Articles Posted in Defective Drugs

A plant used as an herbal remedy in Asia for hundreds of years, kratom is rapidly becoming the subject of controversy and conflicting opinions in the United States. Some people swear by the natural supplement’s ability to treat pain, anxiety, and even addiction. Others are concerned about its potential for abuse and negative health effects — including death.

Even governmental bodies don’t quite know what to do with it. Kratom is illegal in some states, legally regulated in others, and unregulated in others. The Drug Enforcement Administration (DEA) temporarily banned the substance in 2016, but then reversed course a few months later. Although the Food and Drug Administration (FDA) does not regulate kratom, it has specifically warned Americans not to use it.

What Are the Uses of Kratom?

When Uloric hit the market in 2009, it was celebrated as the first new medication for gout in over 40 years. But ten years later, the news wasn’t so rosy. The U.S. Food and Drug Administration (FDA) issued a black box warning for Uloric in 2019, the most serious alert for drugs still on the market.

The FDA now recognizes that people taking Uloric (febuxostat) have an increased risk of death compared to those taking another gout medication. And since Uloric was the best-selling gout drug at the time of the warning, a potentially large number of patients may have already been harmed.

How Does Uloric Work?

Zostavax is an approved vaccination manufactured by Merck Co. Inc. utilized to prevent the contraction of the shingles virus, known as herpes zoster. However, the vaccine has been shown to cause possible serious side effects in those who take it, and has resulted in lawsuits and class action suits against the company for failure to warn of possible dangers associated with the vaccine. If you or a loved one has experienced harm following inoculation with the vaccine, contact Altman & Altman LLP today.

Shingles is caused by the same virus that causes chickenpox, varicella-zoster, although it is not known exactly why or how the virus – which goes dormant and resides in your body after healing from chickenpox – reoccurs as shingles in people over the age of 50. Regardless, shingles causes a painful rash in those afflicted, and can reoccur numerous times in those susceptible to it.

Symptoms associated with recognized side effects caused by the Zostavax vaccination include:

• Redness, pain, itching, swelling, hard lump, warmth, or bruising where the shot was given.
• Headache
• Allergic reactions, which may be serious and may include difficulty in breathing or swallowing.
• Contraction of chickenpox
• Fever
• Hives at the injection site
• Joint pain/muscle pain
• Nausea
• Rash on body, normally at the injection site
• Contraction of shingles
• Swollen glands near the injection site
• Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs, and

upper body)

• Partial facial paralysis

However, these symptoms that are recognized by Merck are not the only symptoms that have been reported by those who have taken the Zostavax vaccine. In fact, there have been much more severe side effects noted that have been reported to the U.S. Food and Drug Administration (FDA) and prompted recent legal action against the company, including:

• Blindness or damage to eyesight, including necrotizing retinitis
• Paralysis
• Brain damage
• Death – at least 36 on record
• Gastrointestinal disorders

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Zostavax, a shingles vaccine manufactured by Merck, is the only live virus vaccine of its kind currently on the market. According to the CDC, all adults age 60 and older should receive the vaccine to reduce the risk of developing this painful disease. Unfortunately, Zostavax has recently been linked to serious medical complications, including death.

What is Shingles?

Characterized by an extremely painful skin rash, shingles usually affects only one side of a person’s body. Anyone who has had chicken pox in the past is at risk of developing shingles, but those with weakened immune systems are most susceptible. This includes people who have cancer or HIV, are under significant stress, or are 50 and older. Most people first notice a tingly, burning, or itchy feeling before the rash appears. The rash, which can hang on for 30 days or more, often blisters before disappearing. The nerve pain associated with the disease can last for months.

Shingles can cause serious damage to the nervous system and may lead to dangerous conditions such as encephalitis, meningitis, and stroke. Some people have even died after developing secondary conditions such as Guillain-Barre syndrome and congestive heart failure. A Boston drug injury lawyer can help you determine how to proceed if you’ve been injured due to a dangerous or defective drug.

What’s Wrong with the Zostavax Vaccine?

Zostavax contains a live dose of varicella zoster, the virus that is responsible for causing both chicken pox and shingles. If you’ve ever had chicken pox, the varicella zoster virus remains dormant in your body. If your immune system becomes compromised due to a health problem, or simply getting older, the virus may “come back to life” and cause a painful case of shingles. According to Merck, the weakened form of varicella zoster in its vaccination is intended to stimulate the immune system, thus keeping the virus in its dormant state and preventing the formation of shingles.

Unfortunately, in addition to being only about 51 percent effective at preventing shingles, the vaccine may actually cause the disease it is supposed to be preventing. Victims of Zostavax side effects and complications have filed lawsuits alleging that, among other things, the vaccination’s warnings fail to adequately warn of these risks. A MA drug injury attorney can help you recover damages if you’ve been injured due to the negligence of a drug manufacturer.

What Injuries are Linked to Zostavax?

In addition to alleging that Merck failed to warn the public of side effects linked to Zostavax, lawsuits also claim that patients treated with Zostavax suffered shingles, autoimmune diseases, blindness, hearing loss, nerve problems, spinal inflammation, and heart complications. Even more disturbing, some reports have linked Zostavax to death. Of the more than 1,100 serious adverse events reports related to the live shingles vaccine, 90 were for deaths. Continue reading

In May 2017, Teva Pharmaceuticals initiated a recall of its schizophrenia drug, Paliperidone. According to a report released by the pharmaceutical company, the drug may not be dissolving properly, which could lead to less-than-sufficient levels of the medication being absorbed by the patient’s body. The potential hazards of such a defect are actually quite serious. If a patient with schizophrenia fails to maintain therapeutic levels of Paliperidone in their system, life-threatening complications can result.

