Disclaimer - By publishing this information on this Web site, the Boston, Massachusetts law firm of Altman & Altman LLP is not claiming to represent any clients or cases mentioned here. The content provided is designed to inform readers and is not intended as legal advice.

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

As with any anticoagulants (blood thinners) on the market today, Xarelto increases the risk of hemorrhaging, also known as excessive bleeding. However, patients on Xarelto have more than double the risk of stomach bleeding than those on another type of blood thinner. Furthermore, there is currently no antidote to reverse excessive bleeding in Xarelto patients. In response to the growing number of lawsuits against Xarelto manufacturer Janssen Pharmaceuticals, some of the thousands of lawsuits have been consolidated into multidistrict litigation (MDL). Contact a Boston Drug Injury Lawyer Today.

A popular blood thinner, particularly among adults undergoing knee and hip replacement surgeries, Xarelto can treat everything from risk of blood clots and hypertension to irregular heart rhythm and other heart conditions. Touted as a low-maintenance alternative to Coumadin, Xarelto is now at the core of thousands of lawsuits alleging serious harm or death. The husband of a patient who died after receiving a blood transfusion to treat Xarelto-related bleeding sued Janssen claiming the company failed to warn physicians and patients about the risks.

Drug companies have a duty to test pharmaceuticals and obtain FDA approval before marketing those drugs to the public. Once that approval is in place, drug companies are required to warn physicians and patients of any known risks or side effects. Failure to properly design or test a drug, or failure to warn the public about associated risks and side effects can result in serious problems for the drug manufacturer.

More than 6,000 Lawsuits Filed Against Xarelto Manufacturer

According to the report released by the United States Judicial Panel on Multidistrict Litigation, a total of 6,457 lawsuits are currently pending against Janssen Pharmaceuticals. Of those cases, 40 have been consolidated into one case in Louisiana federal court. These cases, scheduled to begin in early 2017, will be tried as bellwether cases, setting the tone for upcoming Xarelto lawsuits.

Common Side Effects Associated with Xarelto

Side effects can range from mild to severe. If you develop any of these symptoms or side effects while taking Xarelto, it’s in your best interest to contact your healthcare provider as soon as possible.

  • Bleeding gums
  • Bloody stool
  • Bowel problems
  • Bladder problems
  • Back pain
  • “Pins and needles” or tingling feelings
  • Excessive itching

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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

We are fortunate to live in a time when medical technology and pharmaceuticals can save us from injuries and illnesses that would have killed us a half century ago. Medical conditions such as heart disease and diabetes were death sentences in the not-so-distant past. Today, with prescription drugs, and certain diet and lifestyle changes, patients with these conditions can live long, healthy lives. Unfortunately, prescription drugs can also be harmful, even fatal.

Most medications have side effects, and some of these side effects can be especially dangerous. When pharmaceutical companies fail to warn about side effects, or neglect to perform proper testing on drugs before marketing them for certain uses, it can result in injury and death. Contact a Boston Drug Injury Lawyer Today.

Top 5 Dangerous Drugs

Most prescription drugs can be dangerous if used incorrectly. However, some drugs are associated with a significantly higher risk of injury and death. Below are the top 5 drugs currently involved in litigation for their link to deadly side effects.

  1. Invokamet: Designed to treat patients with type 2 diabetes, Invokamet is linked to multiple serious side effects. The drug is successful at managing insulin levels in patients by regulating the levels of glucose released by the liver. However, Invokament use can also cause urinary tract infections, nausea and vomiting, as well as an increased risk of bone fractures.
  1. Onglyza: Also prescribed for patients with type 2 diabetes, Onglyza is linked to even more serious side effects than Invokamet. In fact, the FDA has recently released a warning that medicines like Onglyza “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”
  1. Risperdal: In patients with bi-polar disorder, schizophrenia, and autism, Risperdal may reduce aggressive behaviors. Unfortunately, it is also linked to gynecomastia, a condition that results in breast enlargement in male patients. Lawsuits allege that Risperdal manufacturer, Johnson & Johnson, failed to warn patients and physicians about the risk of gynecomastia. Furthermore, the drug wasn’t even approved for use in adolescents, the group most affected by side effects. As a result, Johnson & Johnson recently paid $70M in penalties, fines, and victim compensation.
  1. Xarelto: Anticoagulants (blood thinners) have been used for decades to prevent blood clots and strokes in at-risk patients. For a long time, Coumadin was the main option for treatment. Although successful, Coumadin requires constant monitoring, a major inconvenience for patients. Recently, however, a new category of anticoagulants entered the market. Xarelto is included in this new category. This lower-maintenance alternative requires little to no monitoring but, unfortunately, is linked to life-threatening medical conditions. Although hemorrhaging is a risk with all anticoagulants, Coumadin has a reversal agent that stops excessive bleeding in its tracks. Unfortunately, the same is not true for Xarelto and similar drugs.
  1. Zofran: Designed to treat nausea in chemotherapy patients, Zofran’s manufacturer began marketing Zofran to pregnant women as a treatment for morning sickness. Unfortunately, the drug had never been tested on pregnant humans, and its use is now linked to severe birth defects.

