Articles Posted in Defective Drugs

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

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

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

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

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

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

Lipitor is a popular drug for reducing high cholesterol in men and women. In fact, Lipitor is so popular that in 2011, it was the top selling drug in the country with over $7 billion in sales that year. High cholesterol can lead to other serious health complications, such as heart disease, heart attack, and stroke. Unfortunately, in recent years Lipitor has been linked to type 2 diabetes and liver damage, and the risk is especially high in postmenopausal women. Contact a Boston Injury Lawyer Today.

Lipitor is part of a cholesterol-lowering class of drugs called statins, which block liver enzymes that assist in the body’s production of cholesterol. The FDA announced in 2012 that Lipitor’s warning label would be updated to include the potential risk of developing type 2 diabetes. However, the extent of the information provided was inadequate and downplayed the actual risk. According to an article in the New York Times, as many as 100,000 have developed diabetes after taking statins.

Symptoms of Type 2 Diabetes While Taking Lipitor

Type 2 diabetes is a serious medical condition that can lead to heart disease, blindness, nerve damage, kidney disease, and death. If you have developed any of the following symptoms while taking Lipitor, contact your health care provider immediately:

• Frequent urination
• Excessive thirst or hunger
• Sudden weight loss
• Blurred vision
• Fatigue
• Cuts and bruises that heal slowly
• Tingling or numbness in feet and hands

Lipitor’s manufacturer, Pfizer, continues to promote Lipitor as a safe drug. However, in postmenopausal women, the risk of developing type 2 diabetes is approximately 48% higher than in women who have never taken statins. Even worse, evidence suggests that Pfizer knew of the risks for years before any warnings were provided to the public. Multiple lawsuits have been filed against Pfizer. The most common claims include: Continue reading

For patients with atrial fibrillation, the release of a new type of anticoagulant drug known as a thrombin inhibitor was welcome news. Atrial fibrillation is a condition characterized by an irregular heartbeat that can result in poor blood flow to the body. For a long time, treatment options were limited. Warfarin (also known as Coumadin) has been the industry standard for a-fib treatment for decades. As a relatively ‘high maintenance’ drug, Warfarin requires constant blood monitoring to check for hemorrhaging and internal bleeding. Thrombin inhibitors promised to be less invasive, with fewer side effects and no need for blood monitoring. Eliquis is the third drug in this new class, following Pradaxa and Xarelto. Contact a Boston Drug Injury Lawyer.

Thrombin Inhibitors Lack Antidote for Excessive Bleeding

Thrombin inhibitors are relatively new to the market, but they have grown in popularity quite quickly. Unfortunately, quick growth often leaves extra room for error, and the billion-dollar thrombin inhibitor industry is no exception. Shortly after reaching over $1 billion in annual sales, problems started to surface. Pradaxa and Xarelto are linked to multiple injuries and deaths resulting from unstoppable hemorrhaging. All anticoagulants, including Warfarin, carry a risk of excessive bleeding. However, there is one major difference between the old and the new. Warfarin has something called a reversal agent, which is basically an antidote for excessive bleeding. By administering a dose of vitamin K and frozen plasma, a physician can stop the drug’s anticoagulation properties in their tracks. The same is not true for thrombin inhibitors. Continue reading

Nearly 3 million Americans have the hepatitis C virus, which can lead to liver failure and cancer if left untreated. Many of those affected have no choice but to take some form of medication to treat their liver damage. In the past, hepatitis C treatments have required injections and commonly caused flu-like symptoms in patients. However, a new group of pill-only hep C treatments has recently entered the market, causing fewer side effects and eliminating the needle altogether. Pharmaceutical company, AbbVie, makes two of the pill-only treatments, but the FDA has recently linked AbbVie’s drugs to several cases of severe liver damage, the need for transplantation, and even death. Contact a Boston drug injury lawyer today.

AbbVie’s Viekira Pak and Technivie Linked to 26 Drug Injuries

Apparently, the majority of the AbbVie injuries occurred in patients with advanced liver disease, cirrhosis, or severe and irreversible scarring of the liver. In all, the FDA has linked 26 injuries and fatalities to AbbVie’s drugs. According to the FDA’s research, the liver damage usually begins within four weeks of the treatment start date. The AbbVie drugs linked to liver damage are Viekira Pak, and Technivie. The majority of the cases involved Viekira Pak and involved patients with decompensated liver disease.

In response to the release of this information, AbbVie issued a statement that it is adding an updated warning label to the drugs in question. The company is advising patients with moderate to severe liver impairment that they should not use the drugs and that, “Patient safety is of the utmost concern to AbbVie.” A spokesperson for the pharmaceutical company said that the new labels will also warn of a contraindication for patients with Child-Pugh B cirrhosis, and will include a recommendation that medical professionals look for evidence of hepatic decompensation before prescribing Viekira Pak. Continue reading

Inferior vena cava filters, commonly called IVC filters, are used by vascular surgeons to prevent blood clots in the veins from entering the heart or lungs. Patients diagnosed with deep vein thrombosis or pulmonary embolus, trauma victims, and patients unable to take blood thinner medications are among the candidates for IVC filter implantation. This medical device, marketed as temporary and retrievable, is presumably placed in the vena cava vein until the threat of an embolism has passed. However, reports of life-threatening side effects and post-surgery complications have led to lawsuits of negligence against manufacturers C.R. Bard and Cook Medical.

IVC Filter Side Effects

In 2010, the Federal Drug Administration (FDA) released an official warning of potential risks involved with IVC device. Over 300 patients had reported that the filter moved from the intended implantation site, known as device migration. A total of 56 cases of filter fractures were documented by that point, as well as 70 cases of organ perforation. A total of 146 embolisms were reported. The FDA encouraged removal of the device at the earliest possible opportunity, upon recovery from clotting threat. In 2014, the agency updated this warning, stating a more concise removal time frame of between 29 and 54 days after implantation.

Unsuccessful IVC Filter Removal Attempts

The five most controversial types of IVC filters are:

• The Bard Recovery filter
• The Bard G2 filter
• The Bard G2 Express filter
• The Cook Celect filter
• The Cook Gunther Tulip filter

Marketed as temporary devices to be removed after recovery, these five medical products became the target of a 2013 study by the Journal of American Medical Association. In examining 680 IVC filter patients, research revealed only 58 filters were able to be safely removed. Continue reading