Singularity Health Law Blog

CAN THE FDA REGULATE YOUR STEM CELLS?

In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.

 

CALIFORNIA GAY CURE LAW GOES TO APPEALS COURT

Last year California Governor Jerry Brown signed into law California SB 1172, which makes it illegal to provide “conversion” or “reparative” therapy to homosexuals under the  age of 18 in the state. The issue is whether this an unremarkable and rational exercise of the police power of the state or an infringement of First Amendment rights.   Supporters of the bill assert that the “antigay” therapy is worthless pseudoscience and has the potential of harming young homosexuals who are struggling with identity and self worth issues.  They claim that homosexuality is not a disease or an assumed condition, but an intrinsic or genetic positioning on a natural scale of human sexuality.

 

WHEN WILL COMPUTERS THINK?

The Obama Administration recently announced the formation of the “Brain Activity Map Project” to be funded by the National Institutes of Health and other public and private foundations and organizations to undertake a ten year study of the human brain. The effort, which is similar to the organized effort to map the human genome is expected to cost at least 300 million dollars a year over the ten years. It is anticipated by scientists that it will be much for complex and difficult to undertake than the genome project. The hope is to develop a complete model of brain activity and the process of neuron firings that lead to cognition.

 

“OFF LABEL” DRUG PROMOTION CONVICTION VIOLATES 1ST AMENDMENT

160 Common U.S. Food and Drug Administration (“FDA”) approved drugs which are used for “off label” purposes represent approximately 21 percent of all prescriptions in the United states. Physicians may prescribe FDA approved drugs for any therapeutic use that is appropriate in their medical judgment. The FDA, however, prohibits pharmaceutical companies and their employees from promoting the use of FDA approved drugs for “off label” use. Although there is no express prohibition in the Food Drug and Cosmetic Act or its regulations prohibiting the promotion of drugs for off label use, the government uses a criminal statute which prohibits the introduction of “misbranded” drugs into interstate commerce ( 21 U.S.C. 331(a) and 333(a)(1) to prosecute pharmaceutical companies, their employees and sometimes physicians who are “promoting” the off-label use of drugs.

 

INDIAN CARDIOLOGISTS CAN PURSUE DISCRIMINATION CLAIM

 On November 30, 2012, Judge Greg Costa of the U.S. District Court for the Southern District of Texas, on remand from the 5th Circuit Court of Appeals, allowed three Indian cardiologists to move forward with their discrimination claim against David P. Brown, the administrator of Citizen’s Medical Center, finding that under the McDonnell Douglas shifting burden framework, the plaintiff’s had met their burden of showing a prima facie case of discrimination through circumstantial evidence  on 4 out of 8 adverse employment actions alleged by the plaintiffs and that the justifications offered by the defendant were pre-textual.

 

FEDERAL APPEALS COURT ABORTS IDAHO ABORTION PROSECUTION.

The abortion wars continue in Idaho where Bannock County prosecuting attorney, Mark L. Heideman sought to bring felony charges against Jennie Linn McCormack for taking an internet prescribed drug to induce an abortion in alleged violation of Idaho statutes.

SHAM PEER REVIEW BOOK INTERVIEW: Greg Piche´

Those that are interested can find an interview of the author of Sham Peer Review by the Denver Press Club at the following link.

http://denver.granicus.com/MediaPlayer.php?view_id=96&clip_id=5585

JUSTICE ROBERTS AND A BRIDGE TOO FAR

In holding with the minority liberal wing of the court that the Affordable Care Act is constitutional as a tax, Justice Roberts seems to have concluded that the wholesale sinking of the Act by the Supreme Court was “a bridge too far” for the conservative majority which stopped the vote recount in Florida before it was completed, effectively anointing George W. Bush President of the United States on legal grounds not used before or since. That of course brought us 2 middle east wars on a credit card that we are just beginning to pay and the worst financial crash since the Great Depression.

 

PEER REVIEW DAMAGES CLAIM WEARS THIN.

“Yo-yo litigation” bouncing back and forth between trial courts and appellate courts is wearing and expensive. Dr. Richard Chudacoff, M.D. should be able to attest to that.  Prior to moving to Las Vegas, Nevada in 2008, he was a renowned minimally invasive gynecological surgeon at Baylor University in Texas. In May of 2008, the University Medical Center of Southern Nevada, where he was an assistant professor, abruptly suspended his clinical privileges without notice or hearing. The action was described as a “routine administrative action” and not a 30 day emergency action based on immanent harm to patients. His university employment terminated because of the loss of his privileges.  The university hospital  forwarded a report of the suspension to the National Practitioner Data Bank in Washington asserting that the suspension resulted from “substandard or inadequate care.” Subsequently the “fair hearing” panel hearing his case disagreed with the grounds for the suspension and sent a recommendation to the Medical Executive Committee that his suspension be lifted and it was, in October, 2008.

PRO-SE DOCTOR WINS SUMMARY JUDGMENT OVERCOMING HCQIA IMMUNITY .

An Albuquerque Obstetrician/Gynecologist, filed a pro-se lawsuit in Federal District Court in New Mexico claiming that a hospital which permanently suspended his privileges deprived him of his civil rights overcame the hospital’s defense of immunity under the Health Care Quality Improvement Act of 1986 (“HCQIA”). In Chinonyerem Osuagwu v. Gila Regional Medical Center, (No. 1:11 -cv-1 3/27/12), Dr. Osuagwu presented evidence that Gila Regional failed to follow its own bylaws and failed to provide him due process in permanently suspending his privileges without meeting the requirements of HCQIA for immunity.  One of the defendants, Dr. Romillard, a non -practicing gynecologist advised the hospital’s peer review committee as to why Dr. O’s privileges should be suspended.