FAQs About Dangerous Drug Mass Torts
Here, we have answered some of the most commonly asked questions that we receive about dangerous drug mass tort cases. Start learning the answers to your questions by browsing our frequently asked question section.
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Why didn't the FDA prevent my asbestos-related cancer from Johnson & Johnson baby powder?
We trust the United States Food and Drug Administration (FDA) to protect us from potentially harmful substances that we put in our bodies. As the name of the agency suggests, the FDA regulates food, over-the-counter medications, and prescription drugs that are available to consumers in the United States. Specific safety standards must be satisfied before food or medicine can be sold.
But Talcum Powder Is Not a Drug
Instead, talcum powders, such as Johnson & Johnson’s talcum-based baby powder, are classified as cosmetics.
The FDA’s authority to regulate cosmetics is limited to the authority that the United States Congress explicitly gives the FDA. Currently, federal law does not require cosmetics or cosmetic ingredients (except for color additives) to have FDA approval before being sold in the United States.
However, specific federal laws such as the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act do apply to cosmetic products used in interstate commerce. For example, the FDA could take action against a cosmetic manufacturer if:
- There is a contaminant that may make the cosmetic harmful
- The cosmetic is improperly labeled or handled
Therefore, while the FDA does not have to approve cosmetics that go on the market, it does have the authority to request a voluntary recall to get some dangerous cosmetics off the market.
What Happened With Johnson & Johnson’s Talcum-Based Baby Powder?
According to a Reuters investigation, the FDA has relied on the cosmetic industry to self-report on the safety of talcum-based baby powder for the last half-century. The agency claims that it does not have the authority to require manufacturers to conduct any asbestos tests or to report the results of any tests to the government.
Instead of conducting its own tests, the FDA relied on the word of the manufacturers until recently. Recently the FDA did pay for its own tests of 11 different cosmetics that contain talcum powder. The tests included Johnson & Johnson’s baby powder and resulted in the recall of 33,000 bottles of Johnson & Johnson baby powder.
As of January 2020, however, the FDA has refused to issue warnings about potential asbestos contamination in Johnson & Johnson talcum powder or other cosmetics containing talc. The FDA has said, however, that no amount of asbestos is known to be safe and that it will encourage cosmetic product recalls even when only small amounts of asbestos are found in a product.
The Reuters investigation indicates that the FDA had plans to require specific testing for talc powders and cosmetics, but abandoned those plans in the 1970s. If the agency had reached a different decision, then the public may have known about the potential asbestos contamination and the possible health risks earlier and lives may have been saved.
Do You Have Cancer From Asbestos Found in Johnson & Johnson’s Baby Powder?
The FDA did not protect you. Johnson & Johnson did not protect you. Now, you are suffering from ovarian cancer or mesothelioma.
While no one can undo the harm that you’ve already suffered, your doctors may help treat your cancer, and our experienced lawyers will fight hard to help you with your legal and financial recoveries.
It may be challenging to prove that Johnson & Johnson's baby powder caused your cancer. However, other people with ovarian cancer and mesothelioma have successfully sued Johnson & Johnson and recovered millions of dollars for their injuries. Their recoveries often include compensation for past and future medical bills, lost income, out-of-pocket expenses, physical pain, emotional suffering, and punitive damages that are designed to punish Johnson & Johnson for what happened.
Our New England baby powder injury lawyers are here to make sure that your rights are protected. We will gather all of the necessary evidence and fight hard to help you make a fair recovery. Call us today or fill out our online contact form to have us contact you.
What is Fournier’s gangrene?
Gangrene is a medical condition that occurs when your body’s tissue dies. Fournier’s gangrene is a rare type of gangrene that begins in your genitals and the area around them, but that can spread to other parts of the body. Men, women, and children can develop Fournier’s gangrene, but it is most common among men.
Immediate medical treatment is required to treat Fournier’s gangrene. Without it, the condition can be fatal. Therefore, there are some essential facts that you should know about Fournier’s gangrene—especially if you take an SGLT2 inhibitor such as Invokana to control your diabetes.
Fournier’s Gangrene Symptoms and Diagnosis
Fournier’s gangrene begins as an infection of the scrotum, penis, or perineum, which can spread to other areas like the thighs, stomach, chest, and bloodstream.
Symptoms of Fournier’s gangrene which require immediate medical attention include:
- An unpleasant or rotten smell
- Skin that turns a reddish-purple or a blue-gray color
- Popping or crackling of the skin when it is touched
- Rapid heartbeat
If your doctor suspects Fournier’s gangrene after a physical exam, then your doctor will likely take a tissue sample that will be sent to a lab for testing. Additionally, blood tests and medical imaging tests, such as an MRI, CT scan, ultrasound, or x-ray, may be used to confirm the diagnosis.
Fournier’s Gangrene Treatment and Prognosis
Treatment for Fournier’s gangrene includes:
- Antibiotics. Antibiotics are a necessary part of treatment for Fournier’s gangrene, but antibiotics are not enough to resolve the condition on their own.
- Surgeries. Surgery, and often multiple surgeries, are required to remove the dead tissue. Reconstructive surgeries and skin grafts may also be necessary.
Even with treatment, however, the condition may be fatal. Many people who survive the infection will live with chronic pain and sexual difficulties.
Warnings Issued About Some Diabetes Medications
Most people live their entire lives without ever getting Fournier’s gangrene. When the condition does occur, it can happen because of a bladder infection, urinary tract infection, or hysterectomy.
