Articles Posted in Miscellaneous

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:

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

In an attempt to combat next-morning impairment caused by several brands of sleep aids, the Food and Drug Administration has slashed the recommended dosage of Lunesta in half to one milligram. This is just the latest in a move to combat numerous dangerous side effects caused by the potent medications including Lunesta and its competitor Ambien. The FDA lowered the dose further from its original recommendation of two milligrams and advised its manufacturer, Sunovion Pharmaceuticals to reflect this change on the label.

The smaller dose reduces the amount of the powerful drug left in the patients’ bloodstream in the morning. The FDA aims to eliminate the dangerous side effects that may impair a patient’s ability to drive or operate machinery while taking a prescription sleep aid. The New York Times as well as several other news outlets alleges the change came in part from the result of a British study on 91 subjects in 2012. The study concluded that patients who consumed three milligrams of Lunesta experienced “severe impairment of memory and motor skills the morning after taking the drug, compared with a placebo.” The study also found the earlier prescribed dose of two milligrams, which was thought to be safe, can still “hamper driving, memory and coordination for up to 11 hours after the drug was taken.” Researchers found that most of the patients did not know or realize that they were actually impaired, potentially creating an extremely dangerous situation.
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According to an analysis by the Wall Street Journal, over 100 patients have developed partial or permanent paralysis in recent years after receiving spinal-cord stimulator implants in their backs. A number of defective medical devices have been filed as a result.

A lot of the cases involved patients with spinal cords that were compressed or punctured by stimulator electrodes. These are usually inserted in the spine’s epidural space. The spinal stimulators that were involved came from different manufacturers, including Boston Scientific Corp. and Medtronic.

About 50,000 people in the US a year are implanted with a spinal cord simulator device to treat back pain and other issues. The simulator sends low electrical currents through wires up electrodes close to the spine. This is supposed to distract the brain from identifying pain signals.

A jury has awarded the family of Breanna Sadler a $7.25 million defective ear implant verdict. The 11-year-old girl, who was born deaf, suffered electrical shock multiple times four years after she was implanted with a Cochlear ear implant. Because the defective medical device had to be taken out of her skull and replaced with a competitor model, Sadler was forced to undergo a lengthy open-head surgery.

In their Cochlear ear implant lawsuit against manufacturer Advance Bionics, they claim that the company kept selling the faulty device even after they knew there was a problem with it while delaying disclosure of the defect to make a profit. They say that one electric shock incident was so painful for Sadler she screamed that her face felt like it was melting and on fire. The implant had to be disconnected and for several weeks Breanna was forced to stay completely deaf until the removal/replacement surgery could take place.

Meantime, Advance Bionics unsuccessfully argued that medical device federal regulation pre-empted the family’s lawsuit. They also tried to place some of the blame on a supplier that provided the part that they believe caused the electric shock. Advance Bionics claims that Sadler’s ear implant failed because moisture got in through a “feed-through,” which is the part that transmits electronic signals into the inner ear.

The recent fungal meningitis outbreak continues to spread, as more innocent patients have been diagnosed over the past week. Experts explain that those affected may suffer from a fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status. Patients are urged to seek medical attention if they experience “visual changes, pain, redness or discharge from the eye, chest pain or drainage from the surgical site.” Doctors are urged to contact patients who have been treated with medications distributed by the New England Compounding Center (“NECC”). The NECC agreed to cooperate with the ongoing investigation to find the specific cause for the outbreaks and the medications affected. Their Massachusetts pharmacy has suspended operations until further notice and recalled all of its products.

Since meningitis is a life-threatening illness, federal authorities are taking this investigation seriously and will continuously update their website with pertinent findings. According to the Centers for Disease Control and Prevention, there have been 15 deaths and 214 illnesses associated with the tainted drugs distributed by the NECC in Framingham, Massachusetts. When the drugs were discovered to be tainted, the Food and Drug Administration (“FDA”) issued a warning, claiming that only people with back injuries who received an injected steroid medication would be adversely affected. New studies indicate, however, that there are several drugs from the NECC that can cause other illnesses. These drugs include another injected steroid as well as medications for heart and eye surgery.
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A pounding headache, uncomfortable fever, and disgusting nausea are just a few of the symptoms that are affecting people across the United States today. They may also have a stiff neck, feel dizzy and have eye discomfort from bright lights. Almost half of the states have citizens who have these symptoms and it’s not because of the common flu. Actually, it is a meningitis outbreak, and the company that may be responsible for it all can be found in our very own state – Massachusetts.

