Posted on December 13,2013 in Birth Defects

Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.

However, a recent report indicates that the iPledge program been less than successful, and a small study suggests the focus be placed on more highly effective birth control methods. Dr. Eleanor Bimla Schwarz, director of the Women's Health Services Research Unit of the Center for Research on Health Care at the University of Pittsburgh and the senior author of the study, stated, “What we found is that people need a clear message about what birth control would be most effective, and currently the iPledge materials don't make it clear to most women who enroll in the program.” Schwarz also told Reuters Health that women who take isotretinoin need more information on IUDs and implants to better protect themselves from pregnancy.

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 Posted on December 10,2013 in Defective Medical Devices

If you have ever experienced painful side effects due to a defective medical device, drug or vaccination, you are not alone. Consumer Reports notes that “tens of millions of Americans live with medical devices implanted in their bodies,” including artificial joints, heart defibrillators and surgical mesh. And while Americans may assume that these devices have been tested for safety and effectiveness, Consumer Reports indicates that this is rarely the case. However, there is a free mobile app that allows you to report any device or drug problems and complaints directly to the FDA.

The MedWatcher app, available in both the Apple iTunes and Google Play stores, is the only app that allows users to track and report negative side effects, obtain recalls, and receive government safety alerts. Users also receive reports of the side effects submitted by other users, thus helping to make medical products safer for everyone.

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 Posted on December 06,2013 in Illinois Defective Medical Products Lawyer

USA Today published a stunning report that reveals that, across the country, there are thousands of doctors who are forbidden to practice in hospitals or other medical establishments, yet have not received any kind of punishment from state medical boards. Those doctors, despite having settled multiple medical malpractice suits, still maintain their medical license.

The publication collected data and statistics from multiple sources, including the National Practitioner Data Bank. The law mandates that any “adverse action” filed against a physician must be reported to the data bank – the intention being that the data bank would be closely watched by the state boards. Other sources of information were hospital disciplinary records and malpractice payment records.

The investigation revealed that almost 6,000 physicians had clinical privileges revoked between the years 2001 and 2011. But astonishingly, more than half of these same doctors never received any kind of discipline or reprimand from their state licensing boards. No fines, restrictions, suspensions or revocations were issued against these doctors.

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 Posted on November 29,2013 in Defective Medical Devices

The FDA announced recently that federal health regulators will be able to track millions of medical devices around the country soon with a new electronic system. The goal of the program, which works with pacemakers, hip replacements, and a broad array of medical devices, is to protect patients by identifying problems early on. Serious problems from defective medical devices have led to complications, follow-up surgeries, and attorneys tackling the issue head-on.

The new rules required that the majority of medical devices sold within the U.S. be connected with a unique code including the make, lot number, and manufacture date. The database of the information collected from these devices will be stored publicly to allow consumers, physicians, and companies to monitor whether any safety issues present a concern.

The concept of the tracking system is not new; those concerned with the growing number of painful and complicated issues reported by victims of defective medical devices have been calling for its use for several years. Doctors will now also be able to use the codes in the medical records belonging to their patients, developing an electronic trail of information that will flag defective devices earlier.

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 Posted on November 25,2013 in FDA

Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice over the alleged illegal marketing of Risperdal, Invega and Natrecor. Johnson & Johnson has been accused of improperly promoting the antipsychotic drug Risperdal for the elderly, children, and people with developmental disabilities. The Food and Drug Administration had only approved the drug for limited pediatric uses in 2006. Further, According to the Department of Justice, Johnson & Johnson paid kickbacks to physicians and to Omnicare Inc., a pharmacy that provides certain medications for nursing homes. The settlement is the third-largest in United States history for pharmaceutical cases, and the is only the latest in a succession of lawsuits involving the marketing of anti-seizure and antipsychotic medications as a way to control patients with dementia and children with developmental disabilities, notwithstanding substantial health risks with the drugs.

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 Posted on November 22,2013 in Defective Medical Devices

The Food and Drug Administration recently announced a new regulatory requirement for medical devices. All devices must now have a unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The development and safe operation of medical technology is literally of life and death importance, and manufacturers must uphold high standards in both quality and safety. The FDA UDI system will allow manufacturers to identify their products with a unique number.

The Unique Device Identification system will have a 14-digit number, which must be displayed conspicuously on device labeling and packaging. Further, attributes of each device associated with a particular UDI number must be submitted and stored in the FDA' Global Unique Device Identifier Database.

