Disclaimer - By publishing this information on this Web site, the Boston, Massachusetts law firm of Altman & Altman LLP is not claiming to represent any clients or cases mentioned here. The content provided is designed to inform readers and is not intended as legal advice.

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.

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

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

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

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.

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

If you or somebody you love has taken Abilify and experienced adverse affects such as compulsive gambling or compulsive spending, you could be eligible to join a class action lawsuit against the drug’s manufacturers, or initiate a lawsuit of your own.

Abilify is an antipsychotic medication developed by Otsuka Pharmaceutical and Bristol-Myers Squibb that was intended to treat symptoms from schizophrenia, bipolar disorder, Tourette’s syndrome, autism and depression. Specifically, the medication is meant to decrease hallucinations, increase the ability for organized thinking, decrease frequency and severity of mood swings and help with depressive thoughts.

The most common side effects to taking Abilify include anxiety, blurred vision, constipation, dizziness, drooling, drowsiness, headaches, nausea, restlessness, lightheadedness, trouble sleeping and weight gain.

However, it has been revealed that Abilify causes serious other side effects, most notable an increase in compulsive behavior that can lead to excessive shopping, eating, sex and, most notably, gambling.

Although the FDA did not update Abilify’s side effect warning to include these compulsive behaviors until 2016, scientific research into the drug showed that the drug had been linked to such strange behaviors since at least 2010. It is maintained by attorneys and experts involved in class action suits that the drug’s manufacturers knowingly misled patients by refusing to warn them about these potential side effects.

The side effects are so prevalent that they have been observed happening in patients with absolutely no history of compulsive behavior prior to taking the drug. The exact cause of compulsive gambling, specifically, is unknown, but has been linked to the brain’s production and release of dopamine, a chemical produced by the body that regulates emotions and the pleasure/risk/reward relationship.

It is still unclear how Abilify so drastically alters this mechanism, but it is apparent that the drug impacts the dopamine “pathway” in the brain significantly, causing these uncontrollable urges to engage in potentially dangerous and harmful activities as a result.

The FDA released its updated warning based on about 200 reported cases of Abilify causing compulsive behavior issues in its users. The warning extends to “other compulsive behaviors…such as compulsive eating, shopping and sexual actions.”

These behaviors can ruin lives

While shopping, sexual activity, eating and even (in careful moderation) gambling can be a part of any normal person’s life, these actions can become severely and negatively impactful to anybody’s life if they become compulsive; meaning the person becomes unhappy or physically or mentally pained if they are not engaging in these actions.

Gambling addicts can blow through life savings, college funds for their kids and spend money that they need for other areas of their life (healthcare, food, rent or mortgage payments) to satisfy their inherent need to continue the risk/reward/pleasure cycle of gambling.

Similarly, overeating and over-engagement in sexual activity can have crippling physical and mental consequences as well, and can lead to additional, costly treatment in hospitals and other medicinal and therapeutic care. Continue reading

Abilify is a prescription medication used to treat multiple mental and emotional disorders, including bipolar disorder, schizophrenia, and depression. In some cases, it’s even prescribed for less-serious issues, such as insomnia and anxiety. Unfortunately, the drug is also linked to several compulsive behaviors, including hyper-sexuality, gambling, and even eating and shopping. Despite the fact that these side effects have been known since at least 2010, warning labels weren’t updated until 2016, following a tidal wave of adverse event reports cited by the FDA. Canada and Europe added such warning labels several years prior to the U.S.

In October 2016, a total of 22 federal Abilify lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court, Northern District of Florida. MDL cases are often formed in response to a significant number of federal lawsuits that share similar characteristics. As of March 2017, the number of pending MDL cases had grown to 60. A Boston dangerous drug lawyer can help you determine how to proceed if you’ve been injured by Abilify.

The MDL panel stated the following in its transfer order:

“Plaintiffs in these actions each allege that they experienced compulsive gambling behaviors as a result of taking Abilify. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.”

Although all forms of compulsive behavior associated with Abilify may have resulted in financial complications, compulsive gambling has produced the most devastating losses. Many of the individuals who report uncontrollable gambling claim to have never had a problem before taking Abilify. For many, their compulsive gambling caused severe financial loss, personal harm, and relationship problems. Some racked up credit card debit, ended up in jail, and even engaged in prostitution to fund their new habit

How Does Abilify Cause Compulsive Behaviors?

Although the exact cause is unknown, many compulsive behaviors, such as gambling and shopping, may be related to a dopamine disorder. Dopamine is naturally released in the body and regulates mood, emotions, and the feeling of pleasure. Unfortunately, too much dopamine can result in compulsive behaviors, whereas not enough dopamine can lead to depression and suicidal tendencies. When dopamine is manipulated with chemicals, such as those found in Abilify, patients may seek out intensely-rewarding behaviors, such as gambling and sex.

