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  • Avandia: Strong Link to Heart Failure
    Jul-5-07 Coleman, TX Gene Canales is a Vietnam Veteran and a diabetic. Three years ago, his doctor at the VA hospital prescribed Avandia, but now Canales is more worried about his heart than diabetes. "They started me with 8mg but I started to get chest pains," says Canales. "I had a stress test and the doctor told me that I had an irregular heartbeat so he r...
  • Zyprexa: Courts Can Help
    Jul-5-07 Brooklyn, NY Somewhere on YouTube is a video clip featuring Shahram Ahari, a former account executive at Eli Lilly, claiming that he was told to play down the adverse side effects of Zyprexa , which he used to sell on behalf of the company. A spokesperson from Eli Lilly & Co. counters that Ahari is a paid witness in a case against a New Hampshire...
  • Zyprexa: Rampant Off-Label Use
    Jul-3-07 Brooklyn, NY Yet another example of an anti-psychotic drug allegedly presenting links to diabetes and weight gain is Zyprexa , manufactured by Eli Lilly & Co. and prescribed for the treatment of schizophrenia and bipolar mania. However, patients may be getting more than they bargained for, with the possibility of hyperglycemia, diabetes, blood su...
  • How Class Action Members Receive Notice
    Jul-2-07 New York, NY: LawyersandSettlements.com asked notice expert Todd Hilsee how people involved in a class action lawsuit (also called plaintiffs or members) are found and notified of settlements -- and how to ensure they get the right benefits. "It is a very careful process: lawyers must notify members of their legal rights and they also need to notify the...
  • Problems Associated with Ketek Extend Beyond Liver Problems
    Jul-2-07 Washington, DC: The side effect most people think of when they hear the name Ketek is liver failure. However, at least one person has had a different, life-threatening reaction to Ketek; now patients are investigating the possibility of filing lawsuits against the manufacturer Sanofi-Aventis for serious side effects like toxic epidermal necrolysis (TEN)...
  • Intergel Scandal: A "Dangerous Precedent" at FDA?
    Jun-24-07 Washington, DC In the wake of the Gynecare Intergel recall, many critics are questioning why the Food and Drug Administration (FDA) ever approved Intergel for medical use. Could it be, as some suggest, that the FDA is playing politics to its drug-company funders? Intergel: Initially "Not Approvable" Initially (2000) the FDA rejected Intergel as "no...
  • Part 1: Avandia and the FDA: The Bottom Line
    Jun-19-07 Washington, DC The FDA has come under vocal criticism in the last three weeks over its handling of Avandia , the widely-prescribed GlaxoSmithKline diabetes drug. The FDA's supporters and its critics are still offering their views of what happened, what should have happened, and what should happen in the future. As regular readers will know, Avandia wa...
  • The FDA Issues Warning for MRI Drug
    Jun-18-07 Washington, DC Nephrogenic Systemic Fibrosis (NSF) is a rare condition that can disable or even kill a person unlucky enough to have it. "Patients with NSF experience an increase of collagen in the tissues, causing thickening and hardening of the skin of the extremities and often resulting in immobility and tightening or deformity of the joints," explains...
  • FDA and The Crisis of China's Poisoned Products
    Jun-17-07 Silver Spring, MD Of all defective products you can have, the worst are the ones that you put in your mouth and ingest. Unlike something you swear at when it doesn't work properly, tainted foods and medicines do the damage silently, on the inside. By the time the situation reveals itself, it is often too late. Throughout the last several months there...
  • Glaxo now faces Lawsuit by Shareholders over Avandia Problems
    Jun-16-07 New York, NY GlaxoSmithKline PLC, the maker of the popular diabetes drug Avandia, just can't stay out of the news. And the news is all bad. Since May 21, when a meta-analysis (that is, an analysis of pooled data) of 42 clinical trials involving nearly 28,000 diabetes patients was published, showing that those taking Avandia had a 43% higher risk of...
