Philadelphia Personal Injury Lawyer - Medical Devices & Implants

Synthes Components Recalled

Jamie Sheller — Wed, 18 Nov 2009 21:17:38 GMT

Recently, Synthes, a Swiss medical device company, voluntarily recalled its Synex II Central Body components. According to the company, all surgeons and hospitals with the recalled devices were to immediately stop implanting them. The FDA has classified the recall as a Class I, which means that they could pose an imminent health hazard. The Synthes devices are used to replace damaged or unstable vertebral body in the T1-L5 portion of the spine. The recall was issued after reports of device failure causing loss of vertebral body replacement height. Those problems could lead to neural injury, increased pain and possible need for further surgery.

Originally posted at InjuryBoard by Jamie Sheller

Portable Headphones Can Cause Interference With Cardiac Devices

Jamie Sheller — Sat, 10 Oct 2009 17:11:24 GMT

According to a recent study published in the journal Heart Rhythm, the magnets in portable headphones may cause temporary malfunction of some cardiac devices. Therefore, the researchers suggest that patients with implantable cardioverter-defibrillators or pacemakers should not place headphones from MP3 players too close to their chests. The interference that can be caused by the headphones includes inhibition of tachyarrhythmia detection in ICDs and asynchronous pacing in pacemakers. Patients with these devices don't need to avoid portable headphones, they should just keep them at least 3 centimeters (1.2 inches) from their chests. Cardiac arrhythmia specialists have long told patients not to place electronic equipment directly over their devices.

According to the study's researchers, the FDA has already concluded that digital music players are unlikely to interfere with implanted devices, but not much was known about potential interference from portable headphones. In the recent study, electromagnetic levels from portable headphones exceeded levels sufficient to disable sensing in an implanted device, when the headphones were less than 2 centimeters from the chest. Most of the devices returned to normal functioning once the headphones were moved away. Patients with ICDs were more likely to have an interaction, than patients with pacemakers. The headphones' magnetic fields were the same whether the MP3 player was turned on, or the headphones were plugged in.

Originally posted at InjuryBoard by Jamie Sheller

Recall of Defibrillators

Jamie Sheller — Sat, 10 Oct 2009 15:55:21 GMT

Certain models of the HeartStart FR2+ brand of automated external defibrillator (AED), manufactured by Phillips, have been recalled. Recently, the voluntary recall was announced by the FDA. According to the FDA, the AEDs have a memory chip failure that can cause the device not to work. The AED is supposed to alert the defibrillator user when the patient needs a life saving shock. The AED determines when a shock is necessary by automatically analyzing the patient's heart rhythm. Between mid-2007 and early 2008, the memory chip failed some self-tests done by Phillips. There are no reported injuries from failed memory chips. Phillips will provide replacements for the recalled AEDs. The recalled AED models are the M3860A and M3861A, distributed by Phillips, and models M3840A and M3841A distributed by Laerdal Medical.

Originally posted at InjuryBoard by Jamie Sheller

Fetal Monitors With Inaccurate Readings

Jamie Sheller — Tue, 22 Sep 2009 21:41:41 GMT

The FDA has notified doctors and hospitals of reports that some Philips Avalon Fetal Monitors are producting inaccurate readings, most often during the second stage of labor. Philips issued an Important Device Safety Alert on September 4, 2009. If the inaccurate readings are not recognized and addressed, doctors may be unaware of fetal distress or may recommend unnecessary interventions based on false information. In order to avoid serious injuries, doctors must recognize the conditions and respond appropriately. The affected models are the FM20, FM30, FM40 and FM50 with the ultrasound transducer.

Originally posted at InjuryBoard by Jamie Sheller

Guilty Pleas in Bone Cement Case

Jamie Sheller — Thu, 23 Jul 2009 22:31:54 GMT

In June 2009, Synthes, its Norial Corp. unit and four executives were indicted in federal court in Philadelphia. Synthes, based in West Chester, PA, is the world's largest maker of bone-related medical devices. The government alleges that the company and its executives were involved in a conspiracy to hold unauthorized clinical trials of Norial XR and Norian SRS bone cement. According to the indictment, despite knowing the risks of these bone cement products, the company and its executives bypassed the FDA approval process for clinical trials. During the unauthorized trials, three patients died from a rapid drop in blood pressure during surgery. Recently, two of the indicted Synthes executives pleaded guilty to a misdemeanor charge of shipping misbranded Norial XR across state lines. The potential penalties include up to one year in prison and a $100,000 fine.

If you or a family member had Norian bone cement used during a procedure, contact Sheller, P.C. to discuss whether you have a legal claim. Sheller, P.C. represents individuals and classes of individuals who have suffered a range of injuries. Sheller lawyers have successfully represented people who have been injured by prescription drugs and medical devices. Contact us to discuss your potential claim.

Originally posted at InjuryBoard by Jamie Sheller

Did Some Medical-Device Makers Pay Kickbacks To Surgeons?

