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FDA Issues Draft Guidance on Medical Device Cybersecurity
  • Cooley LLP
  • USA
  • February 8 2016

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices”


Consumer Product Recalls: Week In Review
  • Husch Blackwell LLP
  • USA
  • February 8 2016

The United States Consumer Product Safety Commission announced ten recalls during the week of February 1, 2016. The recalls include a diverse set of


Five Types of Exclusivities
  • Baker & Hostetler LLP
  • USA
  • February 8 2016

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of


Yates Memo Creates a Privilege Paradox for GCs
  • Vedder Price PC
  • USA
  • February 8 2016

Let’s say you’re the general counsel for a manufacturing company that builds armored transport vehicles for sale to the U.S. military. One of your


Key Components of FDA’s Draft Guidance for Medical Device Cybersecurity
  • Montgomery McCracken Walker & Rhoads LLP
  • USA
  • February 8 2016

On January 22, 2016, FDA issued draft guidance to manufacturers regarding the postmarket management of cybersecurity vulnerabilities in medical


District of Massachusetts Rejects Relators’ Attempt to Convert Products Liability Theory into FCA Claim
  • McDermott Will & Emery
  • USA
  • February 8 2016

On February 2, 2016, U.S. District Court for the District of Massachusetts dismissed a complaint alleging sweeping allegations of purported fraud


Wright Medical Technology Files Brief In Support Of Post-Trial Motions In Hip Implant Case
  • Mayer Brown LLP
  • USA
  • February 8 2016

A couple of months ago, we reported on a $10 million punitive verdict in the first hip implant case to go to trial against Wright Medical Technology


House Committee to Hold Hearing on Industry Perspectives on CPSC
  • Husch Blackwell LLP
  • USA
  • February 5 2016

The House Energy & Commerce Committee will hold a hearing entitled “Industry Perspectives on the Consumer Product Safety Commission.” The hearing


Learned Intermediary: Arizona Supreme Court Restores Order in the Desert
  • Reed Smith LLP
  • USA
  • February 5 2016

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases


OEHHA Creates New California Proposition 65 Website Based on Information from Manufacturers
  • Sidley Austin LLP
  • USA
  • February 5 2016

The California Office of Environmental Health Hazard Assessment (OEHHA), the California agency which implements Proposition 651, has adopted a final