Yet another scandal involving the Walter Reed Army Medical Center has surfaced. Apparently Dr. Timothy R. Kuklo, a former surgeon at Walter Reed, may have falsified his study of Medtronic Inc.’s Infuse Bone Graft.

During his time at Walter Reed, Kuklo conducted, published, and promoted a study in which he claimed that soldiers’ leg injuries healed faster when Infuse was used.

However, major news agencies such as the Wall Street Journal and the New York Times have reported that Kuklo lied about the number of patients and injuries treated, did not obtain the Army’s permission to conduct the study and forged the signatures of his co-authors.

Kuklo is currently an associate professor at the Washington University medical school in St. Louis. He is a paid consultant for Medtronic and even gave speeches on Medtronic medical devices while at Walter Reed.

His position at Medtronic may cause legal problems for both of them since Kuklo employed an off-label use for Infuse in his study and pharmaceutical companies are forbidden from promoting off-label use of their products.

The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says.

According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier this month that FDA scientists wrote to President-Elect Obama’s transition team looking to end corruption at the agency

The FDA is responsible for making sure that drugs, medical devices, and other products are safe to the American public.

It seems it has failed again and continues to put untold citizens who have been fitted or implanted with sensitive and high-risk medical devices in jeopardy.  The GAO’s report charges the FDA to immediately work to ensure high-risk medical devices be thoroughly reviewed as a opposed to it merely providing clearance, said Dow Jones.  Of note, external cardiac compressors are among the types of devices that do not receive thorough review.

If you or a loved one was injured because of a defective medical device, it is important to contact an attorney experienced in medical malpractice law.

According to a report published on Bloomberg.com, scientists and physicians at the Food & Drug Administration (FDA) have charged that the agency has corrupted the process by which new medical devices are approved.

The names of scientists who made the charges, as well as the devices to which they refer, have been redacted in the copy of a letter released to the public.

But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”

The letter was sent to members of the House Energy and Commerce Committee, the Congressional arm that provides oversight of the FDA.

The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.

The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.

The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.

The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”

According to the FDA, it does no such thing.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The Food and Drug Administration is warning doctors — and the public — about an growing but largely unrecognized problem plaguing surgery patients: UFDs.

Unretrieved device fragments, medical devices that break and leave behind potentially deadly debris after surgery, is responsible for at least 72 deaths and 4,675 injuries since 2003, an FDA database reports.

This is on par with mistakes that have received far more attention — sponges and instruments left in abdominal cavities — with this difference: doctors usually know they’re there, but they either make no attempt to retrieve the devices or are unsuccessful when they try.

FDA records show that more than 200 medical devices contribute to the problem. The most common problem occurs when wire guides for catheters used in heart operations break or fracture, leaving the device or fragments behind. Bone screws used in orthopedic operations are often culprits as well.

Some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging.  One worry is that metal objects can overheat during MRIs, scorching patients from the inside.

While the FDA works to develop some sort of reporting system, it’s up to patients to protect themselves. Ask doctors to explain potential complications of medical procedures and devices well before surgery begins. If a device is being removed, they should ask to see it. Afterward, they should ask if anything was left behind.

If you are suffering from this sort of problem, seek out an experienced lawyer who can help you with professional insight and to determine what sort of financial compensation is available.

Two US lawmakers have asked a group of doctors and researchers to disclose the amount financial and other support they have received from five companies that manufacture medical devices.

The manufacturers include Abbot Labs, Medtronic Inc. and Johnson & Johnson, companies that, in the past, have been the subject of defective medical product lawsuits.

The lawmakers, Senators Charles Grassle and Herbert  Kohl, have been looking into the financial ties between doctors and industry. They have sponsored legislation that would force drug companies and device makers to disclose their spending on doctors.

Despite manufacturer claims, the safety of several medical devices, especially heart stents and particularly drug coated stents – is far from established.  Several studies have linked the devices to blood clots and heart attacks.

In fact, a recent study indicated that Medtronic’s Endeavor drug-coated stent was associated with more heart attacks and deadly blood clots than another stent made by Johnson & Johnson.

Faulty medical devices can cause injuries, even death. If you or a loved one has been harmed because of a defective stent or other medical device, contact an attorney for professional insight into developing litigation. This may be the only way for you to recover some of the costs you and your family bear for these mistakes.

Back in February, the United States Supreme Court dealt a hefty blow to citizen protection to seek compensation after being injured by a defective medical device. In this landmark case, our highest court ruled against Charles Riegel, the victim of a defective balloon catheter used during his angioplasty procedure. Though Riegel was seriously injured at the negligent hands of Medtronic, the court found that Federal regulations overruled state law, rather than the two working in tandem as it had been before.

The repercussions of this decision have yet to take their full effect. As Public Citizen lawyer Allison Zieve noted, “The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels… and to remove unsafe products from the market.”

Luckily, the consumer advocacy group Public Citizen is working to remedy this gaping hole in consumer protection. With the support of Representatives Henry Waxman and Frank Palone, and Senators Ted Kennedy and Patrick Leahy, they are trying to push through the Medical Device Safety Act of 2008. This new legislation would nullify the implications of the Supreme Court ruling, and give power back to the injured.

A new electronic system is being backed by the U.S. Food and Drug Administration (FDA), the American Medical Association (AMA) and many more groups and manufacturers. The new system will notify physicians electronically if a drug or medical device has been linked to new dangers.

The system is called the Health Care Notification Network (HCNN). The HCNN is expected to begin operation next month. Over 100,000 physicians have already signed up to the service.

HCNN is a free service offered to physicians that is being funded by drug and medical device manufacturers. The service will deliver the same information that is currently delivered to physicians via the postal service. The new electronic system is intended to deliver the information quickly to physicians, which can potentially help to save lives. The information will be delivered via e-mail.

Defective drug attorneys are working to help support those who have suffered from serious adverse reactions due to faulty prescription medications or medical devices.

The Food and Drug Administration (FDA) has stated that at the end of the year albuterol inhalers, which are commonly used to treat asthma, will no longer be available for use.

Albuterol inhalers typically use a chemical called chlorofluorocarbons, or CFCs. This chemical is used to propel the drug into the patient’s lungs, but has been found to be damaging to Earth’s ozone layer.

The Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer have settled on a treaty in which the United States has agreed to stop producing and importing substances harmful to the ozone, including CFCs. Therefore, as of December 31st, inhalers containing these chemicals can no longer be made or sold in the U.S.

The alternative will be inhalers using hydrofluoroalkanes, or HFAs. The FDA has already approved ProAir HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol, as well as Xopenex HFA Inhalation Aerosol which contains levalbuterol.

The FDA has confirmed that these alternatives are safe and effective for those switching from CFC inhalers, although they will taste and feel different. Each has different priming, cleaning, and drying instructions to prevent the medicine from building up in the inhaler.

The FDA states that there is an adequate supply of the HFA inhalers as increased production has already started, but urges those with asthma to start talking to their doctors now.

Defective drug attorneys are working on cases in which prescription drugs have caused harmful and serious side effects.