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Invokana, also known by its generic canagliflozin, is a prescription medication used to control high blood sugar in people who have type 2 diabetes.  Proper diet and exercise is used in collaboration with Invokana to help prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems that can occur from high blood sugar.  Invokana works by signaling your kidneys to remove more sugar from the blood stream.  Invokamet is another prescription drug used to treat type 2 diabetes which is a combination of canagliflozin and metformin.  In addition to increasing the removal of sugar by your kidneys, Invokamet also lowers the amount of sugar made in your liver and decreases how much sugar your body takes in through your stomach and intestines.  Invokana and Invokamet are members of a new class of diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors.  SGLT2 is a protein in humans that facilitates glucose reabsorption in the kidney.  These inhibitors block this reabsorption, as well as increase glucose excretion, and lower blood glucose levels.  However, these types of diabetes medications have recently been associated with patients developing diabetic ketoacidosis and other complications, leading to many lawsuits.

Lawsuits have been filed against the manufacturers of both Invokana and Invokamet, that being Janssen Pharmaceuticals and its parent company, Johnson & Johnson.  Many of these lawsuits claim that the manufacturers of these drugs failed to warn patients and physicians of the increased risks of kidney failure, heart attacks, and ketoacidosis.  The claim argues that if physicians had known the increased risks, they would have prescribed alternative medications, and patients who did take these drugs also would have been more vigilant about monitoring their health and potentially severe side effects.  The side effects that patients experienced are serious and can be lethal in cases.  Kidney failure is a common complication.  The kidneys are essential to filtering out waste from the blood, controlling blood pressure, balancing electrolytes, and producing red blood cells.  When the kidneys stop working, waste products and electrolytes can build up causing weakness, shortness of breath, lethargy, confusion, abnormal heart rhythms, and sudden death.  Heart attacks were also an alleged side effect of the diabetes medications, a condition in which a blood clot starves part of the heart of oxygen eventually causing the tissue to die.  Continue reading

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Inferior vena cava filters, or IVC filters as they’re more commonly known, are used to treat patients with blood-clotting disorders who don’t tolerate more traditional treatments, such as blood thinners. In these special cases, IVC filters can be a life-saving alternative. However, in recent months, IVC filters have been at the center of numerous lawsuits. Concerns about device migration, where the filter moves to other areas of the body, and partial migration, where a piece breaks off and migrates, have resulted in new warnings by the Food and Drug Administration (FDA). So, if you have an IVC filter, should you have it removed? Contact a Boston Defective Medical Products Lawyer Today.

Filters Should Be Removed as Soon as Possible

In response to numerous adverse event reports by patients claiming they were injured by the defective filters, the FDA updated its guidelines for device monitoring and removal. According to the agency, patients with an IVC blood filter should be closely monitored by their physician while the filter remains implanted. Furthermore, filters should be removed as soon as possible, based on the patient’s individual circumstances. In layman’s terms, this means that IVC filters should be removed the moment they are no longer medically necessary. More specifically, the FDA warns that IVC filters should be removed between the 29th and 54th day following implantation.

The Risk of Embolism

The FDA gave special attention to a problem called embolization, in which parts of the filter migrate to the patient’s lungs or heart. This potentially life-threatening condition is of great concern. In addition to the risk of puncturing vital organs and blood vessels, broken and fractured filters are also extremely difficult to remove. When migration and fracture occur, the removal process itself can be risky.

The main culprits in the IVC filter lawsuits are manufacturers Cook Medical and C.R. Bard.

The lawsuits claim defective design, failure to warn, negligence, and breach of implied warranty. In 2010, the FDA received more than 900 adverse event reports related to IVC filters. Included in those reports were 328 device migrations, 146 embolisms, 70 filter perforations, and 56 filter migrations.

Talk to Your Doctor

Long story short, the longer an IVC filter remains in a patient’s body, the higher the patient’s chance of experiencing an adverse event. Every patient’s circumstances are unique, but if you currently have an IVC filter implant, or are getting one, it is in your best interest to discuss the risks with your doctor. Continue reading

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As we age, it is normal that our bodies begin to deteriorate.  Common areas prone to deterioration are the joints, i.e. knees, hips, etc.  Wear and tear on these parts of the body can cause pain, stiffness, and difficulty walking.   Physicians typically prescribe conservative treatment such as physical therapy, exercise and medications, but often times, joint deterioration requires total replacement or resurfacing.  Hip replacements are one of the most common joint replacements.

