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Bard IVC Filter Lawsuits Consolidated and Transferred

On August 17th almost two dozen Bard IVC filter cases were consolidated and transferred to the District of Arizona by the U.S. Judicial Panel on Multidistrict Litigation (JPML). It was determined that centralization of the cases will avoid duplicative discovery and help the cases reach a quicker resolution. Most of the lawsuits share common allegations regarding common design defects. This particular brand of IVC filter was manufactured by C.R. Bard.

IVC filters are used to prevent blood clots in the inferior vena cava which is a major vein that carries blood to the heart. The filter is a small, cage-like device that’s inserted during surgery and is designed to keep blood clots from traveling to the lungs or heart. While designed as a permanent device, many complications have resulted from defects in the device’s design. The filter will frequently migrate, tilt, fracture, or perforate over time, causing a myriad of complications including cardiac tamponade (fluid buildup), deep vein thrombosis, pulmonary embolism, severe pain, shortness of breath, hemorrhage, respiratory distress, and sometimes even death.

Due to the above complications, the FDA now strongly recommends the removal of all retrievable IVC filters including those manufactured by C.R. Bard. Most IVC filter lawsuits claim the manufacturers of the device didn’t satisfy safety concerns. There is evidence suggesting that manufacturers have continued creating and selling the filters to hospitals and physicians without delivering any warnings regarding the FDA’s recommendations. The market value of the filters continues to grow.

There is also evidence suggesting that most IVC filters are not being removed from patients despite the recommendations. This is most likely due to insufficient clinical follow-ups, failed retrieval procedures, and a failure on behalf of the manufacturer to reach out to patients who have had the procedure done. Many affected patients feel the manufacturers are not doing enough to properly warn the public regarding the danger of these devices and the necessity of filter removal.

Another IVC manufacturer, Cook Medical, has already had its cases centralized by JPML. The consolidation and transfer of these cases should help the courts reach a verdict quicker regarding each individual case. This will ideally force C.R. Bard and Cook Medical to stop selling new filters and better communicate to physicians and affected patients as necessary to ensure the filters get properly removed.

If you or someone you love has been a victim of complications which have resulted from having an IVC filter inserted or not having it removed, now is the perfect time to seek legal aid and help bring justice to those who were impacted. Medical manufacturers around the world need to know that it’s not right to keep defective equipment on the market without warning when it can cause irreversible harm or even death. Contact Thomas Law Offices today to receive a free consultation. We can help you and your family get back on your feet again.

Tracking Down the Silence behind Antibiotic-Related Injuries

Despite how often antibiotics are prescribed for multitudes of reasons every day, some types of antibiotics have potentially dangerous side effects. The most risky types of antibiotics are generally those belonging to the fluoroquinolone family. Levofloxacin (often referred to as Levaquin) and ciprofloxacin (often referred to as Cipro)—both fluoroquinolones—are two of the drugs most commonly regarded as to having some of the most serious adverse side effects among all drugs. Avelox is the name of another fluoroquinolone that can have dangerous side effects.

Year after year, cases of serious, incurable impairments and even deaths are reported as a result of side effects from taking these three drugs, yet the drugs remain on the market and the FDA remains stubbornly silent regarding the matter. Why is that?

The answer to that question largely lies with that fact that physicians are often unaware of just how dangerous these side effects can be or do not pay close attention to the changes in FDA warnings. According to data accessible at RxISK.org which is an independently-ran research site, reported medical conditions that result from adverse side effects from fluoroquinolones far exceed those reported that result from all other types of antibiotics. Over 79,000 cases have been linked to Cipro alone. This includes over 1,700 deaths during the last 10 years.

The Realities of Warning Labels

In the grand scheme of things, the above numbers still look slight when compared to how many prescriptions physicians write for fluoroquinolones on a regular basis. Millions of prescriptions are handed out every year for these drugs. Many physicians simply feel that antibiotics are a safe, generalized approach to curing many ailments and hand out prescriptions unnecessarily. Many others fail to tell their patients about the array of negative possible side effects.

The vast majority of physicians also rarely take initiative when it comes to reporting side effects to the FDA. This often results in data points that are largely inaccurate and/or difficult to prove. According to this editorial written by health writer Idelle Davidson, there is currently a study starting up at University of California at San Diego which may help researchers gain a better idea of how fluoroquinolone-based side effect symptoms progress and how the FDA can better inform patients and physicians regarding these side effects.

According to the FDA, all warning labels currently placed on both Levaquin and Cipro display all of the information patients need to be aware of. All fluoroquinolones carry a warning with a black border, in fact, which is the FDA’s strongest grade of warning. Problems often arise when physicians don’t inform patients about the seriousness of these warnings and fail to take factors like age and current joint/tendon health into consideration.

One of the largest issues with injuries caused by side effects from taking fluoroquinolones is the fact that many of the injuries related to taking the drugs are permanent. Irreversible tendon ruptures and nerve damage top the list of serious ailments caused by fluoroquinolones and can cause lifelong pain and suffering. Other adverse side effects include disorientation, convulsions, anxiety, cognitive disorders, and difficulty breathing/walking. Many of the cognitive issues caused from adverse side effects are also irreversible.

