Accident & Injury Law in Texas

Archive for the ‘Medicine’ Category

Federal prosecutors in Boston announced Thursday that they have filed a health care fraud charge against a doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex.

Court documents indicate that anesthesiologist Scott Reuben has agreed to plead guilty in exchange for prosecutors recommending a sentence of up to 10 years in jail, a $250,000 fine and forfeiture of assets received for the research worth at least $50,000.

Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield, Mass., received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege.

Two of the drugs that Reuben reported favorable results for, Vioxx and Bextra, were pulled from the market amid evidence they raised the risk of heart attack, stroke and death.

How can someone who is supposed to be a healer and care for people show such callousness, knowing that his reports would affect drug use by thousands of patients?

Two popular heartburn medications can interfere with the blood thinner Plavix, a drugtaken by millions to reduce risks of heart attack and stroke.

The Food and Drug Administration said the stomach-soothing Prilosec and Nexium cut in half the blood-thinning effect of Plavix, or clopidogrel.

The Texas Medical Board fined Dr. Philip W. Caterbone of Pflugerville $1,000 for a record-keeping violation. He was among 75 doctors disciplined at the board’s meeting this month.

The board’s order said that Caterbone, who is engaged in family practice, failed to document the progress notes from a patient’s visit in September 2008.

Patients who lack health insurance are more likely to die from car wrecks and other traumatic injuries than people who belong to a health plan, even though emergency rooms are required to care for all patients. regardless of ability to pay, according to a study to be published today.

An analysis of 687,091 patients who visited trauma centers nationwide between 2002 and 2006 found that the odds of dying after an accidental injury were nearly twice as high for the uninsured than for patients with private insurance, researchers reported in Archives of Surgery.

Trauma physicians said they were surprised by the findings, even though a slew of studies had previously documented the ill effects of going without health coverage. Uninsured patients are less likely to be screened for certain cancers or be admitted to specialty hospitals for procedures such as heart bypass surgery.

They also often wait longer to see doctors in ERs.

And patients without insurance may have higher rates of untreated underlying conditions that make it harder to recover from trauma injuries, the research team from Harvard University and Brigham and Women’s Hospital in Boston said. They also may be more passive with doctors and nurses because they don’t interact with them as often.

Overall, about 18,000 deaths each year have been traced to a lack of health insurance.

Three years ago, the maker of a surgical clip called the Hem-o-lok issued an urgent recall notice warning doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in their bodies, with “serious, even life-threatening consequences.”

Experts say deaths resulting from missed recalls are the result of a major weakness in the nation’s system for recalling thousands of medical devices routinely implanted in people’s bodies, from screws and plates to artificial knees and hips.

“There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know,” said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.
Unlike the auto industry, medical equipment makers have no centralized system for tracking products throughout their life span. That means in some instances, manufacturers do not have an easy way of knowing where problematic devices are or which patients got them.

Meanwhile, the number of items implanted is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in fiscal 2008, according to the Food and Drug Administration. That was nearly double the number reported the previous year and a 164 percent increase since 2000.

In 2006, surgeons implanted a million hip and knee replacements, according to the American Academy of Orthopaedic Surgeons. That number is expected to quadruple by 2030.

Fadem’s foundation and other groups have been pushing for years for better tracking of devices, hoping to create something like the patient registries used in Sweden, England and Australia to keep tabs on artificial joints.

Health care overhaul legislation being considered in Congress includes a proposal to set up the nation’s first comprehensive medical device registry. Doctors say its primary use would be to uncover safety problems, but it could also be used to find patients quickly during a recall.

The. FDA currently requires comprehensive tracking of only 14 types of devices, including pacemakers, mechanical heart valves and breast implants. The agency says it is working toward better registration and tracking of other devices.

Manufacturers trace many other medical products only as far as the distributor. Finding them again is not always easy, particularly after they have been implanted into someone’s body. Hospitals record the model and lot numbers of implants, but that information is often buried deep in billing records or log books.

Manufacturers send out thousands of letters about recalls, and the FDA puts the information online, but the warnings can go unnoticed.

More than 1,000 such recall notices were sent out in the first seven months of 2009 involving devices such as tracheal tubes, catheters, pacemakers, prosthetic hips, screws, pain pumps and pieces of artificial spine. More than 1,00 were ranked as “Class 1″ recalls by the FDA, which involve a defect serious enough to create a “reasonable probability of adverse health consequences or death.”

Premier Inc., an alliance of 2,200 U.S. hospitals, said it examined one recent recall and found that even after a device with a potentially dangerous flaw was pulled from the market, doctors at more than 40 hospitals implanted it in at least 50 patients.

The FDA has been laying the groundwork for a registry of patients with artificial joints, which are more prone to breakage than other types of implants. The agency is also working on a system that would make tracking easier by associating each device with an ID number.

Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drugmaker a repeating corporate cheat for illegal prescription drug promotions that plied doctors with free golf, massages and resort junkets.

Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

A portion of the $1 billion civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.

Texas’ Medicaid program will get $55 million, according to Texas Attorney General Greg Abbott.

Authorities called Pfizer a repeat offender, noting it is the company’s fourth settlement of government charges in the past decade.

The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.
“They were entertained with golf, massages and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the same laws with other drugs.

To prevent backsliding, Pfizer’s conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can, help the American public at a time when budgets are tight and health care costs are rising.”

Kathleen Sebelius, secretary of Department of Health and Human Services, hailed the settlement. “Health care is too important to let a single dollar go to waste,” she said.

Officials said the U.S. industry has paid out more, than $11 billion in such settlements over the past decade.

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators.

Authorities said Pfizer’s sales staff created phony doctor requests for medical information so that they could send unsolicited information to doctors about unapproved uses and dosages.

Use of drugs for so-called “off-label” medical Conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that haven’t been approved by the Food and Drug Administration.

Authorities said Pfizer’s junkets and other company-paid perks were designed to promote  Bextra and other drugs to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra was pulled from the U.S. market amid evidence it raised the risk of heart attack, stroke and death.

Wednesday’s settlement covered Pfizer’s promotions of Bextra, nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.

A treatment that uses medical cement to fix cracks in the spinal bones of elderly people worked no better than a sham treatment, the first rigorous studies of the popular procedure show.

Pain and disability were about the same up to six months later.

The treatment is so widely thought to work that the researchers had a hard time getting patients to take part when it was explained that half of them would not get the real thing.

“All of us who do the procedure have seen apparently miraculous cures,” said Dr. David Kallmes, a radiologist at the Mayo Clinic who led one of the studies. But he said there were also “miraculous cures” among those who got the fake treatments.

The researchers said it is yet another example of a medical procedure coming into wide use before good studies are done to show that it is safe and effective.

About 750,000 Americans suffer painful compression fractures in the spine each year. Bone-thinning osteoporosis is the most common cause. There are about 80,000 bone cement procedures done in the United States each year, Kallmes said.

Medicare pays $1,500 to $2,100 for the procedure.

The findings were published in today’s New England Journal of Medicine.

Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

“Loss of the sense of smell is potentially life-threatening and may be permanent,” said Dr. Charles Lee of FDA’s compliance division. “People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house.”
Matrixx defended the safety of its products but said it may remove them from the market.

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that is not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.
A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

“The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval,” said Deborah Autor, director of FDA’s drug compliance division.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

Government scientists say they are unaware of any data supporting Zicam’s labeling, which claims the drug reduces cold symptoms, including “sore throat, stuffy nose, sneezing, coughing and congestion.”

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Three Austin doctors were among 71 disciplined recently by the Texas Medical Board, including one who the board said abused substances and misprescribed drugs.

Dr. Michael Bowen Pickrell, an internist and rheu-mathlogist, sought treatment for problems that the board said were related to substance abuse, depression and “steroid psychosis” starting in December 2006 and continuing into 2007, but he left the programs against medical advice, according to the board’s order. He also self-medicated, improperly prescribed narcotics or other painkillers to six patients, and failed to follow up with a seventh patient who was tested and might have had a disease, the order said. Neither Pickrell nor his attorney could be reached for comment Thursday.

Last week the board ordered Pickrell to abstain from using alcohol, steroids and a list of other medications. He also must undergo drug testing, be evaluated by a board-designated psychiatrist and cooperate with treatment.

The board also ordered:

■ Dr. Theodore Dale Smith, who practices family medicine, to take a course in medical record-keeping because of inadequate documentation of a patient’s treatment for depression. The patient was given Prozac, which was appropri ate, but committed suicide, the order said. The death was not related to using the medicine, according to the board.

Smith’s records didn’t show whether he had discussed suicidal thoughts with the patient or whether he had scheduled the patient for a return visit. Smith, who did not return a call seeking comment, told the board he now prescribes only a one-month supply and requires a follow-up evaluation.

■ Dr. Erika Irene Zimmerman, who practices family ,medicine, to take a course in either psychopharmacology or the treatment of depression. Zimmerman had missed a deadline to complete a required training course the board had ordered her to take several years ago.

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Hydroxycut has been linked to liver damage by the U.S. Food and Drug Administration (FDA) and it is warning consumers to immediately stop using Hydroxycut products.

If you or a loved one has taken Hydroxycut product and suffered jaundice, liver damage, elevated liver enzymes, rhabdomyolysis, seizures, cardiovascular disorders or death then you should call us now to find out if you may be eligible to make a claim for compensation.

Here are the hydroxycut products that have been recalled:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Regular Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Call us immediately if you have been diagnosed with liver damage after taking Hydroxycut!

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