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Sort by date 1,437 pages found matching black box- FDA Finally Yanks Permax Off the US Market
Apr-6-07 Washington, DC: On March 29, 2007, the FDA withdrew Permax (pergolide) from the market because it increases the risk of valvular heart disease. Permax belongs to a class of drugs known as dopamine agonists that help regulate balance and movement in Parkinson's patients who suffer from a lack of dopamine. When Permax was FDA approved in 1988, Eli Lilly... - Maytag Dishwasher Fires: Customers Left Waiting
Apr-6-07 Newton, IA: Consumers have been left frustrated by the recent Maytag dishwasher recall that occurred after reports of fire associated with the appliance. Some customers waited for weeks after the recall before their Maytag dishwashers were fixed or before they received their rebates. A report at WCNC.com highlighted a man who was unable to use his dis... - Protopic linked to Child's Leukemia
Mar-26-07 Lafayette, LA In March 2005, the FDA advised that Protopic should not be used in children under the age of two. That warning came six years too late for Madison. She was prescribed Protopic at 18 months old and diagnosed with leukemia when she was five. "My daughter has undergone chemotherapy, spinal taps and bone marrow taps," says Jody Haines (not... - Investigators Zero In on Pill Pushing Doctors
Mar-14-07 Washington, DC: The number one goal of drug makers in dispatching sales representatives to meet with doctors face-to-face is to increase sales by convincing doctors to prescribe drugs off-label for unapproved uses, by saying whatever it takes to achieve that goal. A May 2006, study titled, "Turning Medicine Into Snake Oil," analyzed FDA warning letters... - Suicide Risk of Neurontin Kept Hidden for Years
Feb-27-07 Washington, DC: Neurontin , the all-time poster child for an illegally promoted off-label drug, was marketed by Warner-Lambert and its Parke-Davis division until Pfizer acquired the company in 2000. The term "off-label" means prescribing a drug for indications not listed on the label, upping the recommended dose, prescribing a drug in combination with... - Depakote: A Brief History
Feb-26-07 Portland, OR: Since 1983, Depakote has been marketed in the United States as a medication for the treatment of epilepsy. More than two million Americans have some form of epilepsy, and 125,000 new cases of epilepsy are reported each year. For the drug maker, Abbott Laboratories, sales were brisk, but there were other markets to tap into - also known as "... - MRI Health Risks—Contrast Dye Burn
Jan-19-11 Oxford, MN Jennifer had a pacemaker implanted a few years ago and needed to have an MRI beforehand. She'd had MRIs before, and had no idea there were any MRI health risks . But this time was different. "As soon as the radiologist said, 'The contrast dye is coming through now,' my arm started to burn, and it became unbearable," said Jennifer (pictured be... - Elidel Lawyer wins pre-emption ruling with the FDA
Jan-23-07 Los Angeles, CA: In a landmark case ruling, (No. 05-530) Larry Roth, of law offices of Larry M Roth, PA, in cooperation with the law firm of Seeger Weiss, are the first lawyers to win an FDA pre-emption ruling sought by a drug manufacturer in an Elidel lawsuit. Elidel is a topical immunosuppressant drug linked to lymphomas. When people suffer an injur... - Public has Right to know Secrets revealed in Zyprexa Documents
Jan-15-07 Washington, DC In deciding whether to allow Eli Lilly to continue to use court orders to hide documents that show the company illegally marketed Zyprexa for unapproved uses and failed to warn the public about the serious health risks associated with the drug for a decade, the court needs to consider the harm done to the public by Lilly's conduct. Th... - Permax Linked to Heart Valve Leakage
Jan-15-07 Biloxi, MS Two studies published in the January 4 issue of the New England Journal of Medicine have linked Permax , a drug used to treat Parkinson's disease, with heart valve problems that can result in death. The problems, known as cardiac valve regurgitation, occur when the heart valves do not seal properly in the reverse-flow direction. This is c... - FDA Ignores Bayer Trasylol Fraud
Dec-21-06 Washington, DC: On December 15, 2006, the FDA said a new label for Trasylol will specify that it should only be used during coronary artery bypass graft surgery but the agency said nothing about what it plans to do about the fraudulent conduct of Bayer Pharmaceuticals in concealing a study that showed the increased risks associated with the drug. Righ... - Ketek Fraud Investigation Derails Confirmation of New FDA Commissioner
Dec-6-06 Washington, DC: When the Democrats won control of Congress, Senator Charles Grassley may have lost the chairmanship of the Senate Finance Committee, but the current acting FDA commissioner had better not get too settled in because the Senator is apparently not ready to throw in the towel in the on-going battle with him. In a recent press release accompa... - FDA Advisory Committee Schedules Hearing on SSRIs and Suicide
Dec-5-06 Washington DC: The FDA's Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants. The panel is expected to vote on whether the risk of suicidality in adults should be inclu... - Biggest Off-Label Drug Marketing Scheme in History - Part II
Dec-1-06 [ Read Part I ] Washington DC: In fairness to off-label prescribing doctors, until recently, studies that showed SSRIs were ineffective and dangerous when used by children were kept hidden and thus, the data made available to physicians painted a rosy, but false, picture of success with SSRIs. And up until recently, many doctors were not even awar... - Maryland Nonprofit Group Files Housing Lawsuit
Nov-30-10 Baltimore, MD A nonprofit group in Baltimore, Maryland, that promotes equal housing opportunities has filed a discrimination lawsuit claiming an apartment complex in the state offered fewer available apartments to black tenants, the Baltimore Sun reports. According to the lawsuit, two black "testers" for Baltimore Neighborhoods Inc. were informed... - Ketek: A Timeline of Lies
Nov-3-06 Washington, DC Despite information indicating that using Ketek (telithromycin) carried a serious risk of liver disease and other problems, the US Food and Drug Administration (FDA) approved the antibiotic for sale in April, 2004. This occurred even though evidence that the drug was effective was unreliable at best and fraudulent at worst. Use of Ke... - "I Overdosed on Chantix"
Nov-12-10 Seattle, WA After taking her first Chantix pill, Kimberly felt irritable—no surprise for someone trying to quit smoking. "I figure that withdrawal from nicotine was a small price to pay, and knowing that nicotine only stays in your system for 72 hours, I looked forward to having a better mood soon," Kimberly says. Instead, the Chantix side effect... - Illinois Nursing Home Abuse Isn't Sole Domain of the Elderly
Nov-8-10 Chicago, IL When debating the subject of nursing homes, the assumption is that we are talking about the elderly. But that's not always the case. There are other nursing home facilities providing care for children with developmental disabilities, for example. And akin to nursing homes serving seniors, these nursing homes in Illinois caring for children have... - Coumadin (Warfarin) Lawsuit Legal News and Information
Coumadin (Warfarin) is an anticoagulant medication, used to prevent the formation and migration of blood clots (known as thrombosis and embolism). Although the medication is effective, Coumadin side effects can be serious, and involve interactions with a wide range of other medications and food. Furthermore, Coumadin birth defects , including brain dama... - FDA Still Dodging Bullets Over Ketek
Sep-27-06 Washington, DC: In recent months Senator Charles Grassley (R-IA) has been like a dog with a bone when it came to investigating why FDA officials approved the antibiotic Ketek , despite its knowledge that the main pre-approval study on the drug was riddled with fraud. Ketek first sought approval in 2000, but approval was denied due to indications of s...