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All-metal hip replacements have been in the spotlight recently due to thousands of lawsuits filed against manufacturers of these products. Lawsuits allege the implants are linked to serious medical complications, including metal poisoning and bone deterioration. Plaintiffs in lawsuits against Johnson & Johnson for its DePuy Pinnacle hip replacement claim they suffered from metal poisoning and other complications after the implant shed metal, affecting surrounding tissue. Despite these risks, J&J has not issued a recall for its all-metal hip replacements.

Medical Complications Linked to DePuy Pinnacle Hip Implants

All-metal hip implants pose the risk of several serious medical conditions, including:

  • Severe pain
  • Dislocation
  • Deterioration of surrounding bone
  • Death of surrounding tissue
  • Implant loosening
  • Inflammation and swelling
  • Infection
  • The need for revision surgery
  • Metallosis (a type of metal poisoning)

It was originally believed that all-metal hip replacements would last longer and be more durable than their ceramic or plastic counterparts. However, it appears that the vast majority of complications are linked to the all-metal implants. In fact, many patients report that their all-metal device failed only a few years after being implanted. Research has shown that the issue is likely due to the process of metal shedding that often occurs with these implants. When metal particles are released into the surrounding tissue, high levels of cobalt and chromium may build up in the blood, resulting in a condition called metallosis. This painful, potentially-debilitating condition can lead to death of surrounding tissue, and deterioration of surrounding bone.

Symptoms of a Malfunctioning Hip Implant

According to a report from the National Joint Registry in Great Britain, up to 14 percent of all-metal hip replacements need to be removed within seven years. If you have a hip replacement device, the following symptoms may indicate a malfunction with your implant.

  • Severe pain in the hip, leg or groin
  • Difficulty walking
  • Difficulty standing
  • Swelling at or around the hip joint
  • Popping, squeaking, or grinding sounds
  • Kidney problems
  • Skin rashes
  • Depression
  • Thyroid problems
  • An enlarged heart

In 2011, the FDA issued a warning about the potential dangers of metal debris from all-metal hip replacements. The agency said that high levels of cobalt and chromium in the blood may cause additional illnesses and medical complications, including problems with the heart, thyroid, and nervous system. A Boston defective medical device attorney will help you recover damages if you’ve been injured due to an all-metal hip implant. Continue reading

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More than 200,000 Americans suffer from the formation of blood clots in the veins every year. Anti-clotting medications exist, but some patients cannot take these drugs for various reasons. At first, IVC filters seemed to be the answer. IVC filters are medical devices intended to prevent blood clots from traveling to certain areas of the body. When implanted in the inferior vena cava, they may prevent clots from forming in the first place, thus reducing the risk of stroke and other serious medical conditions. Unfortunately, complications with these devices can be just as deadly as the blood clots themselves. As such, manufacturers of IVC filters are facing numerous product liability lawsuits for defective products.

What is the Danger?

It is shockingly common for pieces of IVC filters to break off, find their way to other areas of the body, and puncture organs and veins. According to the New England Society for Vascular Surgery, IVC filters have a 31 percent rate of fracture. In fact, most of these “splinters” migrate to the heart, lungs, or hepatic vein. And the risk of splintering increases the longer the filter remains in the patient’s body. A Boston defective medical products attorney can help you determine how to proceed if you’ve been harmed by an IVC filter.

Risks Associated with IVC Filters

These medical devices pose many life-threatening hazards, including:

  • Migration of the filter to other areas of the body
  • Fracture “splintering” of the filter
  • Perforation of organs and veins
  • Inability to retrieve filter
  • Pulmonary embolism
  • Respiratory difficulties
  • Stroke
  • Death

The most disturbing aspect of this new information is that manufacturers may have known the risks and continued to market the filters anyway. Lawsuits allege that Bard knew about the risk of splintering as early as 2003, but failed to report its findings to the FDA, doctors or patients. In fact, Bard continued aggressive marketing of these deadly devices. A MA defective medical products lawyer can help you recover damages if you’ve been injured by an IVC filter.

