No-decision from the Supreme Court on suing drug companies.  Vote was 4-4.  The vote, however, allows the lawsuit against Pfizer will continue.  Meanwhile, Pfizer executives have decided to mass-suicide themselves with Lipitor.
http://omniphysicians.com/2008/03/04/supreme-court-no-decision-of-suing-drug-companies/
This is what happens when you don’t move patients in the ER.  Two months later, the guard began foaming at the mouth.
http://omniphysicians.com/2008/03/04/consequences-of-a-long-er-wait/
There is nothing quite like having to resuscitate a newborn found cold and blue outside of your ER.
http://omniphysicians.com/2008/03/04/not-a-good-way-to-start-or-end-your-shift/
Well, Massachusetts is trying once again to ban any ties between drug companies and physicians.  If it succeeds, it’ll be the first state to do so.  Then there’ll be a snowball effect elsewhere.  That’s the end of free booze, broads, and ballpoint pens!
http://omniphysicians.com/2008/03/04/to-be-banned-in-boston/
The CDC statement about the Hep C outbreak in Las Vegas is rather ominous.  The suggestion is that what happened there is just the tip of the iceberg.  However, it does underscore the necessity of reporting to local public health if you find something amiss or unusual. 
http://omniphysicians.com/2008/03/04/tip-othe-iceberg/
 

AP (3/4, Neergaard) reports that a decade “after government approval of the first sickle cell treatment, only a tiny fraction of patients use the drug — despite new research showing the disease is far more painful than doctors ever suspected.” According to an expert panel convened by the National Institutes of Health (NIH), “Ignorance on the part of both physicians and patients is to blame for underuse of hydroxyurea.” Sickle cell “afflicts up to 100,000 Americans, most of them black — not only shortening their lives, but causing regular pain attacks so severe that they frequently require long hospitalizations.” Hydroxyurea, which costs “less than $100 a month,” is the only FDA-approved treatment for the disease. It has been shown “to dramatically reduce sickle cell pain crises, hospitalizations, and some organ damage.” The drug “may even prolong survival,” but only about “five percent of those who qualify” use it. The panel blames unfounded fears about hydroxyurea, and encourages patients and physicians to be patient because it can take up to six months for patients to show improvement with the drug.

Philadelphia Inquirer (3/3, Burling) reported that on Tuesday, “[m]embers of the” Montgomery County “bar association and medical society, along with Abington Memorial Hospital” in Pennsylvania, will launch “a pilot project they hope will keep more malpractice disputes out of court.” Physicians and attorneys “will work in teams to mediate conflicts between patients and the hospital or doctors,” in hopes “that the new approach will resolve problems more quickly and humanely, without the demonization of both sides that can occur in malpractice battles.”

According to John J. Kelly, M.D., Abington Memorial’s chief of staff, the project’s primary goal is “to avoid the ‘harshness’ of litigation.” The idea is to work “with unhappy patients and their families through a two-step process.” During the first phase, physicians and nurses provide detailed information about the situation, and then, if the patients and/or their families are still dissatisfied, they move to the mediation phase.

Bloomberg (3/4, Matsuyama) reports that the Food and Drug Administration has approved Eisai Co.’s Aloxi (palonosetron hydrochloride), “to prevent nausea in surgical patients.” According to Eisai, approximately 40 percent of “surgical patients given general anesthesia in the U.S. are treated to prevent nausea.” The majority “of these patients are given a class of drug that includes Aloxi.”

NY Times, 3/4/08:  A 4-to-4 vote on Monday left the Supreme Court unable to decide a pharmaceutical pre-emption case that was argued a week ago.The tie vote, with Chief Justice John G. Roberts Jr. not participating, will permit a lawsuit to proceed against the Warner-Lambert Company, the maker of a diabetes drug, Rezulin. The plaintiffs are 27 diabetes patients from Michigan who suffered liver damage while taking the drug. Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency’s request.

A tie vote at the Supreme Court automatically affirms the lower court’s judgment. In this case, the federal appeals court in New York had rejected the company’s argument that the reasoning of a seven-year-old Supreme Court precedent barred individual damage suits that are based on the claim that a drug manufacturer obtained F.D.A. approval through fraud. Affirmance by a tie vote resolves only the particular dispute, without setting a precedent for other cases.

According to his financial disclosure form, Chief Justice Roberts owns $5,001 to $50,000 in stock in Pfizer Inc., Warner-Lambert’s corporate parent. When there is a tie vote, the court issues a one-sentence order that does not identify the positions of the justices who voted.

This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration’s approval of a drug’s label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices.

The Warner-Lambert case, by contrast, specifically questioned the status of lawsuits alleging that F.D.A. approval was obtained by withholding or misrepresenting crucial information — in other words, by fraud. A 2001 Supreme Court decision, Buckman v. Plaintiffs’ Legal Committee, barred general claims of fraud.

But the lawsuit by the Rezulin patients was brought under the specific provisions of a Michigan law that, while prohibiting product liability suits against makers of approved drugs, specifically permits claims that the manufacturer withheld or misrepresented information that was important to the approval process. The question was whether the existence of the state law placed the lawsuit on a different footing for the purpose of pre-emption analysis.

