Recent reports purport to link certain chemicals used in nail salon products to serious health problems such as cancer, asthma, respiratory disease, and miscarriages.  Though past efforts to impose stricter regulations on these chemicals have been largely unsuccessful, a recent slew of New York Times articles have drawn significant attention to the issue.  In response, New York Governor Andrew Cuomo issued a number of emergency regulations to protect salon workers, and New York City mayor Bill de Blasio has announced his own efforts to address the issue.  These responses could indicate a willingness on the part of lawmakers to revisit the laws regulating the cosmetics industry.
Continue Reading Scrutiny of Nail Salon Chemicals Raises Mass Tort Risk

The United States Supreme Court has decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground such claims were covered under the federal preemption memorialized in the 2011 U.S. Supreme Court decision Pliva v. Mensing.
Continue Reading Supreme Court Declines to Weigh in on Generic Preemption

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.

Continue Reading FDA Reopens Comment Period for Drug Labeling Rule