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.

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?

When Deane Berg was 49 she was diagnosed with advanced ovarian cancer. While searching the internet for possible causes of this deadly cancer, she was surprised to see talcum powder on the list. Although Berg had no other risk factors, such as endometriosis, she had been using baby powder for feminine hygiene every day, for at least 30 years. “I knew nothing about this before,” said Berg. “I figured baby powder is for babies, it must be safe.”

Ms. Berg was the first in a long line of women who filed lawsuits against Johnson & Johnson, claiming that the manufacturing giant’s baby powder products caused their deadly disease. Johnson & Johnson stands behind its baby powder, saying the product is safe, despite thousands of lawsuits claiming the opposite. In fact, research dating back to 1971 links talc particles used in the genital area to ovarian cancer and cervical tumors. According to this research, and many studies that have been conducted since, talc particles have been found embedded in ovarian tumors. In response, the International Agency for Research on Cancer classified talcum powder as a human carcinogen when used for feminine hygiene.

Johnson & Johnson plans to appeal two recent jury awards, both in the tens of millions of dollars. The company says that research linking talc to cancer is flawed. “We have children ourselves,” said Tara Glasgow, the head of research and development for J&J’s baby products franchise. “We would never sell a product we didn’t believe was safe.” A Boston injury lawyer can help if you think you were harmed by a talc-based product.

24% Greater Risk of Developing Ovarian Cancer Among Women Who Use Talcum Powder

In addition to evidence showing that talc particles can enter the vagina and migrate through the fallopian tubes and into the ovaries, talc is often mined near asbestos, a known – and very deadly – carcinogen. In the early 80s, Harvard professor Dr. Daniel W. Cramer led a study comparing 215 healthy women with 215 women who had ovarian cancer. The women who used talcum powder in the genital area regularly had more than three times the risk. Similar studies involving 20,000 women found that talcum powder use is linked to a 24 percent increase for ovarian cancer risk.

As cancers go, ovarian cancer is particularly aggressive, and deadly. In 2008, a nonprofit organization called Cancer Prevention Coalition petitioned the FDA for warning labels on talc-based products. The FDA denied the request. However, in the 2014 denial letter, the agency admitted that talc “may elicit a foreign-body-type reaction and inflammatory response that, in some exposed women, may progress to epithelial cancers.” A MA defective products attorney can help you determine how to move forward if you have developed cancer after using talcum powder.

In 2006, J&J’s talc supplier added a warning label to the talc…but J&J didn’t transfer the warning to its products containing that talc. “Talcum powder is an interesting case, because it’s not something that’s necessary,” said Dr. Anne McTiernan, an epidemiologist at Seattle’s Fred Hutchinson Cancer Research Center. “If there’s any doubt, why should anyone use it?” Continue reading

Earlier this month, a federal judge ordered Caldera Medical to pay a total of $12.3 million to settle over 2,700 injury claims related to the company’s transvaginal mesh products. Tens of thousands of women have suffered injuries as a result of transvaginal mesh products from multiple manufacturers. Many of the women allege that manufacturers provided “false and misleading information” about the effectiveness and safety of the products. Complications range from severe pain to the need for multiple revision surgeries. If you have been harmed by a mesh implant, read on for more information about legal options that may be available to you.

Why Should Transvaginal Mesh Manufacturers Be Held Accountable?

Lawsuits against mesh manufacturers include several allegations, including that they:

  • Intentionally mislead physicians, patients, and the FDA as to the safety and effectiveness of their products.
  • Failed to perform adequate testing on the use of mesh products for treating disorders of the female pelvic floor.
  • Failed to determine safe methods of removal for when complications arise.
  • Failed to properly and adequately warn patients and physicians of associated risks.

Complications Associated with Transvaginal Mesh

Within weeks of surgery, mesh can begin eroding through vaginal walls. The result can be extremely painful, and injuries may be permanent. Possible complications include:

  • Severe pain
  • Erosion of the mesh
  • Pain during sexual intercourse
  • Abdominal pain
  • Urinary incontinence
  • The need for revision surgeries

A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by transvaginal mesh. Due to the nature of the complications, injuries can be emotional as well as physical. A woman from Illinois is suing the manufacturer of her mesh product for nearly $10 million as a result of the complications she experienced. Jill L. Dewey had the medical product implanted in 2005 following her organ prolapse.

In addition to the above cases, thousands of federal lawsuits have been consolidated in multi district litigation (MDL), and thousands more are currently pending at the state level. The manufacturers facing the lion’s share of the lawsuits are Ethicon and American Medical Systems, but Boston Scientific, Coloplast, C.R. Bard, Neomedic, and Cook Medical are also facing their fair share of injury claims.

If you have received a transvaginal mesh implant and are concerned about the associated risks, speak to your healthcare provider. If you have been injured due to a mesh device, or a similar medical product, a MA injury lawyer can help you obtain the compensation you deserve for your injuries.

More Defective Medical Products

In addition to transvaginal mesh products, several other medical devices have caused serious harm to patients in recent years. The devices below have been at the center of tens of thousands of injury claims.

  • Metal hip replacements
  • Drug-coated stents
  • Guidant defibrillators
  • IVC blood clot filters
  • DaVinci surgical robots

Continue reading

As of December 2016, approximately 34 Eliquis lawsuits were pending against the drug’s manufacturers, Bristol-Myers Squibb and Pfizer, Inc. The plaintiffs claim they were harmed as a result of the manufacturers’ failure to warn of serious, potentially life-threatening risks linked to Eliquis and other drugs like it.

