Are you unable to work because of a disability? Get the answers you need on Social Security Disability to protect your rights
Keefe Disability Law has compiled a list of the most frequently asked questions in response to the overwhelming number of people who need help with the Social Security Disability process in Massachusetts, New Hampshire and Rhode Island. If you are disabled and need help with disability benefits, read on to learn how to protect your legal rights.
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What is preemption?
According to the United States Constitution, federal law must be followed by every state in the nation. That means that states can only enact laws that do not contradict federal law. This frequently complicated and nuanced legal concept is known as preemption, and it is often relevant in medical device injury cases.
Preemption in Medical Product Injury Cases
Preemption is a defense raised by medical device manufacturers in some medical device injury cases. The medical device makers argue that they cannot be sued if they followed the requirements of the U.S. Food and Drug Administration (FDA).
Specifically, the preemption defense is often used when the medical device in question was approved through the FDA’s premarket approval (PMA) process. Before marketing a Class III medical device, the medical device manufacturer can get premarketing approval from the FDA. The medical device makers argue that as long as they follow all of the FDA’s requirements, they should not be legally responsible for injuries that result from their products.
A 2008 U.S. Supreme Court case established that the preemption doctrine applies to medical devices that the FDA decides are safe and effective during the PMA process. According to the court, once a medical device has PMA approval, state safety regulations that are different from or more stringent than federal safety regulations cannot be enforced. However, the court left open the possibility that state regulations that are the same as federal regulations may be enforceable if someone is hurt by a defective medical device.
Preemption of Essure Claims
In 2002, Essure got conditional pre-market approval from the FDA, and many women were given the option of a permanent form of birth control without surgery. Instead, during a doctor’s office visit, a woman could have a coil implanted in each fallopian tube. Over a few months, scar tissue would develop around the coils and prevent pregnancy.
Unfortunately, Essure had potentially dangerous side effects that many women didn’t know about before they consented to the procedure. Some of these women suffered significant pain, perforation of the uterus or fallopian tubes, migration of the coils into other parts of the body, and unintended pregnancies.
Some women began to file injury lawsuits. Bayer argued, however, that their claims should be preempted and not heard because Essure had PMA approval from the FDA.
Judges in California and Pennsylvania held that some claims against Bayer could move forward according to state laws because the state laws were the same as federal laws. These decisions allowed women to bring lawsuits against Bayer claiming negligent failure to warn, breach of warranty, fraud, and negligent misrepresentation.
Does Preemption Apply in Your Case?
Preemption is a powerful defense that could prevent you from making a fair legal recovery in your medical device injury case. Before you pursue a claim, you deserve to know about the strengths and weaknesses of your potential claim so that you can decide whether or not to seek justice.
The lawyers of Keefe Disability Law are committed to providing you with a thorough and honest review of your Essure or other medical device claim. The medical device manufacturer did not give you all of the information that you needed to consider all of your options and make a sound decision that was in your best interest—that shouldn’t happen to you again.
Therefore, we will provide you with an honest review of your potential claim so that you can decide whether you want to join or move forward with a mass tort medical device lawsuit. If you do have a case against a medical device maker, then we will fight hard to get you the compensation for your past and future medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other damages that you deserve.
Call us or start a live chat with us at your earliest convenience to schedule a free, no-obligation consultation with an attorney in our Natick law office.
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.
Why are women filing Essure lawsuits?
Essure seemed like the best option for many women. Without surgery and without taking daily medication, women could enjoy the benefits of birth control. A doctor could insert two small coils into a woman’s fallopian tubes during an office visit. Over time, the coils would cause scar tissue that prevented sperm from reaching an egg and thereby prevent pregnancy.
Unfortunately, for some women, Essure caused significant health problems due to Bayer’s alleged negligence, and, for these reasons, they are now seeking legal relief.
Some of the injuries suffered by women after Essure implants were caused by:
- Migration of the coils. Women allege that the Essure coils moved out of their fallopian tubes and cut into other organs.
- Breaking of the coils. Women allege that the Essure coils broke after implant, and the broken pieces caused them injury.
- Corrosion of the coils and nickel allergies. Before July 2011, it was recommended that women be tested for nickel allergies before an Essure implant. However, the medical device maker presented studies to the Food and Drug Administration (FDA) that showed a minimal amount of nickel and the warning was removed. The medical device label was changed to indicate that Essure could be an option for women with nickel sensitivity. Yet, women with nickel allergies have suffered injuries when the Essure coils corrode and release nickel into the bloodstream.
- Corrosion of the coils and autoimmune conditions. Metal exposure may cause a dangerous autoimmune reaction.
These injuries caused severe physical pain, significant emotional suffering, unwanted pregnancies, and in some cases, death. Women who have filed lawsuits allege that their health, jobs, and marriages have suffered due to Essure injuries.
