Patient Sues Medical Device Manufacturer Over Superbug Outbreak

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UCLA SuperbugAn 18-year-old patient is suing a medical device manufacturer blaming the company for a superbug outbreak at the UCLA Medical Center, which infected at least seven patients and has been blamed for the death of at least two.

According to a CBS Los Angeles news report, the lawsuit was filed by Aaron Young in Los Angeles Superior Court against Olympus America, Inc. seeking unspecified damages, alleging products liability, fraud and negligence.

Lack of Protocols for Sanitizing

Young still remains a patient at the hospital after he and many others were exposed to a contaminated endoscope between October and January.

The lawsuit alleges that the company redesigned its duodenoscope last year. However, it did not offer a clear method to clean and disinfect the scopes, which have a complex construction and many tiny parts.

The lawsuit alleged that Olympus failed to take the critical step of establishing cleaning and disinfecting protocols with medical facilities and professionals.

Instead, the manufacturer provided doctors and hospitals with a safety cleaning protocol for an older endoscope that had a significantly different design.

As a result, users were not able to properly clean and sanitize the redesigned scope, the lawsuit states. The lawsuit does not blame UCLA for the superbug outbreak.

So far, the hospital has notified 179 patients who underwent these endoscopic procedures between October and January that they may have been exposed to the superbug, also known as CRE. Hospital officials were able to trace the infections to the tainted duodenoscopes.

Holding Product Manufacturers Liable

Based on statements made by experts to media, it appears that this superbug is tough to treat even with antibiotics.

The U.S. Food and Drug Administration (FDA) has issued a safety alert to hospitals and doctors warning about the potential for contamination with this particular device. About 500,000 people get treated and diagnosed with these types of endoscopes.

It is not clear if the manufacturer is planning on issuing a recall for these endoscopes.

It is unacceptable for a manufacturer to put a product, especially a medical device used on cancer patients and other seriously ill individuals that could pose an infection risk.

Apparently, this device has so many nooks and crannies that it may be impossible to thoroughly clean and disinfect it.

How is such as product even in the market?

As product liability attorneys, we certainly hope the FDA is looking into this issue to ensure the safety of thousands of patients who may be exposed across the nation.

UCLA Superbug Outbreak Linked To Contaminated Endoscopes

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EndoscopeThe U.S. Food and Drug Administration (FDA) has issued a warning about a particular type of endoscope saying the devices that are used to look inside patients’ bodies, are so poorly designed that it is not possible to clean and disinfect them thoroughly.

According to an NBC news report, the endoscopes have been linked to an outbreak of drug-resistant bacteria that have killed at least two patients and infected five more at UCLA Medical Center.

The university has also sent out warnings to about 180 people saying that they may have been exposed to the potentially deadly bacteria.

How Do The Endoscopes Work?

The endoscopes the FDA has issued the warning about are not the scopes used in procedures such as colonoscopy. But they are used in diagnosing and treating a range of diseases and health conditions from gallstones to cancer. The scopes in question, generally called duodenoscopes, are used at least on a half-million people in the United States and have a number of tiny parts.

Duodenoscopes are flexible lighted tubes that are threaded through a patient’s mouth, throat, stomach and into the top of the small intestine, also known as the duodenum. They contain a hollow channel that allows the injection of a contrast dye or the insertion of other instruments to obtain tissue samples for biopsies or treat certain abnormalities.

The device’s design allows germs to be carried from one person to another. Experts say the process for cleaning and disinfecting the devices is complicated.

The Result of Defective Design?

There is no question that these endoscopes are sophisticated devices. They present a non-invasive alternative to many seriously ill patients.

But is it not the manufacturer’s responsibility to make a device that can be properly cleaned and disinfected in the real world? How could a manufacturer put a device in the market that could potentially cause germs to be transferred from one patient to another?

This is a real problem this manufacturer will need to address right away. We hope that the FDA does its due diligence when it comes to oversight on this matter.

If you or a loved one has been affected by these contaminated endoscopes, please contact an experienced product liability attorney in Los Angeles to obtain more information about pursuing your legal rights. You may be eligible to receive compensation for your significant losses.

Bard to Pay $21 Million as Part of Major Vaginal Mesh Accord

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Bard Mesh SettlementC.R. Bard has agreed to pay more than $21 million to resolve more than 500 lawsuits alleging that its vaginal mesh implants seriously harmed women.

According to a Bloomberg news report, this is the first large-scale settlement of claims over the company’s devices. The medical device manufacturer agreed to pay an average of more than $43,000 per claim to settle hundreds of vaginal mesh cases.

The deal comes a federal judge in West Virginia ordered lawyers for Bard to prepare for trials of 500 lawsuits that alleged the defective medical devices damages women’s organs and left them with chronic and excruciating pain. With the trials looming, Bard agreed to settle the cases.

More of these settlements are expected in the future as the company faces over 12,400 suits over the vaginal mesh implants.

Severe and Painful Complications

The U.S. Food and Drug Administration (FDA) ordered manufacturers of vaginal mesh implants including Bard, Johnson & Johnson, Boston Scientific Group and others to study rates of organ damage and complications linked to the devices. The FDA has also said that the implants should be subject to more stringent safety requirements.