Never Intended for Permanent Placement

IVC filters were never intended to remain in the body permanently. They are meant to be retrieved as soon as the risk of blood clots and pulmonary embolism has passed. Bard, one of the manufacturers of IVC filters, allegedly pushed for approval of permanent placement. Although Bard is the leading manufacturer of IVC filters, Cook and B. Braun are also at the center of multiple lawsuits for their defective filters. Continue reading

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Bair hugger warming blankets are medical devices used to control the body temperature of patients undergoing surgical procedures. These devices are commonly used during knee and hip replacement surgeries, but are increasingly linked to serious medical conditions, including deep joint infections, sepsis, and antibiotic resistant staff infections. As such, multiple lawsuits have been filed against Bair Hugger’s manufacturers, Arizona Healthcare and 3M Company.

Invented by Dr. Scott Augustine in the 1980s, warming blankets have been used to prevent hypothermia in tens of millions of patients. However, Augustine recently testified that the risk of infection in patients receiving implants outweighs the benefits. Specifically, patients receiving knee and hip implants, and artificial heart valves should not be treated with warming blankets.

“There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” said Augustine. ”With regard to orthopedic infections, a scare is what’s needed. This product should never be on another orthopedic patient.” A MA defective medical products attorney can help you determine how to proceed if you’ve been injured by a Bair Hugger warming blanket or similar device.

How Do Warming Blankets Cause Infections?

Bair Hugger warming blankets force warm air through disposable blankets used to cover patients during surgery. Unfortunately, contamination may occur when bacteria in the patient’s surroundings enters the warming system and is circulated around the patient’s body. If the patient has open wounds in the surgical site, bacteria may enter those wounds, resulting in potentially life-threatening infections.

“We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,” said Augustine. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”

Symptoms of Infection Related to Bair Hugger Warming Blankets

The FDA has yet to issue a recall of Bair Hugger warming systems despite numerous adverse event reports, including burns and various equipment malfunctions. If you have recently been treated with a Bair Hugger warming blanket and develop the following symptoms, talk to your doctor:

  • Fatigue
  • Fevers, chills and night sweats
  • Increased pain or stiffness
  • Swelling
  • Warmth and redness around the wound
  • Wound drainage

A Boston defective medical device attorney can help you recover damages if you’ve been injured by a Bair Hugger warming blanket or any other defective medical device. Patients who have developed sepsis, MRSA, or other infections due to Bair Hugger warming blankets may need to undergo one or more of the following procedures to treat the infection:

  • Multiple hospitalizations
  • Additional surgeries
  • Antibiotic spacers (inserted into infected joint)
  • IV antibiotic therapy
  • Physical therapy
  • Revision surgery
  • Amputation of infected limb

A 70-year-old Texas man required 15 operations after developing a deep joint infection from the Bair Hugger warming blanket. Another patient developed a MRSA infection that resulted in the amputation of his leg after bacteria from the hospital floor was “kicked up” by the Bair Hugger warming blanket. Even as lawsuits continue to pile on, these devices are estimated to remain in use in about 80 percent of U.S. hospitals. Continue reading

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Medical complications linked to blood-thinning medication Xarelto have been making headlines the past few years, but the most recent news reports are especially disturbing. The anticoagulant is still being prescribed, despite reports that the drug was linked to more than 15,000 adverse events in 2016. According to a recent study by the Institute for Safe Medication Practices (ISMP), the number of injuries and deaths related to Xarelto continues to climb.

ISMP’s study revealed that serious injuries and fatalities related to Xarelto increased by 41 percent last year. As with all anticoagulants, Xarelto can cause excessive, uncontrolled bleeding. However, this controversial drug is missing one very important quality of its predecessor, warfarin; there is no antidote to the bleeding. When a patient on warfarin experiences uncontrolled bleeding, a physician can administer a dose of vitamin K and fresh plasma to stop the bleeding. This combination acts as a reversal agent. No such reversal agent exists for Xarelto.

