Lansing Personal Injury Lawyer - Medical Devices & Implants

Rapid CT Heart Scan Better at Diagnosing Blocked Arteries

David Mittleman — Fri, 20 Nov 2009 10:00:00 GMT

According to a recent study, a rapid CT heart scan is better able to provide doctors with a more efficient method of diagnosing blocked arteries after a patient complains of chest pain. In the past, doctors have routinely used electrocardiograms, treadmill, and resting stress tests along with nuclear imaging, to diagnose blocked arteries. However, these tests are often longer and don’t always provide a clear diagnosis.

The author of the study, Kavitha Chinnaiyan of William Beaumont Hospital in Royal Oak, MI, discovered that the rapid CT heart scan cuts the diagnosis time in half, and also saves 40% of the cost of the previous diagnostic methods. However, there is one drawback to the test: patients increase their exposure to medical radiation. Some doctors are concerned about the effects of such exposure on patients who routinely and frequently go to the hospital for chest pains.

Nevertheless, approximately 6 million people per year travel to the hospital complaining of chest pains, 60% of which are told that their symptoms are not serious and are sent home. Subsequently, 4 to 13% of those patients that are sent home suffer “missed” heart attacks, which can be fatal 10 to 25% of the time. Thus, the rapid CT heart scan could help reduce the incidence of “missed” diagnoses, ultimately saving lives.

Originally posted at InjuryBoard by David Mittleman

206 Stroke Patients Given Overdose of Radiation During CT Scans at Cedars-Sinai

David Mittleman — Tue, 13 Oct 2009 16:50:33 GMT

Cedars-Sinai Medical Center recently made a startling discovery: because of a setting error, hospital staff realized that at least 200 potential stroke patients were given CT scans at radiation doses 8 times the normal level.

On Monday, doctors admitted that the error occurred in February 2008, the same time that the hospital started a new protocol for scanning for potential strokes in patients. Specifically, doctors thought that the new procedures would help them to gather more useful data in analyzing the flow of blood to brain tissue.

Apparently, when a hospital employee set the scanner, they did not fully understand the set of directions that came with the machinery. Instead, they set the scanner at 8 times the normal radiation levels, which remained the default setting for the next 18 months. Doctors weren’t aware of the problem until a patient contacted the hospital to report that his hair had started falling out after receiving a CT scan. In response, hospital staff reviewed their records and found that 206 patients had received the higher dosages of radiation from the CT machine. When contacted, most of those patients also reported patchy hair loss as well as reddening of their skin. Fortunately, the incident prompted the Food and Drug Administration to issue a warning to all hospitals to check their CT scanners to make sure they are properly set.

Originally posted at InjuryBoard by David Mittleman

FDA Issues Warning to Evenflo After Reports of Electrical Shock from Breast Pump Use

David Mittleman — Thu, 17 Sep 2009 10:00:00 GMT

Several women who used the Evenflo breast pump were shocked while expressing their breast milk—literally. Recently, the Food and Drug Administration issued a warning to the Evenflo Company for failing to properly investigate the complaints of several women who reported receiving electrical shocks while using the company’s breast pump.

In an August 25^th letter that was released on Tuesday, the FDA said it found manufacturing violations at two Ohio Evenflo plants. Inspections at the two facilities revealed that Evenflo wasn’t in compliance with the federal manufacturing rules that make it mandatory for companies to review and evaluate all complaints. In fact, Evenflo received a total of 55 various complaints and only reviewed 37 of those. The 18 other complaints were left uninvestigated, with at least three of those complaints specifically relating to reports of electrical shock from using the breast pumps.

Moreover, according to federal regulations, companies are required to report issues with medical devices to the FDA. However, Evenflo did not follow through on these requirements, and the FDA reports that the company has still failed to address these concerns. Lindsay Harris, Evenflo’s vice president of quality and product integrity, maintains that the company is “working cooperatively with the FDA” to address the agency’s concerns.

Originally posted at InjuryBoard by David Mittleman

Fulton County Woman Joins Suit Against Pelvic Prolapse Medical Device Maker

David Mittleman — Sun, 23 Aug 2009 14:02:47 GMT

A Fulton County, Atlanta woman is but one of several plaintiffs suing the makers of a medical device intended to treat pelvic organ prolapse. The personal injury and product liability lawsuit was filed against New Jersey-based C.R. Bard Inc. last month in U.S. District Court in Atlanta. The suit alleges that the company made a defective device, the Avaulta Plus Anterior BioSynthetic Support System, which caused serious injuries in patients.

