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Was the FDA Aware of Migration Risk Prior to Implanon Approval?

Was the FDA Aware of Migration Risk Prior to Implanon Approval? December 29, 2016. By Gordon Gibb.
Washington, DC: Anyone doing an online search for 'Implanon' will immediately be led to a site index where consumers will find links to both patient information intended for consumers, and prescribing information intended for doctors. And while there appears to be no indication as to if, and when the latter may have been updated, the patient document intended for consumers is identified as having been updated with regard to Implanon usage and Implanon birth control side effects in March of this year.
Read [ Was the FDA Aware of Migration Risk Prior to Implanon Approval? ]

Stockert 3T System “No Easy Fix” and the FDA’s Catch-22

Stockert 3T System “No Easy Fix” and the FDA’s Catch-22 December 27, 2016. By Jane Mundy.
Washington, DC: Reports from both the US and Germany have identified the M chimaera contamination of  heater/cooler devices, of which 60 to 70 percent stem from the Stockert 3T heater-cooler system. But controlling the infection is challenging—to say the least.
Read [ Stockert 3T System “No Easy Fix” and the FDA’s Catch-22 ]

Stryker Hip Settlement Expanded

Stryker Hip Settlement Expanded December 27, 2016. By Heidi Turner.
New York, NY: Patients who had certain Stryker hip replacements implanted but found themselves ineligible for the 2014 Stryker hip settlement received some good news. Those patients who had the Stryker ABG II Modular Neck Hip Stem and Rejuvenate Modular Neck Hip Stem implanted from 2014 to December 19, 2016, are now eligible to take part in the 2014 settlement. The announcement does not affect the Accolade TMZF, but settlements in lawsuits concerning other hip replacement devices could indicate a willingness to settle Accolade claims.
Read [ Stryker Hip Settlement Expanded ]

Will FDA Guidance Help Stem Endoscope Lawsuits Going Forward?

Will FDA Guidance Help Stem Endoscope Lawsuits Going Forward? December 26, 2016. By Gordon Gibb.
Washington, DC: This past year has been rife with reports of infections linked to endoscopes and / or duodenoscopes; devices used for diagnostic endoscopic procedures which are intended to be cleaned and re-used. However, many an endoscope lawsuit over the past year have asserted that such devices are either not cleaned and disinfected properly, or feature design flaws that suggest a thorough disinfection is practically impossible.
Read [ Will FDA Guidance Help Stem Endoscope Lawsuits Going Forward? ]

Ten Long Years: Transvaginal Mesh Victim Finally gets Justice

Ten Long Years: Transvaginal Mesh Victim Finally gets Justice December 26, 2016. By Jane Mundy.
Newark, NJ:Finally, Linda Gross’ transvaginal mesh case is over, after J&J can no longer appeal the verdict that awarded her more than $11 million in damages for her TVM injuries.
Read [ Ten Long Years: Transvaginal Mesh Victim Finally gets Justice ]

Surgical Mesh Lawsuit to Proceed

Surgical Mesh Lawsuit to Proceed December 23, 2016. By Gordon Gibb.
Providence, RI: A Rhode Island man who received recalled abdominal mesh just prior to a product recall in 2005, will see his surgical mesh lawsuit go forward after a Rhode Island judge refused to dismiss the case.
Read [ Surgical Mesh Lawsuit to Proceed ]

Taxotere Hair Loss: a Look Back at 2016

Taxotere Hair Loss: a Look Back at 2016 December 22, 2016. By Gordon Gibb.
Washington, DC: The close of another year affords an opportunity to look back and review the various events that characterized the legal implications of Taxotere hair loss over the past year.
Read [ Taxotere Hair Loss: a Look Back at 2016 ]

C.R. Bard Reveals Latest Litigation Cases in SEC Filing

C.R. Bard Reveals Latest Litigation Cases in SEC Filing December 22, 2016. By Gordon Gibb.
Murray Hill, NJ: Performance filings with the US Securities and Exchange Commission (SEC) are informative in more ways than one, as documents often reveal the state of a corporation’s liability and litigation threats. Such is the case with C.R. Bard Inc. (C.R. Bard), a noted manufacturer of inferior vena cava filters that has been targeted with a rash of IVC Filter lawsuits.
Read [ C.R. Bard Reveals Latest Litigation Cases in SEC Filing ]

Three Points for Alere INRatio Device

Three Points for Alere INRatio Device December 21, 2016. By Jane Mundy.
Dallas, TX: Negligence allegations against Janssen Pharmaceuticals, Johnson & Johnson and Bayer AG may have fizzled somewhat. Two recent issues do not bode well for plaintiffs filing Alere INRatio lawsuits. The FDA recently announced that the Alere INRatio anti-coagulation monitoring device had no substantial effect on the outcome of the ROCKET-AF trial and in turn did not significantly favor Xarelto as earlier suspected, and a California Alere class action suit in September was dismissed.
Read [ Three Points for Alere INRatio Device ]

Olympus America Attempts a Power Morcellation Comeback

Olympus America Attempts a Power Morcellation Comeback December 19, 2016. By Gordon Gibb.
Orlando, FL: In spite of a position taken by the US Food and Drug Administration (FDA) that Laparoscopic Uterine Surgery for women Involving power morcellators only be used in relatively rare cases, Olympus America Inc. has released a new power morcellator equipped with a containment bag.
Read [ Olympus America Attempts a Power Morcellation Comeback ]

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