Jamie Sheller — Sun, 19 Jul 2009 21:47:21 GMT

According to recently unsealed federal lawsuits filed in Texas, several medical-device makers paid kickbacks to have their products used. The claims were made by former employees of the companies, who allege that heart surgeons were paid to use certain devices to treat atrial fibrillation,which a heart-rhythm defect in which blood pools inside the heart. It can lead to stroke. In surgical ablation, surgeons use devices that emit radiofrequencies to correct the heartbeat. At least four companies are named in the lawsuits, including Medtronic Inc., Boston Scientific Corp., St. Jude Medical Inc., and AtriCure Inc. Though the lawsuits were filed in 2007, a federal judge in Texas only recently unsealed them. The allegations in the lawsuits are related to a US Justice Dept. inquiry in Texas. The lawsuits allege that the medical-device companies engaged in a "fraudulent marketing and inducement campaign" in which Medicare was excessively billed due to kickbacks to doctors and hospitals. The plaintiff in the case against Boston Scentific is a former saleswoman who claims that after she complained about illegal practices, she was fired. This woman is also a plaintiff in cases against Medtronic and AtriCure, alleging that surgical ablation equipment was improperly marketed for use in treating atrial fibrillation, despite the lack of FDA approval for that use. Federal law prohibits companies from marketing their products or medical devices for unapproved uses, even though doctors can use some products for off-label use.

Originally posted at InjuryBoard by Jamie Sheller

Medtronic Recalls Insulin Infusion Device

Jamie Sheller — Mon, 13 Jul 2009 08:21:36 GMT

An insulin infusion device used with an insulin pump was recently voluntarily recalled by its maker. According to Medtronic, the device can cause serious injury or death, due to a mechanical malfunction that could prevent proper air ventilation, causing either too much or too little insulin to be delivered. Medtronic says that about 60,000 of its Quick-set infusion sets are involved in the recall. The Quick-set infusion sets are used wth MiniMed Pardigm insulin pumps. The affected devices have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers starting with "8." Consumers can locate the lot numbers on the box and on individual infusion packaging.

Originally posted at InjuryBoard by Jamie Sheller

Synthes Executives Indicted For Improper Marketing

Jamie Sheller — Sun, 21 Jun 2009 12:55:29 GMT

The United States Attorney in Philadelphia has indicted Synthes Inc. and four of its executives on federal charges. Synthes is a medical device maker, and according to the indictment, they improperly marketed it's bone filler, Norial XR for unapproved uses. The company is charged with conducting an unauthorized clinical trial, using the bone filler in two types of back surgery, called vertebroplasty and kyphoplasty. Three people died in the surgeries, though there is no proof that the deaths were caused by the bone filler. In vertebroplasty and kyphoplasty, a cementlike material is injected into a spinal fracture to repair it. However, the bone filler can escape and create a blood clot in the patient's system. In 2002, the FDA issued a warning of these risks after receiving reports of injuries and deaths. Though the FDA approved the bone filler for general bone repair, Synthes was not to promote it for spinal procedures.

According to prosecutors, Synthes allowed its salesforce to promote the bone filler for unapproved uses and misled FDA inspectors. The four indicted Synthes executives are charged with shipping unapproved medical devices. Those criminal misdemeanor charges carry a potential one year prison term. Usually the federal government files civil lawsuits for this activity, and it is rare for criminal charges to be filed against company executives.

If you have received a Synthes bone filler product, contact the lawyers at Sheller, P.C., 215-790-7300, to discuss whether you have a potential claim. Sheller attorneys work aggressively to represent people injured by defective medical devices. We have successfully obtained compensation for injured people from medical device manufacturers and pharmaceutical companies.

Originally posted at InjuryBoard by Jamie Sheller

Warning About Defective Medtronic Pacemakers

Jamie Sheller — Thu, 21 May 2009 13:58:19 GMT

There is a potential wiring defect in some Medtronic pacemakers. According to Medtronic, that wiring defect could cause a malfunction in 37,000 of its Kappa and Sigma pacemakers. Medtronic sent letters to physicians warning them that some of these pacemakers could run out of battery power or fail to respond when necessary. Medtronic advises doctors to consider removal of a pacemaker in this category that is required for daily survival. According to Medtronic there have been two reports of deaths that may be linked to the pacemaker. There are no programming fixes for this wiring defect. Also, Medtronic says that there are no tests to show which devices might fail. If a patient experiences fainting or lightheadedness, they should immediately call their doctor.

Originally posted at InjuryBoard by Jamie Sheller

Complications Lead to Lawsuits for Maker of Urinary Leak Device

Jamie Sheller — Thu, 07 May 2009 12:17:19 GMT

A purportedly quick and simple fix for urinary incontinence has led to serious complications for many women. A device called a vaginal sling, made of synthetic meshlike material, is inserted under the urethra to stop urine leaks. However, after the surgery, many women develop painful, persistent and bloody vaginal discharge. Dozens of women are suing Mentor Corporation, the maker of one vaginal sling called ObTape. Mentor Corp. is based in Santa Barbara, California, and was recently acquired by Johnson & Johnson. Though the company asserts that there is nothing wrong with ObTape, they stopped selling it in 2006.

ObTape was cleared for sale by the FDA. However, recently FDA scientists have criticized the way that the agency clears medical devices after only minimal testing if they are shown to be "substantially equivalent" to devices already in use. In the case of Mentor's ObTape, it was cleared for sale after it was found substantially equivalent to two earlier vaginal slings, one of which had been recalled in 1999. Soon after ObTape came to the market, the FDA started receiving many adverse event reports. In 2004, there were 266 reports of adverse events linked to ObTape. According to experts, the problems seem to stem from the ObTape material, which allow it to become encapsulated and expelled, rather than being incorporated into the body. Such problems often require surgical intervention. According to many of the women suing Mentor, the complications are much worse than the problem ObTape was meant to fix.

Originally posted at InjuryBoard by Jamie Sheller