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Drug Headlines of 2011

Published on January 21, 2012 by Scott G. in *Featured, FDA, General Drug News & Safety

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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Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Published on December 23, 2011 by Scott G. in Kugel & Transvaginal Mesh

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

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Vaginal Mesh Lawsuits Scheduled for Trial in N.J. Ethicon/Gynecare Litigation

Published on November 19, 2011 by Scott G. in Kugel & Transvaginal Mesh

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

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President of DePuy Orthopedics, David Floyd, Has Submitted His Resignation

Published on August 19, 2011 by Scott G. in DePuy Hip

Posted August 15, 2011 by the InjuryBoard Blog When I first learned of the DePuy ASR hip implant recall, I recognized it for what it was: an absolute calamity. One in 8 of these devices would fail, according to the recall statement. Who would imagine such a faulty device being implanted in people’s bodies? And so many people – 93,000! Of those, roughly 12,000 patients would need a second surgery to replace the implant. But the news is getting worse – much, much worse. Almost half of one version of the devices are failing after six years. This is according to a report from two British orthopedists’ groups. Let me give you a brief review

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Johnson & Johnson Wins Second Trial Over Levaquin Claims

Published on June 23, 2011 by Scott G. in Carey & Danis, General Drug News & Safety

Posted June 21, 2011 on SF Chronicles June 17 (Bloomberg) – Johnson & Johnson properly warned of the risks of its antibiotic Levaquin and isn’t responsible for a tendon injury sustained by an 84-year-old man, a Minneapolis jury said. Calvin Christensen, who said he ruptured the Achilles tendon in his right foot after taking the drug while hospitalized with pneumonia, sued the company and its Ortho- McNeil Pharmaceutical unit in 2007. Christensen said the companies downplayed the risks of Levaquin to boost the drug’s sales. Johnson & Johnson denied any failure to warn and contended Christensen needed Levaquin to treat the pneumonia. The Minneapolis federal court jury rejected his claim today. Christensen was seeking unspecified

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Failure Rate of DePuy ASR XL Hip Implant Rising

Published on April 6, 2011 by Scott G. in DePuy Hip

Posted April 6, 2011 on PR NewsWire New study indicates that failure rate of the DePuy ASR XL may be as high as 49% after 6 years FORT WORTH, Texas, March 31, 2011 /PRNewswire/ — Recent information presented at the British Hip Society Annual Conference held from March 2 -4, 2011 indicates a rise in the failure rate of the DePuy ASR XL Acetabular Hip Replacement System which was manufactured and marketed by DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. The British Orthopaedic Association has released a summary of the results of the study presented, stating that the early failure rates “range from 21% revision rate at 4 years (potentially rising to 35%

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DePuy Hip Recall Filed in Australia

Published on March 1, 2011 by Scott G. in DePuy Hip

Posted February 28, 2011 on AboutLawsuits.com A class action lawsuit over the recalled DePuy ASR hip implant has been filed in Australia on behalf of 5,000 people due to design defects with the metal-on-metal hip replacement which may cause individuals to experience problems with their artificial hip within a few years after it is implanted. The DePuy hip recall class action suit was filed this week in Sydney Federal Court on behalf of lead plaintiff Tammy Stanford, who received a DePuy hip replacement in 2005, but had to undergo revision surgery in January. Doctors discovered that the bone in the area of the implant had degenerated and that Stanford suffered an inflamed hip joint and

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New DePuy Hip Implant Receives FDA Clearance

Published on February 27, 2011 by Scott G. in DePuy Hip

Posted February 26, 2011 on LAS Newswire Warsaw, IN: With DePuy hip replacement lawsuits piling up in Canada and the US, the unit of Johnson & Johnson recently received 510(k) clearance from the US Food and Drug Administration for use of a new titanium foam in two new implant systems. The DePuy GRIPTION TF Acetabular Augment System for hip replacements and the GRIPTION TF Cones for knee replacement surgery are the first implants to be manufactured from the technology. David Floyd, DePuy Orthopaedics’ worldwide president, said that the newly approved technology will be particularly useful in instances of complex joint replacements. “DePuy’s GRIPTION TF System features several unique advances to create customized intraoperative solutions for

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Depuy Hip Lawsuits Heating Up in Canada

Published on February 24, 2011 by Scott G. in DePuy Hip

Posted February 22, 2011 on Jane Mundy Saint John, New Brunswick: Several DePuy hip replacement victims in New Brunswick are the latest Canadians to join the DePuy Lawsuit against DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The company recalled its ASR series hip implants last August after receiving reports of patients requiring revision surgery shortly after having a DePuy ASR implanted. Hip replacements should last anywhere from 15–30 years, but a higher than normal number of patients have required revision surgery within a year or so after their implant. One such victim is 37-year-old Zoey Nicoles, who had a hip replacement in late 2009 due to injuries suffered in a car accident. He was

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DePuy Hip Replacement Recall: “They Waited Too Long”

Published on February 16, 2011 by Scott G. in DePuy Hip

Posted February 11, 2011 by Gordon Gibb Nashville, TN: Hip replacement patients in Tennessee who have reported DePuy Hip Replacement problems are the latest to join the wave of nationwide lawsuits alleging defects and flaws with the prosthetic hip devices. The Tennessean reported in January that about a dozen people from Middle Tennessee have joined the parade of litigants lined up to challenge DePuy Orthopaedics and its parent company, the gigantic Johnson & Johnson. The multi-million dollar lawsuits recently filed in US District Court in Nashville are akin to hundreds of similar lawsuits nationwide. Around the globe, upwards of 13,000 patients have either reported problems with their prosthetic hip device or risk experiencing pain and

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Posts Tagged ‘Johnson Johnson’:

Drug Headlines of 2011

Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Vaginal Mesh Lawsuits Scheduled for Trial in N.J. Ethicon/Gynecare Litigation

President of DePuy Orthopedics, David Floyd, Has Submitted His Resignation

Johnson & Johnson Wins Second Trial Over Levaquin Claims

Failure Rate of DePuy ASR XL Hip Implant Rising

DePuy Hip Recall Filed in Australia

New DePuy Hip Implant Receives FDA Clearance

Depuy Hip Lawsuits Heating Up in Canada

DePuy Hip Replacement Recall: “They Waited Too Long”

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