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FDA Clears Bair Hugger for Post-Surgical Use

FDA Clears Bair Hugger for Post-Surgical Use September 12, 2017. By Lucy Campbell.
Washington, DC: 3M’s , Bair Hugger, the subject of some 2600 defective products lawsuits across the US, has received clearance for use from the US Food and Drug Administration (FDA). According to a spokesperson for the FDA, the agency has no conclusive evidence to establish an association between use of a forced air thermal regulating systems and an increased risk of surgical-site infections.
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$300M Benicar Settlement Reached

$300M Benicar Settlement Reached August 3, 2017. By Lucy Campbell.

Santa Clara, CA: The makers of the controversial blood pressure medication, Benicar, have agreed a $300 million settlement potentially ending multi-district litigation (MDL) that claims the drug caused gastrointestinal injuries. Forest Laboratories Inc., and Daiichi Sankyo Inc., and about 2,300 plaintiffs in the MDL reached the agreement earlier this week. The settlement addresses claims filed collectively in state and federal court. The plaintiffs alleged personal injury stemming from defective design of Benicar (known generically as olmesartan), which is also in blood pressure products Benicar HCT, Azor and Tribenzor.

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Women Speak Out About Essure Health Problems

Women Speak Out About Essure Health Problems July 31, 2017. By Lucy Campbell.
Santa Clara, An in-depth investigative piece in the Washington Post highlights the considerable adverse health effects, even pregnancies, that thousands of women have experienced and continue to experience as a result of having Bayer’s Essure contraceptive devices implanted.
Read [ Women Speak Out About Essure Health Problems ]

ED-530XT Duodenoscopes Recalled

ED-530XT Duodenoscopes Recalled July 21, 2017. By Lucy Campbell.
Santa Clara, CA: An urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria.
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Party Animal “Cocolicious” Dog Food Subject of Class Action

Party Animal “Cocolicious” Dog Food Subject of Class Action July 1, 2017. By Brenda Craig.
Pasadena, CA Two companies involved in the manufacture and distribution of an upscale dog food known as “Cocolicious” are the subject of a class action lawsuit filed in Los Angeles County Court. The suit alleges Party Animal Inc. of California and Evanger’s Dog and Cat Food Company of Illinois are responsible for selling cans of Party Animal dog food that, according to a Texas A&M testing of the dog food, contained the animal euthanasia drug pentobarbital.
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Judge Approves $67MM Settlement in BP Defective Product Class Action Lawsuit

Judge Approves $67MM Settlement in BP Defective Product Class Action Lawsuit February 3, 2017. By LAS Staff Writer.
Danville, CA: On December 22, 2016, U.S. District Court Judge Susan Illston granted final approval of a nationwide class action settlement between BP Solar International, Inc. and an estimated 8,000 class members. The effective date of the settlement was January 23, 2017, allowing for the distribution of settlement benefits to class members. There are two settlement categories. The first is a $45.33 million common fund to pay for the removal and replacement of a subset of Class Panels (Category 1), which have a high failure rate. The second is a separate $20 million claims made fund for the remaining subset of Class Panels (Category 2), which have a demonstrated lower failure rate. Additional details about the settlement is available at www.bpsolarsettlement.com.
Read [ Judge Approves $67MM Settlement in BP Defective Product Class Action Lawsuit ]

Older Model Duodenoscopes Pulled from Market

Older Model Duodenoscopes Pulled from Market January 13, 2017. By Lucy Campbell.
Santa Clara, CA: Fuji, the maker of allegedly defective duodenoscopes, has announced it plans to remove its legacy 250/450 duodenoscope models from clinical use. The decision is reportedly based on the limited number of duodenoscopes currently in use, not because of a known safety risk, and noted that it has not received any recent reports of adverse events associated with these scopes.
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$13.7M Ethicon Vaginal Mesh Award Should Stand

$13.7M Ethicon Vaginal Mesh Award Should Stand January 6, 2017. By Lucy Campbell.
Santa Clara, CA: A $13.7 million judgement in favor of a plaintiff who has sued Johnson & Johnson’s subsidiary Ethicon, over injuries related to Ethicon's mid-urethral sling device, should not be reversed on appeal. That’s the opinion of Philadelphia Court of Common Pleas Judge Kenneth J. Powell Jr., who is presiding over the case and who wrote "The evidence of defendant-appellant's wanton and willful disregard for plaintiff adequately supported the jury's award of punitive damages."
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FDA Mandates New Study and Warnings on Labels for SGLT2 Inhibitors

FDA Mandates New Study and Warnings on Labels for SGLT2 Inhibitors December 7, 2015. By Lucy Campbell.
Washington, DC: A review by the US Food and Drug Administration (FDA) of specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors, has resulted in the agency adding warnings to the labels concerning the risks for serious urinary tract infections (UTIs) too much acid in the blood. Both these conditions can result in hospitalization.
Read [ FDA Mandates New Study and Warnings on Labels for SGLT2 Inhibitors ]

FBI Investigating J&J over Power Morcellator

FBI Investigating J&J over Power Morcellator May 28, 2015. By Lucy Campbell.
San Francisco, CA Johnson & Johnson, the maker of a highly controversial surgical instrument known as a power morcellator, is under investigation by the FBI. Specifically, the Federal Bureau of Investigation is trying to determine if J&J kept selling the devices after it was discovered it could spread a type of cancer.
Read [ FBI Investigating J&J over Power Morcellator ]

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