Articles Posted in Defective Drugs

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

Since being approved in October of 2010, the prescription blood thinning drug, Pradaxa, has established itself as an upgrade to warfarin because it performed the same functions while also preventing strokes. Other competitors to warfarin, such as Xarelto, have also come onto the market.  While these drugs netted gigantic profits for their manufacturers and were used by millions of patients, it has been revealed over time that these drugs can pose a serious, and deadly, risk to certain types of people. In May of 2014 alone, Boehringer Ingelheim, the German manufacturer of Pradaxa, settled more than 4,000 lawsuits for a combined amount of $650 million.

Just two years after its introduction, Pradaxa was blamed for over 500 deaths stemming from uncontrollable bleeding and internal hemorrhaging. The aforementioned settlement came under the condition that Boehringer Ingelheim would have to admit to no fault regarding the deaths, stating that the benefits of the drug far outweighed the negative side effects.  While the benefits of the drug are certainly evident, should thousands of lawsuits and hundreds of deaths prompt, at the very least, more research, development, and awareness campaigns to ensure that the wrong people don’t take the drug and wind up in dire straits? Pradaxa costs about $3,000 a year and made $209 million in sales just in the first quarter of 2012, so it is not an issue of not having enough money.

What is Pradaxa?

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

Talc, also known as talcum powder, is a naturally occurring mineral made up of magnesium, silicon, and oxygen that is highly stable, chemically inert and odorless.  Talcum powder is generally accepted as safe for cosmetic and personal use, as it is known to absorb moisture and prevent friction, thereby functioning to keep skin dry and prevent rashes.  Most people are aware of its presence in baby powder and adult body/facial powders.  When found naturally, talc can contain asbestos, a known carcinogen when inhaled.  However, all consumer talcum products have been required to be asbestos-free since the 1970s.  Still, there are concerns that there may be a link between talcum powder and cancer.  These concerns have focused on two main risk groups.  People who have long-term exposure to natural talc fibers at work, talc miners for example, may be at a higher risk for lung cancer as a result of inhaling talc fibers while on the job.  The other risk group is women who regularly apply talcum powder to the genital area, as they may have an increased risk of ovarian cancer.

Although companies that manufacture talcum powder products, most notably Johnson & Johnson’s Baby Powder, repeatedly claim their products are safe and non-cancer causing, some studies have surfaced that have highlighted the link between genital talcum powder use and ovarian cancer.  The first study linking the two was in 1971 published by several Welsh doctors in which talc particles were found in tumors of the cervix and ovaries.  After this initial study, numerous other studies were completed and published, many supporting the link between genital talc use and ovarian cancer.  Recently, a report released by Cancer Epidemiology Biomarkers & Prevention claimed a 44 percent increased risk for invasive epithelial ovarian cancer among African American women who applied talc to their genitals regularly.  Johnson & Johnson still holds that its baby powder is safe, although several claims against the company have resulted in multimillion-dollar awards by the company.

Of the dozens of studies involving talcum powder and cancer, many supporting the link between talcum powder and cancer, and many providing no evidence between the substance and cancer at all.  The studies that allege a relationship between talcum powder and ovarian cancer argue that by dusting female genitals or feminine products with talcum powder, talc particles can enter the vagina, travel in the uterus, and finally to the ovaries.  The products were targeted towards women, with manufacturers noting the appeal of a powder that could keep women comfortable and free of vaginal odors.  Johnson & Johnson, although has been the recipient of several claims regarding ovarian cancer and their body powder products, has claimed that the research linking talcum powder and cancer is inconclusive and has failed to place any sort of warning label on its products.  Since 2013, the drug manufacturer has spent over $5 billion to resolve various legal claims regarding Johnson & Johnson drugs and medical devices.  Julie Hennessy, a marketing professor at Northwestern’s Kellogg School of Management, commented on the lawsuits saying, “Whether or not the science indicates that Baby Powder is a cause of ovarian cancer, Johnson & Johnson has a very significant breach of trust.”  Aside from the cancer risk, these products are made for babies.  If there is a potentially cancerous element to Johnson & Johnson’s Baby Powder, parents should be made aware, shouldn’t they?  The only label that the product does have warns against inhalation, saying it is for external use only.  Although some lawsuits against Johnson & Johnson have been successful and resulted in damages paid to the claimants, it may be some time before enough studies conclusively prove that there is a link between the talcum powder products and ovarian cancer. Continue reading

Proton pump inhibitors (PPIs) are often prescribed as treatment for acid-related conditions because of their ability to block the enzyme in the wall of the stomach that makes acid, thereby decreasing the production of acid in the body.  Examples of some protein pump inhibitors that are often prescribed are omeprazole (Prilosec and Losec), lansoprazole (Prevacid), pantoprazole (Protonix), esomeprazole (Nexium), and a rapid release form of omeprazole (Zegarid).  These medications are used for the prevention and treatment of conditions such as duodenal stomach ulcers, NSAID-associated ulcer, ulcers, heartburn, acid reflux, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome.  In 2013, over 15 million Americans were using these proton pump inhibitors.

