Latest updates

CPSC imposes record-high penalties in 2014
  • USA
  • December 04 2014

The Consumer Product Safety Commission recently announced the latest penalties imposed on companies in 2014 for failure to report potential product defects. The significant increase in penalties levied against companies over the past few years shows that the commission is intent on staking its claim as a serious enforcement agency.

Engle: a mass tort run amok
  • USA
  • October 30 2014

The Eleventh Circuit's recent decision in In re Engle Cases highlights the frustrations that many defendants face in litigating mass tort claims against plaintiff law firms which file hundreds of cases without investigating or properly pleading their cases. Siding with the defendants, the Eleventh Circuit affirmed the lower court's decision to dismiss 750 lawsuits that had been filed with egregious defects.

For better or worse: OEHHA solicits input on Proposition 65 revisions
  • USA
  • October 23 2014

California's Office of Environmental Health Hazard Assessment (OEHHA) recently released a pre-regulatory proposal to revise its longstanding regulations governing "clear and reasonable warnings". The proposal met with substantial opposition from a broad coalition of businesses and, as a result, OEHHA is expected to unveil a new slimmed-down version later this autumn.

New consumer product categories under California's Green Chemistry Initiative
  • USA
  • September 25 2014

California's Department of Toxic Substances Control recently released its draft Priority Product Three-Year Work Plan, identifying new consumer product categories that may be the focus of the state's Green Chemistry Initiative. The innovative law requires product manufacturers to examine whether they can replace existing chemical ingredients with alternatives that are deemed safer for consumers and the environment.

Ghosts of litigation holds past
  • USA
  • August 14 2014

In Actos a Louisiana court recently ordered a drug manufacturer to pay $6 billion in punitive damages. An adverse ruling regarding spoliation of evidence likely played an important role in the verdict. Actos does not alter the protection that broad litigation holds provide to manufacturers in product liability litigation. However, the ruling starkly exposes the under-appreciated risk of maintaining a litigation hold for years.

Drugs and the Internet: draft guidance on social media platforms and prescription drugs
  • USA
  • July 17 2014

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance documents represent the FDA's latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media.

Launch of openFDA increases accessibility to adverse drug event reports
  • USA
  • July 03 2014

The Food and Drug Administration recently launched openFDA, a programme designed to improve access to publicly available data, beginning with adverse event reports. While greater accessibility to adverse event reports has industry benefits, it may also put drug manufacturers at greater litigation risk. This potential exposure highlights the need to prepare adverse event reports with an eye towards avoiding admissions on causality.

GE food-labelling bill fails in California Senate
  • USA
  • June 19 2014

Despite the recent passage of a genetically engineered (GE) food-labelling law in Vermont, and similar bills appearing in legislatures in other states, proponents of labelling have again failed to pass such a law in California. The latest such initiative, SB 1381 (Evans), recently failed on the Senate floor; the defeat follows on the heels of the failure of Proposition 37 in 2012.

Epic Buckyballs saga settles
  • USA
  • June 05 2014

The Consumer Product Safety Commission has settled an unprecedented proceeding against Craig Zucker, the former chief executive of Buckyballs manufacturer Maxfield and Oberton Holdings, LLC. Although the events leading to the settlement raise more questions than they answer, individuals who find themselves in a similar situation can point to the saga as setting a low bar for settlement.

Looking to litigate in secret? Fourth Circuit creates hurdles for product manufacturers
  • USA
  • May 29 2014

The Fourth Circuit recently ruled that a manufacturer could not hide behind a veil of secrecy, even after successfully enjoining the Consumer Product Safety Commission (CPSC) from publishing an inaccurate report of harm. In light of this opinion, manufacturers must tread carefully if the CPSC attempts to publish a suspect report that could unfairly harm the manufacturer's reputation.

Genetically engineered food labelling bill moves through legislature
  • USA
  • May 15 2014

SB 1381, California's revived genetically engineered food labelling bill, has passed through the California Senate Judiciary Committee. As the bill has moved through the legislature since it was introduced in February 2014, various amendments have been introduced that could significantly affect the food industry. Perhaps the most noticeable change in the bill is an expansion of the enforcement provision.

First consumer products subjected to new green chemistry rules
  • USA
  • April 03 2014

The California Department of Toxic Substances Control (DTSC) has announced the products and chemicals to be evaluated under the state's Safer Chemical Product Regulations. The DTSC's announcement is the next major step in implementing its innovative Green Chemistry Programme, which seeks to regulate toxic chemicals in consumer products.

$4 billion price tag? FDA's proposed generic drug labelling rule
  • USA
  • March 13 2014

The Food and Drug Administration has proposed a rule allowing holders of abbreviated new drug applications to update product labelling to reflect newly acquired information related to drug safety, regardless of whether the revised label is different from the reference listed drug's label. The proposed rule will increase annual healthcare costs by $4 billion, according to a recent study.

Lead paint companies hit with billion-dollar public nuisance fine
  • USA
  • February 06 2014

In a decision with potentially far-reaching implications, three paint companies have been ordered to pay $1.15 billion to clean up lead paint in homes throughout California. The case has analogies to other unsuccessful attempts to expand the theory of liability for public nuisance, such as the state's previous allegations that auto manufacturers were responsible in tort for contributing to the public nuisance of climate change.

New Jersey punitive damages analysis ignores established precedent
  • USA
  • January 23 2014

Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court rulings have refused to follow New Jersey law, creating unnecessary inconsistency and uncertainty with respect to how New Jersey's punitive damages law should be applied.

Comment period extended for proposed rule on changes-being-effected supplements
  • USA
  • January 16 2014

The Food and Drug Administration has extended until March 13 2014 the comment period for Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products, its proposed rule which would allow generic manufacturers to strengthen warnings using 'changes being effected' supplements.

Goodbye to generic preemption? FDA publishes proposed rule
  • USA
  • December 19 2013

The Food and Drug Administration (FDA) recently published a long-awaited proposed rule in the Federal Register in an effort to "create parity" between brand-name and generic manufacturers for their labelling obligations. Implementation of this rule will significantly impact the entire pharmaceutical industry, and as a result, patient safety. All affected parties are urged to submit comments to the FDA.

California implements Safer Consumer Product Regulations
  • USA
  • December 12 2013

California's Safer Consumer Product Regulations recently became law. They require product manufacturers to examine whether they can replace existing chemical ingredients with safer alternatives. For many consumer product companies, the regulations will require major investments in compliance and changes to product design planning and supply chain management.

Buckyballs strike back: former CEO sues CPSC
  • USA
  • December 05 2013

For the first time, the Consumer Product Safety Commission (CPSC) has attempted to hold an individual personally responsible for a company recall. In an equally unprecedented step, that individual has sued the CPSC. Product manufacturers should follow this case closely to learn whether the CPSC can force an individual to conduct a recall, and what options an individual might have in fighting its efforts.

Strategic use of Lone Pine motions
  • USA
  • February 28 2013

Causation is frequently a dispositive issue in product liability and mass tort cases. 'Lone Pine' orders require plaintiffs to set forth their causation theory and support it with expert and other evidence early in the case. Lone Pine orders have been employed in a wide variety of personal injury, medical monitoring and property damage cases. However, they are underutilised and often not well understood.