In December 2018, the U.S. Food and Drug Administration (FDA) warned the public that Fournier’s gangrene occurs more frequently among people taking SGLT2 inhibitors than other diabetes medications. Specifically, the FDA received:
- Twelve reports of Fournier’s gangrene among patients taking SGLT2 inhibitors over a five-year period, from March 2013-March 2018. Seven of the 12 reported cases were men and five were women. All 12 patients developed Fournier’s gangrene within months of starting an SGLT2 inhibitor. Additionally, all 12 patients were hospitalized and required one or more surgeries. One patient died.
- Six other cases of Fournier’s gangrene among people taking medication to treat diabetes over a thirty-year period. All six patients were men.
Accordingly, the FDA required that a new warning be added to the prescribing information and patient medication guide of all SGLT2 inhibitors, including Invokana.
A study published in the June 4, 2019, Annals of Internal Medicine, also found an increased risk of Fournier’s gangrene among people with diabetes who were taking SGLT2 medications. Researchers identified 55 cases of people who developed Fournier’s gangrene while taking SGLT2 inhibitors from March 1, 2013 through January 31, 2019. In comparison, only 19 cases of Fournier’s gangrene were reported among people who took other drugs to control diabetes from 1984 through January 31, 2019.
Fournier’s Gangrene Lawsuits
If you have been diagnosed with Fournier’s gangrene or if your loved one has died from this disease while taking Invokana or another diabetes medication in the SGLT2 family, then you may be entitled to a legal recovery.
You may be able to recover for all of your medical expenses, lost income, physical pain, emotional suffering, and other costs. However, you will have to fight for your fair recovery, and your time to pursue a drug injury lawsuit is limited by law.
We don’t want you to leave any compensation on the table. You’ve already suffered enough. Let our experienced attorneys provide you with a free and honest review of your claim. Schedule your free consultation by starting a live chat with us now or calling us at any time.
Who takes Invokana?
Invokana® is an oral medication used to treat adults with type 2 diabetes. A doctor may prescribe Invokana for one of three reasons:
- To regulate blood sugar
- To reduce the likelihood of heart attack, stroke, or cardiovascular-related death in adults with type 2 diabetes who have cardiovascular disease
- To reduce the risk of end-stage kidney disease and decreased kidney function in adults with type 2 diabetes and diabetic kidney disease, or nephropathy, who have a certain level of protein their urine
Before taking Invokana, you should thoroughly review the benefits and potential risks of the medication with your doctor. It is especially important to discuss:
- Your other medications
- Over the counter medications that you take, including vitamins
- Your medical history including amputations, heart disease, risks for heart disease, blocked or narrowed blood vessels, nerve damage in the leg, diabetic foot ulcers, kidney problems, liver problems, urinary tract infections or urinary problems, diet, pancreas problems, alcohol use, and allergic reactions to medications
Who Should Not Take Invokana
According to Invokana’s website, Invokana should not be taken by people:
- With type 1 diabetes
- With diabetic ketoacidosis
- Who have severe kidney disease and are taking Invokana to lower their blood sugar
- Who are on kidney dialysis
- Are pregnant or breastfeeding
Additionally, Invokana is not approved by the U.S. Food and Drug Administration (FDA) to treat people under the age of 18.
How to Know If Someone Is Taking Invokana
You likely know if you are taking Invokana. If you have any questions about your own prescriptions, then you can contact your doctor or pharmacist to confirm your medications.
If your loved one is conscious and alert, then you can ask your loved one about his medications. However, if your loved one is seriously ill or has died, then you will need to get the information another way. Your loved one’s power of attorney may be able to talk to the doctor or pharmacist or request a copy of your loved one’s medical records so that you can confirm his medications.
Invokana Injuries and Recoveries
Invokana helps many people manage the health risks of type 2 diabetes, but like most medications, it also has risks. When medication risks are fully disclosed to doctors and patients, then patients can make informed decisions about whether they want to accept the risks.
However, many people have sued Johnson & Johnson, the maker of Invokana, alleging that they were not warned about potentially serious or fatal side effects, including:
- Amputations. People with diabetes have an increased risk of amputation. However, the risk of amputation is even higher for people taking Invokana. Johnson & Johnson first warned people of this risk in May 2016 and added a black box warning about it a year later in May 2017.
- Fournier’s gangrene. This serious condition is caused by an infection around the genitals. It can occur in both men and women. In some cases, Fournier’s gangrene can be fatal. Johnson & Johnson warned the public of this risk in August 2018.
The plaintiffs in Invokana cases allege that they were hurt by Johnson & Johnson’s failure to warn them of these risks before they suffered from them. They are fighting for fair recoveries of past and future medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other losses, and if you’ve been hurt by Johnson & Johnson’s failure to warn about Invokana side effects, then you may be able to pursue a similar recovery.
If you or a loved one suffered a serious Invokana side effect before a warning was added to the drug’s label or insert, then we encourage you to contact Keefe Disability Law today for an honest case review. We will thoroughly review your claim and provide you with all of your legal options so that you can make an informed decision about your next legal steps. Call us today to schedule your free initial consultation.
Should valsartan have been recalled sooner?
The U.S. Food and Drug Administration (FDA) recalled some lots of valsartan in July 2018 because of reported contamination with the carcinogen N-nitrosodimethylamine (NDMA). The recall surprised and frightened many patients who were taking valsartan to treat high blood pressure or congestive heart failure. The recall alerted them to the fact that their possible exposure to NDMA could put them at an increased risk of developing liver problems or cancer.
While the valsartan recall surprised patients, it did not surprise everyone. Twenty-two other countries recalled valsartan before the United States took action, and at least one FDA inspector had concerns long before the FDA recall.
A Former FDA Inspector Comes Forward
In May 2019, a former FDA inspector told NBC News that he knew of potential problems with valsartan more than a year before the recall occurred. Massoud Motamed worked as an FDA inspector for three years and spent much of his FDA career inspecting drug manufacturing facilities overseas.
