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Ninth Circuit rules on expert causation evidence in bisphosphonate treatment injury case

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • April 10 2014

The Ninth Circuit Court of Appeals has determined that a district court erred in excluding the causation testimony of the plaintiff's expert as

FDA modifies list of recognized standards

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 6 2014

The U.S. Food and Drug Administration (FDA) has announced the availability of its publication, "Modifications to the List of Recognized Standards

Biomedical device maker enters plea, failed to provide information to FDA

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • February 6 2014

San Diego-based Valor Medical, Inc., a biomedical device manufacturer, and four of its employees have reportedly pleaded guilty to counts of failing

Eighth Circuit finds no error in jaw disease verdict

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • January 16 2014

While the Eighth Circuit Court of Appeals has affirmed a $225,000 jury award to the estate of a woman who developed osteonecrosis of the jaw (ONJ

FDA seeks to create labeling parity for generic drug makers

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 27 2013

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would speed the dissemination of new safety information about generic

Court finds no error in remedy for inconsistent jury verdict in drug-warning case

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 27 2013

Rejecting the defendant's claim that a new trial should have been ordered when the jury initially returned an inconsistent verdict, a federal court

Posner calls for courts and lawyers to lose fear of science and technology

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • November 7 2013

Affirming a lower court's dismissal of cruel-and-unusual-punishment claims filed by an Illinois prison inmate against a nurse practitioner and

CRS publishes report on drug and medical device claim preemption

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2013

The Congressional Research Service (CRS) has prepared for Congress a report titled "Preemption of Drug and Medical Device Claims: A Legal Overview."

Drug compounding oversight bill advances in House

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • October 3 2013

The U.S. House of Representatives has reportedly passed by voice vote a bill (H.R. 3204) to strengthen the Food and Drug Administration's (FDA's

FDA publishes guidance on wireless technology in medical devices

  • Shook Hardy & Bacon LLP
  • -
  • USA
  • -
  • August 22 2013

The Food and Drug Administration (FDA) has published guidance titled "Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry