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Prescription drugs and other medical advances have resulted in a steady increase in life expectancy over the years. However, prescription drugs have also wreaked havoc, as the abuse of painkillers continues to grow and defective or incorrectly prescribed medications cause potentially life-threatening injuries in patients. Across the country, thousands of lawsuits have been filed against manufacturers of dangerous or defective drugs. Contact a Boston Drug Injury Lawyer Today.

Which Drugs Are Most Dangerous?

Recent statistics reveal that nearly 50% of Americans have used some type of prescription medication in the last month. Even more shocking, approximately 85% of adults age 65 and older are currently taking at least one, but an average of three, prescription drugs. Of course, medicine often saves lives. We are fortunate to live in a time when advanced medical care and medications are available when we need them, but we must be careful. In addition to always following prescription instructions, it is important to notify your healthcare provider if you develop any unexpected symptoms or side-effects while taking a medication. While any drug can be dangerous if taken incorrectly, the following drugs are considered to be some of the most dangerous on the market today:

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Lawsuits against manufacturers of the drug Invokana have been increasing rapidly as reports of serious injuries rise. Potentially life threatening conditions, such as kidney failure and high levels of blood acid are linked to the drug. Invokana, the first in a new class of drugs for diabetes treatment, quickly became a popular medication following FDA approval in 2013. In fact, it generates an estimated $1 billion in sales annually. Contact a Boston Drug Injury Lawyer Today.

Manufactured by Johnson & Johnson, Invokana belongs to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana is approved as a treatment for type 2 diabetes, along with several other SGLT2s, including Glyxambi, Xigduo XR, Farxiga, and Jardiance. This class of drugs works by altering the function of normal kidneys so that excess sugar is excreted in the patient’s urine. Unfortunately, hundreds of adverse event reports have been linked to the drug. These include medical problems ranging from urinary tract infections to a life-threatening condition known as ketoacidosis. Diabetic ketoacidosis occurs when a build-up of blood acid causes serious health problems that typically require emergency treatment. This condition can also lead to permanent injuries and death.

FDA Issues Updated Warnings for Invokana and Other SGLT2 Inhibitors

In response to these claims, the FDA issued a communication in May of 2015 warning consumers and physicians of the risk of ketoacidosis associated with taking SGLT2 inhibitors. The warning was updated in December, cautioning patients to immediately stop taking Invokana if any ketoacidosis symptoms appear. The FDA warning also cautions that urinary tract infections occurring while taking Invokana may be an early symptom of blood infection or kidney failure.

Common Side-effects and Conditions Linked to Invokana

A recent onslaught of lawsuits allege that Johnson & Johnson did not properly warn consumers and physicians of the serious side-effects associated with Invokana. Although this drug and several other SGLT2 inhibitors are still widely marketed and prescribed, the FDA continues to receive adverse event reports of life-threatening side effects. Common side-effects and conditions include:

 

  • Breathing difficulty
  • Nausea and vomiting
  • Abdominal pain
  • Urinary tract infections
  • Dehydration
  • Hypersensitivity
  • Unusual weight loss
  • Urofungal infections
  • Kidney stones
  • Kidney failure
  • Ketoacidosis

 

According to a May 6, 2015 report issued by the Institute for Safe Medication Practices (ISMP), there were 457 adverse event reports linked to Invokana during the drug’s first year on the market. This is likely only a small fraction of the actual health problems caused by Invokana. The majority of the adverse event reports were related to kidney problems, ranging from kidney stones to kidney failure. In fact, the incidence of adverse event reports was 92% higher for Invokana than for all other drugs regularly monitored by the ISMP. Furthermore, a new safety warning issued by the FDA cautions consumers and medical professionals of a potential risk of bone fractures in patients using Invokana. This new warning will soon be added to the drug’s label. Continue reading

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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

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In the wake of almost countless lawsuits against prescription drug manufacturers, physician groups are advocating a ban on direct-to-consumer advertising. This aggressive form of mass marketing encourages patients to request certain prescription drugs, medical devices, and treatments that they may not otherwise seek out. The American Medical Association (AMA) is concerned that this results in unnecessary prescribing and increases potential risks to patients. Earlier this week, the AMA voted to end aggressive marketing campaigns that do not serve to educate physicians or patients, but rather to encourage patients to ask their doctors about specific medications or products. Contact a Boston Drug Injury Lawyer Today.

In addition to protecting the health and safety of patients, banning direct-to-consumer advertising would likely also result in a significant decline in health care costs. In a press release following the vote, AMA Board Chair-elect, Dr. Patrice A. Harris, said, “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotion, and the role that marketing costs play in fueling escalating drug prices.Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” Approximately $4.5 billion is spent annually on direct-to-consumer advertising, according to the AMA. This is a 30% increase from the previous two years. Interestingly, only the United States and New Zealand allow these types of ads.

Drug Prices Have Spiked 4.7% in the Last Year

The AMA would like to see the creation of a physician task force and an accompanying advocacy campaign that encourages drug pricing transparency. In addition, they wish to see more drug options and an increase in competition among pharmaceutical companies. This year alone, drug prices have escalated by 4.7%. This increase negatively impacts the ability of patients to afford effective drugs, medical products, and treatments. Direct-to-consumer marketing also results in the widespread use of drugs that are sometimes not as effective as another option, and may be altogether unsafe. In fact, a 2014 BBC report revealed that most major pharmaceutical companies spend significantly more on marketing than they do on research. Continue reading

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Invokana is the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 inhibitors (SGLT2). Shortly after its release in March of 2013, patients began reporting adverse side effects, including nausea and vomiting. A Georgia woman named Paula Brazil recently filed a lawsuit against Invokana’s manufacturer, Johnson & Johnson, alleging that she developed ketoacidosis after taking the drug. Ketoacidosis is characterized by abnormally high levels of blood acid and can be extremely dangerous, often resulting in hospitalization. The lawsuit claims that Johnson & Johnson and its subsidiary Janssen neglected to adequately warn of Invokana’s potential for causing ketoacidosis. Contact a Boston Drug Injury Lawyer Today.