By the spring of 2017, Dr. Motamed had more than two years of experience with the FDA. In May 2017, he traveled to Linhai, China to inspect the Zhejiang Huahai Pharmaceutical plant. Zhejiang Huahai Pharmaceutical manufactures the main ingredients in the valsartan that was eventually recalled. Dr. Motamed spent four days inspecting the plant and filed an official report with the FDA that included the following information:
- Facilities and equipment were not properly maintained
- Testing anomalies were not investigated
- “Unknown impurities” were dismissed as lab errors without investigation
Dr. Motamed reportedly recommended that the FDA issue a warning letter to Zhejiang Huahai Pharmaceutical. The FDA refused and instead allowed Zhejiang Huahai to fix its problems independently.
The FDA’s recall didn’t come until July 2018—more than one year after Dr. Motamed’s May 2017 visit to Zhejiang Huahai Pharmaceutical. In January 2019, the FDA issued a press release saying, “… our inspections did reveal systemic problems of supervision that could have created the conditions for quality issues to arise.”
There is a concern that what happened with valsartan at the Linhai, China facility could happen to with other medications made in foreign countries. Approximately 85 percent of the facilities that make ingredients found in U.S. medications are outside of the United States. While manufacturing medication overseas is less expensive, there is also less government oversight, which may make it riskier.
You Can Come Forward If Your Hurt by Valsartan
It is possible that the FDA should have known about the risks and issued a recall of valsartan before July 2018. Either way, it is essential that all valsartan users and their loved ones understand their rights now.
If you develop a liver condition or cancer, or your loved one dies from a liver condition or cancer, after taking valsartan, then you need to know whether the medication that you took was contaminated with NDMA. Your doctor and pharmacist can help you get the necessary information, and an attorney can help you protect your legal rights.
Dozens of lawsuits have already been filed, and many more are expected in the coming months and years. People who took valsartan may not yet be diagnosed with cancer or liver injuries, and their lawsuits may come later.
You took valsartan to improve your health. You were not warned that cancer from NDMA exposure could be a potential side effect. Accordingly, if you do develop cancer after taking a contaminated batch of valsartan, then it is important to contact a mass tort injury lawyer as soon as possible.
Keefe Disability Law is committed to helping every client make a full individualized recovery. We will fight hard for your compensation for medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other damages. While mass tort cases consolidate some litigation expenses, your recovery will remain unique, and you will remain in control of your case. To learn more, please contact us via this website today for a free, no-obligation consultation.
Is Zostavax safe?
You need to prevent shingles, but you also need the vaccine that you take to prevent shingles to be safe. Zostavax has been approved by the Food and Drug Administration (FDA) for more than a decade. However, lawsuits have been filed against Merck, the make of Zostavax, alleging that Zostavax is ineffective at preventing shingles and that the vaccine may cause shingles.
Zostavax FDA Approval
In 2006, Zostavax was approved by the FDA as a shingles vaccine. Zostavax contains the live chickenpox virus that causes both chickenpox and shingles. It is a one-shot vaccine that may be available at doctors’ offices and pharmacies, but it is not the preferred shingles vaccine.
According to the Centers for Disease Control and Prevention (CDC), Shingrix is the preferred shingles vaccine even though it is a two-shot vaccine rather than a one-shot vaccine. While there is a preference for Shingrix, Zostavax may still be used for healthy patients who are 50 or older if:
- A person is allergic to Shingrix
- A person requests Zostavax
- Shingrix is unavailable, and the person needs or requests an immediate shingles vaccination
A Zostavax vaccine is supposed to prevent shingles for about five years.
Shingles Risk After a Zostavax Vaccine
While Zostavax may be given to people who are at least 50 years old, it is recommended for patients aged 60 years and older. According to the CDC, the vaccine is most effective in people age 60-69, but it also provides some protection from shingles for people who are 70 or older.
Overall, Zostavax is only about 51% effective at preventing shingles and 67% effective at preventing a shingles complication known as post-herpetic neuralgia. Additionally, people may be at risk of developing shingles from this live-virus vaccine.
Shingles Is a Serious Health Risk
It is recommended that every adult age 60 or older receive a shingles vaccine to prevent the pain of a shingles infection and the possibility of serious medical complications.
The CDC estimates that more than 99% of Americans over age 40 have had chickenpox. Shingles develops from the same virus as chickenpox. Thus, even if you don’t remember having chickenpox, it is important to assume that you did have this illness as a child and that the virus is still in your body. After being dormant for many years, the virus can come back as shingles.
Shingles shows up as a painful rash that is often along one side of your torso or your face. Some people also experience fever, headache, and fatigue. The pain may continue long after the rash clears up in a condition known as post-herpetic neuralgia. Shingles can also result in other complications such as blindness if it occurs near the eye, neurological problems if certain nerves are affected, and skin infections if the rash blisters aren’t treated.
People around the country are currently filing lawsuits claiming that they developed shingles after receiving the Zostavax vaccine. Specifically, people who have been hurt are alleging that:
- Zostavax can result in serious injury
- Merck knew that Zostavax could cause shingles during its premarket studies but did not add shingles as a potential side effect on the vaccine’s label for many years
- Recipients of the vaccine were not adequately warned of Zostavax risks
If you were diagnosed with shingles within one year of receiving the Zostavax vaccination, then it is important to find out more about your rights. You could have a potential case against Merck, but your time to file a lawsuit is limited by law.
