Skilled nursing facilities have long been subject to civil money penalties (CMPs).  Depending on where the facility is located, it could mean CMPs of hundreds of thousands of dollars or less than $10,000 (with a waiver) for the same type of deficiency.   No longer.  Effective April 1, 2013, Regional Offices (RO) for the U.S. Department of Health and Human Services, Centers for…

New Hampshire law applies a hybrid design-defect standard that imposes liability for harm caused by a drug product if the drug product, in light of the manufacturer’s warning on the label, is unreasonably dangerous. Does such a framework avoid federal preemption issues that have doomed failure to warn negligence claims premised on taking allegedly dangerous generic pharmaceuticals? That was the question addressed by the Supreme Court at oral argument in Mutual Pharmaceutical Co. v. Bartlett, the third in a trilogy of cases addressing preemption of state tort claims against drug manufacturers based on federal laws mandating prescription drug labeling requirements. While several justices appeared uncomfortable with the possibility of creating a system that allowed for FDA approval to serve as both a ceiling and a floor for generic drug liability, overall it appeared that the Court would find preemption, consistent with the defendant and Solicitor General’s arguments.

Three years ago in Wyeth v. Levine, the Court held that a state law failure-to-warn claim related to a branded pharmaceutical was not preempted federal drug laws. The next year in a 5-4 decision, the Court held in PLIVA, Inc. v. Mensing that a negligence claim for failure to warn by a generic manufacturer was preempted by federal law because the Hatch-Waxman Act (which sets up the generic pharma framework) allowed for no discretion in what a generic pharmaceutical manufacturer can put on its label.

Mutual comes to the Supreme Court after the First Circuit upheld a New Hampshire Federal District Court’s jury verdict premised on the finding that a generic version of sulindac was unreasonably dangerous. The arguments before the Court centered on whether a design defect claim was somehow different from a failure to warn claim, and therefore merited a different result than the one reached in PLIVA.

With so many rating systems and awards, hospital administrators and patients alike are increasingly frustrated and confused about which hospitals are the “best.”  According to an article by Kaiser Health News (KHN) in conjunction with The Philadelphia Inquirer, one-third of all U.S. hospitals received at least one distinction from a major ratings group or company…

This post was prepared by Toni Blackwood and Tim Hilton, labor and employment attorneys at Husch Blackwell. 

Following 12 months of public comment, U.S. Citizenship and Immigration Services (USCIS) issued a revised Form I-9 on Friday, March 8, 2013. The form has a new look, contains more specific instructions and solicits additional information. Although the form is available for use now, it becomes mandatory in May 2013.

Every U.S. employer is required to record on Employment Eligibility Verification Form I-9 the employment authorization and identity of every person hired in the U.S. High profile enforcement actions by Immigration and Customs Enforcement (ICE), growing employer experience with high administrative fines resulting from ICE I-9 audits, and the public debate over illegal immigration have combined to raise awareness in recent years of the importance of Form I-9 to all employers. These factors all make it vital that employers have a clear understanding of the form itself and how to complete it.

The new form contains additional data fields, such as those asking for the email address, telephone number (both optional) and foreign passport number for the employee in Section 1. The new form includes a prominent warning to new employees of the consequences of using false documents or making false statements when completing Form I-9. This is an important addition, as ICE has pursued remedies against individuals for using false documents and for making false claims of citizenship on Form I-9. There are also overall improvements in the form’s layout, making the employer’s Section 2 easier to read and understand. Perhaps the most obvious change is that the form has expanded to two pages.

This post was provided by Debbie Juhnke in Husch Blackwell’s Information Governance group.

According to a recent KPMG report on data loss, the healthcare industry’s greatest exposures for data loss are hard copy loss/theft, PC theft, and social engineering, ranking first (in a tie), second, and third against other sectors respectively for percentage of data…

More and more judges are rejecting settlements negotiated between federal regulators and companies accused of corporate fraud. Two recent examples illustrate this trend.

1. WakeMed

In January of 2013, a judge in North Carolina rejected a settlement reached between the Department of Justice and WakeMed Health and Hospitals, an 870-bed hospital system. WakeMed was accused…

Cyber security is on everyone’s mind.  President Obama signed an executive order in February aimed at increasing protection of our nation’s critical infrastructure, while HHS released its new HIPAA mega rule in January (effective in March) in an effort to strengthen the security of electronic health records.  As providers work to update their HIPAA policies…

On Thursday, March 7, 2013, the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services (CMS) released a notice and request for information concerning using additional policy levers to accelerate the adoption of electronic health record systems (EHRs). In part, the agencies are looking to increase the number of provider practices satisfying the core requirements for Meaningful Use under the Health Information Technology for Clinical and Economic Health (HITECH) Act.

In the notice, the agencies state that they are looking to accomplish this acceleration by “engaging other policy areas” within the jurisdiction of the U.S. Department of Health & Human Services (HHS), and may include a combination of incentives, payment adjustments, and new requirements. The agencies have identified three main areas in which to use the policy levers:

  • Low rates of EHR adoption and exchange of health information among post-acute and long-term care providers;

This post was contributed by Erik Flom and Edward Manzo, intellectual property lawyers at Husch Blackwell.   

Companies having inventions to patent should seriously consider filing their patent applications at the U.S. Patent and Trademark Office on or before Friday, March 15th – the “Ides of March.” This is the final day that entirely new applications can be filed and still be treated under the current patent system. There are five, simple reasons why you might want to meet the deadline:

  1. An applicant under the current system is entitled to prove a date of “invention” that is earlier than the application filing date. The earlier the date of invention, the more likely it is that you will be able to overcome some prior art references or to win a priority contest against a later inventor who filed an earlier application.
  2. Because the definition of “prior art” changes under the America Invents Act, prior art that can be cited against patent applications with an effective filing date after March 15, 2013, generally expands in scope. Unless that prior art derives from the applicant, it cannot be overcome except in narrow circumstances. Often, such prior art is not known until it arises in patent litigation. If the patent has an effective filing date before March 16, 2013, then the patent owner can attempt to overcome some of the prior art on the basis of dates of invention.