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Articles Posted in Defective Drugs

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

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

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