  • Mere Weeks after AMO Recall, Lawsuits Start Coming
    Jun-14-07 Chicago, IL It didn't take long for lawyer's phones to start ringing after Advanced Medical Optics of Santa Ana, California pulled their stock of AMO Complete MoisturePlus Multi-Purpose Solution from store shelves last month. On June 8th a resident of Santa Clara County, Nicole Lazar, was named as the lead plaintiff on behalf of California consumers who...
  • Fireworks on Capitol Hill: FDA on the Defensive, Avandia Warnings Toughened
    Jun-7-07 Washington, DC In an obvious attempt to save face, the U.S. Food and Drug Administration (FDA) yesterday announced severely toughened black box warnings for Avandia , and Actos - two diabetes drugs strongly suspected of increasing the risk of heart attack. In front of a packed Congressional hearing yesterday called to investigate the long delays by reg...
  • Avandia Maker Tried to Silence Doctor who had Concerns
    Jun-5-07 Washington, DC: A noted diabetes specialist who first raised the red flag on the diabetic drug Avandia in 2000, claims that the drug manufacturer attempted to gag his criticism and quash his findings, to the point where a colleague refused to write prescriptions for Avandia because GlaxoSmithKline was giving his friend such a hard time. Worse, alleged...
  • Health Advocates Concerned as FDA Approves New Dosage Strength of Fosamax
    Jun-4-07 Washington, DC The FDA has approved a new dosage strength of Fosamax Plus D, despite an avalanche of lawsuits related to Fosamax and concerns among health advocates. Hundreds of lawsuits have been filed related to Fosamax, Merck & Co.'s best-selling drug and one of the most prescribed drugs to increase bone density in patients with osteoporosis. "Th...
  • SSRIs and Birth Defects: More Data Urgently Needed
    Jun-1-07 Atlanta, GA There is a problem out there for prospective mothers and fathers. The problem is that instead of being able to find good information on the interplay between SSRIs (a group of antidepressants including Zoloft, Paxil and Prozac) and safe pregnancy, there is a big black void. In its information on medication use during pregnancy and breastfe...
  • Battle of Device Maker Shelhigh and FDA Rages On Part I
    May-31-07 Newark, NJ: In a New Jersey court hearing on May 15, 2007, US District Court Judge William Martini informed medical device maker Shelhigh that it was unlikely that he will allow the release of any inventory seized by US Marshals at its Union City plant, after the FDA found "significant deficiencies in the company's manufacturing processes." A seizure...
  • High Anxiety over Avandia Report
    May-30-07 Washington, DC Even the United States Senate is getting involved in the worried reaction to the report published last Monday claiming the popular diabetes drug Avandia raises the risk and severity of heart attacks. On May 21 the New England Journal of Medicine reported that an analysis of 42 separate studies on the drug concluded that Avandia rais...
  • Lawmakers Want to End Big Pharma Recruitment Schemes - Part 1
    May-29-07 Washington, DC: Federal lawmakers are stepping up the pace to put a stop to the pharmaceutical industry's customer recruitment schemes used to boost the sale of psychiatric drugs by tugging at heartstrings in promoting mental health screening programs as suicide prevention tools. On May 18, 2007, US House of Representative Ron Paul (R-Texas), a physicia...
  • Zelnorm Canada: Life Goes on at Novartis
    May-27-07 Dorval, PQ In concert with the Food and Drug Administration in the United States (FDA), Health Canada took steps with Novartis Pharmaceuticals to ensure that sales and marketing of Zelnorm have been halted, and pharmacists are going so far as to contact patients in a bid to have the medication returned. In a memorandum to health care professionals d...
  • Protopic and Elidel Prescribed to Kids Despite Cancer Risk
    May-24-07 Rockville, MD When a significant side effect is linked to a drug, the Food and Drug Administration warns that the benefits of taking a drug should be weighed against the risks; however, in the cases of Elidel and Protopic , which have been linked to cancer, there is almost no way that the possible benefits could ever be greater than the risks. Now, law...
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