http://lawsuitinformation.org Pharmaceutical Product Liability News Sat, 21 Jan 2012 14:00:12 +0000 en hourly 1 http://wordpress.org/?v=3.3.1 http://lawsuitinformation.org/drug-headlines-of-2011-2466 http://lawsuitinformation.org/drug-headlines-of-2011-2466#comments Sat, 21 Jan 2012 14:00:12 +0000 Scott G. http://lawsuitinformation.org/?p=2466
Posted December 20, 2011 by The Scientist A list of this year’s newsworthy successes—and failures—in drug development Developing new medicines is tricky business, requiring sound science, regulatory savvy, and marketing skills. The past year has seen success and failure in all these realms. Here, The Scientist recounts some of the noteworthy drug developments of 2011. Notable Drug Approvals: First new lupus drug in 52 years After more than 18 years of development, the US Food and Drug Administration (FDA) approved the first drug to treat lupus in more than a half-century. Benlysta (belimumab) is a human monoclonal antibody, produced by Human Genome Sciences and GlaxoSmithKline, that cuts B-cells proliferation, a proposed mechanism underlying the autoimmune

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Posted January 9, 2012 by The Scientist The FDA approved 30 drugs last year, the highest number in the last 7 years. The US Food and Drug Administration approved 30 drugs in 2011, compared with 21 in 2010, according to an analysis by Bloomberg News. That number is the highest since 36 drugs were approved in 2004. Some of the headline drugs to get the green light include Yervoy, a drug that primes the immune system to attack melanoma; Xarelto, which reduces clotting for patients with irregular heartbeats; and Benlysta, the first lupus drug approved in 50 years. The FDA toughened its data requirements in 2007, after critics faulted its response to claims of heart

[Continue Reading]]]> http://lawsuitinformation.org/drug-approvals-up-for-2011-2463/feed 0 http://lawsuitinformation.org/faulty-implants-dodgy-drugs-and-a-toothless-watchdog-thats-failing-patients-2461 http://lawsuitinformation.org/faulty-implants-dodgy-drugs-and-a-toothless-watchdog-thats-failing-patients-2461#comments Fri, 20 Jan 2012 17:00:14 +0000 Scott G. http://lawsuitinformation.org/?p=2461
Posted January 10, 2012 by MailOnline Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely. It struck him as highly unusual. ‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says. But these implants had failed after only two to three years, and the patients had not been involved in any impact.’ All the implants were made by the French firm Poly Implant Prothese (PIP).

[Continue Reading]]]> http://lawsuitinformation.org/faulty-implants-dodgy-drugs-and-a-toothless-watchdog-thats-failing-patients-2461/feed 0 http://lawsuitinformation.org/jj-c-r-bard-must-study-safety-of-vaginal-mesh-fda-says-2459 http://lawsuitinformation.org/jj-c-r-bard-must-study-safety-of-vaginal-mesh-fda-says-2459#comments Fri, 20 Jan 2012 14:00:33 +0000 Scott G. http://lawsuitinformation.org/?p=2459

[Continue Reading]]]> http://lawsuitinformation.org/jj-c-r-bard-must-study-safety-of-vaginal-mesh-fda-says-2459/feed 0 http://lawsuitinformation.org/coming-out-from-the-shadow-of-paxil-birth-defects-2457 http://lawsuitinformation.org/coming-out-from-the-shadow-of-paxil-birth-defects-2457#comments Thu, 19 Jan 2012 21:00:15 +0000 Scott G. http://lawsuitinformation.org/?p=2457
Posted December 13, 2011 by Gordon Gibb Washington, DC: Anyone sitting on the fence over whether or not to go after GlaxoSmithKline (Glaxo) over Paxil side effects need only contemplate the reported $3 billion that Glaxo has agreed in principal to pay, in order to settle charges of off-label marketing and fraud. Combine that figure with the reported $1 billion Glaxo is believed to have paid out last year to settle many a Paxil lawsuit, and suddenly we are talking about amounts of money so vast, it's beyond comprehension for most. Four billion dollars would buy more than 1,300 very nice cars, at about $30,000 each. People with vehicles about to fall apart would be