Keefe Disability Law is currently evaluating Zostavax cases. If you experienced shingles after getting the Zostavax vaccine or if your loved one died from shingles complications after receiving the Zostavax vaccine, then we encourage you to contact us for a free case evaluation. Other people in Massachusetts, Rhode Island, or New Hampshire may have suffered similar injuries and we may be able to help you. Your time to pursue an injury case is limited. Call us or start a live chat with us today to learn more.
What is it like to live with ovarian cancer?
If you have recently been diagnosed with ovarian cancer after using Johnson & Johnson’s baby powder, then your first concern may not be potential legal action against Johnson & Johnson. Instead, you want to know what your life is going to be like now.
Ovarian Cancer Symptoms
You already know how your current symptoms feel. While your disease may have been asymptomatic in its early stages, you may now be or may soon be experiencing:
- Bloating or swelling in your abdomen
- Discomfort in your pelvis
- Unexplained weight loss
- A change in your bowel habits
- Frequent urination
If cancer spreads from your ovaries to other parts of your body, additional symptoms may occur. Additionally, ovarian cancer treatments can significantly impact your health and your everyday activities.
Ovarian Cancer Treatment
Treatment for ovarian cancer may include:
- Surgery. One or both ovaries may need to be removed. Additionally, one or both fallopian tubes may need to be removed, and your uterus may need to be removed. If your ovarian cancer has spread to other parts of your body, such as your lymph nodes, then additional surgical procedures may be necessary.
- Chemotherapy. Chemo drugs may be taken by IV transfusion or as oral medications, depending on the specific prescription. Chemotherapy may be used on its own to fight ovarian cancer, or it may be used with surgery.
- Clinical trials and targeted therapies. These treatments may be used if surgery and chemotherapy are ineffective or if your cancer returns.
- Palliative care. The goal of palliative care is to improve or maintain your quality of life. Your palliative care doctors will try to reduce your pain and symptoms. This may be done with other treatments or on its own.
These treatments may leave you:
- Tired and anemic
- Constipated or with diarrhea
- Anxious and depressed
- More susceptible to infection
- With mouth or throat problems
- With muscle and nerve problems
- In pain
You may be unable to work, to take care of yourself or your family, or to do any of the things that you enjoy.
Ovarian Cancer Prognosis
Ovarian cancer that is caught at an early stage has a better chance of being successfully treated. Unfortunately, most women with ovarian cancer do not receive early diagnoses because the symptoms of this disease are so vague and so similar to other more common and benign conditions.
According to the National Ovarian Cancer Coalition, about 80% of women who are diagnosed with ovarian cancer are diagnosed at stage III or higher. The survival rate for women diagnosed at stage III or higher may be as low as 28%.
Ovarian Cancer Litigation
The impact of ovarian cancer on your everyday activities and life expectancy are your most important concerns. However, you may also have financial concerns and a desire to hold the company that is responsible for your cancer diagnosis accountable.
If you regularly used Johnson & Johnson’s baby powder on your genitals, then you may have the right to pursue legal action against the company. Other women have successfully filed lawsuits against Johnson & Johnson, and you may be able to do the same.
You can join with other women who have developed ovarian cancer from Johnson & Johnson’s baby powder in a mass tort action, and you can fight for your fair recovery of past and future medical bills, lost income, out-of-pocket expenses, pain, suffering, and other damages. Together, you and others who have been hurt can join in the expenses of discovery and litigation, but you will maintain the individual right to settle your claim at all times.
For more information about how to protect your rights in a Johnson & Johnson’s baby powder mass tort action, please contact our Massachusetts mass tort lawyers today via this website or by phone. We would be pleased to schedule a free consultation with you to discuss your rights and possible recovery.
Have any warnings been issued about Johnson & Johnson's baby powder?
The Food and Drug Administration (FDA) has not issued any formal warnings about the risk of talcum powder but is currently reviewing scientific studies and reports of asbestos contamination in talcum-based products. Talcum powder is not a drug that is regulated by the FDA. Instead, it is classified as a cosmetic under the Federal Food, Drug, and Cosmetic Act.
How the FDA Regulates Cosmetics
- Does not review or approve cosmetic products before they are sold to consumers in the United States
- Requires cosmetics to be properly labeled with all ingredients
- Requires cosmetics to be safe when used according to the directions on the label or consistent with customary use
- Monitors for safety problems with cosmetics and takes action when necessary to protect the public. However, any action may only be taken if the FDA has, “… sound scientific data to show that it is harmful under its intended use.”
Therefore, as a cosmetic, talcum powder is regulated in a very different way than prescription medications.
The FDA Has Not Issued a Talcum Powder Warning... But Others Have
The Centers for Disease Control and Prevention (CDC) has warned that repeatedly inhaling talc could hurt the lungs.
The World Health Organization through its International Agency for Research on Cancer (IARC) claims that talc-based products are generally non-carcinogenic, but maintains that there could be a small risk of cancer when a talc-based powder is used on the genitals.
Additionally, the European Union has banned talc as an ingredient in cosmetic products. However, talc can still be used in cosmetic products in the United States and, to date, no agency has issued a strong warning about its safety.
What Johnson & Johnson Knew and When It Knew It
In the past, including in a lawsuit brought by a woman with mesothelioma in the late 1990s, Johnson & Johnson claimed that its baby powder was asbestos-free. However, the results of a Reuters investigation released in December 2018 found that Johnson & Johnson knew otherwise.
Specifically, the Reuters investigation found that from 1971 through the early 2000s:
- The talc used in Johnson & Johnson’s baby powder and the finished baby powder itself sometimes contained small amounts of asbestos
- Johnson & Johnson executives and others including scientists and lawyers knew about the test results
- Johnson & Johnson executives and others including scientists and lawyers worried about how to handle the asbestos problem without disclosing the information to federal regulators or the public
- Johnson & Johnson successfully attempted to influence scientific research about the potential health concerns associated with talc and U.S. regulators efforts to limit talc in cosmetics
Johnson & Johnson maintains that it never hid any evidence regarding the safety of its talcum-based products and the Reuters report is “false and misleading.”
