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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 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 Illinois Defective Medical Products Lawyer

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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 Posted on October 19, 2013 in Defective Medical Devices

It was recently reported in Insurance Journal that a $15 million radiation treatment lawsuit settlement was finalized. The lawsuit was filed by the family of Zacarias Chichioco, Jr., who died in 2011, against Varian Medical Systems Inc. and physicians affiliated with the Pacific Cancer Institute in Wailuku, Hawaii.

According to the article, the victim was diagnosed with lung cancer in February 2008. He was being treated by Dr. Daryl Makishi, a doctor at the Pacific Institute. Dr. Makishi developed a treatment plan of radiation treatments for his patient. Chichioco received 35 radiation treatments delivered through a linear accelerator which was developed by Varian Medical Systems.

Very quickly after beginning these treatments, Chichioco began hallucinating and had pain when swallowing. He also suffered hearing loss and the left side of his face became paralyzed. He was operated on for skin grafts in the hopes to alleviate these symptoms, but nothing worked.

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 Posted on October 15, 2013 in Defective Medical Devices

The business of hip and knee implants is growing. It's not just baby boomers who need these implants, but the under 65 market is expanding as well. Estimates are that by 2030 when 4 million replacements will be put in, half of all patients will be under 65. Since people are getting replacements at a younger age, they will have these implants for a longer time.

Consumers Union, the advocacy side of Consumer Reports, has stated that since these people will have the implants longer, then they should be backed by a warranty. They feel that patients should know how long these replacements should last. It would also be good for patients to have a clear recourse if their devices fail. Now this advocacy group has asked manufacturers to provide warranties for their products which would have them replaced at no cost within the warranty period of 20 years.

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 Posted on October 08, 2013 in Drugs

Doctors spend years studying medicine before they are allowed to make care decisions. Even once they receive their doctoral degrees, they work underneath doctors with tenure and on the job experience. Yet the fear of lawsuits makes most doctors practice defensive medicine. That means that instead of focusing on helping a patient, these doctors are practice medicine to avoid legal action.

Defensive medicine is when doctors second guess their initial diagnosis. Instead of treating the condition that the symptoms point to, the doctor will order additional tests, procedures and other diagnosis tools to rule out other possible options. Defensive medicine can also mean that doctors avoid certain patients or procedures that are high-risk.

It might not seem to be commonplace but it is. Jackson Healthcare, a large healthcare staffing agency, said that 75 percent of doctors practice defensive medicine. Even though it would seem that over testing is a good practice, especially since the high stakes associated with healthcare, but the opposite might be true.

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 Posted on October 03, 2013 in Defective Medical Devices

With the government shutdown looming over Washington and numerous federal locations across the country, the Consumer Product Safety Commission (CPSC) announced that their inspectors would be told to stay home as well. The Food and Drug Administration, which holds the responsibility for inspecting the food eaten all around the nation, suspended their regular inspections and monitoring activities for imported food and drugs. Illinois residents may receive injuries as the result of recalled or dangerous products, which may lead to an increasing number of personal injury lawsuits.

The Center for Disease Control and Prevention officially furloughed nearly 70% of their existing staff, with the remaining personnel expressing concern about their ability to respond to any disease or food outbreaks. Since the length of the shutdown is currently unknown, there could be dire consequences from the shutdown that won't even be known for weeks or months after it's resolved. With the CPSC for the most part offline, the lack of reviewing and monitoring activities will lead to a pileup of work to be completed when the government returns to work. In the meantime, consumers across America could be interacting with dangerous products.

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