Ending the Silence

The fact that many of the most serious side effects caused by fluoroquinolones are irreversible should be cause for concern among physicians and patients alike, especially when other families of antibiotics have a safer track record and potentially cause side effects that are easily curable. When Idelle Davidson interviewed Beatrice Golomb, a professor of medicine at UCSD, Golomb said the following:

“It’s true that every antibiotic class has the potential for some problems, but in many cases they are curable. These people seem to be left with a life-altering situation from which many years out they haven’t recovered. The reason we should care is that many of these problems are needless sources of permanent, horrifying, life-altering effects that did not need to happen.”

Quotes like this are why UCSD feels the fluoroquinolone study is so important. Studies can lead to cold, hard facts that will help the FDA and physicians become more informed. This, in turn, will help patients become more informed and may lead to other antibiotics being prescribed more often in place of Levaquin, Cipro, and Avelox. With knowledge comes a possibility of an end to silence on the matter.

One other way to end the silence regarding the dangers of fluoroquinolone-based antibiotics is by taking legal action against the manufacturers of these drugs that fail to make the side effects of their drugs better known. At least 3,400 cases have been filed against Johnson & Johnson, the manufacturer of Levaquin, since 2006. Most cases claimed the company failed to adequately warn physicians regarding the risks of tendon-related injuries.

Currently, there are roughly 60 pending federal cases against Johnson & Johnson as well as against Bayer, the manufacturer of both Cipro and Avelox. The plaintiffs claim the drugs caused irreversible peripheral neuropathy and/or nerve damage and were sold without proper warning labels depicting those risks. All of these cases have now been combined in what is known as an MDL, or Multi-district litigation. The MDL, known as In Re Fluoroquinolone Products Liability Litigation MDL 262, will be heard in front of Judge John Tunheim in the District of Minnesota.  A copy of the transfer Order is attached 2015-8-17 In Re Fluoroquinolone MDL Transfer Order.

Lawsuits like these can’t cure irreversible nerve or tendon damage, unfortunately, and they cannot take away years of pain. But they can help these drug manufacturers realize that their products are causing serious harm and many physicians do not realize how much harm they’re causing. In time, these drugs may even be taken off the market if enough cases are successfully filed.

If you or someone you know has suffered from personal injuries you feel may be related to side effects caused by Levaquin, Cipro, Avelox, or any of the drugs on this list, contact Thomas Law Offices today to see how we can be of assistance. It’s time to put an end to the silence regarding the dangers of antibiotics.

Nursing Home Staffing Regulations: A Necessity that Sometimes Gets Overlooked

Last week we talked about Hurstbourne Care Centre at Stony Brook, a Louisville adult care facility which will be forced to have its Medicare agreement terminated due to poor conditions that were negatively affecting both the health and safety of its residents. Situations like this happen all too often and are extremely painful for both the residents and their family members. In a second blog posted earlier this week, we shared advice for family members who might one day find themselves in a similar situation.

Why are such conditions allowed to happen, though? Nursing homes and adult care facilities are heavily regulated and inspected by agencies like Centers for Medicare & Medicaid Services (CMS) and Adult Protective Services, but issues still sometimes fall through the cracks. In most cases, poor conditions can be linked back to one thing that is often overlooked—improper facility staffing regulations.

Steps for Protecting a Loved One from Unsafe Nursing Home Conditions

Making the decision to place a loved one into a nursing home or adult care facility can be one of the most difficult decisions you’ll ever have to make. How can you trust they’ll get the proper care? Between local organizations and federal, state, and facility regulations, adult care facilities are watched with a rather critical eye. If anything should happen at a facility which may detriment the health and/or safety of the residents, the officials will be notified quickly and appropriate action will be taken. Cases where this is deemed necessary do not happen often, but they aren’t completely unheard of.

One such case recently struck close to home at Hurstbourne Care Centre at Stony Brook, located in Louisville, KY. We reported on the incident in detail last week. The adult care center was investigated by federal health officials after multiple complaints were filed. The investigation found that the facility was endangering the health and safety of its residents by failing to follow doctor’s orders, monitor past injuries, and keep the patient’s rooms properly clean. One patient was even found in bed with ants crawling on them at the time of the inspection.

The facility is currently scheduled to have its Medicare agreement terminated by the end of July. Until that time, residents are being transferred to other facilities where they can be properly cared for.

Louisville Adult Care Center Scheduled to Lose Medicare Funding Due to Unsafe Conditions

Hurstbourne Care Centre at Stony Brook, located in Louisville, KY, is currently scheduled to have its Medicare agreement and funding terminated as of July 25th due to a state-led investigation which questioned the level of care residents were receiving. The investigative report found that the adult care facility was jeopardizing the health and safety of its residents.

As reported by local news, the Kentucky State Survey Agency began investigating the facility on May 22nd after receiving numerous complaints. When the resulting report was presented to the facility on June 24th, the following statement by Sandra Pace, Health and Human Services Associate Regional Administrator, was issued:

“The survey found that your facility was not in substantial compliance with the participation requirements, was providing substandard quality care to residents, and that conditions in your facility constituted immediate jeopardy to residents’ health and safety.”

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