Medical products and pharmaceuticals may cause devastating side effects even when properly administered. Lilly O'Toole & Brown LLP, has experience in handling cases involving may types of drugs and particularly Baycol, Fen Phen, Prempro, Remicade, Rezulin and Vioxx.

Drug Cases

Defective Medicine: Pharmaceutical Liability

Serving Central Florida, Orlando and Tampa, FL

Medical products and pharmaceuticals may cause devastating side effects even when properly administered. Injuries and illnesses caused by asbestos, pharmaceutical products and medical devices may be compensable. Lilly O'Toole & Brown LLP, is a statewide civil trial firm which concentrates on the areas of product liability, medical malpractice, wrongful death and personal injury. Our firm works closely with our clients to optimize recovery on their behalf or on behalf of their estates.

 

The law firm has experience in handling cases involving may types of drugs and particularly Baycol, Fen Phen, Prempro, Remicade, Rezulin and Vioxx.

Baycol

Baycol is a prescription drug manufactured by Bayer A.G. Pharmaceutical. Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

Rhabdomyolysis is a condition where the muscle cells are damaged, thus releasing a pigment called myoglobin into the bloodstream. The myoglobin becomes entrapped in the kidneys, clogging up the filtering process of the kidneys, leading to kidney or renal failure and other organ system disorders. Symptoms of rhabdomyolysis can include the following: muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting.

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher does, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lower drug. As of the date of the recall of Baycol, August 8, 2001, the FDA had received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

If you or someone you know is suffering from any of the side effects caused by the use of Baycol, you may be eligible to file a claim.

If you have a case involving Baycol, please contact us at 1-888-533-5525.

Fen Phen

Fen Phen was a combination drug mixture of Pondimin or Redux with Phentermine (an amphetamine-like drug) designed to promote weight loss, diet, weight lifting and obesity. Both Redux (dexfenfluramene) and Pondimin (fenfluramine), the "Fen"s in the combination, were diet drugs manufactured by American Home Products ("AHP").

A Mayo Clinic study, published in the New England Journal of Medicine, suggested that as high as one-third of a patient sampling of Fen Phen diet pill users had evidence of heart valve disease. The study found that there was a high incidence of heart valve disease in patients taking these diet pills, without any other known reason for valve disease.

The symptoms of heart valve disease may be subtle and present with complaints such as shortness of breath and chest pain.

Primary pulmonary hypertension (PPH) is a rare disease of unknown cause that results in the progressive narrowing of the blood vessels to the lungs, causing high blood pressure in these blood vessels and eventually leading to heart failure. Secondary pulmonary hypertension (SPH) is the result of other types of lung disease, abnormal breathing processes or heart disease.

Use of certain fenfluramine and dexfenfluramine has been found to increase the risk of developing PPH, especially use lasting more than three months.

Initial symptoms of PPH may be very minor, and diagnosis may be delayed for several years until symptoms worsen. Typical symptoms may include: shortness of breath following exertion, excessive fatigue, dizziness, fainting and weakness, ankle swelling, bluish lips and skin and chest pain.

If you or someone you know is suffering any of the side effects listed above caused by the use of Fen Phen, you may be eligible to file a claim.

If you have a case involving Fen Phen, please contact us at 1-888-533-5525.

Prempro

Prempro (a combination of estrogen and progestin) is a leading hormone replacement therapy (HRT) drug. It is prescribed for the treatment of postmenopausal symptoms.

Four years ago, 46 million U.S. women were using the second most prescribed drug in the United States, Prempro. But the results of several studies in the United States and foreign countries released since 2002 have found Prempro can cause a number of serious or fatal side effects. Some studies were stopped years before completion, when findings indicated that the risk of continuing therapy was too great. They found an increased risk of breast cancer, abnormal mammograms, heart attack, strokes, heart disease, blood clots, asthma, ovarian cancer and hearing loss. Studies released in 2004 have found increased risk of colorectal cancer and increased risk for dementia in women over the age of 65.

Prempro litigation began after an article published in the Journal of the American Medical Association (AMA) revealed that the side-effects of Wyeth's Prempro included increased risk of probable dementia in postmenopausal women 65 years or older.

The Women's Health Initiative (WHI) Memory Study enrolled 4,532 postmenopausal women free of probable dementia aged 65 years or older. Participants received either one daily Prempro tablet or a matching placebo in a randomized, double-blind, placebo-controlled clinical trial. The results of the memory study showed the following side-effects of Prempro: 66 percent of the 61 women diagnosed with probable dementia were receiving Prempro.

Prempro is also linked to strokes, coronary heart disease (leading to heart attacks), and venous thrombotic embolisms (blood clots in veins). The combined risk offsets the benefits of a decrease in colon-rectal cancer and hip fractures (from osteoporosis).

Other comparable medications include: Activella, femhrt, Ortho-Prefest and Premphase.

If you or someone you know is suffering from any of the side effects caused by the use of Prempro, you may be eligible to file a claim.