There are several types of hip implants used in replacement surgery, five currently being available in the United States.  These are, Metal-on-Polyethylene, Ceramic-on-Polyethylene, Metal-on-Metal, Ceramic-on-Ceramic, and Ceramic-on-Metal.  All of these implants have different risks and benefits.  The same implant can also react differently depending on the patient.  The different types of implants refer to the different materials used to make the ball and sockets of the artificial hip.  In metal-on-metal hip implants, both the ball and the socket of the device are made from metal.  Some notable advantages of metal-on-metal hip implants are “bone conservation on the femoral side with possible lower dislocation rates”, better range-of-motion, more normal walking posture, increased activity, and “increased ease of insertion with proximal femoral deformities or retained hardware, and straightforward revision”.

However, there are many risks with these replacement surgeries.  Common adverse effects regardless of the type of implant are hip dislocation, bone fracture, joint infection, local nerve damage, device loosening or breakage, difference in leg lengths, and bone loss.  Even with these potential complications, data from an FDA study performed of patients from Australia and the U.K. shows that 95 percent of patients with any type of total hip replacement have not undergone revision surgery for at least seven years after their initial operation.  Specifically with metal-on-metal implants, over 85 percent of patients have not have a revision for at least seven years after the initial implant.  Interestingly, patients with larger heads, defined as 36mm or larger, had more revisions than those with smaller heads.

Although this is true for this study, there has recently been a massive recall for several different manufacturers of hip implants in the U.S.  Consumer’s Union found that from 2002 to 2013 hip implant recalls six major manufacturers, Biomet, DePuy, Smith & Nephew, Stryker, Wright and Zimmer.  However, these recalls came after the implants had already been used in hundreds of thousands of hip replacement surgeries.  In total, more than 500,000 patients in the United States received metal-on-metal hip implants after they were claimed to be more durable and provide a greater range of motion when compared to older forms of artificial implants.  However, it was later found that the manufacturers’ claims that the implants were more durable were false.  These metal hip replacements began failing rather quickly.  Common symptoms of hip replacement failure are regular and prolonged pain around the groin, hip, or leg, swelling near the hip joint, and difficulty walking.  The key reason these metal-on-metal hip replacements are failing is due to the friction caused by the normal movement of the device.  This friction releases microscopic shavings and metal debris into the tissue around the joint.  Consequently, this can cause metallosis, a build up of metal fragments in the soft tissues of the body, which causes painful and inflamed joints and a high blood-metal count.  Continue reading

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Zofran, also known by its generic name ondansetron, is a prescription drug that blocks chemical reactions in the body that cause nausea and vomiting.  The drug works by blocking serotonin, a neurotransmitter, in the body, which is the natural substance responsible for nausea.  Zofran is a type of medication called an antiemetic and is part of 5HT3 receptor antagonists.  The drug is typically used to prevent nausea and vomiting caused by surgery or cancer drug treatment such as radiation and chemotherapy.  Because Zofran treats nausea and vomiting, it has been prescribed to pregnant women as a treatment to morning sickness.  Zofran, Zuplenz (another brand name for ondansetron) and the generic are only approved to treat nausea and vomiting after cancer treatments and surgery.  However, doctors often prescribe them for unapproved uses such as morning sickness in pregnant women and treating stomach problems in children.  The manufacturer of Zofran acknowledged the new potential for their product and began advertising to doctors and expecting mothers the relief that the drug could offer to pregnant women.  Many women turned to Zofran as a respite for their morning sickness, but recently data has linked the drug to birth defects.

Who manufactures it?

GlaxoSmithKline (GSK) is a British pharmaceutical company stationed in Brentford, London.  The company is the sixth largest pharmaceutical company as of 2015.  The company describes itself as “a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer” on its website.  GSK is known for its global initiative to develop medicines that are affordable in developing countries.  Additionally, GSK has recently partnered with Pfizer, another pharmaceutical company, to establish ViiV, a company devoted to the fight against AIDS and rebuilding the health of communities affected by HIV.  Other noteworthy acts include GSK’s partnership with the World Health Organization.  GSK donated 100 million albendazole tablets in 2002 as treatment against intestinal worms.  GSK is also one of the largest vaccine companies worldwide, dispensing over 1.1 billion doses of vaccines to 173 countries.  GSK had a relatively pristine reputation in the past, but in recent years, their company has been tarnished through several damaging discoveries.  One of their drugs, Avandia, was the world’s most popular diabetes pill until it was linked to an increased risk of heart attack.  Another scandal occurred when GSK was caught with illegal marking and withholding of data in 2012.  Additionally, the company has had problems with Zofran, Paxil and Wellbutrin (antidepressants), and Advair (used to treat asthma).