[Continue Reading]]]> http://lawsuitinformation.org/coming-out-from-the-shadow-of-paxil-birth-defects-2457/feed 0 http://lawsuitinformation.org/lights-out-for-bayers-yaz-2454 http://lawsuitinformation.org/lights-out-for-bayers-yaz-2454#comments Thu, 19 Jan 2012 17:00:05 +0000 Scott G. http://lawsuitinformation.org/?p=2454
Posted January 6, 2012 by InjuryBoard Bayer AG, Germany’s largest drugmaker, blinked and swallowed hard, at the end of December, when it begged the Court overseeing the YAZ litigation. ayer managed to avoid the first trial which was set to start January 9th, over claims its birth-control pills caused blood clots after Judge Hearndon appointed a mediator in hopes of settling the cases. The plaintiffs were opposed to the setting of a mediator and wanted their day in court. Mediation Ordered U.S. District Judge David Herndon in Illinois postponed the January 9th trial of a lawsuit which alleged that Bayer mislead women about the health risks of its Yasmin family of birth-control pills. The case

[Continue Reading]]]> http://lawsuitinformation.org/lights-out-for-bayers-yaz-2454/feed 0 http://lawsuitinformation.org/fda-announces-10-drugs-with-severe-birth-defect-warnings-2469 http://lawsuitinformation.org/fda-announces-10-drugs-with-severe-birth-defect-warnings-2469#comments Thu, 19 Jan 2012 14:46:23 +0000 Scott G. http://lawsuitinformation.org/?p=2469

[Continue Reading]]]> http://lawsuitinformation.org/fda-announces-10-drugs-with-severe-birth-defect-warnings-2469/feed 0 http://lawsuitinformation.org/parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft-2452 http://lawsuitinformation.org/parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft-2452#comments Thu, 19 Jan 2012 14:02:48 +0000 Scott G. http://lawsuitinformation.org/?p=2452

[Continue Reading]]]> http://lawsuitinformation.org/parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft-2452/feed 0 http://lawsuitinformation.org/judge-rules-against-gsk-in-paxil-mass-tort-2436 http://lawsuitinformation.org/judge-rules-against-gsk-in-paxil-mass-tort-2436#comments Fri, 23 Dec 2011 21:07:01 +0000 Scott G. http://lawsuitinformation.org/?p=2436

[Continue Reading]]]> http://lawsuitinformation.org/judge-rules-against-gsk-in-paxil-mass-tort-2436/feed 0 http://lawsuitinformation.org/antidepressants-used-by-11-percent-of-americans-2210 http://lawsuitinformation.org/antidepressants-used-by-11-percent-of-americans-2210#comments Fri, 23 Dec 2011 20:20:05 +0000 Scott G. http://lawsuitinformation.org/?p=2210
Posted December 22, 2011 by Seattle Times The woman leaning against a pillar didn't know more Americans — twice as many — take antidepressants than go to movie theaters weekly. She hadn't heard that a federal study found the meds are used by 23 percent of middle-aged women — almost one in four. But she knows Prozac. "Good stuff," she said, remembering how it helped her deal with a splintering marriage. Data released by the U.S. Centers for Disease Control and Prevention in November showed that 11 percent of Americans ages 12 and older used Prozac, Zoloft, Paxil or other antidepressants. Women were prescribed the pills more than men, according to national surveys that asked

[Continue Reading]]]> http://lawsuitinformation.org/antidepressants-used-by-11-percent-of-americans-2210/feed 0 http://lawsuitinformation.org/united-states-joint-committee-wants-limit-on-the-use-of-vaginal-mesh-products-2206 http://lawsuitinformation.org/united-states-joint-committee-wants-limit-on-the-use-of-vaginal-mesh-products-2206#comments Fri, 23 Dec 2011 19:39:27 +0000 Scott G. http://lawsuitinformation.org/?p=2206

[Continue Reading]]]> http://lawsuitinformation.org/united-states-joint-committee-wants-limit-on-the-use-of-vaginal-mesh-products-2206/feed 0 http://lawsuitinformation.org/dangerous-injuries-caused-by-transvaginal-meshes-and-other-pelvic-mesh-bladder-slings-2204 http://lawsuitinformation.org/dangerous-injuries-caused-by-transvaginal-meshes-and-other-pelvic-mesh-bladder-slings-2204#comments Fri, 23 Dec 2011 19:35:10 +0000 Scott G. http://lawsuitinformation.org/?p=2204
Posted December 23, 2011 by InjuryBoard Sometimes as we age, our bodies don't function like they once did. Women of any age can experience pelvic organ prolapse (POP) which causes pelvic organs to fall into the vaginal wall(s) causing discomfort, difficulty urinating and other problems. Specifically, women who have gone through a difficult delivery or have delivered a large baby may experience such a problem. Some time ago, various manufacturers developed a product to assist women experiencing this problem - a mesh to hold the pelvic organs in the proper place. The following is a list of such mesh products: Boston Scientific Uphold and Pinnacle Pelvic Floor Repair Kits, Gynecare (Ethicon) Prolift Anterior, Perigee and