More than 3,000 Deaths Linked to Oral Blood Thinners Last Year Alone

Oral blood thinners including Xarelto resulted in more E.R. visits than any other type of medication in 2016. ISMP said that more than 3,000 deaths were related to these blood thinners last year. Of the blood thinners involved, Xarelto accounted for more than 68 percent of all adverse events. This shocking report coincides with the first trials in the more than 18,000 lawsuits against Xarelto’s manufacturers, Janssen Pharmaceuticals and Bayer Healthcare.

“These injury findings are disheartening, but unfortunately not all that surprising,” said Andy Birchfield, an attorney representing the plaintiffs in the Xarelto multidistrict litigation (MDL). “The statistics are testament that Xarelto is one of the most high-risk drug treatments in medicine today, and the reason we are pursuing justice for the victims of this potentially deadly medication.” A Boston drug injury lawyer can help you determine how to proceed if you’ve been harmed by taking Xarelto.

Failure to Warn

Lawsuits allege that Janssen and Bayer failed to warn patients and physicians of the risks of taking Xarelto, and that the companies aggressively marketed the blood thinner as superior to warfarin. Xarelto was marketed as a more convenient, lower-maintenance alternative to warfarin, but the increased risks were kept a secret.

Xarelto Side Effects

Multiple medical complications have been linked to Xarelto use. Among them are:

  • Internal bleeding
  • Wound complications
  • Infection
  • Brain hemorrhaging
  • Abdominal bleeding
  • Excessive, uncontrolled bleeding
  • Bleeding from the eyes
  • Abnormal liver function
  • Spinal epidural hematoma (blood clot in the spine)
  • Stroke
  • Death

Despite all of these risks, Xarelto is still being prescribed to new patients every day. A MA defective drug lawyer can help you determine how to recover damages if you’ve been injured by Xarelto or a similar drug. If you are currently taking Xarelto to prevent blood clots – or for any other reason – it may be in your best interest to discuss the risks with your physician. Continue reading

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Have you been negatively affected after taking Risperdal as a child or as an adult? Have you suffered humiliation due to enlarging breasts, and never received warning that such a side effect could occur from taking Risperdal? You are not alone, and you may be entitled to financial compensation.

Lawsuits filed by patients who took the antipsychotic medication, Risperdal, now number in the thousands, worth potentially billions of dollars in settlements to be paid by drug manufacturer, Johnson and Johnson. One case involving Risperdal netted a plaintiff a $70 million settlement last summer in Philadelphia.

Plaintiffs claim that the drug caused a rare condition called Gynecomastia, which results in breast enlargement in males, causing humiliation and mental anguish for those affected. In some cases, the enlargement is so severe that those affected may actually need breast reduction surgery in order to correct the condition. Others allege that they were prescribed the medication as juveniles despite the drug not being approved by the Food and Drug Administration for anybody under the age of 18.

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Inferior vena cava (IVC) filters are surgical devices that are threaded into the body through the skin and are intended to prevent blood clots after a medical procedure or accident. IVC filters can be implemented permanently or temporarily and removed once the patient’s risk of blood clotting is reduced. Over 250,000 of these devices have been installed as of 2012.

Although they are intended to save lives, IVC filters are incredibly prone to snapping or moving out of place of their originally-intended location, which can cause severe health complications and even a risk of death. There are thousands of ongoing and settled lawsuits resulting from damages – and wrongful deaths – caused by malfunctioning IVC filters against many different manufacturers.

Devices that are claimed to be liable in such lawsuits include:

  • Bard recovery filter
  • Bard G2 filter
  • Bard G2 Express filter
  • Cook Gunther Tulip filter
  • Cook Celect filter
  • Boston Scientific Greenfield filter

Although IVC filters are primarily intended to be a temporary measure to help stabilize a patient, a study of patients who had temporary IVC filters installed found that over 25 percent of them were ultimately unable to have their filters successfully removed. Simply put, the longer a temporary filter is left in the body, the higher the likelihood of it malfunctioning, moving or breaking.