You Can Take Action If You’ve Developed Cancer From Talcum Powder
Despite the lack of official warning about the dangers of using Johnson & Johnson’s talcum-based baby powder, it is possible to pursue a legal recovery if you’ve developed ovarian cancer or mesothelioma after regularly using Johnson & Johnson’s baby powder.
Thousands of other people have already filed baby powder cancer lawsuits, and a few of these cases have already been heard in court and decided. Plaintiffs in these lawsuits are claiming that they have developed cancer or their loved ones have died from cancer because they used Johnson & Johnson’s talcum-based baby powder. They further allege that they were not warned about this potential risk before they used the product.
It can be challenging to go up against a big company like Johnson & Johnson on your own, but you don’t have to do this by yourself. You can join with other people who have suffered similar injuries to pursue a mass tort action. Our mass tort lawyers would be happy to meet with you, free of charge, to discuss whether you may have a claim against Johnson & Johnson and how a mass tort case works. Please contact us today to learn more about your rights and your possible recovery.
Are proton pump inhibitors safe for kids?
Acid reflux and gastrointestinal reflux diseases (GERD) are uncomfortable and potentially serious medical conditions that require treatment. One potential treatment is with a class of oral medications known as proton pump inhibitors. Proton pump inhibitors reduce the amount of stomach acid that is produced in the body. Some proton pump inhibitors, such as Prilosec and Nexium are available without a prescription, while other proton pump inhibitors such as Prevacid and Dexilant require a prescription.
Proton Pump Inhibitors Are Prescribed for Children
Proton pump inhibitors are one option for treating pediatric acid reflux and GERD. In November 2016, researchers published an article about the use of gastric acid inhibitors in infants in the World Journal of Gastrointestinal Pharmacology and Therapeutics. In the abstract for that article, researchers stated, “… proton pump inhibitors are widely and increasingly used, often without objective evidence or investigations to guide treatment.”
Different Studies Find Proton Pump Inhibitor Problems for Children
Despite their widespread use for infants and children, proton pump inhibitors may cause potentially serious side effects for children. These side effects include increased risks of:
- Respiratory infections
- Gastrointestinal tract infections
- Vitamin B12 deficiency
- Magnesium deficiency
- Bone fractures
- A significant increase in stomach acid once the medication is stopped
In the January 2018 Archives of Disease in Childhood researchers also cautioned that proton pump inhibitors could pose toxicity risks for infants and children that are not yet fully known.
Later in 2018, different researchers published a study in JAMA Otolaryngol Head & Neck Surgery. This study looked at the medical charts of 293 children under the age of two who had abnormal results on videofluoroscopic swallow studies at Boston Children’s Hospital in 2015 with follow-up in 2015 or 2016. According to the study:
- Approximately 53% of the 293 children had aspiration, and the other 47% had isolated laryngeal penetration.
- About half of the 293 children were hospitalized.
- Approximately 51% of the children with swallowing difficulties took proton pump inhibitors.
- Children who took proton pump inhibitors were about twice as likely to be hospitalized and two to three times as likely to spend the night in the hospital as compared with children in the study who did not take proton pump inhibitors.
According to the researchers who conducted the study and wrote the findings, “These results support growing concerns about potential risks of PPIs and suggest the need to reevaluate the use of pharmacologic acid suppression in children with aspiration…”
What to Do If Your Child Is Hurt by a Proton Pump Inhibitor Medication
Proton pump inhibitors have been on the market in the United States for decades. During this time, millions of people, including children, have taken the medication and may have been unaware of the serious side effects that could occur.
Pharmaceutical companies that make proton pump inhibitors have a duty to:
- Design safe medications
- Manufacture safe medications
- Provide reasonable warnings about a medication’s side effects.
If a pharmaceutical company fails to do one of these three things and your child is hurt as a result, then you may have a legal claim against the pharmaceutical company.
Pharmaceutical injury cases can be difficult to bring on your own. You need a lot of information that is in possession of the pharmaceutical company. Safety studies, manufacturing records, and other information may be important to your case.
You shouldn’t have to worry about how to get this information and make a successful claim as you care for your child. Instead, you have the right to work with a mass tort lawyer who can represent your child’s unique interests.
A mass tort case is not the same as a class action case. You may be able to share the costs of litigation and discovery with others who have been similarly hurt, but your lawyer will fight for your child’s personal recovery in a mass tort lawsuit.
To learn more about protecting your child’s rights, please contact us today via this website or by phone to schedule a free, no-obligation consultation.
Who takes Taxotere?
Taxotere is a type of chemotherapy drug that is used to fight various forms of cancer. It is available only by prescription and only for the treatment of certain illnesses.
Taxotere Treats Different Forms of Cancer
Currently, Taxotere (docetaxel anhydrous) is approved by the Food and Drug Administration (FDA) for the treatment of:
- Breast cancer
- Non-small cell lung cancer
- Metastatic prostate cancer
- Advanced stomach cancer
- Head and neck cancer
Since Taxotere already has FDA approval, doctors may also prescribe the medication if they think it would be beneficial in the treatment of other conditions such as small cell lung cancer, bladder cancer, ovarian cancer, pancreatic cancer, soft tissue sarcoma, and melanoma.
These types of cancers are not unique to one age group or gender. Therefore, Taxotere may be considered for both men and women.