[Continue Reading]]]> http://lawsuitinformation.org/dangerous-injuries-caused-by-transvaginal-meshes-and-other-pelvic-mesh-bladder-slings-2204/feed 0 http://lawsuitinformation.org/vaginal-mesh-lawsuits-have-senate-seeking-increased-safety-measures-2201 http://lawsuitinformation.org/vaginal-mesh-lawsuits-have-senate-seeking-increased-safety-measures-2201#comments Fri, 23 Dec 2011 19:29:49 +0000 Scott G. http://lawsuitinformation.org/?p=2201
Posted December 21, 2011 by OpenPR (openPR) - Los Angeles, CA, December 20, 2011 – Nadrich & Cohen LLP reports that the U.S. Senate has proposed a new piece of legislation aimed at reducing the number of consumers who suffer serious injuries caused by a defective medical device. The bill, which would require manufacturers to conduct ongoing safety studies of these devices after obtaining FDA approval, was drafted in part as a response to the growing number of lawsuits filed against the makers of problematic vaginal mesh implants. Currently, the Food and Drug Administration allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers need only to demonstrate that

[Continue Reading]]]> http://lawsuitinformation.org/vaginal-mesh-lawsuits-have-senate-seeking-increased-safety-measures-2201/feed 0 http://lawsuitinformation.org/fda-issues-warning-for-drug-alleged-to-cause-elon-students-death-1906 http://lawsuitinformation.org/fda-issues-warning-for-drug-alleged-to-cause-elon-students-death-1906#comments Mon, 21 Nov 2011 22:41:39 +0000 Scott G. http://lawsuitinformation.org/?p=1906

[Continue Reading]]]> http://lawsuitinformation.org/fda-issues-warning-for-drug-alleged-to-cause-elon-students-death-1906/feed 0 http://lawsuitinformation.org/birth-control-pill-subject-of-thousands-of-lawsuits-1904 http://lawsuitinformation.org/birth-control-pill-subject-of-thousands-of-lawsuits-1904#comments Mon, 21 Nov 2011 22:39:22 +0000 Scott G. http://lawsuitinformation.org/?p=1904
Posted October 7, 2011 by News Junky More than 7500 lawsuits are pending in various state and federal courts as a result of blood clots and gallbladder injury that allegedly resulted from the use of Bayer Pharmaceutical’s Yaz and Yasmin birth control pill products, according to Brenda Fulmer, a partner at the Florida law firm of Searcy Denney Scarola Barnhart & Shipley. In an interview with Dr. Daniel Heller, founder of PMS Comfort, an e-commerce brand dedicated to helping women learn about PMS (premenstrual syndrome) and PMDD (premenstrual dysphoric disorder), Ms. Fulmer pointed out that the number of serious medical incidents allegedly resulting from the use of these medications may be even higher than the

[Continue Reading]]]> http://lawsuitinformation.org/birth-control-pill-subject-of-thousands-of-lawsuits-1904/feed 0 http://lawsuitinformation.org/club-foot-a-frequent-potential-paxil-birth-defect-1902 http://lawsuitinformation.org/club-foot-a-frequent-potential-paxil-birth-defect-1902#comments Mon, 21 Nov 2011 22:35:28 +0000 Scott G. http://lawsuitinformation.org/?p=1902
Posted November 17, 2011 by Articlesnatch Just like other antidepressants that are similar to it, Paxil has its own list of potential side effects. Paxil has been known to cause heart defects in the fetus, women who are in their first trimester are the most at risk for this type of birth defects The most common birth defect potentially caused by Paxil is club foot. Club foot, also known as congenital talipes equinovarus (CTEV), is a congenital deformity involving one foot or both. The affected foot appears rotated internally at the ankle. Currently there are to groups that TEV can be classified in: Postural TEV or Structural TEV. Without treatment, persons afflicted often appear to