Meningitis is “an inflammation of the membranes (meninges) surrounding your brain and spinal cord, usually due to the spread of an infection.” While some forms of meningitis can be spread to others, the outbreak that will affect thousands of people this week is not contagious and has been categorized as a fungal infection. Meningitis, for some people, can resolve itself in a couple of weeks but for others it has been known to be life-threatening. In fact, there have been eight deaths reported so far this week as a result of the outbreak.

The Centers for Disease Control and Prevention (CDCP) are conducting an ongoing investigation regarding this outbreak, predicting that as many as 13,000 patients might have received products from the New England Compounding Pharmacy, Inc. (also known as New England Compounding Center). The source of the outbreak is believed to be this pharmaceutical company, which is based in Framingham, Massachusetts. Due to the medical alarm among federal and state health officials, the New England Compounding Pharmacy, Inc. announced over the weekend a voluntary “recall of all products currently in circulation that were compounded at and distributed” at its facility. While meningitis is believed to be found in one of its products, the company decided to cease its operations over the weekend and recall all of its products as a precautionary safety measure.
This pharmaceutical company’s theoretical tainted product is an epidural steroid injection, a medication that is injected into the spine. This injection is believed to have fungal meningitis, a form of meningitis that causes gradual symptoms and appear mild at first. Patients from 23 states have received these injections.
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According to the Centers for Disease Control and prevention, a steroid called methylprednisolone acetate that was contaminated by a fungus may have been injected into about 13,000 people in 23 US states. The injectable steroid was made by the New England Compounding Center, which is based in Framingham, Massachusetts. To date, there have been at least 105 related cases of this rare form of meningitis confirmed in 9 states-Virginia, Florida, Tennessee, Indiana, Ohio, Maryland, North Carolina, Minnesota, and Michigan-with the death toll at at least 8. The tainted drug was also sent to California, Georgia, Connecticut, Idaho, New Hampshire, Illinois, Nevada, New Jersey, Rhode Island, New York, Pennsylvania, South Carolina, Texas, and West Virginia.

The steroid is usually applied via injection as a painkiller for the back. The contaminated drugs were made in May of this year or later and through last month they were sent to at least 75 medical facilities. If you believe you contracted fungal meningitis from a steroid injection or any other illness from what may have been a contaminated drug, contact our dangerous drug lawyers at Altman & Altman, LLP right away.

Previous complaints had been filed against the New England Compounding Center before this outbreak. Now, in the wake of this health crisis, the company has suspended its operations while an investigation takes place. Its initial recall of three lots of the steroid-impacting 17,676 vials-has been expanded to now include all products that were distributed and compounded at the Framingham facility.

Compounding Pharmacies Are Subject to Limited Oversight
Per a 2003 Government Accountability Office report, close to 10% of drugs that are administered in this country are processed by compound pharmacies. These facilities take medicines made by pharmaceutical companies and break them up into specific strengths and dosages.

Unfortunately, the US Food and Drug Administration has restricted authority over these pharmacies’ daily operations and it is mainly up to the state boards to monitor the licensing, practices, and the certification of pharmacists and pharmacies. Also, compounded products don’t require FDA approval in order to be sold in the US, and the federal agency has no oversight over how the products are labeled or made.

Fungal Meningitis
While fungal meningitis is not contagious, it can lead to serious neurological problems, small strokes, and other health complications. Symptoms may include chills, fever, stiff neck, and headaches. The sooner someone is treated, the better his/her prognosis for survival. An anti-fungal medication that is administered intravenously is given to initially combat this affliction, but some patients may require months of treatment.

Meningitis-linked steroid may have affected 13,000 people in U.S., CDC, Reuters, October 8, 2012

More patients linked to fungal meningitis infections, CDC says, CNN, October 6, 2012

More Blog Posts:
Use of Ocella Birth Control Pill May Cause Higher Stroke Risk, Drug Injury Lawyers Blog, October 3, 2012

Birth Control Depo-Provera Associated with An Increased Risk of Breast Cancer in Young Women, Drug Injury Lawyers Blog, September 25, 2012

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyers Blog, June 19, 2012 Continue reading