What are the side effects?

Zofran, Zuplenz, and the generic ondansetron are labeled as Pregnancy Risk Category B.  This classification means that there is no evidence that the drugs are hazardous to humans.  This fact, along with GSK’s advertising of the drugs as treatments for morning sickness in expecting mothers, assured mothers that the drug was safe for them and their babies to take.  However, this led to a variety of birth defects, including mental, vision, and stomach problems, club foot, physical deformities, heart defects, cleft lip/palate, webbed toes, hearing loss, abnormal blood pressure, and skull deformities.  In a 2014 study by Dr. Gideon Koren, taking Zofran or similar drugs while pregnant caused a “2-fold increased risk of cardiac malformations, leading to an overall 30% increased risk of major congenital malformations.  Zofran can also have dangerous side effects for the mother.  Such side effects include Serotonin Syndrome, a life-threatening condition that causes high fever, irregular heartbeat, seizures and unconsciousness and QT Syndrome, a syndrome that can cause erratic heartbeats. Continue reading

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Pradaxa, also known by its generic name dabigatran, is used as a preventative treatment to reduce the risk of stroke and blood clots in people who have atrial fibrillation.  Atrial fibrillation is the most common type of arrhythmia, or irregular heartbeat.  Pradaxa helps to prevent blood platelets from clotting together, which, if occurs, can create a blockage in the vein.  Pradaxa can also be used to treat blood clots in the veins found in legs or lungs and can reduce the risk of their reoccurrence.  Pradaxa was approved in October 2010 and immediately proved strong competition to the popular blood thinner already on the market, warfarin.  Pradaxa began gaining popularity as it was found that it requires less maintenance than warfarin, which requires regular trips to the doctor, blood tests and diet restrictions.  Additionally, Pradaxa was advertised to have fewer, less severe side effects than warfarin, whose negative effects include brain hemorrhages and internal bleeding.  In clinical trials, Pradaxa did in fact outperform warfarin.  More and more patients with atrial fibrillation began to fill prescriptions for Pradaxa partially accredited to the promotion of the drug by Boehringer Ingelheim, its German manufacturer.  In 2011, Boehringer Ingelheim put $464 million into promoting Pradaxa, and in the first quarter of the next year, sales had already reached $209 million.  The anticoagulant drug was growing rapidly, with minimal negative feedback initially.  However, a few short years after its entrance into the pharmaceutical market, patients began reporting numerous cases of hemorrhaging and uncontrollable bleeding which contributed to more than 500 deaths.  Both Pradaxa and warfarin have positive and negative side effects, but recently Pradaxa has been highlighted in the news for several of its lethal side effects.  In March 2012, a Cleveland Clinic study found that Pradaxa causes a 33 percent increased risk of heart attack or severe symptoms of heart attack when compared with warfarin.  Bleeding is always a risk factor to be conscious of when taking blood thinners.  However, Pradaxa is especially risky because once excessive bleeding stops, it cannot be controlled.  Because warfarin functions differently from Pradaxa, excessive bleeding can be controlled for patients taking warfarin by administering vitamin K.  Pradaxa does not have an antidote like warfarin does, which makes fatal hemorrhaging more likely on Pradaxa.  Continue reading

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Pharmaceutical companies are one of the most profitable industries on the planet. Many rake in billions of dollars in profits annually. Although some prescription medicines have immense benefits for the patients taking them, others seem to cause more harm than good. There is a dark side to the pharmaceutical industry that cannot be denied. In a six-year period, between 2004 and 2010, several industry leaders paid about $7 billion in fines and lawsuits. Fortunately for them, but unfortunately for those who are injured and killed by these drugs every year, their sky-high profits mean these lawsuits and penalties are just a drop in the bucket. Eli Lily, for example, made $36 billion from one drug. Contact a Boston Personal Injury Lawyer Today.

Flaws and Dishonesty in Clinical Trials

The Food and Drug Administration (FDA) approves an average of 24 drugs annually. Many of these drugs pose serious health risks and are so new to the market that there hasn’t been sufficient time for adequate clinical trials. Even when clinical trials are conducted in their entirety, they are often inaccurate based on certain factors, including studies of extremely small groups of people, and failure to report negative results to the FDA.

Adverse Reactions

When adverse reactions to a certain drug are reported, the FDA responds in many ways, including holding meetings, issuing reports, demanding more trials, sending letters to physicians, and demanding additional label warnings. However, these actions can take several years to create any kind of actual change. That doesn’t help patients who are taking dangerous drugs today.