[Continue Reading]]]> http://lawsuitinformation.org/club-foot-a-frequent-potential-paxil-birth-defect-1902/feed 0 http://lawsuitinformation.org/lawyers-lobby-and-donate-to-koster-1899 http://lawsuitinformation.org/lawyers-lobby-and-donate-to-koster-1899#comments Mon, 21 Nov 2011 22:28:21 +0000 Scott G. http://lawsuitinformation.org/?p=1899
Posted November 6, 2011 by STL Today JEFFERSON CITY • For months, a group of New Mexico lawyers lobbied Missouri Attorney General Chris Koster to let them sue, on behalf of the state, the makers of a diabetes drug linked to increased risk of heart disease. The lawyers visited Jefferson City in October 2010, sent the attorney general's office multiple emails and even prepared a 45-page draft lawsuit with Koster's name already on it. Koster finally opened up the bidding for lawyers to represent the state in a lawsuit over the drug — after the New Mexico lawyers donated $25,000 to his re-election campaign. Now, more than 20 groups of lawyers from around the country

[Continue Reading]]]> http://lawsuitinformation.org/lawyers-lobby-and-donate-to-koster-1899/feed 0 http://lawsuitinformation.org/proposed-avandia-settlement-would-pay-u-s-3b-for-off-label-marketing-1897 http://lawsuitinformation.org/proposed-avandia-settlement-would-pay-u-s-3b-for-off-label-marketing-1897#comments Mon, 21 Nov 2011 22:23:16 +0000 Scott G. http://lawsuitinformation.org/?p=1897
Posted November 7, 2011 by About Lawsuits GlaxoSmithKline and the federal government have reached a tentative $3 billion settlement over Avandia marketing charges, alleging that the company promoted the controversial and dangerous diabetes drug for uses that were not approved by the FDA or determined to be safe and effective. The Avandia settlement was announced on Thursday in a statement by Glaxo officials, who said they expect to finalize terms of the agreement next year, along with other cases that it defines as its most significant U.S. liabilities. If approved, the blockbuster settlement would be the largest ever for a drug company accused of illegal marketing. The U.S. Department of Justice (DOJ) has accused GlaxoSmithKline

[Continue Reading]]]> http://lawsuitinformation.org/proposed-avandia-settlement-would-pay-u-s-3b-for-off-label-marketing-1897/feed 0 http://lawsuitinformation.org/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1895 http://lawsuitinformation.org/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1895#comments Mon, 21 Nov 2011 22:19:27 +0000 Scott G. http://lawsuitinformation.org/?p=1895
Posted November 11, 2011 by Bloomberg Nov. 8 (Bloomberg) -- GlaxoSmithKline Plc, which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication. U.S. District Judge Cynthia Rufe said yesterday she appointed a mediator to “preside over settlement negotiations” for an unspecified number of Avandia cases consolidated before her in Philadelphia. Rufe set a 75-day deadline to resolve 85 percent of the remaining cases, according to court filings. “If we don’t make it within the time period, the judge will start fast-tracking cases for trial,” said Paul Kiesel, a lawyer representing California residents

[Continue Reading]]]> http://lawsuitinformation.org/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1895/feed 0 http://lawsuitinformation.org/avandia-injury-lawsuit-settlement-negotiations-continue-1892 http://lawsuitinformation.org/avandia-injury-lawsuit-settlement-negotiations-continue-1892#comments Mon, 21 Nov 2011 22:15:06 +0000 Scott G. http://lawsuitinformation.org/?p=1892

[Continue Reading]]]> http://lawsuitinformation.org/avandia-injury-lawsuit-settlement-negotiations-continue-1892/feed 0 http://lawsuitinformation.org/gsk-breaks-record-with-3-billion-penalty-for-illegal-drug-marketing-1889 http://lawsuitinformation.org/gsk-breaks-record-with-3-billion-penalty-for-illegal-drug-marketing-1889#comments Mon, 21 Nov 2011 22:11:33 +0000 Scott G. http://lawsuitinformation.org/?p=1889
Posted November 5, 2011 by All Gov A pharmaceutical giant has broken yet another record for legal settlements stemming from claims of illegally marketing drugs and defrauding federal healthcare programs. GlaxoSmithKline (GSK) said this week that it would pay $3 billion to resolve federal government civil and criminal investigations into its sales practices for numerous drugs. The cases included allegations of illegal selling of Avandia, a diabetes drug linked to heart risks, as well as paying doctors and manipulating medical research to promote the drug. The $3 billion also will settle a Justice Department probe into GSK’s Medicaid pricing practices and an investigation led by the U.S. attorneys in Colorado and Massachusetts into the sales