In 2010, more than 70,000 women got the implants, which are threaded through incisions in the vagina to shore up pelvic muscles in order to support internal organs or treat incontinence.

Many women reported severe and side effects and complications including the device disintegrating and causing nerve damage, incontinence and pain during intercourse. Our legal team has come across a number of cases where women’s quality of life and livelihoods have been destroyed due to these defective devices.

Lack of Proper Testing

There are a number of medical devices in the market that have been put in the market without being tested properly. These defective vaginal mesh devices are among such products. A number of women have been led to believe that these procedures are minimally invasive and have virtually no side effects.

These women were not given accurate information on which they could make important decisions that would have a significant impact on their health and future.

C.R. Bard and other vaginal mesh implant manufacturers should do right by their customers and compensate them for their losses – physical, financial and emotional. If you or a loved one has suffered side effects due to a vaginal mesh implant, please contact our vaginal mesh attorneys to obtain more information about pursuing your legal rights.

Have You Been Injured By A Defective Hip Implant?

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Defective Knee and Hip ImplantsWhen your car is a lemon or is recalled for safety issues, you get it fixed at no cost at the dealership. But, what happens when your artificial hip is defective?

Thousands of Americans have been faced with this problem over the last decade or so. Each year, about 400,000 people in the United States undergo hip replacement surgeries. But, when these hip implants are defective, they create significant problems for those who receive them.

For example, DePuy, a subsidiary of Johnson & Johnson recalled its metal-on-metal hip implants because they were failing very quickly, within a year or two of surgery.

Reports of Early Failure

A WFMY News report gives the example of one patient who felt “clicking” in her newly replaced hip. Not until several years after she got her hip did DePuy admit it had a problem and recalled the device.

DePuy hips are made with all metal. Between 2000 and 2010 DePuy and other companies like Stryker made these components of chromium cobalt metal.

As the parts grind against each other, they produced particles of chromium cobalt that could cause metal poisoning after debris built up in the soft tissues of the body.

Side Effects of Metal Hip Implants

There are many ways in which metal hip implants can fail. Our legal practice has observed based on cases we handle that faulty hip implants can produce significant side effects for patients including:

  • Premature death of body tissue of soft tissue damage due to excessive wear of the implant.
  • Elevated cobalt and chromium levels in the blood, also known as metal poisoning or metallosis.
  • Severe pain in the implant rendering the patient unable to walk.
  • Fluid collection around the joint.

 Protecting Victims’ Rights

Brands of hip implants such as Biomet, Stryker and DePuy have been the subject of a number of recalls and lawsuits. However, when an implant that has been placed inside your body fails, it is not easy to get it out and get it fixed, like you may repair a car part. In such cases, patients must undergo revision surgeries.

This means that the defective implant is surgically removed and replaced with a new device. Patients undergo not only the physical pain and suffering due to unnecessary surgery, but they endure financial burdens, paying medical expenses, hospitalization, cost of surgery and rehabilitation, not to mention lost income.

Some individuals are permanently injured or disabled due to these defective hip implants.

If you or a loved one has received a defective hip implant and have endured serious side effects, please contact an experienced medical device attorney who can help protect your rights and hold the negligent manufacturers accountable.

Incidence Of Hip & Knee Implant Failures Expected To Increase

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Defective Knee and Hip ImplantsWith more and more Americans getting hip and knee implants each year, the likelihood of more these implants failing also increases.

According to a Lawyers and Settlements report, with a continuing rise in replacement procedures and continuing problems with latest-generation devices such as metal-on-metal implants, it is fair to assume that more hip and knee implants are likely to fail.

Dramatic Increase in Replacement Surgeries

The Sandusky Register of Ohio reports that more than two out of every 100 people in the United States More

Generic Versions of Heart Drug Recalled for Serious Side Effects

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generic heart drug recallTwo large Indian manufacturers of generic heart drugs have announced recalls over the last two months totaling more than 100,000 bottles because of serious reported side effects.

According to an article in The New York Times, the recalls are the latest in the string of recent problems involving generic drugs made by Indian manufacturers such as Wockhardt and Dr. Reddy’s Laboratories.

The drug is a beta blocker that treats More

FDA Warns about Defective Philips Defibrillators that May Fail in Emergency

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The U.S. Food and Drug Administration (FDA) has issued a fresh warning to consumers about some models of HeartStart automated external defibrillators (AED) may not work during a cardiac emergency. According to a CBS news report, about 700,000 of the medical devices, manufactured by Philips Medical Systems, had been recalled in 2012, but people may still have the faulty models in their possession. The FDA is urging consumers to inspect and monitor the capabilities of these AEDs and also know how to use them during an emergency, particularly when there are no other available options.

The Philips AEDs first got FDA approval in 2004. The AEDs that are being recalled were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. These devices were recalled in 2012 because an internal electrical component was malfunctioning, causing the machine not to give a shock.