Most Dangerous Prescription Medications

There are many potentially dangerous drugs on the market today. Among the most dangerous are:

  • Birth control pills Yasmin and Yaz
  • Antidepressants; Prozac, Paxil, Lexapro, Zoloft
  • Diabetes drugs Actos and Avandia
  • Anticoagulants (blood thinners) Pradaxa and Xarelto
  • Acne medicine Accutane
  • Osteoporosis medicine Fosamax

The drugs above are linked to a variety of medical complications, including heart attacks, strokes, bleeding disorders, suicidal behaviors, liver damage, and birth defects. If you are currently taking any of the medications above, it is in your best interest to consult with your physician about how these potential side-effects may impact your health. Even if you are not currently experiencing symptoms, it is wise to seek medical advice. Many of the side-effects do not become apparent for several weeks or months. Continue reading

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Xarelto, a blood thinner linked to irreversible hemorrhaging and other serious medical problems, is now under investigation for problems that may have occurred during the FDA’s initial testing of the drug. The FDA is investigating whether a device used during clinical tests may have negatively affected test results by understating the bleeding risk of patients. Contact a Boston Defective Medical Equipment Lawyer Today.

Xarelto quickly grew in popularity following its approval by the FDA in 2011. The anticoagulant, which is billed as a low-maintenance alternative to warfarin, is prescribed to patients at risk of blood clots and stroke. Up until recently, warfarin was the only option for patients suffering from these types of conditions. Warfarin requires frequent blood monitoring, an inconvenience that Xarelto patients don’t have to endure. Both warfarin and Xarelto have a risk of excessive bleeding, but there’s one major difference between the two. Warfarin-related bleeding problems have an antidote; a dose of fresh blood plasma and vitamin K, administered by a physician. Unfortunately, no antidote exists for patients who experience hemorrhaging while undergoing Xarelto treatment. This oversight has resulted in thousands of injuries and deaths.

Was there Evidence that the Device was Malfunctioning During Clinical Trials?

Until recently, the FDA’s spotlight was on the drug itself. However, new evidence indicates that a malfunctioning device during clinical trials may be to blame for the injuries and deaths. According to a recent article in the New York Times, the FDA has recently begun asking Xarelto’s manufacturer, Johnson & Johnson (Janssen), “…detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.”

The article also reported that, “Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.” It was indicated that Johnson & Johnson (Janssen) and Bayer reportedly, “…notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding.” Continue reading

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At Altman & Altman, LLP we’ve previously reported on the link between diabetes drug Invokana and a dangerous medical condition called ketoacidosis. However, the lawsuits against the drug’s manufacturer, Janssen Pharmaceuticals (a division of Johnson & Johnson corporation) are continuing to pile up. The most recent Invokana lawsuit was filed by a Texas woman who alleges that the drug caused her serious harm. The plaintiff is requesting more than $10 million in damages, claiming she suffered life-threatening injuries. Contact a Boston Drug Injury Lawyer Today.

Invokana is a member of a relatively new class of drugs called SGLT2 inhibitors. SGLT2 inhibitors have been touted as an effective treatment alternative for patients with type 2 diabetes. In conjunction with a healthy diet and exercise, Invokana prevents the kidneys from reabsorbing excess glucose, helps the kidneys excrete glucose, and lowers the blood glucose levels overall. Unfortunately, Invokana and other SGLT2 inhibitors are also linked to multiple serious side effects. The Texas woman who recently filed an Invokana lawsuit claims that the drug caused her to develop severe kidney damage and a life-threatening condition called diabetic ketoacidosis. She also claims that her health problems started almost immediately. According to the plaintiff, she started Invokana treatment in October of 2013, but stopped taking the drug only a month later.

A Canadian woman also recently filed an Invokana lawsuit. Rosalba Joudry is seeking $1 billion in damages on behalf of herself and others in her class-action lawsuit, claiming that she developed kidney failure after only eight months on the drug.

The FDA Recently Issued a New Warning About Invokana

Diabetic ketoacidosis is a condition that develops when excessive levels of a toxic acid, called ketones, build up in the bloodstream. If left untreated, this condition can lead to comas and even death. In addition to ketoacidosis, the FDA has also received multiple adverse event reports linking Invokana to kidney damage. In response, the FDA recently issued a communication, warning the public of the risk of ketoacidosis.