Lawsuits Claim Negligence Caused Essure Injuries
Women who suffer Essure injuries are filing lawsuits against Conceptus, the company that originally manufactured Essure, and Bayer, the company that bought Conceptus in 2013.
The lawsuits claim that Conceptus and Bayer were negligent and that their negligence caused injuries. Specifically, the women filing lawsuits allege things such as:
- Negligent training. Essure lawsuits allege that Bayer failed to provide adequate training for doctors. Specifically, it is alleged that Bayer used Essure Simulator Training rather than hands-on training and did not verify that doctors completed any training before using Essure on patients.
- Negligent consideration of adverse events. Essure lawsuits also allege that Bayer failed to notify the FDA of adverse events and failed to consider adverse events when it marketed Essure.
- Negligent failure to warn about potential problems. Essure lawsuits further allege that Bayer failed to warn doctors and patients of known risks or risks that should have been reasonably known when it marketed Essure to the public through its website and other marketing methods.
Take Action Quickly After an Essure Injury
Essure is no longer sold in the United States. However, Bayer did not admit any wrongdoing or acknowledge any safety issues when it took Essure off the market, and women who suffer Essure injuries may still pursue legal recoveries.
All lawsuits, including Essure lawsuits, must be filed before the statute of limitations expires. To protect your rights, we encourage you to contact a mass tort lawyer as soon as possible for a free and confidential review of your potential claim.
Our mass tort lawyers are committed to protecting the rights of women hurt by Essure in Massachusetts, Rhode Island, and New Hampshire. To us, you will never be just another number on a long list of women hurt by Essure. Instead, we will get to know you, and we will fight hard to get you the unique medical device injury recovery that you deserve.
You did not have all of the facts about Essure before you decided to use this form of birth control. Now, we want you to have all of the facts so that you can make an informed decision about whether to pursue legal action. Call us, or contact us via this website, to schedule a free, no-obligation consultation.
Why should I hire a local lawyer for my mass tort case?
No one you know has been in this situation before, and you don’t know whom to trust. To recover damages from the pharmaceutical company that hurt you, you are going to need the help of a mass tort attorney, but whom are you going to hire? Without a personal recommendation, do you go with the attorney advertising on television or with someone else?
Choose a Local Mass Tort Lawyer Dedicated to Your Success
A mass tort case isn’t an individual personal injury case or a class action case. Instead, it has benefits of both types of legal actions. When you pursue mass tort litigation against a pharmaceutical company, you get to share in discovery and litigation costs, as you do in a class action case. However, your lawsuit will be decided independently as it would in a personal injury case.
In a mass tort case, you also have control over your own settlement or court case. Therefore, it is essential to hire an attorney whom you’ve met face to face and whom you trust to provide you with the legal representation that you need.
At Keefe Disability Law, we:
- Answer our clients’ phone calls. You won’t be frustrated by leaving a message that is not returned. We do everything possible to have a member of our legal team answer your call and talk to you. If that is not possible, then you will receive a call back quickly. Nationwide, one of the biggest frustrations with lawyers is the lack of return phone calls. We never want you to feel that frustration with our law firm.
- Partner with you. The more that we know about you, your medical condition, and your medical treatment, the more we can help you with your recovery. We want to know exactly how the medication or medical device hurt you so that we can fight for your full and fair recovery.
- Fight for your just recovery. We won’t stop fighting until you have received compensation for all of your past and future medical expenses, lost income, out-of-pocket costs, physical pain, and emotional suffering. Additionally, we will fight to hold the pharmaceutical company accountable by advocating for punitive damages, when appropriate.
Beware of Some National Mass Tort Attorney Advertisements on TV
A 2018 study found that pharmaceutical injury lawyer television advertisements that look like health warnings could mislead consumers. Some consumers stop their medications without the advice of their doctors after seeing these ads.
Additionally, many mass tort attorneys who advertise on TV have large national legal practices. Their size provides them with a large marketing budget to reach potential clients, but it does not give them the opportunity to provide clients with the personal attention they deserve.
Call Our MA NH RI Mass Tort Law Firm for a Free Consultation
You may never meet your attorney if you decide to hire someone who advertises nationally, but if you have been hurt in Massachusetts, Rhode Island, or New Hampshire, then you have the opportunity to meet with a mass tort lawyer close to home.
Our mass tort law firm represents people in all kinds of pharmaceutical mass tort cases, including cases where people were hurt by potentially dangerous medications, such as:
- Proton Pump Inhibitors
Our mass tort lawyers also represent people injured by defective medical devices, such as:
- Defective hip replacements
- Defective knee replacements
- IVC filters
- Hernia mesh
Additionally, our mass tort attorneys will represent people hurt by personal care products, such as Johnson & Johnson’s talcum-based baby powder and Monsanto’s Roundup® weed killer.
