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

On the surface, a power morcellator is an intriguing and seemingly fantastic showcase of modern medical technology. The drill-like device is able to perform laparoscopic surgeries, such as hysterectomies and myomectomies, without being overly invasive, requiring a less than two centimeter incision, and reduces the patient’s recovery time and post-operative pain drastically.

A morcellator works by cutting large chunks of tissue, such as a uterus, into smaller chunks and then using suction to vacuum the flesh out of the body via its long tubular attachment. A majority of the devices were manufactured and distributed under the Johnson & Johnson umbrella through their subsidiary company, Ethicon.

Power morcellators may cause cancer

The popular heartburn medication Nexium, released by pharmaceutical giant AstraZeneca in 2001, has been used by millions around the globe to treat their chronic heartburn with relatively few side effects. Minor side effects include dry mouth, headaches and minor abdominal pain, which are certainly manageable.

However, more severe side effects have come to light in thousands of patients, side effects undisclosed by AstraZeneca and not mentioned on Nexium’s list of side effect, and hundreds of these patients have filed lawsuits seeking financial compensation for their pain and suffering as a result.

Serious side effects include…

Lipitor has the distinction of being the best-selling prescription medication of all time. Manufactured by pharmaceutical titan company, Pfizer, Lipitor is prescribed to help treat high cholesterol and reduce the risk of heart attacks and strokes. There is no doubt that Lipitor has helped millions of people since it was approved by the FDA in 1996.

However, recent studies have linked Lipitor to an increased risk of developing another serious disease: type 2 diabetes. In 2012, the FDA released a warning that cholesterol-reducing statin drugs, such as Lipitor, could elevate blood sugar levels in those who take it and lead to diabetes. Pfizer was ordered to add this warning on the Lipitor label.

This warning did not help people who had already developed diabetes while taking Lipitor, and it has led to lawsuits regarding inadequate warnings and a decreased quality of life as a result of this failure to warn consumers about all the potential risks.

About Lipitor

Lipitor is a prescription medication known as a “statin” drug, which means it works with the body to help stop the liver from producing too much “bad” cholesterol, which can lead to heart disease and blood clots (which can lead to strokes).

Lipitor was first approved by the FDA in 1996, and by 2012 had made over $130 billion in sales. Doctors continue to prescribe Lipitor and other statin medications today because of their proven track record of helping reduce the risk of heart disease and strokes.

However, there are other risks associated with statin medication, including muscle damage, memory loss and the aforementioned risk of developing diabetes. Doctors are less inclined to direct a patient to stop taking statin medication because of the former two symptoms (since heart disease and strokes are much more serious afflictions), but developing diabetes is obviously problematic also, so good awareness and consistent checkups and blood sugar testing should be standard when taking these medications.

If you developed diabetes while on Lipitor

You may have a good case for financial recompense if you developed type 2 diabetes while taking Lipitor prior to 2012. Whether or not it was known to Pfizer prior to the FDA demanding they place a warning on their bottles of Lipitor, it is still unacceptable that it took so long to find this link between Lipitor and another very serious disease.

Diabetes has life-altering effects on those who are diagnosed, including costly medical appointments, possible dialysis and surgeries, not to mention a complete change in lifestyle in order to constantly monitor their blood sugar levels. Further risks of diabetes include blindness, neuropathy and deadly kidney disease.

Hundreds of lawsuits regarding Lipitor and diabetes have been filed across the country, and the legal professionals at Altman & Altman LLP have the expertise to figure out the appropriate course of action if you or a loved one was diagnosed with diabetes as a result of taking Lipitor or other statin medications.

There are grounds for lawsuits based on negligence, failing to monitor the safety of a prescription medication, misleading consumers of the risks of a medication, inadequately labeling a prescription medication and ignoring potential risks of a prescription medication. Continue reading

The popular heartburn medication Nexium, released by pharmaceutical giant AstraZeneca in 2001, has been used by millions around the globe to treat their chronic heartburn with relatively few side effects. Minor side effects include dry mouth, headaches and minor abdominal pain, which are certainly manageable.

However, more severe side effects have come to light in thousands of patients, side effects undisclosed by AstraZeneca and not mentioned on Nexium’s list of side effect, and hundreds of these patients have filed lawsuits seeking financial compensation for their pain and suffering as a result.

