As recent decisions dismissing Avandia class actions highlight, defendants should be familiar with the essential elements of consumer class actions involving pharmaceuticals, such as the requirements for a plaintiff to state a cognizable claim and what is and is not considered as having alleged causation, says Jessica Rickabaugh of Pepper Hamilton LLP.
Among 10 battle-proven strategies for getting your witnesses ready for trial is to role-play the cross-examiner. For instance, if you expect the cross-examiner to yell, get in the witness’ face or use scathing sarcasm, do that during practice to minimize surprises at trial, say Dawn Solowey and Lynn Kappelman of Seyfarth Shaw LLP.
While physician interaction was no doubt subject to considerable company oversight before, the Indiana Court of Appeals' recent decision in Medtronic Inc. v. Malander provides additional incentive for device and pharmaceutical companies to erect appropriate safeguards, say Andrew Campbell and Joseph Winebrenner of Faegre Baker Daniels LLP.
Recent events, from the Westgate Mall attack in Nairobi to the Lac-Mégantic train derailment in Quebec, underscore the need for in-house counsel to keenly weigh risks and benefits for their companies doing business on a multinational scale. There are a number of best practices to consider that set the right tone for mitigating risk, whether you are doing business in one or hundreds of locations around the world, says Veta Richardson, president and CEO of the Association of Corporate Counsel.
The U.S. Supreme Court recently acted on two False Claims Act cases with pending petitions for certiorari, calling for the views of the solicitor general. If the court grants the petition in the KBR Inc. case, that would be good news for potential FCA defendants, but a review by the court of the Takeda Pharmaceuticals North America Inc. case could be bad news for potential defendants, say Dave Nadler and Joseph Berger of Dickstein Shapiro LLP.
Because those who purchase misbranded medications can be subject to criminal fines and imprisonment, physicians need to watch for the red flags these medications carry, such as product packaging and handling, say Yvonne McKenzie and Colleen Kelly of Pepper Hamilton LLP.
The general lack of state regulation regarding urgent care is likely a direct result of urgent care’s historical outgrowth of the physician practice. However, as the urgent care model continues to evolve and proliferate, and strategic buyers continue to vertically integrate with urgent care facilities as a cost containment mechanism, there is likely to be an uptick in regulation, say attorneys with McGuireWoods LLP.
As the shutdown of the federal government moves into its third week, the congressional calendar becomes all the more scrambled, delaying action on a number of issues of high priority to health care stakeholders, such as sustainable growth rate cuts and the medical device tax repeal, say Nick Manetto and Allison Durham of Faegre Baker Daniels Consulting.
Unfortunately, the credentials normally supplied by Big Law firms in beauty contests simply do not tell in-house counsel what they really want to know. Without discounting the difficulty of obtaining helpful information from candidates for outside counsel, there is one question that may be useful for in-house counsel to pose, says Andrew Jarzyna of Ulmer & Berne LLP.
While the recently issued guidance on how companies may remind patients to refill their prescriptions under the Health Insurance Portability and Accountability Act provides some latitude regarding the content of and payment for such communications, uncertainties about permissible remuneration remain, say Robyn Shapiro and Jeremy Shapiro-Barr with Drinker Biddle & Reath LLP.