Common Symptoms of Ketoacidosis and Kidney Damage

Although Invokana and SGLT2 inhibitors are increasingly surrounded by controversy, they are still being marketed to the general public. If you or a loved one is currently taking Invokana, it may be wise to discuss these risks with your doctor. If you develop any of the following symptoms while taking an SGLT2 inhibitor, seek medical attention immediately.

  • Nausea and vomiting
  • Gastrointestinal symptoms
  • Loss of appetite
  • Excessive urination
  • Urinary tract infection
  • Dehydration
  • Excessively dry mouth
  • Severe headache
  • Dizziness
  • Muscle weakness
  • Fatigue

Invokana has been linked to several serious, and potentially life-threatening illnesses, including:

  • Heart attack
  • High blood pressure
  • Ketoacidosis
  • Kidney stones
  • Kidney disease
  • Kidney failure
  • Liver disease
  • Death

Continue reading

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Up until recently, people at risk of stroke and blood clotting only had one highly-effective treatment option, warfarin. This decades-old anticoagulant (blood thinner), also known by its brand name Coumadin, has been used by millions of patients since it was introduced to the market in 1954. Although effective, warfarin is relatively high-maintenance, requiring that patients undergo routine monitoring and testing. In 2012, a new group of oral anticoagulants entered the market. Known as thrombin inhibitors, drugs including Xarelto and Pradaxa are marketed as a lower-maintenance, more convenient alternative to warfarin. The drugs’ manufacturers claim that monitoring and testing are not necessary while taking thrombin inhibitors. Unfortunately, this convenience has come with a price. Contact a Boston Drug Injury Lawyer Today.

Patients taking Xarelto are at an increased risk of dangerous hemorrhaging. 

Warfarin has similar risks, but with one major difference – an antidote. If a patient on warfarin develops uncontrollable bleeding, the physician can administer a dose of vitamin K and fresh blood plasma to halt the bleeding. No such antidote exists for Xarelto. Therefore, uncontrollable bleeding in a Xarelto patient can lead to serious health complications, and even death.

Xarelto Lawsuits Consolidated into Multi-District Litigation in Louisiana

Due to the high volume of lawsuits against Xarelto manufacturer, Bayer, Xarelto cases have been consolidated into a multi-district litigation (MDL) lawsuit in the Eastern District of Louisiana. Many of the claimants allege that after using Xarelto they developed uncontrollable bleeding, resulting in emergency health situations and, in some cases, death. Now that the lawsuits have been consolidated into an MDL, a settlement negotiation process will begin. As the bellwether trial, the outcome of this MDL is likely to set the tone for future Xarelto litigation. In addition to the failure of Bayer to adequately warn physicians and consumers about the risks associated with its drug, the FDA claims that the manufacturer also made misleading claims about the associated risks. Last May, the manufacturer of Pradaxa, a similar thrombin inhibitor, agreed to settle about 4,000 lawsuits for a total of $650 million. This is good news for claimants in Xarelto lawsuits.

Common Xarelto Side Effects That May Indicate More Serious Complications

If you develop any of the following side effects or symptoms, contact your health care provider immediately:

  • Blood in urine or stool
  • Coughing or vomiting up blood
  • ‘Pins and needles’ feeling anywhere on the body
  • Bleeding gums
  • Severe back pain
  • Trouble swallowing
  • Difficulty breathing
  • Dizziness or faintness
  • Severe headache
  • Chronic nosebleeds
  • Numbness
  • Weakness in legs

Continue reading

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Women diagnosed with pelvic organ prolapse or stress urinary incontinence may have transvaginal mesh devices implanted during surgery to repair the damage. This plastic, net-like material made of polypropylene, also known as urogynecologic surgical mesh, has caused health issues in thousands of patients. These health problems typically occur because of faulty product design or improper surgical implantation technique. While the mesh can be implanted via abdominal surgery, vaginal implantation is the more common route for women suffering from pelvic floor disorders. Vaginal implantation is far less invasive than traditional surgery, with less time spent in the operating room. Contact a Boston Defective Medical Device Lawyer Today.

Pelvic Floor Disorders

Pelvic floor disorders generally occur after childbirth or hysterectomy, or in postmenopausal women. Prolapse is usually due to weakening of the pelvic muscles, which allows the uterus, bladder or rectum to enter the vagina. Surgeons use prepackaged transvaginal mesh kits to repair the prolapse. The problems experienced by women undergoing these procedures are directly linked to certain manufacturers. Currently, C.R. Bard, Ethicon, and Boston Scientific are facing the majority of injury lawsuits for mesh devices.

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