Serious side effects include…

It has been revealed that Nexium can lead to severe kidney complications and even accelerated dementia in its patients. Lawsuits stemming from kidney damage have been filed against AstraZeneca as far back as 2004, and yet they have continued to release the product without mentioning the potential risk of kidney damage. On Nexium’s own website, there is no mention of these well-established risks.

Three studies from 2015 and 2016 showed evidence that patients who were currently taking Nexium were twice as likely to sustain an acute kidney injury, that patients had a 20 to 50 percent higher chance of developing chronic kidney disease, and that patients taking Nexium had a 44 percent higher risk of developing dementia.

Clearly, the risks are not insignificant. These side effects are not only dangerous to a person’s overall health and wellbeing, they can be incredibly costly as well.

Kidney disease sufferers may need to undergo dialysis, transplants or grafts, and will likely maintain consistent hospital visits throughout the rest of their lives to keep an eye on their condition. Kidney failure accounts for about $42.5 billion annually in private and Medicare costs according to the National Institute of Diabetes and Digestive and Kidney Diseases.

Sufferers of dementia can lose their independence, their job, and more, as they may need to be moved into an expensive assisted living facility. Dementia can be extremely painful for both the individual and their families to go through, not to mention the fact that the average assisted living care facility can cost upwards of $70,000 or more per year.

History of legal action

Hundreds of patients who have been negatively affected by Nexium have sought financial recompense as a result of their pain and suffering, both individually and as a group through class action lawsuits. AstraZeneca has been sued over the past decade for negligence, fraud, negligent misrepresentation, and product defects.

Three of these class actions suits were settled in 2015. One ended with a $24 million settlement, another ended with a $20 million settlement, and the last one settled for $7.9 million. More lawsuits are cropping up in recent years with yet another allegation – that Nexium causes bone density loss leading to an increased risk of bone fractures. Continue reading

The FDA has warned that fluoroquinolone antibiotics, including Levaquin and Cipro, are linked to serious, potentially permanent medical conditions. According to reports, manufacturers of these drugs knew about the risks but failed to properly warn physicians and patients. As a result, many lawsuits have been filed. If you are experiencing painful or debilitating side effects after taking a fluoroquinolone, contact your healthcare provider immediately.

What is a Fluoroquinolone Antibiotic?

Fluoroquinolones belong to a family of synthetic antibiotics, which kill bacteria by interfering with the replication of DNA. The types of fluoroquinolones on the market are:

• Ciprofloxacin (Cipro)
• Moxifloxacin (Avelox)
• Levofloxacin (Levaquin/Quixin)
• Ofloxacin (Ocuflox/Floxin/Floxacin)
• Norfloxacin (Noroxin)
• Gatifloxacin (Tequin)

Hospitals routinely use fluoroquinolones for treating opportunistic infections in patients. However, frequent or routine use of this type of antibiotic can have harmful side effects, including tendon damage and nerve damage. According to the FDA, fluoroquinolones should only be used when no other options are available. In addition, physicians should notify patients of the associated risks prior to administering the medication. Considering that most fluoroquinolones are distributed by a pharmacy and that pharmacies are required to provide notification of side effects, the manufacturers are usually held liable when harmful side effects develop. If you are suffering from side effects after taking a fluoroquinolone antibiotic, contact a Boston drug injury lawyer today.

Side Effects Linked to Fluoroquinolones

The fluoroquinolone family is linked to multiple side effects, but the most commonly-cited serious side effects include:

• Nervous system problems, including a condition called peripheral neuropathy, pain, tingling, numbness, weakness, headaches, loss of memory, loss of concentration, and anxiety.

• Musculoskeletal problems, including tendonitis, tendon ruptures, tendon weakness, and swelling of the joints.

• Sensory symptoms, including problems with hearing, sight, and smell.

• Cardiovascular problems, including chest pain, palpitations, and shortness of breath.

• Skin problems, including rashes, intolerance to heat or cold, and excessive sweating.

• Gastrointestinal problems, including nausea and vomiting, diarrhea, and severe abdominal pain.

Continue reading