The FDA released the following safety announcement in response to nearly 200 reports of compulsive behavior:

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions.

In each of these cases, the compulsive behaviors disappeared when the drug was stopped, or the dose was reduced. A MA injury lawyer can help if you’ve been harmed by the negligence of a pharmaceutical company or healthcare provider.

Allegations Against Abilify Manufacturers, Otsuka and Bristol-Myers Squibb

  • Uncontrollable gambling caused by Abilify resulted in financial, physical, and psychological damages.
  • Abilify’s manufacturers were aware – or should have been aware – that the drug could cause compulsive behaviors.
  • Otsuka and Bristol-Myers Squibb failed to conduct adequate safety testing.
  • At least $10.6 million was paid to physicians to promote Abilify.
  • Otsuka and Bristol-Myers Squibb promoted Abilify for unapproved uses.
  • Abilify caused economic loss, physical and neuropsychiatric injury, emotional trauma and distress, and the loss of a spouse’s consortium.

Continue reading

Xarelto is a type of anticoagulant (blood thinner) medication that quickly grew in popularity following its release in 2011. For decades, warfarin had been the only reliable treatment for patients with blood-clotting disorders, such as atrial fibrillation and deep vein thrombosis. Although effective, warfarin requires regular blood monitoring. Xarelto, on the other hand, does not. Unfortunately, in an effort to fulfill the skyrocketing prescription orders for this new, low-maintenance drug, adequate safety testing may have been “overlooked.”

All anticoagulants carry a risk of excessive bleeding and hemorrhaging, but warfarin has an antidote. If excessive bleeding occurs while undergoing treatment with warfarin, the physician can administer a dose of vitamin K and fresh blood plasma, and the bleeding will stop. Unfortunately, no such antidote exists for Xarelto users. A MA drug injury lawyer can help if you’ve suffered medical complications after taking Xarelto.

Manufactured by Bayer and Johnson & Johnson, Xarelto has thousands of reported complications and adverse event reports with the FDA. Despite these risks, Xarelto sales continue to rise. It has even surpassed sales of other drugs in its class, including Eliquis and Pradaxa, both of which are also linked to excessive bleeding.

How Does Xarelto Work?

Xarelto and other drugs in its class work by blocking a blood protein called Factor Xa, which is responsible for initiating the blood’s clotting process. By blocking Xa, a clotting enzyme called thrombin is not produced, and clots do not form. It can take up to 24 hours for Xarelto to be eliminated from a person’s system. For older adults, it may take even longer and the anticoagulation effects may last longer.

Complications Linked to Xarelto

The use of Xarelto and similar drugs carries the risk of excessive bleeding, but this is not the only complication. Additional medical conditions associated with this drug include:

  • Tingling sensation in muscles
  • Itching
  • Arm or leg pain
  • Muscle pain
  • Liver problems
  • Wound bleeding that does not stop
  • Congestion
  • Sinus irritation
  • Jaundice
  • Fainting
  • Hemorrhaging
  • Death

Xarelto News

  • As of November 2016, there were 13,700 reported lawsuits pending in Multidistrict Litigation (MDL) against Xarelto manufacturers.
  • According to the American Medical Association, patients undergoing treatment with Xarelto have a higher rate of death than those using Pradaxa.
  • The Institute for Safe Medication Practices named Xarelto the nation’s most dangerous drug in 2016.
  • In 2015, more than 10,000 Xarelto-related complications were reported to the FDA.

Our Lawyers can help if you have been harmed by taking Xarelto or a similar drug, such as Pradaxa or Eliquis. If you are undergoing Xarelto treatment and are concerned about the risks, it may be wise to speak with your health care provider. If you develop any of the following symptoms while on Xarelto, seek immediate medical attention:

  • Bleeding gums
  • Red or brown urine
  • Uncontrolled bleeding
  • Black stool
  • Heavy vaginal bleeding
  • Coughing up blood clots
  • Feeling dizzy
  • Feeling weak or fatigued
  • Severe headaches
  • Vomit that looks like coffee grounds or contains blood

Continue reading

More than 100,000 hernia mesh devices are implanted in patients annually in the United States. Despite growing evidence that these medical products come with a high risk of complications, several of the most dangerous types of hernia mesh products remain on the market today. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by a hernia mesh implant.

The FDA is aware of the serious risk associated with hernia mesh implants, but incorrectly claims that most of the dangerous mesh products have been recalled. Here is an excerpt from a 2016 statement put out by the FDA: “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” However, only one month after the release of this statement, Ethicon, a subsidiary of Johnson & Johnson, recalled its Physiomesh hernia mesh product after mounting reports of serious injuries.

Why are Hernia Mesh Products So Dangerous?

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