Eliquis belongs to a newer class of anticoagulants (blood thinners) that has been hailed as a lower-maintenance alternative to the long-standing warfarin. Along with Pradaxa and Xarelto, injury claims against Eliquis have been on the rise, and they’re not expected to slow down anytime soon. If you have been injured by Eliquis or another defective medication, it is in your best interest to consult with a Boston drug injury lawyer today.

Eliquis was approved by the FDA in 2012 for treatment of blood clots in patients with disorders such as atrial fibrillation. Demand for the new drug grew quickly; unlike its predecessor warfarin, Eliquis doesn’t require “inconvenient” blood monitoring. This benefit, however, was soon overshadowed by one very negative side effect. As with all anticoagulants, Eliquis reduces blood clotting and can increase the risk of excessive, uncontrollable bleeding. Warfarin has an antidote to stop the excessive bleeding – vitamin K. Unfortunately, no such antidote exists for patients on Eliquis, Pradaxa, and Xarelto. Basically, if a patient starts bleeding uncontrollably, there is no way to stop it.

Medical Complications Linked to Eliquis

If you develop unexplained bruising, feel faint or dizzy, or begin bleeding uncontrollably while on Eliquis, contact your physician immediately. The complications below can all be fatal if undetected, or when left untreated.

  • Brain hemorrhaging
  • Bleeding of the kidneys or intestines
  • Deep vein thrombosis (DVT)
  • Uncontrolled bleeding
  • Death

Approval Based on a Flawed Study

The FDA’s approval of Eliquis was largely based on a study published in a 2011 issue of the New England Journal of Medicine. The ARISTOTLE study concluded that Eliquis was more effective at preventing stroke and systemic bleeding than warfarin. It also stated that Eliquis caused less bleeding and, thus, was linked to a lower rate of mortality. However, the study was later found to be riddled with flaws. Side effects of Eliquis were concealed by agents of the defendants. In fact, one of those concealed side effects resulted in a patient’s death during the study. In addition, some study participants who were not being treated with Eliquis were said to be taking the drug. Research has shown that the study’s results were largely manipulated. But Eliquis remains on the market today.

Eliquis sales amounted to about $774 million in 2014, a hefty sum helped along by the $8 million paid to physicians in 2013 to encourage prescriptions of the drug. A MA injury lawyer can help you determine whether to file a claim if you’ve been harmed by Eliquis or a similar dangerous drug. Pharmaceutical companies make billions in profits. When their negligent actions result in injury or death, they should be held accountable for their actions. New evidence reveals that manufacturers of Eliquis, Pradaxa, and Xarelto likely knew about the associated risks but failed to warn physicians and the public. Continue reading

People suffering from depression and bipolar disorder may be prescribed Abilify, an antipsychotic drug meant to help reduce the negative symptoms of these emotional disorders. Unfortunately, the side effects of Abilify may be significantly worse than the symptoms it’s intended to treat. From hyper-sexuality to compulsive gambling, Abilify has been linked to multiple compulsive behaviors, many of which can ruin a person’s life.

One woman lost her home and custody of her children after developing a gambling habit while on Abilify. The mother of two claims she had never had a gambling problem before being prescribed the drug. Her compulsion to gamble while on Abilify was so strong that she missed multiple flights because she couldn’t pull herself away from the casino. “I had to reschedule the first flight I missed and then I went back to the machine waiting for the second flight and I ended up missing that as well,” said the woman, who estimates that she lost  up to $2 million due to her gambling habit, in less than five years. A Boston drug injury lawyer can help you determine whether to file a lawsuit if you’ve experienced similar side effects while on Abilify.

Abilify affects the brain’s dopamine production to reduce negative symptoms of conditions such as depression and bipolar disorder, but it may create an overabundance of dopamine in some patients. Dopamine receptors crave pleasure, which is why Abilify may lead people to gambling, compulsive shopping, hyper-sexuality, and overeating. “I gained about 70 pounds and then lost it subsequently after stopping Abilify,” said the woman, who admits to becoming involved in prostitution as well. “Something I’m ashamed of and embarrassed by.” She claims that following a 2012 move to Colorado, her new doctor refused to prescribe Abilify, and the compulsive behaviors stopped. It was then that she made the connection between the prescription medication and her compulsivity.

FDA Warning Came Too Late For Some

In response to these claims, the FDA finally issued an announcement in May 2016 warning that, “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced.”

Although the warning was issued, it was far too late for some. European patients learned about the link between Abilify and compulsive behaviors back in 2012, when Europe issued a public warning. American patients weren’t clued in for another four years. For patients like the woman above, Abilify may have ruined their lives. If you suffered harmful side effects while taking Abilify or any other prescription drug, contact a MA drug injury lawyer today.

According to the FDA, about 1.6 million Americans were prescribed Abilify in 2015. The drug is still on the shelves, but with the new warning, patients can now decide if they are willing to take the risk. If you are currently taking Abilify or any other form of the drug aripiprazole, you may want to speak with your doctor about the potential side effects. Continue reading

Surgeries for hernia repairs are extremely common in the United States. In fact, about 500,000 surgical repairs are performed annually. Unfortunately, the hernia mesh devices used in many repairs are linked to multiple serious injuries, including organ perforation and bowel obstruction. If you have been harmed due to a mesh implant, the information below will help you determine whether to seek the counsel of a Boston hernia mesh injury lawyer.

Hernia mesh works by covering or “plugging” the areas of weakened muscle in the abdomen. There are several different types of hernia mesh, including those made from synthetic materials and those made from biologic materials. Synthetic mesh is typically made of polypropylene, composite mesh, or polyester fibers whereas biologic mesh is derived from animal or even human tissue.

Complications Related to Hernia Mesh Products

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