These regulations have a major impact on safety because they remove the necessity of renumbering old medical devices in the field. It also reduces the chances that a consumer of the product is using a counterfeit because the identity of all of the products will be known in the FDA's database. Finally, it enhances communication between manufacturers, hospitals, doctors and distributors. With improved communication, malfunctions or negative events caused by devices can be reported from end-users to manufacturers. Communication, of course, will more effectively flow the other way as well, and product recalls from manufacturers to patients can occur on a timelier basis.

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 Posted on November 14,2013 in Defective Medical Devices

Every year, defective medical devices affect thousands of Americans and the problem only seems to be growing, according to Consumer Reports. Medical devices that are implanted into bodies (including but not limited to defibrillators, surgical mesh, and artificial joints) often go untested. “For most implants and other high-risk devices brought to the market,” Consumer Reports claims, “manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue.” Sometimes the only testing that occurs, according to Consumer Reports, is in the bodies of patients who undergo treatments or surgeries thinking that the product has already undergone an extensive testing phase.

Some meta organizations have called on the FDA to change, or at least tighten, their approval process in an effort to curb the number of cases of people dealing with the effects of a defective medical device. In 2011, according to Consumer Reports, “a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market.” This is not only because many medical devices end up in the market without having undergone testing, it's also because “there's no systematic way for the government, researchers, or patients to spot or learn about problems with devices.” This is because medical devices don't often have serial numbers the way even common appliances, such as toasters, do. According to the FDA, the Center for Devices and Radiological Health “is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.” Medical devices are classified into three categories, and regulatory control increases with the level of classification. In 2012, Congress passed legislation that helped to loosen controls of regulation through the FDA Safety and Innovation Act, which included Medical Device User Fee Amendments.

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 Posted on November 11,2013 in Defective Medical Devices

The metal-on-metal hip replacements that have caused such a catastrophe for so many U.S. patients have been banned in the U.K., according to the Daily Telegraph. According to the U.S. Food and Drug Administration (FDA), there are always risks associated with hip replacements, and metal on metal (MoM) hip replacements carry additional risks unique to MoM hip implants. “In MoM hip implants,” states the FDA, “the metal ball and the metal cup slide against each other during walking or running. Metal can also be released form other parts of the implant where the two implant components connect.” The release of the metal, states the FDA, will eventually cause some small particles to rub off the implant and can cause the implant to slip. There's also the risk that “some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream,” according to the FDA.

It wasn't until late October of this year, after “a study found unacceptably high failure rates among implants in 17,000 patients,” Daily Telegraph, that the National Health Service (NHS) in the United Kingdom decided to ban NHS hospitals from using MoM hip replacements. Two models were immediately taken off the market, “and thousands of patients fitted with the implants have been told to have annual checks, often including blood tests,” reports the Telegraph. The blood tests are meant to measure whether or not toxic levels of metal had leaked into the bloodstream of patients fitted with the MoM replacement.

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 Posted on November 07,2013 in Defective Medical Devices

In late September, spurred by the massive Stryker hip recall earlier this year, “the U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices… that is says will target product problems more quickly and improve patient safety,”according to Newsday. The Stryker hip recall, the firm announced in late October and reported by PRWeb.com, will cost “anywhere from $700 million to $1.13 billion.” The devices affected some 20,000 patients across the country, and the company is now answering to more than 600 lawsuits from patients who are “alleging pain, swelling, metallosis and other complications” in one of the largest defective medical device recalls in history. Cases allege that “Stryker failed to adequately warn about the potential for this complication,” according to PRWeb.com.

All patients who received the implant have been advised by the manufacturer to “undergo routine cross-sectional imaging and blood testing to monitor for elevated metal levels in the blood stream,” according to PRWeb.com. This is being advised whether patients are feeling symptoms of the endemic to the recall or not.

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 Posted on November 04,2013 in Drugs

When many patients are diagnosed with a treatable but expensive disease, they turn to generic drugs as a solution. With superstores such as WalMart carrying the availability torch when it comes to generic brand pills, it's no surprise that, according to the New York Times, “now account for 80 percent of all prescriptions in the United States.” Not only are generic drugs cheaper, they're also more likely to be carried by pharmacies that don't require health insurance and offer a store-specific spending plan. Earlier this year, however, a case that is “enough to make anyone squeamish,” according to the New York Times, resulted in a ruling that Supreme Court ruling that generic drug-makers couldn't be sued for bad reactions to their products. While name brand drug-makers are still held responsible for the quality of their products, generic drugs no longer are considered under the same tight restrictions.

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