The Fulton County woman, Anne McVay, was an avid runner. But, she discovered, much to her own embarrassment, that when she returned from her runs, her pants were soaked. However, the wetness wasn’t caused by sweat—rather, it was caused by urinary incontinence. McVay was diagnosed with stress urinary incontinence and pelvic organ prolapse nearly two years prior. She also experienced incontinence when she laughed, coughed, or sneezed. In fact, her vaginal wall had collapsed as a symptom of pelvic organ prolapse, which contributed to her incontinence.

When McVay found out from her doctor that there was a medical device that could help with her unsightly incontinence, she decided to have the Avaulta Plus Anterior BioSynthetic Support System implanted. However, within just a few weeks she experienced worse pain than before—including bleeding and discharge. Eventually, she underwent two more surgical procedures to have as much of the mesh device removed as possible. Now, McVay and the other female plaintiffs state that they were left with severe scarring and experienced “significant mental and physical pain and suffering and have sustained permanent injury and substantial physical deformity.” C.R. Bard has not commented on the pending litigation. The suit seeks unspecified damages.

Originally posted at InjuryBoard by David Mittleman

Osteoporosis Treatment No More Effective Than Placebo, Two Studies Show

David Mittleman — Thu, 13 Aug 2009 10:00:00 GMT

Vertebroplasty was once one of the most revered treatments for easing the pain caused by osteoporosis. During the treatment, acrylic cement is injected into cracks in the spinal column. Doctors began performing the procedure in the 1990s and many patients reported instantaneous relief from their terrible pain. The only problem was that no clinical trials were ever performed to see whether the treatment really worked, or if could potentially cause worse problems in the future. In fact, the procedure does have risks—while rare, complications can be serious, including damage to the heart and lungs and even death if the cement leaked into surrounding blood vessels. Moreover, there are also unresolved questions about whether cementing one cracked vertebrae can caused stress on other vertebrae and lead to more breaks in the future. If vertebroplasty is not as effective as it claims to be, then the risks are not justified if there is no real benefit.

Indeed, two new studies cast serious doubt on the effectiveness of the treatment. Studies began several years ago at medical centers in the U.S. and in Australia. Working independently of on another, the two research teams randomly selected patients to either receive the real injection or a placebo. The American team assessed the patients one month after the procedure and the Australian team assessed their patients at one week and then at one, three and six months after the procedure. The results of the study showed that vertebroplasty failed to dramatically improve patients’ pain any better than the placebo.

One of the researchers in the American team, Dr. Kallmes, helped develop vertebroplasty and has been performing the treatment for 15 years. He says he is “shocked at the results”, but knows that other doctors will not be so quick to stop performing the procedure. Specifically, he stated: “the only way medical practice would change would be if Medicare and other insurers were to stop covering vertebroplasty or to cover it only when it was part of a study.” Other doctors, such as Dr. Robert R. Recker of the National Osteoporosis Foundation, said that there needs to be more studies before his foundation abandons vertebroplasty as a viable treatment option. Moreover, Dr. Marcel E. Salive, a director in the Medicare division said Medicare has no national policy on vertebroplasty and has been letting the states decide whether or not cover the treatment—most states have. Dr. Salive also said there are a lack of randomized, controlled studies to provide enough evidence to affect Medicare coverage.

The new studies are indicative of the type of research that health policy experts and President Obama have been calling for, to find out if the nation is spending its health care dollars wisely, on treatments that actually work. A bill passed by Congress this year provides $1.1 billion for effectiveness research.

Originally posted at InjuryBoard by David Mittleman

Estech settles lawsuit over bogus Medicare claims and false advertising for $1.4 Million

David Mittleman — Fri, 17 Jul 2009 14:50:00 GMT

Endoscopic Technologies, Inc. or Estech recently settled a lawsuit for $1.4 million after the Food and Drug Administration accused the company of violating the Food, Drug and Cosmetic Act and the False Claims Act. Specifically, the FDA accused Estech of falsely marketing its product, and of encouraging bogus Medicare claims as well as paying kickbacks to healthcare providers.

The San Ramon, California company makes medical devices for surgical ablation, where focused energy is used to create scar tissue on a patient’s heart or other organs. However, Estech also marketed its product to treat atrial fibrillation (the most common type of heart arrhythmia), which was not a use of the device that was approved by the FDA. Furthermore, Estech promoted costly heart surgeries to increase use of their product, when other less invasive treatments were more appropriate. The company also advised doctors to classify surgical procedures using the devices to increase Medicare payments and paid kickbacks to health-care providers who used it devices.