Failure to Warn

Brazil claims that after beginning treatment with Invokana, she immediately began to experience significant weight loss, nausea, and vomiting. Within two weeks, she was admitted to the hospital and was subsequently diagnosed with ketoacidosis. Invokana is specifically designed to treat type 2 diabetes, a condition that is not typically associated with ketoacidosis. In addition to vomiting and nausea, ketoacidosis also involves symptoms such as confusion, difficulty breathing, fatigue, and abdominal pain, and it typically requires emergency healthcare and/or hospitalization. Brazil’s lawsuit stated that, “Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death.” It went on to say that, ““As the developers, manufacturers and distributors of Invokana, Defendants knew or should have known that it was associated with serious complications, including diabetic ketoacidosis.”

FDA Received 457 Adverse Event Reports for Invokana

Brazil’s lawsuit is only the latest in a rising number of lawsuits filed against Invokana’s manufacturer’s in recent weeks. In addition to claims of developing ketoacidosis, several plaintiffs allege they developed kidney failure, kidney stones, urinary tract infections, and other forms of kidney impairment. Following the FDA’s safety warning issued in May 2015, lawsuits have begun to grow rapidly. The warning indicated that reports of high levels of blood acid among Invokana-users was being investigated. The Institute of Safe Medication Practices (ISMP) also released a report evaluating 457 adverse drug event reports, potentially linking Invokana and other SGLT2 drugs with kidney problems in patients. In fact, Invokana receives more adverse event reports than 92% of the drugs monitored by the same group. ISMP’s report addressed the questions of whether the benefits outweigh the risks, and if a recall of Invokana should be issued. Continue reading

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In most cases, patients are required by their insurance companies to take cheaper, generic versions of prescription drugs if and when they are available. But an I-Team investigative report by CBS discovered there is an unsafe drawback to these medicines that both doctors and pharmacists don’t want patients to know about. One local family is speaking out in the hopes that their story will create change for a legal loophole that’s putting numerous patients at risk.

According to CBS Boston, Foxboro resident Alisa Steele gave birth to her daughter, Rowan, last November. Rowan was delivered more than two months prematurely and diagnosed with a congenial heart defect; a condition that Alisa was devastated to learn was most likely caused by her use of a generic version of the prescription morning sickness pill, Zofran, called Ondansetron. The drugs are currently approved by the FDA to treat nausea in cancer patients receiving chemotherapy and radiation treatments, as well as post-operative nausea. Never have either Zofran or its generic form, Ondansetron, been tested on or approved for use in pregnant women yet they are both readily prescribed off-label to treat severe morning sickness.

Kimberly Dougherty, a Boston attorney, says she’s seen countless injuries caused by generic drugs. The problem is, according to the current law, only patients who were injured after taking the brand name drug are allowed to sue the manufacturer.

“The current law does not allow generic manufacturers to be held liable when their drug injures someone. That means that even though several recent studies have linked Zofran to an increased risk of birth defects, including heart problems and cleft palate, them manufacturer of the identical drug cannot be touched in court,” Dougherty said. In light of the numerous reports linking generic drugs to injury, the FDA proposed a rule change that would also give patients more legal rights when they take generic drugs, though the drug industry continues to fight it. A decision is expected early next year.

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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

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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

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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

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Ciprofloxacin is an antibiotic used to treat common types of bacterial infections, including urinary tract and ear infections. Approved by the U.S. Food and Drug Administration (FDA) in 1987, Ciprofloxacin (Cipro) is in a class of synthetic antibacterial drugs called fluoroquinolones, and has become one of the most commonly prescribed antibiotic treatments. However, in 2008 the FDA required Cipro’s warning labels to alert patients of potential side effects, including tendon ruptures. Five years later, in 2013, the FDA required the use of labels warning patients about a central nervous system condition called peripheral neuropathy. Subsequent pharmaceutical liability lawsuits have claimed the manufacturers of Cipro and other fluoroquinolones had previously known about the associated health risks, yet failed to warn both patients and healthcare professionals.

What is Peripheral Neuropathy?

Peripheral neuropathy is a general term for numerous kinds of nerve damage occurring between the brain, spinal cord, and body’s tissues (muscles, tendons, ligaments, ligaments and connective tissue). The two categories of peripheral neuropathy are motor nerve damage and sensory nerve damage:

  • Motor nerve damage affects coordination and use of the hands and arms, resulting in muscle spasms, difficulty walking, significantly decreased strength, and muscle cramping.
  • Sensory nerve damage affects the sense preceptors of the nerves serving the skin, causing numbness, paresthesia (tingling sensations), sharp pain, and extreme sensitivity to touch.

Cipro’s Effects on Collagen

Collagen is a protein found in connective tissues, vital for providing strength and structure to the human body. Collagen is necessary for healthy relationships between bones, cartilage, tendons, muscles, and skin. Studies have shown that Cipro and other fluoroquinolones erode existing collagen and prevent collagen synthesis. The tendon ruptures cited in the FDA’s 2008 mandatory warnings are thought to be caused by this collagen breakdown. Paired with the potential for peripheral neuropathy, collagen degeneration provides excessive risks to patients prescribed Cipro. Continue reading

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