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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

Testosterone is a naturally occurring hormone produced in the human body.  This hormone is mainly produced in the testicles of men and is responsible for sperm production, a man’s sex drive, and building muscle and bone mass.  Testosterone production tends to naturally decrease as men age.  As a result, men can experience various symptoms if testosterone levels decrease below a normal range.  Low testosterone, also called low T or hypogonadism, can often be mistaken as a natural part of aging.  Typical symptoms include low sex drive, difficulty achieving erection, low semen volume, hair loss, fatigue and lack of energy, loss of muscle mass, increase in body fat, decrease in bone mass, and mood changes.  Common treatment for symptomatic low T is testosterone replacement therapy.  This treatment helps many men with clinically proven low levels of testosterone to feel “normal” again, i.e. normal sex drive, able to maintain erection, etc.  However, drug manufacturers have participated in aggressive direct-to-consumer advertising urging men to seek treatment for low testosterone when they likely do not need it.  In these cases, the risks of the treatment typically far outweigh the benefits.

Although testosterone replacement therapy has been shown to reduce the symptoms of low T, there have also been many reported side effects that can be life threatening.  Recently, studies have shown data that suggests some patients taking testosterone supplements delivered as a gel, patch, injection, implant or pill may face an increased risk of cardiovascular problems.   A November 2013 study in the Journal of the American Medical Association (JAMA) suggested that men with certain preexisting heart issues may be up to 29 percent more likely to die, suffer a heart attack or stroke while taking some form of testosterone supplements.   This is not the first study that has shown evidence linking increased cardiovascular risks and testosterone treatments.  In 2009, a study funded by the National Institute of Health examined 200 older men with a high incidence of heart disease.  The men who were also receiving testosterone therapy were found to have a significant spike in the rate of heart attacks.  Researchers decided to cancel the study early due to these findings.  A January 2014 study by PLoS One, a medical journal, found that men over the age of 65 and younger men with pre-existing heart disease might actually face a two-fold increase of risk of heart attacks associated with testosterone treatments.  Collectively, these studies prompted the FDA to issue a drug safety communication in March 2015 revealing that new warning labels will be added to low testosterone drugs regarding the possible increased risk of cardiovascular complications.  The warnings would also reiterate that the drugs should only be used to treat clinically proven hypogonadism.  Continue reading

Risperdal is an antipsychotic drug manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The drug is used to treat bipolar disorder and schizophrenia, among other conditions. Risperdal is also used to treat aggression in some patients with autism. Although it is FDA approved, Risperdal is linked to some serious side effects. In fact, a jury recently awarded $70 million to a boy who experienced physically and emotionally harmful side effects from using the drug. Contact a Boston Drug Injury Lawyer Today.

What is Gynecomastia?

Risperdal use is associated with gynecomastia, a condition characterized by breast enlargement in male patients. A hormone called prolactin is responsible for milk production in women who are breastfeeding. Risperdal may stimulate the production of prolactin in males, resulting in some very undesirable side effects.

Risperdal Doubles the Risk of Breast Enlargement in Young Males

In 2012, a study of autistic boys was conducted to determine side effects of Risperdal in these patients. The results revealed that common side effects included diminished sexual functioning and gynecomastia. In fact, autistic boys between the ages of 10 and 20 had twice the risk of breast enlargement if they were on the drug, and a 14% greater chance of suffering from at least one form of sexual dysfunction.

Did Johnson & Johnson Destroy Evidence?

The $70 million lawsuit was awarded to a boy who developed breasts after using Risperdal. The jury found that material evidence was destroyed, falsified, and/or concealed during the investigation. Previous verdicts have ranged between $500,000 and $2.2 million. This latest verdict may signal a trend of higher verdicts.

Failure to Warn

According to several lawsuits, Janssen may have known about the risk of gynecomastia beginning in 2003. Despite this knowledge, the pharmaceutical company failed to warn physicians and patients. Had they done so, physicians could have chosen an alternative treatment for some of their patients. There are other antipsychotics on the market with similar benefits to Risperdal, but without the emotionally-scarring side effects. In addition, there is evidence that Janssen may have manipulated reporting data to downplay the risk of gynecomastia in young boys. 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

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