FairWarning » Medical Errors

Promoter of Lap-Band Weight-Loss Surgery Warned Over Misleading Ads

Wed, 14 Dec 2011 18:14:04 +0000

Federal authorities have warned a Southern California marketing company promoting Lap-Band weight-loss surgery that it is illegally engaging in false advertising that downplays the serious risks of the procedure.

The Food and Drug Administration told the firm, 1-800-GET-THIN, that its billboards and print advertising “fail to provide required risk information, including warnings, precautions, possible side effects and contraindications.” The agency also said it “is concerned” that the information on medical risks in its print advertising “is too small to be read by consumers.”

In its warning letters, the FDA told the marketing firm and eight surgical centers affiliated with it that failure to end the violations quickly could result in injunctions, fines or seizure of their Lap-Bands. According to the Los Angeles Times, a lawyer who represents 1-800-GET-THIN said the marketing company will work with the FDA to resolve the problems.

The Times, which has reported extensively on the Lap-Band businesses, said five Southern California patients have died since 2009 after surgeries at centers affiliated with the advertising campaign, according to lawsuits, autopsy reports and other public records.

The Lap-Band is a silicone ring surgically implanted around the stomach to discourage overeating. The surgeries, which often are covered by insurance for obese patients, can cost in the range of $12,000 to about $20,000, according to the manufacturer of the device.

Patient deaths and injuries have prompted wrongful death, personal injury and class-action litigation. A lawyer who filed the class-action suit and two wrongful death cases said the operators of the businesses have “gone out of their way to make it sound like it’s a drive-through surgery, a one-hour safe procedure. So I’m glad the FDA is doing this.”

Still, the lawyer added, “It’s unfortunate it’s taken so long. It doesn’t do any good for the five people who’ve lost their lives.”

Separately, a Times business column pointed out that 1-800-GET-THIN and and its affiliates have lashed out at their critics previously. They have accused the director of the Los Angeles County Department of Public Health and an anesthesiology expert for the country coroner’s office with conflicts of interest. They also have repeatedly, and unsuccessfully, sued the Times itself for its coverage.

STUART SILVERSTEIN

Medtronic to Pay $23.5 Million to Settle Charges of Kickbacks to Doctors

Tue, 13 Dec 2011 17:19:30 +0000

The world’s No. 1 maker of medical devices, Medtronic, has agreed to pay $23.5 million to settle federal allegations that it provided kickbacks to doctors who implanted its pacemakers and defibrillators.

As Reuters reports, the U.S. Department of Justice accused the Minnesota-based company of making illicit payments to physicians of $1,000 to $2,000 per patient, and then submitted false claims involving the expenses to the government’s Medicare and Medicaid programs.

Federal officials said Medtronic kicked back the money to doctors by compensating them, if they used the company’s products, for what are known as postmarket studies and device registries. Postmarket studies assess the performance of medical devices or drugs after they are approved by the Food and Drug Administration. Registries are collections of data concerning devices implanted in patients.

“Patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,” Tony West, an assistant attorney general, said in a Justice Department news release. “Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.”

The company admitted no wrongdoing. The settlement will provide about $4 million to two whistleblowers who filed lawsuits exposing the kickbacks.

Separately, Medtronic remains under investigation by the Justice Department and the U.S. Senate over its practices in marketing a bone growth product used in spinal fusion surgery called Infuse. The probes coincide with a report in June by an influential medical publication, The Spine Journal, that said that surgeons who were paid tens of millions of dollars by Medtronic wrote evaluations of the drug that downplayed, or ignored, serious and widespread side effects.

The unreported complications included, among various other problems, cancer and sterility in men.

STUART SILVERSTEIN

Heart Attack Patients Harmed by Slow Transfers to Fully Equipped Hospitals

Tue, 29 Nov 2011 18:37:53 +0000

Heart attack patients often wind up at hospitals ill-equipped to treat them, and their chances of survival sometimes depend on how quickly they can be transferred to another medical center.