Possible health complications of IVC filters

IVC filters have been FDA approved for years, however this does not change the fact that the devices are fragile and prone to breaking. If an IVC filter breaks, pieces of it can then travel through a patient’s blood stream, causing serious or even deadly injuries – like piercing internal organs (oftentimes the heart itself) or causing blockages in the blood stream.

A malfunctioning IVC filter may also cause an irregular heartbeat, loss of consciousness, irregular breathing or chest pain, heart damage and fluid buildup around the heart. The FDA is collecting more analytical information to assess the risks versus benefits of temporary IVC filters.

Lawsuits stemming from damages caused by IVC filters are voluminous, and involve multiple medical device manufacturers. Cook Medical Group had more than 1,900 lawsuits pending in federal court as of 2017 alleging a defective design, misrepresentative marketing and a failure to warn patients of potential danger.

Günther Tulip IVC filters was the subject of a study that claimed a shocking 100 percent of patients fitted with this device had it puncture their heart within 71 days of being implanted. C.R. Bard has settles cases in the past but still have more than 1,500 cases pending that allege gross negligence in addition to other misconduct. Continue reading

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Many people assume that prescription drugs and medical devices are always tested before they hit the shelves. Unfortunately, this is not always true. In many cases, the FDA may approve a new drug if it has the same mechanism of action, form and strength as an existing drug that has already been approved. Sometimes the drug proves just as safe as its predecessor…but not always. The same can be said for medical devices that haven’t been tested properly, or for an adequate period of time. Read on for more information about dangerous and defective prescription drugs, and how you can avoid the risk of serious injury or death.

The Top Offenders

  • Fluoroquinolones are the nation’s most commonly used type of antibiotic; about 33 million people take these drugs annually. Unfortunately, fluoroquinolones may cause multiple serious medical conditions, including peripheral neuropathy, a potentially-permanent form of nerve damage. Cipro, Avelox and Levaquin are the most popular of the fluoroquinolones on the market today. The manufacturers of these drugs – Merck, Johnson & Johnson, and Bayer – are facing a tidal wave of lawsuits from patients who say they weren’t adequately warned about the associated risks. In addition to peripheral neuropathy, fluoroquinolones are linked to aortic aneurysm and aortic dissection, which combined cause approximately 15,000 deaths annually in the United States.
  • Anticoagulants are blood-thinning medications used to treat a number of disorders, including atrial fibrillation and deep vein thrombosis. Up until recently, warfarin was the only treatment option. In 2011, Xarelto was introduced as a lower-maintenance alternative, and it quickly grew in popularity along with Pradaxa and Eliquis. Patients being treated with the new drugs have the same risk of excessive and uncontrollable bleeding as those who take warfarin, but with one major difference. There is an antidote for excessive bleeding caused by warfarin. No such antidote exists for Xarelto. As such, the drug’s manufacturers, Bayer and Janssen (a division of Johnson & Johnson), are at the center of thousands of lawsuits claiming serious injury and death. A Boston drug injury lawyer can help you determine how to proceed if you’ve been injured by a dangerous or defective drug.
  • Antipsychotics are prescribed by doctors to treat conditions such as schizophrenia, PTSD, and bipolar disorder. However, some antipsychotic medications have recently been linked to disturbing side effects, such as sexual promiscuity, excessive gambling, and breast development in males. Ability’s manufacturers, Otsuka and Bristol-Myers Squibb, are facing a growing number of lawsuits from patients who claim they couldn’t control the urge to gamble or over-eat, or that they developed hyper sexual behaviors. Hundreds of lawsuits have been filed against Risperdal’s manufacturer, Janssen Pharmaceuticals, alleging that the drug caused young men to develop breasts, a condition known as gynecomastia.
  • Patients with type 2 diabetes need help regulating their blood sugar levels. Invokana is a popular and effective medication for lowering blood sugar and improving glycemic control for these patients. Unfortunately, it’s also linked to several life-threatening medical conditions. The most serious conditions associated with Invokana use are kidney failure, amputations, and a potentially-fatal condition called Ketoacidosis. As a result, Invokana’s manufacturer, Janssen, is facing multiple lawsuits alleging that the company failed to warn physicians and patients of the serious side effects linked to its drug. A MA drug injury lawyer can help you determine how to recover damages if you’ve been injured by a dangerous or defective drug.

