information regarding a study being conducted at Bayer’s request. Bayer later admitted intentionally withholding that study from the FDA Committee, but argued that it was just a mistake. The FDA then warned doctors across the country that Trasylol may be associated with an increased risk in heart attack, kidney failure, and stroke.  

In December of 2006, the FDA changed the warning label for Trasylol to reflect these new dangers.

More recent studies have confirmed the adverse renal effects of Trasylol, as well as revealed an association between Trasylol use and an increase in patient deaths. In October of 2007, a study designed to compare the efficacy of Trasylol with cheaper alternatives was shut down because Trasylol increased the risk of death. Finally, on November 5, 2007, the FDA forced Bayer to suspend marketing of Trasylol.  At a press conference that day, the FDA stated that it could not identify a patient population in which the use of Trasylol outweighs the risk.

In an interview with 60 Minutes, one prominent medical researcher estimated that as many as 22,000 deaths could have been prevented if Trasylol was taken off the market immediately following the initial studies in January of 2006.

Trasylol Attorney

Plaintiffs contend that even though the risks of death and kidney failure were known to Bayer, it failed to warn the public or physicians about these serious complications. Fleming and Associates is actively investigating additional cases involving Trasylol has suffered from kidney failure and/or death following heart surgery.

If you or a loved one has suffered from kidney failure and/or death following a heart surgery as a result of Trasylol please call or contact us for a free case evaluation and consultation by our Houston Trasylol Attorney.

Fosamax Lawsuit

Fosamax® (alendronate), a prescription drug manufactured by Merck, is used to treat osteoporosis, a disease in which bones become increasingly fragile. Drugs like Fosamax, called bisphosphonates, are prescribed to increase bone density, but recent evidence indicates it may have the opposite effect and destroy bone. A 2004 FDA analysis linked bisphosphonates to osteonecrosis of the jaw (ONJ). ONJ is an irreversible condition in which the jawbone dies and is unable to regenerate,

Fosamax is the most commonly dispensed bisphosphonate in the United States: 22 million prescriptions were written in 2004. Bisphosphonates, once taken, remain in the bones indefinitely.

Symptoms of ONJ include the following:

• Loose teeth
• Jaw pain
• Exposed bone
• Severe mouth infections
• Swelling in the mouth
• Mouth ulcers and sores

Fosamax Attorney

If you or a loved one have been injured as a result of Fosamax please call or contact us for a free case evaluation and consultation by our Houston Fosamax Attorney.

Ortho Evra Lawsuit

Ortho Evra is a birth control patch manufactured by Ortho McNeil, a division of Johnson & Johnson. Recent studies confirm that the use of Ortho Evra significantly increases the risk of blood clots when compared to oral contraceptives.

A 2006 investigation by the Associated Press revealed Ortho Evra users have blood clots in their legs and lungs, and die at a rate three times higher than women taking oral birth control pills. This risk may be connected to the fact that the birth control patch delivers up to 60 percent more estrogen than birth control pills. The report also indicated Ortho Evra put women at a higher risk for heart attacks, strokes, and pulmonary embolism.

Ortho Evra Attorney

If you or a loved one have been injured as a result of taking Ortho Evra, please call or contact us for a free case evaluation and consultation by our Ortho Evra Attorney.

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Read More

• Bayer Put Profits Above the Health and Safety of Patients
• A study has shown that cheaper alternatives to Trasylol® were just as effective in limiting blood loss but didn't cause any of the dangerous side effects.

• Trasylol Side Effects
• The risk of experiencing a heart attack increased more than 50 percent, renal failure nearly doubled, and the risk of stroke increased 181 percent,  in patients who were given Trasylol®.

• Trasylol Boosts Risk of Death
• Patients given the Bayer anti-bleeding drug were more likely to die, according to two U.S. studies published in the New England Journal of Medicine.

• HRT Doubles Recurrence Risk in Breast Cancer Survivors
• Breast cancer survivors treated with hormone replacement therapy had a more than two-fold increased risk of recurrence or a contralateral malignancy, according to long-term follow-up data from a randomized clinical trial.

• Hormone Replacement Therapy Increases Risk Of Breast Cancer
• Postmenopausal women who take combined estrogen/progestin hormone-replacement therapy for three years or more face a fourfold increased risk of developing various forms of lobular breast cancer, according to new findings by researchers at Fred Hutchinson Cancer Research Center.

• Fosamax Linked to Femur Fractures, Bone Pain & Irregular Heartbeats
• In the latest research to cast a shadow on the safety of a popular bone-strengthening medication, researchers report that long-term use of Fosamax is associated with unusual fractures of the thigh bone. The Osteoporosis drug also linked to bone pain and irregular heartbeats in past research.

• Ortho Evra Changes Label to Reflect Risk of Serious Blood Clots
• In January of 2008, the FDA approved changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new public health study. The study found that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills.

• If You've Been Injured by Trasylol
• If you’ve taken Trasylol® and are concerned that you may have developed health problems as a result, you may be entitled to legal compensation.

• Class Action Regarding Trasylol Filed in Canada
• A class action lawsuit regarding Bayer Inc. and its drug Trasylol, has been launched in Canada.

• Osteoporosis Drug Fosamax Linked To Heart Problem
• Women who have used Fosamax are nearly twice as likely to develop the most common kind of chronically irregular heartbeat than are those who have never used it.

• Hormone Replacement Therapy (HRT) Linked To Breast Cancer
• In a recent University of Missouri study, researchers found that one of the hormones used in HRT, a synthetic progestin, could be a major factor in promoting breast cancer.

• Cardiac Surgery Drug Increases Death Rate, Study Confirms
• The largest study to date of a controversial cardiac surgery drug shows it increases death rates and damages kidney function, according Duke University Medical Center researchers.

• 22,000 lives May Have Been Saved if Trasylol Had Been Pulled
• At least one critic of the US Food and Drug Administration (FDA) says the organization acted too slowly when it learned of the dangers of Trasylol. According to Dr. Dennis Mangano, approximately 22,000 lives could have been saved if the FDA had removed Trasylol from the market when it received evidence that the drug was linked to thousands of deaths.