[Continue Reading]]]> http://lawsuitinformation.org/gsk-breaks-record-with-3-billion-penalty-for-illegal-drug-marketing-1889/feed 0 http://lawsuitinformation.org/fda-issues-new-warnings-about-risks-of-vaginal-mesh-1887 http://lawsuitinformation.org/fda-issues-new-warnings-about-risks-of-vaginal-mesh-1887#comments Mon, 21 Nov 2011 22:07:08 +0000 Scott G. http://lawsuitinformation.org/?p=1887
Posted November 5, 2011 by 24-7 PR Recent warnings and requests by consumer advocates to recall vaginal mesh highlight the dangers of the transvaginal placement of surgical mesh. The costs to patients may far outweigh any benefits and the FDA is warning doctors to fully inform patients of the risks prior to completing TVM surgery. November 05, 2011 /24-7PressRelease/ -- Warning that the risks outweigh the benefits of the transvaginal placement of surgical mesh, the Food and Drug Administration (FDA) advised potential patients to fully consider all options and risks before undergoing the procedure to correct pelvic organ prolapsed (POP) or stress urinary incontinence (SUI). Among the risks of transvaginal mesh (TVM) is the possibility

[Continue Reading]]]> http://lawsuitinformation.org/fda-issues-new-warnings-about-risks-of-vaginal-mesh-1887/feed 0 http://lawsuitinformation.org/vaginal-mesh-lawsuits-scheduled-for-trial-in-n-j-ethicongynecare-litigation-1879 http://lawsuitinformation.org/vaginal-mesh-lawsuits-scheduled-for-trial-in-n-j-ethicongynecare-litigation-1879#comments Sat, 19 Nov 2011 23:28:41 +0000 Scott G. http://lawsuitinformation.org/?p=1879
Posted November 9, 2011 by About Lawsuits The first Ethicon Gynecare pelvic mesh lawsuits are scheduled to go before a jury near the end of next year in New Jersey state court. Judge Carol E. Higbee, who is overseeing the consolidated Ethicon vaginal mesh lawsuits in New Jersey Superior Court, has scheduled the first of a number of Ethicon Gynecare test cases, known as bellwether trials, to begin in November 2012. Preliminary discovery for cases being prepared for early trial dates is to be completed by March 30, and expert witnesses are to be deposed by October 5, according to a scheduling order Judge Higbee issued on October 28. More than 350 lawsuits over Ethicon

[Continue Reading]]]> http://lawsuitinformation.org/vaginal-mesh-lawsuits-scheduled-for-trial-in-n-j-ethicongynecare-litigation-1879/feed 0 http://lawsuitinformation.org/judge-blocks-confidential-yaz-litigation-files-from-going-to-fda-1861 http://lawsuitinformation.org/judge-blocks-confidential-yaz-litigation-files-from-going-to-fda-1861#comments Fri, 18 Nov 2011 20:55:53 +0000 Scott G. http://lawsuitinformation.org/?p=1861

[Continue Reading]]]> http://lawsuitinformation.org/judge-blocks-confidential-yaz-litigation-files-from-going-to-fda-1861/feed 0 http://lawsuitinformation.org/could-actos-suffer-the-similar-fate-of-avandia-1856 http://lawsuitinformation.org/could-actos-suffer-the-similar-fate-of-avandia-1856#comments Fri, 18 Nov 2011 20:51:43 +0000 Scott G. http://lawsuitinformation.org/?p=1856
Posted November 17, 2011 by Injury Board Effective today, the diabetes drug Avandia will only be available through certified mail-order pharmacies. These new restrictions are designed to limit the number of people exposed to potential heart side effects of Avandia. The FDA allowed Avandia to remain on the market last year, subject to a new risk evaluation and mitigation strategy (REMS). This special program limits sales of the medication to mail order and requires educational programs before it can be prescribed. Today, is the last day Avandia will be available on retail pharmacy shelves. To continue receiving the medication after this week, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program. These

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