Off-Label Marketing and the First Amendment
Pharmaceutical and medical device manufacturers have argued that FDA restrictions on off-label promotion infringe their First Amendments rights. While First Amendment defenses are difficult, two recent cases have placed this issue back in the spotlight.
Health Care Reform, or 'Qui Tams Made Easy'
While the insurance provisions of the new health care reform law (the Patient Protection and Affordable Care Act or PPACA) have received much media attention, the media have barely noticed another PPACA feature that could have a profound impact on the pharmaceutical, medical-device and health care industries.
The Foreign Corrupt Practices Act
Directors and officers are exposed to personal loss under the FCPA because not only does the FCPA expressly prohibit corporate indemnification, but also there are several D&O policy provisions that may serve to bar coverage for FCPA-assessed fines and penalties.
The Gulf Oil Spill: Considerations for Insurers
A large number of lawsuits already have been filed against the entities associated with the Deepwater Horizon Oil Rig, many of which raise interesting coverage issues, particularly with respect to specialty environmental coverages and first-party business interruption and damage claims. Even more significant insurance exposures may be posed in the future, however, as new parties are joined to the litigation and general liability policies are tested in response to third-party claims for bodily injury and property damage.
Practice Tip: The Rules of the Court of Public Opinion
The abundance of media outlets and the 24/7 news cycle they have created, both driving and feeding America's insatiable appetite for up-to-the minute news and gossip ' make it necessary to be prepared to try high-profile cases in the media as well as in court.
Component Parts Manufacturers in the Cross Hairs
A cluster of asbestos-related cases decided in 2009 has resulted in a trilogy of appellate decisions that reveals the key issues that arise in defending parts manufacturers from liability for components manufactured by others.
Five Steps for Managing the Risks Associated with Sensitive Data
The trend toward cloud computing, use of third-party application service providers, and outsourcing functions that can include payroll, benefits, marketing and more, multiply the potential vulnerabilities, and up the ante when it comes to managing data-related risk.
<i>Tiffany v. eBay </i>
The recent decision of the Second Circuit in connection with the appeal in <i>Tiffany (NJ) Inc. and Tiffany & Company v. eBay, Inc.</i> represents a thorough and well-considered exploration of the basis for finding secondary liability in the electronic marketplace for those who facilitate the sale of infringing goods without ever selling the goods and, conversely, the way for the maker of the marketplace to avoid liability for infringements by those who sell on its site.