Yet a new study has found that nine out of 10 U.S. heart attack patients needing a transfer wound up waiting longer than the recommended 30 minutes.

As Reuters reports, the key to treating many heart attacks is clearing the blocked coronary artery cutting off blood to the heart and then inserting a small tube called a stent to keep the artery open. The reason so many patients need to be transferred for treatment is that less than a quarter of U.S. hospitals are equipped to perform stenting around the clock.

But in more than half of the cases studied, hospitals took longer than one hour to transfer patients.

“What we are finding is really long delays,” said Dr. Harlan Krumholz of the Yale School of Medicine, who was part of the research team. “Some people are being transferred out even after 90 minutes or two hours. There is no way those people are going to get timely treatment.”

The research, based on 2009 data from nearly 14,000 patients at 1,034 hospitals, was published in the Archives of Internal Medicine.

Another new study in the same medical journal, however, pointed out that stents often fail to provide lasting help for patients with blocked arteries. According to a separate Reuters story, nearly one out of every 10 such patients who get stents wind up back in the hospital within 30 days due to complications.

Experts differed, however, on the extent to which the results point to shortcomings in patient care versus other issues, such as how sick some patients were before undergoing the procedure.

STUART SILVERSTEIN

Flawed Test Used to Evaluate Soldiers’ Brain Injuries

Tue, 29 Nov 2011 17:27:32 +0000

Tens of thousands of soldiers serving in Iraq and Afghanistan suffer concussions and other difficult-to-detect traumatic brain injuries, often the result of bombings by insurgents. To identify troops needing care for these injuries, Congress in 2007 passed a measure requiring the military to test soldiers’ brain function before they deploy and when they return.

But an investigation by the news organizations ProPublica and NPR has found that the computerized cognitive test being used by the military, and the way it is being administered, are badly flawed. What’s more, the test — known as Automated Neuropsychological Assessment Metric, or ANAM — was chosen hurriedly, without proof that it is effective.

As a result, ProPublica and NPR found, more than one million troops have taken the test at a cost of more than $42 million to taxpayers, yet the military still has no reliable way to diagnose brain injuries.

Among the problems identified in the investigation, part of a series by the two news organizations on the epidemic of brain injuries suffered by soldiers:

Researchers who developed ANAM for the military and who stood to make money from the test were involved in the decision to use it, raising questions about the impartiality of the selection process.
The Pentagon ignored years of warnings that there was insufficient evidence that the test can diagnose traumatic brain injury.
Top Pentagon officials misrepresented the cost of the test, indicating that because the Army invented the ANAM, the military could use it for free. In fact, because the military licensed its invention to outside contractors, it has paid millions of dollars to use it.
The military has delayed for years a long-promised study to make sure the ANAM is the best available test.

Although studies have shown that ANAM has promise for purposes such as helping doctors determine if soldiers can return to duty after suffering an injury, experts say that neither it or any other computerized test can, on its own, enable doctors to diagnose traumatic brain injury.

“We have failed soldiers,” said retired Col. Mary Lopez, who used to manage the Army’s ANAM program. “It is incredibly frustrating because I can see first-hand the soldiers that we’ve missed, the soldiers that have not been treated, not been identified, [or] misdiagnosed. And then they struggle.”

STUART SILVERSTEIN

Medical Execs Get Prison Terms for Promoting Product Linked to 3 Deaths

Tue, 22 Nov 2011 16:45:48 +0000

Three executives of a medical device company, Synthes Inc., have received prison terms in connection with the business’ promotion of a bone cement for unauthorized uses.

The company’s product was linked to the deaths of three spinal surgery patients in 2003 and 2004, although the Department of Justice never proved that the bone cement caused the fatalities.