According to a recent report in Medscape Medical News, Paliperidone’s dissolution problem may “reduce effectiveness in treating a patient’s mental and/or mood symptoms including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, and aggressive behavior, as well as vocal and motor tics.” A Boston drug injury lawyer can help you determine how to proceed if you’ve been injured by a dangerous or defective drug.

Dangerous drug defects are shockingly common. Prescription medications are regularly in the news and at the center of lawsuits for dangerous side effects ranging from compulsive gambling to death. Although manufacturers have a duty to perform adequate testing before releasing these drugs onto the market, multiple loopholes exist to allow for fast-track approval processes that may fail to detect life-threatening side effects. For example, if a prescription drug is similar to an existing drug, testing requirements may be waived through one of the FDA’s expedited approval programs. As such, defects often go undetected until multiple patients have reported complications. And in far too many cases it’s too late for these patients.

Dangerous Drugs

There are dozens of dangerous prescription drugs still on the market today. Drugs linked to the most serious side effects include:

• Abilify: An antipsychotic used to treat multiple mood disorders, Abilify is linked to compulsive eating, shopping, and gambling, hyper-sexuality, and other serious complications.
• Cipro: This frequently-prescribed antibiotic and other drugs in the fluoroquinolone class are linked to life-threatening side effects, including Stevens-Johnson Syndrome and peripheral neuropathy (a form of nerve damage)
• Xarelto, Pradaxa, and Eliquis: These blood thinners were hailed as a low-maintenance alternative to their only predecessor, warfarin. Unfortunately, excessive bleeding is a side effect of all blood thinners, and these drugs don’t have an antidote to stop that bleeding.
• Invokana: Proven to lower blood sugar levels in diabetic patients, Invokana is linked to several life-threatening side effects, including kidney failure, heart attack, and a condition called ketoacidosis (the buildup of toxic acids in the bloodstream).
• Risperdal: This drug is prescribed to young men and boys who suffer from bi-polar disorder and schizophrenia. Although effective at treating these disorders, Risperdal has a particularly-disturbing side effect; male patients have developed breasts while using the drug. In addition to being painful, this condition, called gynecomastia, can be emotionally traumatizing for young men.
• Zofran: An anti-nausea medication originally marketed to chemotherapy patients, Zofran quickly became popular as a way to prevent nausea and morning sickness in pregnant women. Unfortunately, the drug – which has been prescribed to countless pregnant women without FDA approval – is now linked to multiple birth defects.

A MA drug injury lawyer can help you recover damages if you’ve been injured by a defective or dangerous drug. Continue reading

Essure is a birth control device that was created as an alternative to the pill or tubal ligation, and for which no surgical incision or anesthesia is required. Following its FDA approval in 2002, Essure quickly grew in popularity as a low-impact, highly-effective form of birth control. Unfortunately, within about 10 years, thousands of complaints had been reported. Women claimed that serious side effects had forced them to have the device surgically extracted. Not surprisingly, a surge of lawsuits followed.

How Does Essure Work?

The Essure implant is composed of flexible coils that are inserted into the fallopian tubes using a non-surgical procedure. Once in place, the coils prompt tissue to grow around them, essentially “locking” the coils in place and blocking the fallopian tubes with the new tissue. As a result of this blockage, sperm is no longer able to move through the fallopian tubes, and thus cannot reach, nor fertilize, the eggs.

Once the three-month period has passed, women who have received an Essure implant are supposed to follow up with a radiologist to ensure that the tubes are fully blocked. In some cases, patients never reported for their three-month visit. A Boston defective medical products attorney can help you recover damages if you’ve been injured by an Essure implant.

Complications Linked to Essure Implants

According to the FDA, more than 5,000 women have reported problems with Essure implants since it was approved in 2002. The main issue with these implants seems to be that they were never tested for long-term use. Intended to be implanted for life, Essure was approved based only on a few short-term studies. Reported side-effects and medical complications include:

• Abdominal or pelvic pain
• Vaginal bleeding
• Rash or itching (may be caused by an allergy to metal nickel in the implant)
• Menstrual cycle changes
• Fatigue
• Joint pain
• Ectopic pregnancy
• Unintended pregnancy
• Device migration
• Perforations or punctures in the fallopian tubes, uterus, or abdomen
• Multiple surgeries, including hysterectomy
• Death

According to the FDA, the agency had required that Conceptus conduct a follow-up study within five years of approval, to ensure that long-term use was safe. This should have occurred in 2007, but the results were not published until 2015. And even then, only about 70 percent of women with Essure implants had been followed for the required five-year period. Sadly, these types of delays are quite common in the medical device and pharmaceutical industries. Companies get quick approval for their drugs and devices by telling the FDA that they will conduct post-approval studies, and then fail to do what they promised.

Due to the testing delay, multiple complications were not detected until it was too late for many patients; the stainless steel in Essure implants can rust, the nickel can produce a dangerous oxide, and the implant can leak toxic byproducts. Further, the device can migrate to other parts of the body, resulting in life-threatening punctures and perforations.

There are currently hundreds of product liability and medical malpractice lawsuits against Essure’s manufacturer, Conceptus. Lawsuits claim that Conceptus failed to warn physicians, patients and the FDA about the known risk of abdominal injuries, among other complications. Had they known about these risks, plaintiffs could have chosen a different method of birth control. A MA injury attorney can help you determine how to move forward if you’ve been injured by an Essure implant, or any type of medical device. 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