Taxotere is commonly prescribed with other cancer-fighting medications. It is administered by infusion every few weeks. The dosage and frequency of infusion depend on numerous factors including the type of cancer, the stage of cancer, and the height and weight of the patient.
Taxotere—like other forms of chemotherapy—has significant risks. These risks include stomach upset, mouth sores, temporary hair loss, fatigue, peripheral neuropathy, and an increased risk of infection. Most of these side effects will go away once chemotherapy treatment ends.
However, one major side effect may be permanent. After Taxotere treatment, some women experience permanent alopecia or hair loss. The consequences of permanent hair loss for women can be significant. This type of injury is about much more than physical appearance. A woman who suffers permanent hair loss may always be reminded of her cancer, and she may suffer from low self-esteem. This may impact her ability to get a job, her confidence, her personal relationships, and her quality of life.
Women Have Suffered Permanent Injuries From Taxotere
Sanofi-Aventis, the pharmaceutical company that makes Taxotere, did not warn women about the risk of permanent alopecia until December 2015. The warning came 19 years after the FDA first approved the drug for use in the United States.
During the 19 years between FDA approval and the drug company’s warning, thousands of women used Taxotere not knowing about the risk they faced. During this time, other chemotherapy drugs were available. These other FDA approved chemotherapy drugs were allegedly as effective as Taxotere in the treatment of cancer, but they did not carry the risk of permanent alopecia.
Women were denied the right to make an informed decision about their cancer treatment because of Sanofi-Aventis’s delay in providing an adequate warning about this known risk. Lawsuits filed by women who suffered permanent alopecia from Taxotere indicate that the drug company knew of the risk by 2005. By 2005, the results of a study that began in the late 1990s showed that 9.2% of women who used Taxotere suffered permanent hair loss. Yet, it would take another decade for Sanofi-Aventis to add a warning about permanent alopecia to its drug label.
How to Get Help If You’re Hurt by Taxotere
Women who have suffered permanent hair loss from Taxotere are taking action to protect their legal rights.
Thousands of women have filed Taxotere cases that are currently part of multidistrict litigation (MDL). MDL means that you may hire your own attorney and retain control over your own settlement, but that you may also share in the efficiencies of having the cases heard in the same court. The first Taxotere trials are scheduled for 2019 and 2020.
Don’t wait any longer to find out about your rights. Our Massachusetts, Rhode Island, and New Hampshire mass tort attorneys are here to help you. If you are a woman who took Taxotere or its generic equivalent to treat breast cancer prior to December 2015 and if you have suffered permanent alopecia, then we encourage you to contact our mass tort lawyers today for a free and confidential consultation about your rights and potential recovery.
Who takes Xarelto and who is at risk of being hurt by this medication?
Xarelto was approved by the Food and Drug Administration (FDA) in 2011. Since then people in the United States have been able to take Xarelto with a doctor’s prescription.
FDA Approved Uses for Xarelto
Currently, Xarelto may be prescribed in the United States to a person who has:
- Atrial fibrillation not caused by a heart valve problem. People with atrial fibrillation have hearts that do not beat as expected. This can cause dangerous and potentially life-threatening blood clots to form. Xarelto can reduce the risk of blood clots and strokes for people with atrial fibrillation not caused by a heart valve issue.
- Blood clots in the legs or lungs. Blood clots in the veins of the legs, known as deep vein thrombosis, or blood clots in the lungs, known as pulmonary embolisms, may be treated with Xarelto. Additionally, people who continue to be at risk for developing these types of blood clots after six months of treatment may take Xarelto to try to prevent future blood clots from forming.
- Recent knee or hip surgery. Xarelto can help prevent deep vein thrombosis and pulmonary embolisms in people who recently had hip or knee replacement surgery.
- Coronary artery disease or peripheral arterial disease. Xarelto combined with a low dose of aspirin can help reduce the risk of serious heart problems, stroke, or heart attacks in patients with these conditions.
Xarelto is a blood thinner that can prevent dangerous blood clots from forming, but it is not without risks.
Xarelto Users Risk Serious Injuries
As an anticoagulant, Xarelto works by thinning out your blood to prevent clotting. Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that makes Xarelto, advertises Xarelto as “a latest-generation blood thinner” because it specifically targets one blood clotting factor as compared to older generation blood thinners such as Warfarin that impact six different blood clotting factors and interfere with the body’s vitamin K.
However, newer drugs are not synonymous with risk-free drugs. Xarelto creates certain risks for patients, such as:
- An increased risk of dangerous bleeding. Uncontrollable bleeding is a risk for people taking Xarelto. Brain bleeds and internal bleeding are risks that can result in death. Retinal bleeding is also a risk and can cause permanent vision damage. If you are coughing up blood, if you are dizzy or faint, if you experience vision changes, if you develop any amount of paralysis, if you have a cut that won’t stop bleeding, or if you experience any other signs of a potential bleed then it is important to get emergency medical attention.
- An increased risk of blood clots once a patient stops taking the medication. The very risk that you were trying to control by taking Xarelto may increase when you stop taking the drug. Do not stop taking Xarelto without speaking to your doctor. Your doctor may want to put you on a different type of blood thinner to prevent a blood clot and monitor you more closely.
Anyone who takes Xarelto may be at risk of suffering from these serious and potentially life-threatening medical complications. These complications may occur during treatment or soon after treatment ends.
What to Do If You Have Been Hurt by Xarelto
Even though the side effects of Xarelto are now known, that does not mean that your recovery for Xarelto-related injuries will be automatic. Xarelto cases can be difficult for injured people to win. Janssen Pharmaceuticals has had some success at trial on claims brought by people injured by Xarelto or their surviving family members.
