Holland & Hart Healthcare Law Blog

INTERNET MEDICINE PART II: PHYSICIAN CHAT ROOMS

One of the growing phenomena related to the practice of medicine and the internet is the introduction of physician chat rooms in real time on the web. In new forums like Sermo, approximately 90.000 physicians can currently log on line and discuss clinical issues in real time and obtain broad based input and support and advice from other physicians with respect to clinical issues. This is a form of social networking for physicians. Among the potential benefits of the forum is the ability to compare notes and to alert others to sudden distortions in the health of local populations due to flu or other causes, and the sharing of what works and doesn’t work in clinical practice. 

Stem Cell Research on Again, Time to Celebrate [Guest Editorial]

Among many other things that the Obama administration addresses --one of the most important far reaching actions in my opinion is the go-ahead to stem cell research. This was important scientific research that can help prevent diseases and in the development of better medicine to give a second chance at life to millions of human beings alive today.

FDA Review to “Pre-Empt” State Pharmaceutical Litigation?

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

Stroke, tPA & Statistical Chance

A healthy dose of fatalism should accompany any patient experiencing the symptoms of stroke when presenting at an emergency room for treatment. Assuming the facility is not a stroke center, with enhanced diagnosis resources and treatment options for combating the effects of ischemic stroke, one’s prospects for full or partial recovery could well depend upon the confidence in and willingness of the E.R. physician to administer tissue plasminogen activator or "tPA," a thrombolytic agent, capable of recanalizing a passage through an arterial clot in the brain tissue.

Although the use of tPA is recommended by the American Heart Association as a first line treatment for ischemic stroke the use of the drug is controversial because of significant risk of inducing intracranial hemorrhage and other organic damage in a small but significant number of patients.

Ketek Attack At FDA.

In the April 19, 2007 edition of The New England Journal of Medicine, David B. Ross, M.D., Ph.D.,, a clinical assistant professor at George Washington University School of Medicine and Health Sciences took the FDA to task for its approval of Ketek, a ketolide antibiotic manufactured by Sanofi-Adventis, for use in respiratory tract infections.  The drug underwent three rounds of review by the FDA and followed an unusual structure of review and approval that may suggest outside interference in the process.

Second Circuit Finds 1986 HHS Rule Excluding Medical Coverage for Surgical Transplantation of Experimental Medical Devices Arbitrary and Capricious.

In Yale-New Haven Hospital, et al. v. Michael O. Leavitt, U.S. Department of Health and Human Services, ___ F.3d___, 2006 WL 3317691 (2nd Cir. 2006), Yale-New Haven Hospital and 48 implantees of cardiovascular-defibrillator devices ("ICDs"), sued to recover H.H.S.’s set-off recoupment of $1,500,000.00 in payments for the ICDs implanted in 1994 and 1995. The case turned on the validity of an "interpretive" rule promulgated by HHS in the 1986 Medical Reimbursement Manual. The provision directed all fiscal intermediaries to reject any and all claims for medical devices that had not received pre-approval by the FDA.

Supreme Court's Rejection of Writ in Schering-Plough Case Leaves Contentious Issue of Reverse Payment Patent Settlements Undecided.

Late Last June the United States Supreme Court rejected an opportunity to review the decision of the 11th Circuit Court of Appeals in Schering-Plough Corporation v. Federal Trade Commission, 402 F. 3d 1056 (11th Cir. 2005). In that case the Circuit Court overturned the decision by the FTC finding that several settlements entered into by Schering-Plough with generic drug competitors that involved "reverse payments" by S-P to the generic producers as part of a settlement limiting the generics entry into the market to compete with S-P's K-Dur 20, timed release potassium Chloride tablets, but also granting S-P licenses for certain of the generic companies' products were not restraints of trade in violation of federal antitrust statutes.  The Circuit Court reinstated a similar initial finding by an administrative law judge, which had in turn been reversed by the FTC. The Circuit Court, while noting that the issues in the case were at the clashing intersection of intellectual property law and antitrust law, held that patent cases are different and not subject to either the per se or rule of reason analysis.

Gland Of Opportunity III

This is part three of an Article by Bruce Rushton recently published in the Riverfront Times concerning a Missouri Federal District Court case, in which we are participating, concerning the novel issue of who owns tissue and serum samples donated by grateful patients to a particular surgeon for his research . Bruce.Rushton@riverfronttimes.com

Gland Of Opportunity II

This is part two of an Article by Bruce Rushton recently published in the Riverfront Times concerning a Missouri Federal District Court case, in which we are participating, concerning the novel issue of who owns tissue and serum samples donated by grateful patients to a particular surgeon for his research .mailto:Bruce.Rushton@riverfronttimes.com

Gland of Opportunity

This is part one of an Article by Bruce Rushton recently published in the Riverfront Times concerning a Missouri Federal District Court case, in which we are participating, concerning the novel issue of who owns tissue and serum samples donated by grateful patients to a particular surgeon for his research . Bruce.Rushton@riverfronttimes.com