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 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 Defective Drugs & Treatments

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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 Posted on October 30, 2013 in Defective Medical Devices

There are tens of millions of patients in the United States living every day with the help of medical devices. Running the gamut from heart defibrillators to surgical mesh and artificial joints, the foundation of all these creations is that they were designed to make a patient's life easier. Sadly, however, a lack of standardization across their design and testing has negative impacts when patients and doctors find out too late that these items are defective. After discovering that their pain or complications are related to a defective medical device, they may be required to go through special treatment or follow up surgery.

Manufacturers of medical devices actually go through a relatively non-rigorous process for getting approved despite the importance of their end product. Manufacturers have to pay a user fee of approximately $4,000 to the Food and Drug Administration and file some paperwork to get started. Many devices, considered on the cutting edge at the time of their development, don't go through extensive long-term testing to determine if there are problems that might appear down the road. For some patients getting these devices shortly after they come out, it's like being a guinea pig for an untested product.

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 Posted on October 27, 2013 in Defective Medical Devices

Metallosis is a side effect experienced by some individuals who have metal on metal hip replacements. It results from metal corrosion and release of wear debris from the device into the body of the patient. For the patients who underwent surgery to receive metal hip replacements, what they hoped would make their lives easier could actually end in pain, suffering, and a defective medical device lawsuit.

Hip resurfacing techniques were developed in the 1970's with the goal of limiting bone resection, risk of dislocation, and wear, but the method that was used had a high failure rate, bringing researchers back to the drawing table. Since then, hip resurfacing reemerged in the 1990's with what seemed like positive results. After patients began going through the hip replacement process, however, there were multiple impacts on patients who were given defective hip replacements.

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 Posted on October 23, 2013 in Defective Medical Devices

Boston Scientific, a medical device manufacturer, and its subsidiary company, Guidant, has been ordered by the US Justice Department to pay out over $30 million to settle charges that the company knowingly sold defective heart devices that were used in Medicare recipients.

According to an article by the Mississippi Sun Herald, the US Justice department claimed that the company knew there was a problem and was taking corrective action to fix it. However, at the same time, the company continued to sell selective products. Additionally, while the company was under investigation for faulty device manufacturing, it took steps to cover up the problem from patients.

While this lawsuit was a criminal matter, it may become important in future civil lawsuits as well. This establishes that Boston Scientific may have been intentionally placing defective medical devices into the marketplace.

Defective Medical Devices: A Violation of a Duty

Medical device manufacturers have a duty to ensure that the products they send to market are effective and safe. When a manufacturer fails to take these precautions, patients who use their devices can suffer devastating injuries or even death. In these cases, the law provides for a mechanism to hold the manufacturer of the faulty device accountable; this is called product liability.

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 Posted on October 20, 2013 in Defective Medical Devices

A new study published in the Journal of Patient Safety has concluded that the number of patients who die from medical mistakes in hospitals is significantly higher than past studies have revealed.

In 1999, a report titled “To Err is Human,” which was published by the Institute of Medicine, put that number at 98,000. At the time the report was published, the medical community balked that number but in time accepted it as factual.

Eleven years later, the Office of Inspector General for Health and Human Services released results from a study of how many Medicare patients die each year from medical mistakes in hospitals. Their conclusion was 180,000. Remember – that is the total of only Medicare patients.

This new study puts the total number of patients who die due to preventable medical errors at a whopping 210,000 to 440,000 per year – the third leading cause of death in this country, following heart disease and cancer. According to ProPubilca, these figures were compiled by John T. James, who runs Patient Safety in America. James is also a toxicologist at NASA. He has first-hand experience with this subject, having lost his 19 year-old son from hospital negligence.

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