Thus, before you pursue a Xarelto claim, it is important to know all of your rights and to understand whether you may truly have a legal case that can result in an award of damages. Our New England Xarelto injury lawyers would be happy to review your potential claim for you, free of charge if you have suffered a Xarelto side effect in Massachusetts, Rhode Island, or New Hampshire. To find out more, or to schedule your free consultation with us, please fill out our online contact form or call us directly.
Who is at risk of developing cancer from talcum-based baby powder?
The smell of baby powder may conjure peaceful memories of your child’s infancy or the relaxed feeling you have after a shower. You likely used Johnson & Johnson’s talcum-based baby powder on your child or yourself without a second thought about its safety.
Now, however, reports have come out, warnings have been issued, and lawsuits have been filed alleging that talcum-based baby powder can cause cancer, and you want to know if you, or a loved one, may be at risk.
The Dangers of Talcum-Based Baby Powder
The primary risk of talcum-based baby powder is that talc is contaminated with asbestos when it is mined. Asbestos is a known carcinogen.
A December 2018 Reuters investigation revealed that Johnson & Johnson has known for decades that asbestos may be in its baby powder. Specifically, Reuters found that from at least 1971 through to the early 2000s, Johnson & Johnson’s baby powder sometimes tested positive for asbestos. Johnson & Johnson allegedly knew about the test results and the dangers of asbestos but failed to tell government regulators or consumers.
According to the World Health Organization, and others, there is no safe level of asbestos exposure, and the American Academy of Pediatrics recommends against the use of any baby powder—whether talc-based or not—because of the potential dangers from inhalation.
While the United States Food and Drug Administration (FDA) has not yet issued a warning about talcum powder and cancer, Health Canada issued a talcum powder warning in December 2018. The Canadian public health agency issued a letter to health care providers advising them to advise their patients to stop using talc in their genital areas because of the risk of ovarian cancer and to avoid breathing in talcum powder to avoid lung problems. The Canadian government is also considering further actions to restrict the use of talc.
Women May Be at Risk for Ovarian Cancer
Some women who have used talcum powder in their genital areas have sued Johnson & Johnson alleging that the talcum powder they used near their vaginas traveled to their ovaries and caused ovarian cancer.
Ovarian cancer can be difficult to diagnose in its early stages. This allows the disease to progress and becomes more difficult to treat. By the time many women are diagnosed with ovarian cancer it is often a stage III or IV cancer and the five-year survival rate may be 50% or less.
Men and Women May Be at Risk for Mesothelioma and Lung Conditions
Like ovarian cancer, mesothelioma often presents with vague symptoms or is asymptomatic in its early stages. In its later stages, mesothelioma is nearly always fatal.
Lung conditions and mesothelioma may develop if talcum powder fibers that contain asbestos are inhaled. While the American Cancer Society does not yet recognize this risk from cosmetic talcum powders, a New Jersey man convinced a court that his mesothelioma was the result of using Johnson & Johnson’s baby powder and Health Canada has linked loose talc powder to decreased lung function, breathing difficulties, and fibrosis. These conditions may affect people of any gender.
Know Your Rights If You Develop Cancer After Using Talcum-Based Baby Powder
The potential dangers of talcum-based powder may impact both men and women. Anyone may be hurt, although the specific injuries that are suffered may depend on how the product was used.
If you have developed ovarian cancer or a lung condition that you think might be related to your use of baby powder, then the time to act is now. Our experienced attorneys would be happy to review your case, free of charge, and to advise you about your legal options. If there is a causal connection between your cancer or lung condition and baby powder, then we will fight for your fair and just recovery. To learn more, please contact us today via this website or by phone to schedule your free consultation.
How long do I have to file a lawsuit if I was hurt by a dangerous drug?
Prescription drug injury lawsuits—like all lawsuits—are subject to laws known as statutes of limitations. Each state has its own statute of limitation laws. These laws provide a certain time by which a person must file a lawsuit in court or forego a claim. The time varies depending on the type of case that you are filing. For example, a personal injury statute of limitations may be different from the statute of limitations for a breach of contract.
Drug injury cases are subject to state statutes of limitation. However, statutes of limitations issues can be complicated in these types of cases because it isn’t always possible to know that you were hurt immediately after taking a medication. Accordingly, it is important to understand the general statute of limitation law, how to comply with the law in a prescription drug injury case, and why you can’t let the statute of limitations expire without filing a case in court.
Massachusetts, New Hampshire, and Rhode Island Prescription Drug Injury Statutes of Limitations
The following statutes of limitations apply if you were hurt by a defective drug:
- The Massachusetts Statute of Limitations provides you with three years to file a lawsuit.
- The New Hampshire Statute of Limitations provides you with three years to file a lawsuit.
- The Rhode Island Statute of Limitations provides you with three years to file a lawsuit.
Typically, this means that you must file a formal complaint with the court before the three-year statute of limitations expires. While statutes of limitations typically start running on the date that the action took place that caused your injury, that is not always possible to determine in a defective drug case. Furthermore, your injury may not develop or may not be diagnosed for some time after you take the medication. For this reason, the statute of limitations will begin to run when you knew that you were hurt or when you should have reasonably discovered your injury.
How to Make Sure You Don’t Miss the Statute of Limitations
While every case is different, there are important things that you can do to make sure that you don’t miss the statute of limitations. Specifically, you can:
- See your doctor as soon as you begin to exhibit any symptoms of illness or injury. When you see your doctor, it is important to report all of the medications that you have used, your dosage, and the date that you began and stopped the medications.
- Follow your doctor’s treatment plan. This is important both to your health and to your potential legal case if there is a connection between your symptoms and the medication that you took. It can help create a medical record showing causation and show that you took the recommended medical steps to get better.