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer’s behalf. It argued that “permitting lay juries to second-guess” the adequacy of a drug application would interfere with the agency’s “exercise of its expert judgment.”

HealthCare Security Weekly, 3/3/08:  Patient bites hospital security guard A woman who felt she wasn’t getting prompt care at a Milwaukee hospital attacked a security guard, biting him in the head and spitting in his mouth.

Police arrested the 30-year-old patient at St. Joseph’s Hospital where she had been brought by ambulance to the facility’s emergency department February 23. The hospital’s security director Jeff Mehring told the Associated Press the woman was agitated before she arrived at the hospital and she became more aggressive in the facility.

The woman verbally threatened nurses, then continued to verbally harass security officers when they were called in to help, news reports said. The woman faces felony battery charges for biting one of the officers.

Healthcare Security Weekly, 3/3/08:  Baby found by security guard pronounced dead Denver police are investigating the death of a baby girl found by a security guard in a basket outside the Presbyterian/St. Luke’s Medical Center on February 26.

The infant was left in a basket in front of an emergency call box with the word “Help” on it. Someone pressed the button on the call box around 7:30 p.m.Tuesday, but no voice was heard, police said. A security guard went out to check and took the baby back inside the hospital where medical staff pronounced her dead a short time later, reported Rocky Mountain News.

It was not known whether the baby was alive when she was left at the hospital. Colorado has a “Safe Haven” law that allows a parent to relinquish control of a newborn baby at a fire station or hospital within 72 hours of birth without fear of criminal prosecution. An autopsy was planned to determine the cause of death.

Boston Globe, 3/4/08: 

An outbreak of hepatitis C at a Nevada clinic may represent “the tip of an iceberg” of safety problems at clinics around the country, according to the head of the Centers for Disease Control and Prevention.The city of Las Vegas shut down the Endoscopy Center of Southern Nevada last Friday after state health officials determined that six patients had contracted hepatitis C because of unsafe practices including clinic staff reusing syringes and vials. Nevada health officials are trying to contact about 40,000 patients who received anesthesia by injection at the clinic between March 2004 and Jan. 11 to urge them to get tested for hepatitis C, hepatitis B and HIV.

Senate Majority Leader Harry Reid, D-Nev., met Monday with CDC head Dr. Julie Gerberding, and on a media conference call after their meeting both strongly condemned practices at the clinic.

Health care accreditors “would consider this a patient safety error that falls into the category of a ‘never event,’ meaning this should never happen in contemporary health care organizations,” said Gerberding.

“This is the largest number of patients that have ever been contacted for a blood exposure in a health-care setting. But unfortunately we have seen other large-scale situations where similar practices have led to patient exposures,” Gerberding said.

“Our concern is that this could represent the tip of an iceberg and we need to be much more aggressive about alerting clinicians about how improper this practice is,” she said, “but also continuing to invest in our ability to detect these needles in a haystack at the state level so we recognize when there has been a bad practice and patients can be alerted and tested.”

Reid said he would work with Gerberding to try to get the CDC more resources in an emergency spending bill Congress is to take up in April.

State health officials said they weren’t sure how many of the 40,000 patients they’d been able to contact since making the risk public last Wednesday. At least initially they didn’t have correct addresses for 1,400, officials said.

The head of the clinic, Dr. Dipak Desai, purchased space for an open letter in the Las Vegas Review-Journal on Sunday in which he expressed “my deepest sympathy to all our patients and their families for the fear and uncertainty that naturally arises from this situation.”

Desai offered no apology but said a foundation was being set up to cover testing costs. He also defended practices at his clinic, which performs colonoscopies.

“The evidence does not support that syringes or needles were ever reused from patient to patient at the center,” Desai wrote.

A spokeswoman, Nancy Katz, declined Monday to comment further.

The Clark County district attorney is investigating, as are various health agencies, including the Nevada State Board of Nursing. Several lawsuits already have been filed and a hearing is scheduled for Thursday before a Nevada legislative committee.

It may never be known how many people contracted hepatitis C because of unsafe practices at the endoscopy center, state health officials said. Brian Labus, head epidemiologist of the Southern Nevada Health District, said that because 4 percent of the population has hepatitis C, he expects to get numerous positive results after the at-risk clinic patients are tested and it may be impossible to determine which of those were infected at the clinic.

Of the six cases that health officials did trace to the clinic, five of them happened on the same day and genetic testing was used to make the connection, Labus said.

Hepatitis C can cause fatal liver disease as well jaundice and fatigue, but 80 percent of people infected show no symptoms. Hepatitis B is a more rare and serious disease that attacks the liver.

Meanwhile, state health officials are still looking at a second clinic with connections to the first, called Desert Shadow Endoscopy Center. At Desert Shadow, officials had been found to reuse anesthetic vials but not syringes and so far no patients have been notified of potential risk. That determination could still be made, said Lisa Jones, head of the Nevada State Health Division’s bureau of licensure and certification.