If you have a case involving Prempro, please contact us at 1-888-533-5525.

Remicade

Remicade, in combination with methotrexate, is indicated for the reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate. Remicade is also used to treat patients with Crohn's disease who have not responded to other therapies or who have developed fistulas.

Although Remicade has been touted as a miracle product, it is a potent drug that has been associated with such serious and debilitating side effects as tuberculosis, histoplasmosis, listeria sepsis, invasive fungal infections, lymphoma, pneumocystosis, seizures, multiple sclerosis, lupus, serious infections, heart failure, and death. Patients have neither been warned adequately of these risks nor of their severity.

In August 15, 2002, a "Black Box Warning" was added to Remicade's label warning that tuberculosis, invasive fungal infections, and other opportunistic infections, have been observed in patients receiving Remicade and that some of these infections have been fatal.

On October 5, 2001, Centocor sent health care professionals a letter warning them tuberculosis, and other serious opportunistic infections including histoplasmosis, listeriosis, and pneumocystosis, have been reported in both the clinical research and post-marketing surveillance settings.

The Food and Drug Administration and manufacturer Centocor are warning doctors that patients receiving the drug Remicade to treat rheumatoid arthritis and Crohn's disease have suffered sometimes fatal blood and central nervous system disorders.

People who sustain a severe infections as the result of taking Remicade may be eligible for substantial compensation. The types of injuries that may be compensable are tuberculosis, histopolasmosis, listriosis, pneumocystosis, nervous system problems, demyelinization, demyelination, MS, and congestive heart failure.

In general, the injured user can pursue damages for medical expenses, pain and suffering, and loss of wages. If the patient died as a result having used Remicade, his or her family or estate could also sue for wrongful death.

If you or someone you know is suffering from any of the side effects listed above caused by the use of Remicade, you may be eligible to file a claim.

If you have a case involving Remicade, please contact us at 1-888-533-5525.

Rezulin

Rezulin, also known as troglitazone, was approved by The Food and Drug Administration (FDA) in January, 1997 to treat type 2 diabetes mellitus (adult-onset diabetes). The FDA approved the drug largely because the drug then had a unique mode of action that seemed to help people who did not adequately respond to other treatments. The drug, however, generated controversy because a significant number of Rezulin treated patients developed life-threatening liver dysfunction. Many Rezulin treated patients did, in fact, die of liver failure.

Rezulin was banned in England in 1997 because of liver side effects, but the drug's manufacturer, Warner-Lambert, fought a ban on Rezulin in the United States. However, on March 21, 2000, the FDA advised Rezulin's manufacturer to withdraw the drug from the market, citing ninety cases of reported liver failure, sixty-three of which had resulted in death, and ten cases resulted in liver transplants. Rezulin was withdrawn from the market immediately after the FDA advised Warner-Lambert to remove it.

Symptoms of liver toxicity include:

  • Jaundice
  • Fatigue
  • Abdominal Pain
  • Dark Urine
  • Nausea
  • Loss of Appetite
  • Heart Failure

In addition to liver failure, Rezulin has also been linked to heart failure. In a study conducted before Rezulin's approval, researchers discovered that Rezulin caused abnormal thickening in the left ventricular wall of the heart. Thickening of the left ventricular wall can lead to heart failure. The results of this study were discarded because the study was not conducted properly.

If you or someone you know is suffering any of the side effects listed above caused by the use of Rezulin, you may be eligible to file a claim.

If you have a case involving Rezulin, contact us at 1-888-533-5525.

Vioxx

Vioxx, one of a new kind of nonsteroidal anti-inflammatory drug (NSAID) approved by FDA, was launched in the United States in 1999 and marketed in over 80 countries. It was used to reduce pain and inflammation caused by osteoarthritis; acute pain in adults; and menstrual pain.

Subsequently, the FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. Vioxx is the only NSAID to have demonstrated a lower risk of undesirable side effects such as gastrointestinal ulcers and bleeding.

Unfortunately, three-year data from a prospective, randomized, placebo-controlled clinical trial showed increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of continuous treatment in the patients taking Vioxx compared to those taking placebo. Merck's decision was to voluntarily recall Vioxx and to reimburse anyone with unused medication.

Merck expects about 16,000 people to file legitimate Vioxx law suits against the company. Wall Street analysts project that the number of successful law suits will be significantly higher. In a study based on records of 1.4 million members of Kaiser Permanente, the largest US nonprofit insurer, with 6 million members in California, it was found that Merck & Co.'s Vioxx may have caused as many as 140,000 heart attacks in the U.S. before it was withdrawn Sept. 30, 2004.

If you or someone you know is suffering from any of the side effects caused by the use of Vioxx, you may be eligible to file a claim.

If you have a case involving Vioxx, please contact us at 1-888-533-5525.

See Verdicts/Settlements section of this website for details.

Library for Drug Cases:

 

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