Holland & Hart Healthcare Law Blog

WIFE STATES CLAIM AGAINST DENTAL MANAGEMENT COMPANY FOR DELIVERY OF DRUGS HER SURGEON HUSBAND OVERDOSED ON.

The denial of the defendant’s motion to dismiss in the case of Kim v. Interdent, Inc., No. C 08-5565 SI in the U.S. District Court for the Northern District of California seems to fall among those odd “man bites dog” cases that are both perplexing and irrational. Ms. Kim is the surviving spouse of Dr. Richard D. Bae, who apparently developed a fondness for Fentanyl, a highly addictive drug used primarily by anesthesiologists in sedating patients. The defendant, a dental practice management company, delivered the drug to Dr. Bae, in bulk, which he proceeded to carry around to the various Interdent offices where he performed procedures. Dr. Bae accidently overdosed on the drug and collapsed on the bathroom floor of the Interdent office in Stockton, California, on December 13, 2006. He never regained consciousness and died on April 16, 2007.

COLORADO MEDICAL POT LAW ALL SMOKE?

The good news for Colorado Medical Marijuana smokers is that the Colorado State Constitutional Amendment making possession of pot more medically qualified users and their “personal care providers” is Constitutional. The bad news is that it is still illegal to sell it. On October 29, 2009, in People v. Stacy Clendenen, 08CA064, a panel of the Colorado Court of Appeals affirmed the conviction of apparent pot entrepreneur, Stacy Clendenen, for cultivation of marijuana, possession with intent to distribute marijuana, possession of marijuana-eight ounces or more, and possession of drug paraphernalia, after rejecting her defense that she was a “primary care giver, “protected under the Constitution.

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. 

Pfizer's "Double Blind" Bextra Bind -The Value of Clinical Data

Shortly before Christmas a Santa Clara County, California jury entered a $38 Million Dollar Judgment Against Pfizer, Inc. for allegedly stealing clinical data from the Ischemia Research and Education Foundation ("IREF"), concerning its acute arthritic pain drug, Bextra. Pfizer pulled Bextra from the market in 2005, followig concerns about its safety for heart patients. Not long ago Pfizer entered into a $900,000,000.00 product liability settlement for Bextra and for Cerebrex, both Cox 2 inhibitor drugs that raised safety concerns. IREF filed its suit in 2004, claiming that Pfizer obtained access to the clinical data developed by IREF after its negotiations with IREF collapsed through the device of a contract with an IREF employee and statistican, Ping Hsu. IREF is a non-profit research organization founded by Dr. Dennis Mangano, PhD, M.D., in 1987.IREF has developed a substantial data base of clinical information through the cooperation and participation of over 300 research centers around the world in the twenty plus years of its existence. There was apparently some evidence presented to the jury that Pfizer and Mr. Hsu destroyed or otherwise attemped a coverup of the use of the IREF information. Pfizer asserts that it has been unjustly caught up in the dispute between Mr. Hsu and IREF and denies any theft of the IREF information. It will likely appeal.

PUBLIC CITIZEN SUES FDA TO "BLACK BOX" FLUROQUINOLONES.

In August, 2006 Public Citizen Health Research Group petitioned the FDA to require pharmaceutical companies to place "black box" warnings on their fluroquinolone antibiotics such as Levaquin, Cipro, Tequin, Norflexacin and others advising patients and physicians of high degree of danger to tendons, particularly of the potential of the rupture of the "Achilles" tendon. Public Citizen also requested the FDA to send "Dear Doctor" letters to physicians providing them with individualized warnings. Public Citizen reports that although there are current warnings about tendon damage from the use of the drug they are buried among a plethora of lesser potential reactions.

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.

FDA DRUG LABELING: A FLOOR OR CEILING ON PHARMACEUTICAL LIABILITY?

In April of 2000, Diane Levine was a professional musician in Vermont when she suffered two amputations, one to her right hand and a second to her right arm, following the IV administration of the Wyeth drug Phenergan at Northeast Washington County Community Health, Inc.  Her doctor administered the drug to treat migraine headaches resulting from nausea.  She received two injections.  The first was by intermuscular injection.  She received the second dose by a direct intravenous injection procedure known as an “IV push.”  This last resulted in the inadvertent injection of Phenergan into an artery.  The artery turned gangrenous and the amputations followed.  Litigation following the amputations resulted in a 6.4 Million Dollar verdict against Wyeth which the Vermont Supreme Court affirmed in 2005. The trial centered on the adequacy of Wyeth’s warnings on the Phenergan label.

PHYSICIAN PRIVACY SUITS DUMPED

Two recent federal district court cases that raised physician concerns about privacy were unceremoniously rejected on motion.  In William Andrew Rinell, M.D. and Alan B. Whitehouse, M.D. v. Private Healthcare Systems and The Capella Group, Civil Action No. 106-176 (S. Dist. of Georgia, Augusta Div. 2007), the Plaintiff physicians sought damages in tort against a Preferred Provider Organization (“PPO”) with whom they had entered provider contracts and a discount card company who had purchased provider information and discount data from the PPO.  The physicians argued that their agreements with the PPOs did not contemplate the sale of their information to a purchaser who was not an insurance company and that the sale of such information was a breach of privacy or of some other kind of tort arising out of the contractual duties created by the physicians’ contracts with the PPO.  The court refused to recognize a claim sounding in tort and held that any claim arising out of the contract was fundamentally a contract claim and that since the Plaintiffs did not include a contract claim in its complaint, the complaint must be dismissed.

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.

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.