Holland & Hart Healthcare Law Blog

Libya Sentences Nurses To Firing Squad.

The kaleidoscope of fractured images emerging from the murder trial of five Bulgarian nurses and a Palestinian Physician in Libya is more than vaguely disconcerting.  Kristinia Volcheva, Nasya Nenma, Valentina Sirapuvo', Valya Chermenyaska, Snezhava Dimitrana and Asheraf Al Hajaj have been found guilty by a Libyan court of murdering forty and infecting hundreds of Libyan children through injection of an HIV virus and sentenced to die by firing squad for the second time.  The Libyan Supreme Court overturned their first conviction on December 25, 2005.  The condemned are represented by Lawyers Without Borders an international legal defense organization.

The case while inciting international outrage and condemnation contains many seed of concern which sometimes reverberates through American Courts - overzealous prosecutors pandering to public cries for retribution; fundamental religious overlays in pursuit of eye for an eye justice; the lack of hard evidence; the reliance on coerced confessions; the distrust and rejection of countervailing  scientific evidence when stacked up against passion and belief.

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.

MEDICAL CLINICAL ALGORITHMS: BACK-UP OR FIRST LINE IN DIFFERENTIAL DIAGNOSIS.

What if your doctor was right 98% of the time in his or her differential diagnosis?  A genius?  Perhaps our expectation is that our doctor should score 100%, but that would not only be “aggressive,” it would be wildly inaccurate – after all doctors are human.  That begs the question of the likely future use of medical clinical algorithm’s to aid in the improvement of medical diagnosis.  Medical Clinical Algorithms’ incorporate a method of using medical tests such as The Oxford Text Book of Medicine and hundreds of medical journal articles into a differential diagnosis decision tree model to computer diagnose an illness through the symptom presented by a patient.

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.

Will Drug Coated Stents Become The Next Vioxx?

This coming Thursday in Washington, D.C. the Federal Food and Drug Administration Center for Devices and Radiological Health will commence two days of hearings on the use of medicated stents to control arterial cardiovascular disease.  Drug coated stents first appeared in this country in 2003 in response to clotting problems that appeared from scar tissue forming around bare metal stents then widely in use.  The idea behind the use of stents is to provide a safe tube in the arteries that prevent their collapse or obstruction by cardiovascular disease, sort of like the "big dig" tunnel in Boston. Well, perhaps not exactly like that - they had problems there too didn't they.  The CDRH hearings are taking on the hype and pregame speculation of the Michigan-Ohio State Game.  '(Did Bo have a stent?) Some commentators are suggesting that their are legions of plaintiff tort lawyers lined up and ready to spring into action to represent the survivors of the roughly 2000 patients a year who expire from stent complications, not to mention the millions of patients with stents walking around with their miniature "time bombs" waiting for them to explode.