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Another Step Toward Reasonable Preemption Case Law

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...more

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

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...more

CPSC to Consider New Magnet Set Safety Standards Following 10th Circuit Decision in Zen Magnets

We have entered the next chapter in the ongoing saga of the Consumer Product Safety Commission’s (“CPSC”) regulation of high-powered, small, rare earth magnet sets (“SREMS”). On March 1, 2017, CPSC met and unanimously...more

A Changing of the Guard: Same Enforcement Trend under New CPSC Leadership?

Republican Ann Marie Buerkle was named Acting Chairman of the Consumer Product Safety Commission (CPSC) on February 9, 2017, replacing former Chairman and Democrat Elliott Kaye. This transition has many wondering whether the...more

What The Intuitive Ruling Means For Medical Device Makers

Last month, in Taylor v. Intuitive Surgical Inc., 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...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

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...more

New CPSC Safety Standard on Baby Slings

In early January, the U.S. Consumer Product Safety Commission (CPSC) adopted a new federal safety standard for infant sling carriers. 82 Fed. Reg. 2326-1 (Jan. 9, 2017). CPSC’s new rule follows its 2010 warning that baby...more

Small Magnets, Big Trouble – Zen Successfully Challenges CPSC Rulemaking in the 10th Circuit

The United States Court of Appeals for the Tenth Circuit recently vacated the Consumer Product Safety Commission’s (CPSC) 2014 rulemaking that prohibits the importation and distribution of high-powered, small, rare earth...more

Rare Court Decision in CPSC-Backed Enforcement Action

A federal district court in Wisconsin recently ruled against a product manufacturer, finding it liable for failing to report timely in a rare U.S. Consumer Product Safety Commission (CPSC)-backed lawsuit. United States v....more

California Adopts the Sophisticated Intermediary Doctrine

In a recent opinion, the Supreme Court of California formally adopted the Sophisticated Intermediary Doctrine, clarifying what circumstances may permit a raw materials supplier to discharge its duty to warn consumers. Webb...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

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...more

Still Waiting—FDA Delays Rulemaking

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...more

Generalized Products Liability Claims Not Viable Post-Spokeo

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis...more

Statute of Limitations Taking the Steam out of CPSC-Backed Enforcement Action

It is no secret that the U.S. Consumer Product Safety Commission (CPSC) is ramping up its efforts to enforce various aspects of the Consumer Product Safety Act (CPSA), especially the provisions about a company’s failure to...more

Defendants Secure Rare Summary Judgment in Zoloft MDL

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. These cases were consolidated in 2012 and involved allegations...more

CPSC Definitely Not Zen About High-Powered Magnets

The last weeks of March brought us two interesting and seemingly contradictory opinions that show the many tools the U.S. Consumer Product Safety Commission has at its disposal to enforce its own regulations. These orders...more

Definitely Not Zen – Magnets Attract Unprecedented Action from CPSC

The last weeks of March brought us two interesting and seemingly contradictory opinions that show the many tools that the Consumer Product Safety Commission (CPSC) has at its disposal to enforce its own regulations. These...more

Federal Preemption Claims: Clear Evidence and an Unclear Standard

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...more

CPSC Pledges Higher Penalties

Earlier this month, CPSC Chair Elliot Kaye told regulators, industry, and lawyers about the CPSC’s priorities for the coming year. At the top of the list were increased civil penalties for failure to report potentially...more

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

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...more

Liability for Brand Drug Manufacturers All But Clear

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...more

Defendants Find Relief from Burdensome Discovery Requests

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...more

CPSC Launches “Regulatory Robot”

Businesses face a daunting task when attempting to comply with the U.S. Consumer Product Safety Commission’s (CPSC) reporting requirements. In an effort to simplify and streamline the process for consumer products providers,...more

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

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...more

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

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...more

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