There are some common side effects associated with various types of protein pump inhibitors.  Most often, these include headache, diarrhea, constipation, abdominal pain, flatulence, nausea, and rash.  Still, these medications are typically considered to be well tolerated by patients.  Additionally, the risk of Clostridium difficile infection may increase while taking PPIs, and long-term use may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine.  More serious adverse side effects have recently been discovered.  There may be a connection between proton pump inhibitors and long-term kidney damage, a new study published in January shows.  JAMA Internal Medicine published findings that individuals who take proton pump inhibitors have a 20 percent to 50 percent increased risk of chronic kidney disease when compared with individuals who don’t take the drugs.  Although the study does not solidify a causal relationship between PPIs and kidney disease, Dr. Morgan Grams, an assistant professor of epidemiology at Johns Hopkins University and lead author of the study, said, “We found there was an increasing risk associated with an increasing dose. That suggests that perhaps this observed effect is real.”  Continue reading

 

Inferior vena cava (IVC) filters are blood-filtering devices that are often implanted in people recovering from accidents and surgeries by preventing blood clots from traveling to the lungs.  These devices can be temporary or permanent and are inserted into the largest vein in the body where they trap clots.  By 2012, about 259,000 IVC filters had been inserted into patients.  Doctors typically recommend IVC filters to patients who have recently suffered serious injury or undergone surgery, because they are at an increased risk of blood clots, but cannot take blood thinners.  Those who have just had surgery or a serious injury often cannot take blood thinners because they are at a risk of uncontrollable bleeding, so doctors recommend IVC as an alternative.  Common cases in which doctors might recommend the use of an IVC filter include car accidents, voluntary or emergency surgeries, gunshot or stabbing injuries, dialysis treatment, spinal cord injury, cancer diagnosis or treatment, and serious falls.

The inferior vena cava is the largest vein in the body.  The vein moves deoxygenated blood from the lower legs to the heart and then to the lungs.  IVC filters are specifically used to prevent blood clots from traveling to the lungs, which could result in a pulmonary embolism, a blockage in the lung.  The two types of IVC filters are permanent and optional, or retrievable.  Retrievable IVC filters are often associated with complications including blood vessel and organ perforation, as well as filter migration.  Because of these known potential risks, the U.S. Food and Drug Administration announced a safety alert regarding retrievable IVC filters in 2010.  This report was prompted by 921 reports of adverse events that occurred from 2005 to 2010 as a result of retrievable IVC filters.  Some of these events included device migration, filter perforation, filter fracture, and detached device components.  The most common adverse incident was device migration, accounting for 35 percent of total adverse incidents.  Another problem with retrievable filters is that they are not often removed when they should be.  Follow up studies on retrievable IVC filters performed by the Journal of the American Medical Association (JAMA) found that only 58 of 679 filters that were inserted were actually removed.  Five specific brands of filter prone to failure were Bard’s Recovery, Bard’s G2, Bard’s G2 Express, Cook’s Gunther Tulip, and Cook’s Celect.  Continue reading

Having a baby is supposed to be a joyous time for new parents. Unfortunately, when a baby has birth defects, that joy is often replaced with sadness, fear, and anger. In some situations, birth defects are hereditary, but birth defects related to prescription drugs and physician error are increasingly common. Although compensation alone cannot heal your child, it may help you obtain the necessary care and treatment your child needs to have a healthy, normal life.

When we are ill, we usually go to the doctor. This is just as true for pregnant women. If a doctor prescribes a medication to help us feel better, we put our trust in this advice. After all, why would a physician prescribe medications that hurt us? Unfortunately, just as we rely on doctors for sound medical advice, they rely on pharmaceutical companies to provide safe medications. When drug companies fail to properly test new drugs, or fail to warn about risks associated with those drugs, they should be held accountable.

GSK Only Tested Zofran in Pregnant Animals

The drug Zofran is used to treat nausea in patients undergoing chemotherapy. Pregnancy-related nausea has plagued expectant mothers since the beginning of time. With Zofran, pharmaceutical giant GlaxoSmithKline claimed to have a solution to this problem. In addition to treating chemotherapy-related nausea, Zofran can also decrease the effects of morning sickness.

Zofran is a Category B Drug

Unfortunately, new lawsuits claim that GlaxoSmithKline never got proper FDA approval for the drug’s use in pregnant patients. It was classified as a Category B pregnancy drug, meaning it was only ever tested on pregnant animals. For this reason, use in pregnant patients is considered “off-label” use. Although doctors are allowed to prescribe medications for off-label use, pharmaceutical companies are not allowed to market them for these purposes. It seems as though GSK did not follow these guidelines.

New lawsuits allege that GSK was “using expectant mothers and their unborn children as human guinea pigs” to test Zofran. Unfortunately, Zofran use in pregnant women has been linked to several life-threatening and life-altering conditions, including orofacial and septal defects, congenital heart problems, kidney malformation, and even death. Following an investigation by the Department of Justice, GSK has pled guilty and agreed to pay $3 billion in fines and compensation. Continue reading

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

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