The allegations were made in a lawsuit filed in the U.S. District Court for the Southern District of Texas by a private citizen, under the qui tam provisions in the False Claims Act. Under these specific provisions of the act, private citizens may act as “relators” who can bring lawsuits on behalf of the U.S. and receive a portion of the settlement award. In this case, the relator will receive $210,000 as their share of the settlement. However, Estech denies the accusations and has not admitted any wrongdoing in the settlement.

Originally posted at InjuryBoard by David Mittleman

Arthroscopic Shavers Pose Potential Health Hazard: Human Tissue Left on Devices After Sterilization

David Mittleman — Sat, 11 Jul 2009 10:00:00 GMT

The Food and Drug Administration is conducting an investigation of arthroscopic shavers after receiving reports from several manufacturers of the shavers that human tissue remained in some of these medical devices after surgery, despite doctors following the manufacturer’s instructions for cleaning.

The FDA is not yet ordering public health professionals to discontinue use of arthroscopic shavers because the tissue is not visible to the naked eye. Moreover, the FDA stated: “the nature, magnitude and possible health impact of the situation is not yet clear”. They also cite that they are working with manufacturers of the devices to gather more information about the severity of the situation and its potential health and safety implications for patients that have had arthroscopic surgery. However, the tissue that remains in the shavers compromises the sterilization process.

The FDA is urging facilities that use the devices to thoroughly evaluate their cleaning procedures and to also adhere to the following steps to minimize potential health risks from contamination:

· Ensure that medical staff know and comply with manufacturer-recommended cleaning procedures

· Inspect the inside of the shaver after cleaning with a 3mm video scope to ensure that the channels of the shaver hand piece are free of tissues.

Originally posted at InjuryBoard by David Mittleman

Drug and Device Industry Gifts to Doctors Made Public in Vermont

David Mittleman — Thu, 21 May 2009 15:42:38 GMT

Vermont continues to lead the way in creating greater transparency in the flow of money from drug and device makers to doctors. Coming roughly a month after a report revealed that the drug and device companies spend $2.9 Million in gifts to doctors, hospitals, and universities in Vermont, the Legislature in that state has passed the nation’s toughest state law to regulate the marketing of drugs and medical devices to doctors.

The new law requires these companies to disclose the amounts of money given and the names of the doctors to whom that money is given. This information would allow citizens and prospective patients to know whether their cardiologist receives extravagant gifts from the makers of stents and pacemakers, or whether their orthopaedic surgeon routinely takes free lunches and cash gifts from the makers of artificial knees. Such information helps patients judge for themselves the integrity of the profession, by making these gifts part of the public record. This law signals a nationwide effort to change the old ways of doing business with the drug industry and medical device industry.

Originally posted at InjuryBoard by David Mittleman

FDA Holds Meeting on Medical Device Approval

David Mittleman — Wed, 22 Apr 2009 12:19:14 GMT

In a rare move, the U.S. Food and Drug Administration (FDA) is conducting an "all-hands" meeting to discuss concerns regarding its medical device division. The meeting, set to happen today, is the first such gathering in years.

The division of the FDA responsible for approving medical devices has come under heavy fire in recent months. In January, nine agency scientists authored a letter to then-President-elect Obama in which they accused the FDA of mismanagement, lack of accountability, and even possible corruption. Also in January, the Government Accountability Office released a report criticizing the FDA for lacksidasical regulation of high-risk Class III medical devices. In addition to its questionable approval process, the agency has evidently permitted healthcare facilities to wash and reuse equipment intended to be used only once.

According to the scientists who wrote the letter, the FDA is "fundamentally broken" and honest employees at the agency face intimidation from dishonest employees. As a result of the FDA’s shortcomings, the scientists claim that the agency is "placing the American people at risk."

Originally posted at InjuryBoard by David Mittleman

FDA Demands Info on Older Medical Devices

David Mittleman — Fri, 10 Apr 2009 08:33:00 GMT

Earlier this week, the Food and Drug Administration (FDA) requested information on decades-old medical devices marketed by companies such as Medtronic. These devices, which range from wheelchairs to pacemakers, hit the market prior to 1976 – the year the FDA was first authorized to review and approve medical devices. According to an article by the Wall Street Journal, these medical products were allowed to remain on the market after only a cursory review of their safety.

One major concern is that high-risk devices such as pacemakers – known as Class III devices – might not be as safe and effective as previously believed. Due to what is essentially a loophole in the approval process, the FDA has approved Class III products without the stringent testing now required of new devices.

Medical device companies have 120 days to comply with the request for information. Medtronic claims that its devices are safe and that they have some thirty years’ worth of evidence to back up their assertion.

Originally posted at InjuryBoard by David Mittleman