Media Mentions
2008
John M. Callahan was mentioned in a press release published by Business Wire regarding McDermott's legal counsel to EyeCyte, Inc. in the company's Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Device Litigation, Life Sciences - Health
John M. Callahan was mentioned in the June 23 issue of Forbes.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Devices, Life Sciences - Health
John M. Callahan was mentioned in the June 23 issue of PR-inside.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Devices, Life Sciences - Health
Robert B. Nicholas was mentioned in the June 16 issue of the National Law Journal in an article regarding a new U.S. Food and Drug Administration final rule governing clinical trials held in foreign countries that will spark painstaking legal review of pharmaceutical companies' protocols for trials. "Adhering to the FDA's good clinical practices directives for studies done abroad means more work for clients and their attorneys. We'll be working with companies trying to structure clinical studies that they'll be conducting outside the U.S.," Mr. Nicholas said.
Robert B. Nicholas, Health, Life Sciences - Health
Sheila Walcoff was mentioned in The Washington Post and Congressional Quarterly Daily regarding her recent move to McDermott’s Health Law department and life sciences government strategies practice group in Washington, D.C.
Link to: Sheila Walcoff, Health, Life Sciences – Health, Government Strategies
Government Strategies, Health, Life Sciences - Health
Arnold Friede, Jennifer Geetter, Robert Nicholas, and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Arnold I. Friede, Jennifer S. Geetter, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences - Health
Arnold Friede, Elizabeth Hack, Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Arnold I. Friede, Elizabeth I. Hack, Robert B. Nicholas, Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
Jennifer Geetter was quoted in the May 21 issue of Health Law360 in an article regarding the Genetic Information Nondiscrimination Act, which seeks to prevent unauthorized or required genetic testing of workers by employers and insurers. "A majority of insurers will not be affected by the act because they already do not use risk rating procedures based on genetic testing or family history," Ms. Geetter said.
Jennifer S. Geetter, Health, Life Sciences - Health
Arnold Friede was quoted in the May 7 issue of Medical Devices Law & Industry in an article regarding the FDAAA Clinical Trial Certification requirements. "The draft guidance is helpful but it leaves as many questions unanswered as it does answer. Additionally, the draft guidance is ambiguous about whether certifications are required for compassionate use INDs involving more than one patient," Mr. Friede said.
Arnold I. Friede, Health, Life Sciences - Health
Arnold Friede and Robert Nicholas were quoted in the April 2008 issue of Medical Marketing and Media regarding scientific 'free speech' being threatened. "Calls for an investigation into support for the American Heart Association (AHA) and American College of Cardiology stating are likely to convince other scientific groups not to speak out on issues of public concern," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health, Life Sciences & Medical Devices, Life Sciences - Health
T. Reed Stephens and Arnold Friede were quoted in the February 22 issue of Rx Compliance Report in an article regarding the FDA draft guidance that was issued regarding industry dissemination of medical or scientific journal articles. "It seems entirely probable that enterprising plaintiffs, particularly qui tam whistleblowers, are unlikely to defer to FDA's draft guidance in determining whether certain manufacturer conduct provides a potential basis for False Claims Act liability," Mr. Friede said. "Plaintiffs must push the envelope with state law consumer protection theories as an end-run around FDA's guidance," Mr. Stephens added.
Arnold I. Friede, T. Reed Stephens, Health, Life Sciences - Health
Stephen W. Bernstein and Jennifer S. Geetter were quoted in the February 1 issue of Mass High Tech in an article regarding the state of Massachusetts funding stem cell research. "States see it as a hot new thing, and that's debatable. But in Massachusetts we have all the raw expertise and can use legislation to springboard what's already here," Mr. Bernstein said. "State programs can clarify legal aspects. It's an opportunity for states to clear up any state regulations which may impede stem cell research. State privacy laws are a patchwork, and you can get tangled in ways the legislation didn't intend," Ms. Geeter said.
Stephen W. Bernstein, Jennifer S. Geetter, Health, Life Sciences & Medical Devices, Life Sciences - Health
Elizabeth I. Hack was quoted in the January 24 issue of Rx Compliance Report in an article regarding 2008 being a record year for pharma fraud recoveries along with surge in state, global and Part D enforcement. "Another important signal is that the AWP matters brought by the state are continuing to move forward at a faster pace than the Multi-District Litigation (MDL) in Boston. This is evidenced by the fact that next month Alabama will be the first state to bring to trial the state consumer fraud theories relating to AWP drug pricing," Ms. Hack said.
Elizabeth I. Hack, Health, Life Sciences & Medical Devices, Life Sciences - Health
2007
Paul Radensky was quoted in the July 2007 issue of Clinical Lab Products Magazine in an article regarding the new FDA draft guidance regarding in vitro diagnostic multivariate index assays (IVDMIAs). "I think you get universal agreement, including the FDA, that what was put in the September draft guidance was not clear,"Mr. Radensky said.
Paul W. Radensky M.D., Health, Life Sciences - Health
John Callahan was quoted in the June 14 issue of Muskogee Phoenix in an article regarding the Muskogee Medical Center Authority asking the state attorney general for his opinion before giving millions to the city of Muskogee. Capella Healthcare is paying $120 million to lease Muskogee Regional Medical Center for the next 40 years. “It sounds like you don’t have a decision where the money is going to go. The attorney general may be very concerned with that. You should probably have that decided before you contact him,” Mr. Callahan said.
John M. Callahan, Health, Health - M&A, Life Sciences - Health
Bernadette Broccolo was quoted in BNA’S Health Law Reporter in an article regarding an IRS directive that was issued stating that exempt hospitals might enter into certain arrangements with physicians to help facilitate their adoption of electronic health record technologies without violating federal tax laws. “While CMS’s regulations permitted hospitals to subsidize up to 85 percent of these HER system costs, it had been an open question as to whether IRS would embrace the same percentage given its exempt hospital and private inurement oversight perspective. That questions has now been answered,” Ms. Broccolo said.
Bernadette M. Broccolo, Health, Life Sciences & Medical Device Litigation, Life Sciences - Health, Tax Exemption
