In a split across party lines, the U.S. Consumer Product Safety Commission (CPSC or the “Commission”) recently voted on a largely unprecedented course of action: to ban an entire class of chemicals from popular consumer...more
President Trump announced on September 21, 2017, that his intent to nominate Jones Day partner Dana Baiocco to the position of Commissioner of the Consumer Product Safety Commission (CPSC) for a 7-year term starting next...more
In a unanimous vote, the U.S. Consumer Product Safety Commission (CPSC) eliminated third-party testing for compliance with CPSC’s phthalates prohibitions for seven plastics. The Commission decided that these plastics with...more
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants...more
On July 24, 2017, the White House announced President Trump’s intent to nominate Ann Marie Buerkle (R-NY) as the next Chairman of the Consumer Product Safety Commission (CPSC) for a seven year term beginning October 27, 2018....more
At the midpoint of 2017, we look back on the U.S. Consumer Product Safety Commission’s activity under the new administration, including how recalls and penalties stack up against previous years, new focal points for safety...more
The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more
On June 7, 2017, a Central District Court of California declined to certify a class of consumers who alleged that 5-Hour Energy’s marketing of an energy drink was misleading, finding that individual factual questions...more
On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more
On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
5/5/2016
/ Birth Defects ,
Causation ,
Daubert Hearing ,
Drug Safety ,
Evidence ,
Expert Testimony ,
Multidistrict Litigation ,
Pharmaceutical Industry ,
Pregnancy ,
Prescription Drugs ,
Summary Judgment ,
Zoloft