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Results: 1-10 of 158

Mandated compliance programs as the new normal? Williams-Sonoma agrees to $987,000 CPSC civil penalty & comprehensive compliance program

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • May 8 2013

The tide continues to rise for Consumer Product Safety Commission ("CPSC") civil penalties as the Commission announces a $987,000 penalty against

Round two: President Obama renominates Marietta Robinson as CPSC Commissioner

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • January 29 2013

President Obama has (again) nominated Marietta S. Robinson to fill the open Democrat seat at the Consumer Product Safety Commission. The President

CPSC announces first civil penalty enforcing CPSIA: Daiso agrees to create product safety program, to audit all products, and to pay $2 million civil penalty

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 12 2010

On March 2, 2010, the Consumer Product Safety Commission ("CPSC" or "Commission") announced a settlement agreement with Daiso Holding USA Inc., Daiso Seattle LLC, Daiso California LLC, and one of the companies’ officers (collectively, “Daiso”

Expert testimony failed to meet Daubert standard

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • December 29 2011

Raymond Bielskis was an acoustical ceiling carpenter employed by International Decorators

FDA rule mandating graphic images on cigarette labels struck down by D.C. Circuit under the First Amendment

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • August 27 2012

On Friday, August 24, 2012, the D.C. Circuit upheld an earlier ruling by the D.C. District Court invalidating an FDA rule that would have required one of nine images to be displayed on every cigarette package

California court allows state law claims against Medtronic to proceed; rejects preemption argument

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • August 24 2012

The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion

U.S. Supreme Court upholds Affordable Care Act: significant aspects of Affordable Care Act for generic pharmaceutical companies

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • June 29 2012

On June 28, 2012, the U.S. Supreme Court upheld the Patient Protection and Affordable Care Act (Pub. L. 111-148

Ninth Circuit rejects First Amendment defense in wire fraud case regarding drug misbranding

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 8 2013

This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant's off-label marketing

There’s an app for that: FDA clears iPhone iExaminer app

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • January 29 2013

FDA recently granted clearance to a new telemedicine product - the Welch Allyn iExaminer - which, when used in conjunction with the iPhone, allows

FDA proposes new user fees to finance food & cosmetic safety

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • April 12 2013

On April 10, 2013, the U.S. Food and Drug Administration ("FDA") announced a proposal that could increase the cost of doing business for the food and