- Talk to a lawyer as soon as possible. An attorney can determine both whether you have a potential case and when the statute of limitations began to run.
These steps will help you file your case on time and make a fair recovery.
What Happens If You Miss the Statute of Limitations in Your Drug Injury Case
If you miss the statute of limitations and you file a complaint in court after the statute of limitations has expired, then you can expect the pharmaceutical company to motion the court to dismiss your case. If the court agrees that the statute of limitations has expired, then your case will be dismissed without you recovering anything. The pharmaceutical company will not negotiate a settlement with you because they know that you have no recourse in court.
Don’t let this happen to you. Instead, contact a mass tort lawyer as soon as you think that you might have suffered a prescription drug injury. Our lawyers would be pleased to provide you with a free, no-obligation initial consultation so that you can learn more about your rights and about how to protect them. Simply call us or reach out to us via this website to schedule your meeting.
What is a prescription medication manufacturing defect?
Pharmaceutical companies have a duty to design, manufacture, and market safe medications. If something goes wrong at any of these three stages, then the consequences can be devastating for many people who take the medication.
What Can Go Wrong During the Manufacturing Stage of a Prescription Medication?
A manufacturing defect happens after the medication has already been safely designed. If the medication had been made according to the specifications of the design and then marketed accordingly, then the prescription drug would not be defective.
In the case of a manufacturing defect, something went wrong while the medication was being made. In other words, the medication was not made according to the specifications in the design. This could happen if, for example:
- An ingredient that was included in the design was left out of the drug during the manufacturing process.
- An ingredient that was not included in the design was added to the product during the manufacturing process.
- The right ingredients were used but at the wrong dosages. This will result in a mediation that is stronger or weaker than expected.
- There were unsanitary or contaminated conditions that tainted one or more batches of the medication.
- The wrong label was attached to the medication.
Since the medication that was created was more dangerous than consumers expected it to be given its design and marketing, it is considered to be defective.
Evidence of a Manufacturing Defect
In order to win a defective manufacturing claim, you will need to prove that:
- The medication was defective and became defective during the manufacturing stage.
- You suffered injuries that occurred because of the medication’s defect.
This will require evidence. Much of the evidence that you need will be in the control of the pharmaceutical company that is trying to defend itself. This may include:
- Design plans for the medication. In order to know if the medication was manufactured incorrectly, you need to know if it was made according to the approved design.
- Samples of the medication. The samples can be tested to determine what is in them.
- Quality assurance reports or witness testimony. This can help you determine if anything happened during the manufacturing process that should not have happened.
Obviously, the pharmaceutical company is not going to hand this evidence over to you unless they are legally required to do so. An experienced mass tort lawyer can help you get the evidence you need through the legal discovery process. This may include requests for production of documents, interrogatories, depositions, and other requests that the pharmaceutical company is legally bound to answer.
Get the Damages You Deserve If You Have Been Hurt by a Manufacturing Defect
When a mistake is made in the manufacturing of a medication, serious injuries or death can result. Many people who took the medication, or a batch of the medication, may suffer similar side effects. Together, the injured parties or the loved ones of those who have died may join together in a mass tort action to hold the pharmaceutical company accountable for its negligence.
The pharmaceutical company may aggressively defend itself against your allegations. If you are alone in your attempt to make a legal recovery, then the pharmaceutical company may overwhelm you with its defense.
However, in a mass tort case you and other similarly affected plaintiffs can join forces in discovery and in seeking justice. While you will work together on the legal case, your recovery will be unique. You may recover financial damages for the specific injuries that you suffered.
To learn more about your rights, your recovery, and how a mass tort case works, please contact our mass tort drug injury lawyers for a free, no-obligation consultation today. We would be pleased to review the facts of your case, to provide you with our honest opinions, and, if appropriate, to fight for your full and just legal and financial recovery.
The pharmaceutical company did not warn me about the potential side effects of my medication. Is the pharmaceutical company liable for the injuries I suffered?
The pharmaceutical company may be legally responsible for the injuries that you suffered if it knew, or should have known, about the potential injuries and if it failed to warn you about those injuries.
Two Ways a Pharmaceutical Company May Fail to Warn
A pharmaceutical company may have failed to warn you about potential injuries if it:
- Did not mention potential side effects while advertising or marketing the medication. Pharmaceutical companies are not required to advertise their products. However, if they choose to advertise by sending representatives to doctor’s offices, by promoting their medication on social media, or by running television, radio, internet, or print ads, then they must be truthful in their advertisements or marketing efforts. This means that they must disclose the risks of the medication along with the benefits of the medication.
- Did not include information about side effects in the warnings or instructions that accompanied the medication. Pharmaceutical companies have a duty to include known side effects in the prescribing information that accompanies a prescription drug.
Copies of advertisements, information about marketing strategies, copies of drug inserts, information about what the drug company knew about potential side effects, and other information that may be important to your claim.
You Deserve to Make a Fair Recovery If the Pharmaceutical Company’s Failure to Warn Resulted in Your Injury
You can only rely on the information that you are given. If the pharmaceutical company fails to provide you with complete or accurate information, then you are forced to make a decision about using a medication without the facts that you need.
This can cause you to make a decision about using a drug that you would not have otherwise made and it can cause you to suffer significant injuries. The failure to warn about a potential side effect can be as dangerous as designing a defective drug or manufacturing a defective drug.
You may not be the only one who was hurt by the pharmaceutical company’s failure to warn. Other people may have suffered similar injuries and together you may be able to join in a mass tort action against the pharmaceutical company—so that you can recover the individual damages that you deserve. To learn more, please contact our prescription drug injury lawyers directly via this website or by phone to schedule a free, no-obligation consultation about your rights and possible recovery.