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U.S. food and drug administration 60 articles

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

New Jersey medical manufacturer ceases production after mold is found in its intravenous drugs

A U.S. District Judge has shuttered a New Jersey-based manufacturer of medical products for manufacturing and distributing contaminated drugs and other products and for failing to meet the minimum federal standards for safety and current good manufacturing practice requirements, the U.S. Justice Department said in a statement. Med Prep Consulting Inc. of Tinton Falls, N.J., was ordered to halt production after a Connecticut hospital discovered intravenous drugs containing visible contaminants and reported the products to the U.S. Food and Drug Administration (FDA). FDA officials investigated and found the injectable drugs contained mold. Med Prep manufactures a range of drug products ... 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

U.S., FDA sue Louisiana company for making and selling unapproved prescription drugs

A Shreveport, La., pharmaceutical company has been manufacturing and distributing unapproved and misbranded drug products for several years, even though U.S. Food and Drug Administration (FDA) inspectors discovered unlawful business practices within the company 13 years ago. According to the U.S. Justice Department, Sage Pharmaceuticals Inc. has ignored numerous FDA warnings to bring its drug and wound-treatment products into compliance with U.S. regulations. The U.S. government first obtained an injunction against the company in 2000, banning it from making and selling two new drugs that were never approved by the FDA. Since that time, however, FDA inspectors found that Sage ... 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

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

Five years of Actos likely caused plaintiff’s terminal bladder cancer, doctor testifies

A University of Chicago Medical Center urologist told a Los Angeles jury last week that Takeda Pharmaceuticals’ type-2 diabetes drug Actos was “the most substantial causative factor” in a California man’s development of terminal bladder cancer. The doctor’s testimony was part of the first product liability case against Takeda to go to trial over injuries allegedly caused by the blockbuster drug. Plaintiff Jack Cooper, a 79-year-old San Diego area resident, sued Japan-based Takeda after taking Actos for a five-year period from 2006 to 2011. His lawsuit against Takeda was selected as the first of more than 3,000 similar cases to ... Read More

DePuy’s ASR hip implant caused plaintiff’s bone decay, surgeon tells jury

An orthopedic surgeon testifying on behalf of a woman who alleges she was injured by ASR metal hip implants manufactured by DePuy Orthopedics told jurors in the Circuit Court of Cook County, Illinois, that metal debris from the hip devices “absolutely” caused the plaintiff to suffer from bone decay. DePuy is a subsidiary of Johnson & Johnson. Surgeon Tony Nargol, who has warned about the dangers of metal-on-metal hip implants such as DePuy’s ASR devices, particularly to women, told jurors that plaintiff Carol Strum’s calcar bone had been “eaten away” near the ASR hip device she had implanted in in ... Read More