Why an AED is Life Saving

The federal safety agency is also advising that you keep the recalled HeartStart AEDs in service until you obtain a replacement from Philips or another AED manufacturer. The AED’s function is to analyze heart rhythm and deliver an electric shock, which can restart the heartbeat of those who go into cardiac arrest. In 2013 alone, about 359,400 people will have an out-of-hospital cardiac arrest, the American Heart Association estimates. If you still own one of these devices, contact Philips Healthcare for a replacement AED unit. In North America, call 1-800-263-3342 for more information.

Defective Medical Devices

When an AED fails to work as it is supposed to, it may become difficult or impossible to resuscitate someone whose heart has stopped functioning. Anyone who has been affected by a defective medical device can file a product liability claim against the manufacturer of the defective product. In cases where a person has died, his or her family can file a wrongful death claim against the product manufacturer. Victims or families of deceased victims would be well advised to contact an experienced product liability lawyer who will ensure that the negligent manufacturers are held liable. The best product defect law firms will always offer a free consultation and comprehensive case evaluation to injured victims and their families.

FDA Issues Warning on Medtronic Devices

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Federal health officials have issued a defective product recall for about 15,000 Medtronic guide wires used in heart procedures. According to a USA Today news report, the recall was issued after Medtronic received four serious complaints. Officials say that the defects are severe enough to cause injury or death. The guide wires involved in this recall are inserted through an artery and are used to guide other devices into place, such as stents to hold open blocked arteries.

Potential for Serious Injury or Death

In one complaint involving this device, a patient went into cardiac arrest but was resuscitated. The recall notice warned hospitals and distributors worldwide that the coating on the guide wires could break off, which could increase the possibility of blocking a blood vessel. The coating on the wires is meant to make them slide through the blood vessels more easily. The FDA has classified this as a Class I recall, a category reserved for defective products with the potential to cause serious injury or death.

Medtronic, which is based in Minneapolis, said the recall affected certain lots of the products manufactured since April. The company said it has taken steps to prevent new shipment of the wires and has notified regulators globally. Any problems with the defective medical devices can be reported by calling 1-877-526-7890 or to the FDA’s web site at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

Defective Medical Devices

Flaws in medical devices may occur due to manufacturing defects, defective design or defective marketing. If you have been injured or have suffered a loss as the result of a defective medical device, a number of parties may be held liable. The manufacturing company, a testing lab, a medical sales representative, medical clinic or doctor, may all be potentially liable parties in a product liability lawsuit involving a faulty medical device.

If you have been injured as a result of using a faulty medical device, an experienced product liability attorney can help you prove that the device was faulty and caused your injuries. All product manufacturers have a legal obligation to consumers to manufacturer products that are safe and of good quality. When they fail to do so, they can and should be held accountable. Injured victims in such cases can seek compensation for damages such as medical expenses, lost wages, hospitalization, pain and suffering and emotional distress.

Women Say Permanent Contraceptive Device is Causing Excruciating Pain

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A Ventura County mom says a permanent contraceptive device called Essure has caused her and thousands of other women excruciating pain. According to a news report on CBS Los Angeles, Tanya Lovis says she was walking around hunched over holding on to her stomach for three weeks out of the month and that “the pain was just too much to bear.” For 10 months, doctors could not figure out what was wrong with Lovis. When she started researching her condition online, Lovis says she found 1,800 women on Facebook who had also opted for Essure and were experiencing similar symptoms. More

New Concerns about the Safety of Robotic Surgeries

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A new study in The Journal for Healthcare Quality states that injuries and fatalities caused by the da Vinci robotic surgery system are being grossly underreported. According to an article in The New York Times, the equipment is being made by Intuitive Surgical Inc. based in Sunnyvale, California. More than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the U.S. Food and Drug Administration (FDA).

Among those were 71 reports of deaths and 174 injuries. Combining news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations using the da Vinci system that were not reported to the FDA. The study concluded that adverse events associated with the da Vinci system were “vastly underreported.”

Prevalence of Robotic Surgery

The New York Times cites the example of Erin Izumi, a woman in her 30s from Tacoma, Washington, who underwent robotically-assisted surgery to treat endometriosis. Ten days after an 11-hour surgery she was rushed to the emergency room where doctors discovered that her colon and rectum had been torn during the operation. While what is reported to the FDA only represents the “tip of the iceberg,” many hospitals nationwide are aggressively marketing the benefits of robotic surgery without really telling consumers the high risk involved. Intuitive officials say they have been diligent about reporting adverse events.

Robotic surgery has grown dramatically in the five years between 2007 and 2011 – with a 400 percent increase. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals nationwide. The Johns Hopkins study looks at documents detailing aggressive tactics used to market the equipment and raises questions about the quality of training provided to surgeons in addition to pressure put on doctors and hospitals to use it.

Protecting Victims’ Rights

In my opinion, this is an extremely disturbing report because not only are these devices causing injury and harm, but they are being aggressively marketed to consumers and to surgeons and hospitals. In addition, doctors are not receiving the training to use this equipment. If you or a loved one has been injured as a result of a botched robotic surgery, please contact an experienced California product liability lawyer to obtain more information regarding your legal rights.

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