Class Dismissed

April 05, 2017 - FDA, Drug & Medical Device, Product Liability
Another Step Toward Reasonable Preemption Case Law
By: Erin M. Bosman and Julie Y. Park
Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th Cir. Feb. 21, 2017). This defense decision is another
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March 30, 2017 - FDA, Drug & Medical Device, Product Liability
Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of
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February 17, 2017 - Drug & Medical Device, Product Liability
Expanding Duties and Eroding Protections for Medical Device Manufacturers
By: Erin M. Bosman and Julie Y. Park
Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions from strict liability afforded to manufacturers of certain “unavoidably unsafe” products.
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February 06, 2017 - Drug & Medical Device, Product Liability
Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal
By: Julie Y. Park and Brittany Scheinok
Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc. , winning dismissal of the case in its entirety. [1] The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to dismiss after Defendant Ferring Pharmaceuticals removed the suit to federal
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July 21, 2016 - FDA, Drug & Medical Device, Product Liability
FDA Releases Draft Guidance For Updating Generic Drug Labels
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD)
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June 15, 2016 - FDA, Drug & Medical Device
Still Waiting—FDA Delays Rulemaking
By: Erin M. Bosman and Julie Y. Park
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form. The rule, originally proposed
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June 10, 2016 - Drug & Medical Device, Product Liability, Consumer Products
Generalized Products Liability Claims Not Viable Post-Spokeo
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. [1] As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp. , the analysis set forth in Spokeo is essential to determining the
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May 04, 2016 - Drug & Medical Device, Product Liability, MDL
Defendants Secure Rare Summary Judgment in Zoloft MDL
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. [1] These cases were consolidated in 2012 and involved allegations that the antidepressant drug Zoloft causes birth
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March 30, 2016 - FDA, Drug & Medical Device, Product Liability
Federal Preemption Claims: Clear Evidence and an Unclear Standard
By: Erin M. Bosman and Julie Y. Park
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc. , 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of
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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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Topic Archives: Drug & Medical Device

Another Step Toward Reasonable Preemption Case Law

By: Erin M. Bosman and Julie Y. Park

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

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

Expanding Duties and Eroding Protections for Medical Device Manufacturers

By: Erin M. Bosman and Julie Y. Park

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

By: Julie Y. Park and Brittany Scheinok

FDA Releases Draft Guidance For Updating Generic Drug Labels

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

Still Waiting—FDA Delays Rulemaking

By: Erin M. Bosman and Julie Y. Park

Generalized Products Liability Claims Not Viable Post-Spokeo

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

Defendants Secure Rare Summary Judgment in Zoloft MDL

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

Federal Preemption Claims: Clear Evidence and an Unclear Standard

By: Erin M. Bosman and Julie Y. Park

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

By: Erin M. Bosman and Julie Y. Park