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approval 25 articles

FDA proposes new guidelines for approving diabetic blood glucose monitors

Federal regulators are proposing guidelines for approving diabetic blood glucose testing monitors to help distinguish between monitors sold over the counter and ones intended for professional use. The approval recommendations were made because, the Food and Drug Administration (FDA) said, the different types of devices pose different risks depending on whether they are used at home or in a medical setting. Blood glucose monitors designed for self-use should be easier to use and understand than those designed for use by medical professionals, the agency said. For example, patients are less likely to have the expertise or health to properly used more ... Read More

DePuy settles ASR metal hip complaint before trial start

Johnson & Johnson has settled a personal-injury lawsuit that accused its DuPuy Orthopaedics unit of manufacturing defective metal-on-metal hip replacement devices. The lawsuit had been selected as a bellwether case among several other cases DePuy faces over its ASR hip implants, and was destined for an October 15 trial in San Francisco Superior Court. In March, a Los Angeles jury ordered DePuy to pay Loren “Bill” Kransky, a retired prison guard, $8.3 million in damages for injuries he allegedly received from an all-metal ASR hip device made by DePuy. Mr. Krannsky’s case was chosen as the first of more than ... Read More

Lawyers ask FDA to investigate DePuy after alleged wrongdoing surfaces in ASR hip trials

Lawyers representing patients allegedly harmed by metal-on-metal hip implants have called upon the U.S. Food and Drug Administration (FDA) to investigate allegations of wrongdoing in DePuy Orthopedics, a division of Johnson & Johnson that manufactured and sold and subsequently recalled tens of thousands of defective metal ASR hips. The lawyers say new evidence emerged in testimony given during the first two bellwether personal-injury trials indicating DePuy broke federal laws when it concealed information that could have spared thousands of patients from injuries allegedly brought about by its ASR metal hip implants. That evidence had been sealed by court order until ... Read More

Canadian report reinforces dangers of metal-on-metal hip implants

Hip-replacement patients fitted with all-metal large-diameter modular implants, such as DePuy’s ASR hip devices, are more than three times likely to need to need their devices replace prematurely, according to a new report by the Canadian Institute for Health information (CIHI). While the Canadian report doesn’t shed new light on the risks many metal-on-metal hip devices pose, it echoes the findings of many previous studies and reports that have found certain types of all-metal hip implants are, by design, prone to fail early and injure the patient. The CIHI based its conclusions on voluntary data for 56,942 hip-replacement surgeries performed ... Read More

Lady Gaga reveals she was close to needing a full hip replacement

Lady Gaga was possibly one performance away from needing a full hip replacement after an injury forced her to postpone, then cancel, the remaining 22 gigs on her Born This Way Ball tour, the artist revealed in a recent interview. In February, Gaga’s tour company announced that she suffered from a “labral tear of the right hip,” which is essentially a tear of the cartilage that forms the outside socket of the hip joint. A labral tear is usually painful and immobilizing, but Gaga’s case turned out to be exceptionally severe, she told Women’s Wear Daily. “My injury was actually ... Read More

First New Jersey case alleging DePuy ASR hip injuries to start in October

The first of several hundred ASR-hip lawsuits filed in New Jersey state courts against DePuy Orthopedics and parent company Johnson & Johnson has been scheduled to start October 21. The bellwether case, selected as a representative case to help the court and litigants understand how the rest of the litigation will proceed, will be heard before Judge Brian Marinotti in the Superior Court of New Jersey for Bergen County. More than 600 lawsuits against DePuy alleging injuries from its ASR metal hip implants are pending in New Jersey, where they have been consolidated for Multi-County Litigation (MCL). Johnson & Johnson ... Read More

Judge upholds $8.3-million verdict against DePuy in first ASR hip implant trial

A Los Angeles Superior Court judge has upheld an $8.3-million verdict in favor of plaintiff Loren “Bill” Kransky, the first plaintiff to have his case tried against DePuy Orthopedics over its faulty ASR hip implants. DePuy and parent company Johnson & Johnson asked Judge J. Stephen Czuleger to overturn the jury’s March decision awarding Mr. Kransky, a retired South Dakota prison guard, $8.3 million for severe and extensive injuries that he alleged stemmed from a DePuy ASR metal-on-metal hip implant. Judge Czuleger said that sufficient evidence had been demonstrated that DePuy’s ASR hips were defectively designed. Mr. Kransky, 66, had ... Read More

FDA strengthens Depakote warnings over cognitive risks to unborn children

The U.S. Food and Drug Administration (FDA) is warning childbearing women and their doctors to avoid using Depakote and other drugs containing valproate commonly used to treat migraine headaches after the final results of a study showed the drugs could lower the IQ of unborn children. “Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, M.D., director of neurology drugs in the FDA’s Center for Drug Evaluation and Research. Depakote ... Read More

Judge moves second DePuy hip bellwether trial to September

A federal judge overseeing multidistrict litigation (MDL) involving all-metal ASR hip implants made by DePuy Orthopedics has moved the second bellwether trial from June to September. Judge David Katz, who is presiding over thousands of DePuy lawsuits consolidated in U.S. District Court for the Northern District of Ohio, filed a trial order on April 22 pushing back the case brought by plaintiff Ann McCracken, a 57-year-old single mother and business owner. Proceedings for the first bellwether case were scheduled to start June 3. The U.S. judicial system uses bellwether trials to represent the larger body of litigation when the number ... Read More

New study finds significant link between Depakote use and birth defects

A new study published in an international neurology journal has found “statistically significant associations” between valproate drugs such as Depakote (valproic acid) and spina bifida, as well as malformations of the heart, great vessels, digits, skull bones, and brain. The study, published March 6 in the international neurology journal Acta Neurologica Scandinavica, underscores concerns that Depakote exposure, especially in childbearing women, can interrupt fetal development and lead to a spectrum of birth defects. Another recent study, published in the Lancet Neurology journal in January, linked Depakote exposure prior to birth to lower average IQs in children. Researchers found that the higher ... Read More