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February 29, 2016 - Privacy, Internet of Things, FDA, Drug & Medical Device, Product Liability
FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices
By: Erin M. Bosman and Julie Y. Park
The FDA’s recently issued draft guidance on “ Postmarket Management of Cybersecurity in Medical Devices ” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of
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February 24, 2016 - FDA, Drug & Medical Device, Product Liability
Liability for Brand Drug Manufacturers All But Clear
By: Erin M. Bosman and Julie Y. Park
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand drug manufacturers. Judge Zagel found that GSK had not shown “clear evidence” that
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February 08, 2016 - FDA, Drug & Medical Device, Product Liability, MDL
Defendants Find Relief from Burdensome Discovery Requests
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving end of unreasonable discovery requests in an attempt to overwhelm the party and stall litigation. A recent district court decision in In re
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December 17, 2015 - FDA, Drug & Medical Device, Product Liability, Government Actions
New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing
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December 15, 2015 - ADA, Drug & Medical Device, Product Liability
Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption
By: Erin M. Bosman and Julie Y. Park
Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104 (6th Cir. Dec. 11, 2015). Yates is the first federal appellate authority to recognize
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April 30, 2015 - Drug & Medical Device, Product Liability
Alabama Legislature Says No to Innovator Liability
By: Erin M. Bosman and Julie Y. Park
On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable. .. for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam Ward, the bill supersedes the Alabama
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February 18, 2015 - FDA, Drug & Medical Device, Product Liability
FDA Proposed Rule in Flux?
By: Erin M. Bosman and Julie Y. Park
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and discuss alternatives to the much-criticized rule, which
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January 26, 2015 - FDA, Drug & Medical Device, Consumer Products
Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”
By: Erin M. Bosman
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance [1] concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt to provide some regulatory clarity in the wake of the explosion
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June 25, 2014 - FDA, Drug & Medical Device
Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs
By: Erin M. Bosman
Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance documents, which were originally promised by the FDA in 2010, represent the FDA’s latest
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Topic Archives: Drug & Medical Device

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

By: Erin M. Bosman and Julie Y. Park

Liability for Brand Drug Manufacturers All But Clear

By: Erin M. Bosman and Julie Y. Park

Defendants Find Relief from Burdensome Discovery Requests

By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

By: Erin M. Bosman and Julie Y. Park

Alabama Legislature Says No to Innovator Liability

By: Erin M. Bosman and Julie Y. Park

FDA Proposed Rule in Flux?

By: Erin M. Bosman and Julie Y. Park

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

By: Erin M. Bosman

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

By: Erin M. Bosman