If you are currently taking any of these drugs, it is in your best interest to discuss the risks with your physician. Continue reading

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Essure is a birth control device that was created as an alternative to the pill or tubal ligation, and for which no surgical incision or anesthesia is required. Following its FDA approval in 2002, Essure quickly grew in popularity as a low-impact, highly-effective form of birth control. Unfortunately, within about 10 years, thousands of complaints had been reported. Women claimed that serious side effects had forced them to have the device surgically extracted. Not surprisingly, a surge of lawsuits followed.

How Does Essure Work?

The Essure implant is composed of flexible coils that are inserted into the fallopian tubes using a non-surgical procedure. Once in place, the coils prompt tissue to grow around them, essentially “locking” the coils in place and blocking the fallopian tubes with the new tissue. As a result of this blockage, sperm is no longer able to move through the fallopian tubes, and thus cannot reach, nor fertilize, the eggs.

Once the three-month period has passed, women who have received an Essure implant are supposed to follow up with a radiologist to ensure that the tubes are fully blocked. In some cases, patients never reported for their three-month visit. A Boston defective medical products attorney can help you recover damages if you’ve been injured by an Essure implant.

Complications Linked to Essure Implants

According to the FDA, more than 5,000 women have reported problems with Essure implants since it was approved in 2002. The main issue with these implants seems to be that they were never tested for long-term use. Intended to be implanted for life, Essure was approved based only on a few short-term studies. Reported side-effects and medical complications include:

  • Abdominal or pelvic pain
  • Vaginal bleeding
  • Rash or itching (may be caused by an allergy to metal nickel in the implant)
  • Menstrual cycle changes
  • Fatigue
  • Joint pain
  • Ectopic pregnancy
  • Unintended pregnancy
  • Device migration
  • Perforations or punctures in the fallopian tubes, uterus, or abdomen
  • Multiple surgeries, including hysterectomy
  • Death

According to the FDA, the agency had required that Conceptus conduct a follow-up study within five years of approval, to ensure that long-term use was safe. This should have occurred in 2007, but the results were not published until 2015. And even then, only about 70 percent of women with Essure implants had been followed for the required five-year period. Sadly, these types of delays are quite common in the medical device and pharmaceutical industries. Companies get quick approval for their drugs and devices by telling the FDA that they will conduct post-approval studies, and then fail to do what they promised.

Due to the testing delay, multiple complications were not detected until it was too late for many patients; the stainless steel in Essure implants can rust, the nickel can produce a dangerous oxide, and the implant can leak toxic byproducts. Further, the device can migrate to other parts of the body, resulting in life-threatening punctures and perforations.

There are currently hundreds of product liability and medical malpractice lawsuits against Essure’s manufacturer, Conceptus. Lawsuits claim that Conceptus failed to warn physicians, patients and the FDA about the known risk of abdominal injuries, among other complications. Had they known about these risks, plaintiffs could have chosen a different method of birth control. A MA injury attorney can help you determine how to move forward if you’ve been injured by an Essure implant, or any type of medical device. Continue reading

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The TV commercials and radio advertisements are everywhere – if you have recently undergone hernia repair surgery, you may be entitled to recover for any complications suffered as a result. Not only is it important to understand that this is an option, it is also important to understand why, and what to look for after your surgery. Becoming part of a lawsuit for a defective hernia mesh product can be appealing for several reasons: not only because it provides a remedy for the pain and suffering you have gone through, but also as more studies are conducted to find which mesh products are causing problems, more corporations are being added to lawsuits, including giant corporations like Johnson & Johnson. With the addition of more corporations, comes the increased likelihood of large payouts. After reading this, if you feel that you have been affected by a defective mesh product following your hernia repair surgery, contact your medical provider to see if it was produced by a company like Johnson & Johnson (through their Ethicon unit) that is known to manufacture faulty mesh products.