As The Philadelphia Inquirer reports, Michael Huggins, 54, who was president of Synthes USA, and Thomas Higgins, 55, former president of the Synthes spine division, were sentenced to nine months in federal prison. John Walsh, 48, former regulatory director for the spine unit, was sentenced to five months. Sentencing for a fourth executive, Richard Bohner, former vice president of operations, was postponed after his lawyer collapsed in court.

Federal prosecutors argued that the executives were actively involved in the illegal promotion and clinical testing of bone cement made by the company’s Norian unit. The product was used by doctors in back surgeries, including the procedures that left three patients dead on the operating table.

The sentences, The Wall Street Journal reports, were victories for the Justice Department’s push to hold executives criminally responsible for corporate violations of food and drug laws. Federal sentencing guidelines called for prison terms of zero to six months, but the Justice Department had asked the judge to sentence the former executives to prison for up to a year, partly to serve as a deterrent to other executives.

The four men pleaded guilty in 2009 to a misdemeanor charge of shipping adulterated and misbranded bone cement under what is known as the responsible corporate officer doctrine. They each have agreed to pay the maximum fine of $100,000.

Synthes and its Norian unit agreed last year to plead guilty to charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials of the Norian bone cement in surgeries for vertebral compression fractures of the spine. The surgeries were carried out with the cement even though the product carried a warning that it should not be used for such fractures because it could cause blood clots.

The case was heard in Philadelphia, near West Chester., Pa., where Swiss-based Synthes has its U.S. headquarters.

STUART SILVERSTEIN

Secrecy Order on Doctor Discipline Blasted by Critics

Fri, 11 Nov 2011 09:00:27 +0000

Bowing to widespread complaints, the federal government has restored a website providing records of malpractice payments and disciplinary action against doctors. But journalists and patient advocates protest that authorities are continuing to restrict information to which the public is entitled.

As The Kansas City Star reports, the federal Health Resources and Services Administration, or HRSA, cut off public access to the National Practitioner Data Bank in September. It acted after a Johnson County, Kan., neurosurgeon, Dr. Robert Tenny, complained that reporting by the Star violated his confidentiality.

This week HRSA reopened the website, but with strings attached. One of the key conditions: Anyone downloading its public files will have to agree not to share the data with others or to use the information to zero in on individual doctors, whose identities are masked in the data bank.

However, matching information from the data bank with other public documents, such as court filings, is what reporters long have done to find out if, for instance, disciplinary action has been taken against doctors who repeatedly have been sued for malpractice.

The Star reported that Tenny was among 21 doctors who had spotless Kansas and Missouri medical licenses despite numerous malpractice payouts. The article went on to say that Tenny was sued by patients or their families at least 17 times since 1983. Though Tenny denied the allegations, the Star reported that court records showed that he settled at least seven of those lawsuits.

Charles Ornstein, a reporter with the nonprofit investigative news organization ProPublica and president of the Association of Health Care Journalists, said the new restrictions placed on data bank material will prevent reporters from writing such investigative stories. He said HRSA overstepped its authority.

“The last time I checked, the federal government doesn’t have the authority to check on the reporting methods of reporters,” he said.

Mary K. Wakefield, HRSA administrator, said in a statement that the agency had imposed “appropriate protections so that critically important research can continue” without violating legal requirements on confidentiality.

The data, Wakefield said, can be used for statistical analysis or reporting on unidentified doctors. “We have taken steps to improve patient safety by making more information available to hospitals, health care entities, and state licensing boards than at any other time in the history of the data bank,” she added.

The data bank was created in 1986 to help hospitals, insurers and medical boards keep track of malpractice payments and disciplinary actions across state lines. Its public file has used identification numbers instead of doctors’ names, partly in response to objections by the American Medical Association, according to The New York Times.

U.S. Sen. Chuck Grassley, R-Iowa, is among the critics of HRSA’s latest restrictions. “This agency needs to remember that half of all health care dollars in the United States comes from taxpayers, so the interpretation of the law ought to be for public benefit,” he said.

ROBERT T. NELSON