Depending on the type of surgery, and the amount of damage, the way mesh is used may vary from patient to patient. But in general, the mesh is sutured on the abdominal wall, either on top of or behind the wound site. Once secured in place, it allows for new tissue to grow while simultaneously protecting the growth site. However, recent studies have shown that certain mesh products, especially those made out of polypropylene (like Ethicon’s Physiomesh) are not conducive to working with human tissue. In fact, recent studies have shown that “the scientific evidence shows that the polypropylene material from which the product is made is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the products.”

You may be asking why surgeons continue to use this mesh in their hernia repair procedures. Recent studies, although many of them are apparently funded by mesh manufacturers, have stated that using mesh, “the repair can be done without putting tension on the tissue, which in turn reduces the likelihood of a hernia recurrence … [some studies] suggest that half of all hernia repairs without mesh fail, while only 20 percent of mesh repairs fail.” Despite the potential for skewed studies, the general consensus among medical providers still seems to be that using mesh is the trusted, recommended, and most common way to conduct hernia repair surgeries.

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What is a Stockert 3T Heater-Cooler System? When a patient is under anesthesia during surgery, it is important to regulate body temperature to keep the patient comfortable and safe, and to improve the outcome of the surgery. Heater-cooler devices do this through the use of temperature controlled blankets which can alternately warm and cool the patient’s body. Unfortunately, these devices have recently been linked to life-threatening infections, especially during cardiothoracic surgeries.

Multiple lawsuits against LivaNova PLC, the manufacturer of Stockert 3T Heater-Cooler Systems, claim that it failed to warn physicians and hospitals of the risk of infection. Studies have revealed that the device is capable of transmitting a bacterium called Mycobacterium chimaera to patients during surgeries. This bacteria can lead to a condition called nontuberculous mycobacteria infection, which can be fatal, even after years of treatment with antibiotics. A Boston defective medical device attorney can help you determine how to proceed if you’ve been harmed by a heater-cooler system.

How Do Heater-Cooler Devices Spread Infection?

To cool and warm a patient’s body, a heater-cooler device uses a water-tank system to regulate the temperature of the attached warming blanket. Research has show that when the water in these tanks becomes contaminated, bacteria may be released into the air surrounding the patient’s body through an exhaust vent. If this happens, a patient who may have a weakened immune system and open wounds due to the surgical procedure, has a highly-increased chance of contracting an infection from the bacteria.

Look Out for these Signs and Symptoms

One of the most concerning aspects of nontuberculous mycobacteria infection is that it can take several years for the infection to occur following exposure to Mycobacterium chimaera. If you have undergone cardiac surgery with a heater-cooler device, you should look for the following signs / symptoms:

  • Chronic fever
  • Night sweats
  • Unexplained weight loss
  • Joint pain
  • General malaise
  • Infection in the surgical site
  • Abscess
  • Endocarditis (infection of the lining of the heart)
  • Hepatitis
  • Bacteremia (bacteria in the blood)
  • Kidney failure
  • Pancytopenia (loss of red and white blood cells)
  • Enlargement of the spleen
  • Osteomyelitis (bone infection)

Any of the above complications could be evidence of a nontuberculous mycobacteria infection. Even if your surgery was weeks, months or years ago, it is still possible to develop this potentially-deadly infection. If you notice any of the above symptoms, it is crucial to seek medical attention immediately. Cultures can be taken and diagnostic testing can be performed to determine if you have an infection. The earlier an infection is identified and treated, the better your chances of a positive outcome. A MA defective medical device lawyer can help you recover damages if you’ve been injured due to the negligence of a medical device manufacturer. Continue reading

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