If you have been hurt by any of these medications, medical devices, or products, and you are a Massachusetts, New Hampshire, or Rhode Island resident, then we encourage you to contact Keefe Disability Law today for a free, no-obligation consultation about your rights. Your time to file a mass tort case is limited by law. Talk to a local lawyer directly before you decide who to hire to represent you in a mass tort action.
What is the difference between a class action case and a mass tort case?
Mass tort and class action cases are not the same. While both types of legal cases involve many plaintiffs with similar injuries from the same product, class actions and mass tort cases work differently, and the potential outcome for plaintiffs in each case is different. If you are injured by a defective medical device or dangerous medication, then it is important to know which kind of case might bring you the financial recovery that you deserve.
How Class Action Cases Work
A class action case allows all of the people with similar injuries from the same product to work together as one plaintiff. Class action cases must be established by the court. According to the Federal Rules of Civil Procedure, a class action may be established if the following four criteria are met:
- There are so many potential plaintiffs that joining them is impractical
- There are questions of law or fact that are common to all of the plaintiffs
- The claims and defenses of the representative parties are typical of the claims and defenses of the whole class
- The representatives of the class will represent the interest of the class fairly
Individuals can opt-in or choose to be part of the class of plaintiffs. Acting together as one plaintiff, the individuals with injuries can share in the costs of discovering evidence, hiring legal counsel, hiring expert witnesses, and other litigation costs.
Since there are often many people in the class of plaintiffs, a representative plaintiff, also known as a lead plaintiff, may represent the group’s legal interests, but all plaintiffs will share in the damages awarded by the court or negotiated in settlement talks just as they share in litigation costs. A plan of distribution is typically developed and approved by the court to determine how much the plaintiffs will receive and the order in which they will be paid.
How Mass Tort Cases Work
Mass tort cases are different. In mass tort cases, like in class action cases, many injured people come together to sue a defendant for their injuries from the same product. However, in mass tort cases, the plaintiffs do not join together as one class.
Each plaintiff must file an individual lawsuit, and each plaintiff will obtain a personalized recovery.
Mass tort cases may be consolidated before one judge in a process known as multidistrict litigation (MDL). MDL allows one judge to preside over discovery and pretrial matters in cases that are alike. If a settlement is not reached, however, the case may go back to its original court for trial.
Benefits of Mass Tort Lawsuits
There are several benefits to joining a mass tort lawsuit rather than bringing your own case against a pharmaceutical company or another defendant. In a mass tort case, you:
- Get an individualized recovery. Your potential damages will be based on your own losses.
- Share in the costs of discovery and litigation. By sharing costs with others who have been hurt, you may have the financial resources to get the information you need from a large and well-funded defendant.
- May get a quicker recovery. Mass tort cases often move through the courts faster than individual cases.
- Can have your own attorney. You hire the lawyer whom you want to represent you and not the attorneys hired by other plaintiffs whom you’ve never met.
Contact a Mass Tort Lawyer If You Suffer a Pharmaceutical Injury
There are a lot of complicated legal decisions that need to be made to protect your recovery if you have been hurt by a medication, medical device, or another product.
Our dedicated legal team is here to help you if you have been hurt in Massachusetts, Rhode Island, or New Hampshire. We will thoroughly review your claim and advise you of your rights—free of charge. In addition to providing free consultations, our mass tort attorneys are paid on a contingency fee basis, meaning that you only owe legal fees if your claim is successful.
To learn more about your rights, your legal options, and your possible recovery, please fill out our online contact form or call us directly to schedule your free, no-obligation case evaluation.
What are the Monsanto Papers?
One of the key issues in Roundup® lawsuits is what Monsanto, the company that makes Roundup®, knew about the product’s safety and when it knew it. The Monsanto Papers is a collection of texts, emails, memoranda, studies, and other documents that were discovered during Roundup® litigation that identify what Monsanto knew about the possible dangers of Roundup® and when the company knew this critical information.
What Is in the Monsanto Papers?
In 2017 and again in 2019, information from the Monsanto Papers became declassified, and they are now available to the public.
In 2018 an article entitled The Monsanto Papers: Poisoning the Scientific Well was published in the International Journal of Risk and Safety in Medicine. The study’s author looked at 141 declassified documents in the Monsanto papers to see if Monsanto was influencing how scientific studies about the safety of glyphosate were reported. Glyphosate is the main ingredient in Roundup®. The study found that:
- Monsanto sponsored ghostwriting of articles published in toxicology reports and the media.
- Monsanto interfered with the peer-review process of its research.
- Monsanto created a website that appeared to be an academic website, but that was not an academic website to defend its products.
Additionally, the Monsanto papers reveal:
- Monsanto wrote articles and claimed that they were written by research scientists who did not write them.
- Monsanto was informed that the International Agency for Research on Cancer (IARC) would issue a finding that glyphosate is potentially carcinogenic before the IARC’s finding was public. This allowed Monsanto to prepare a response before the news became public.
- Monsanto may have influenced the Environmental Protection Agency’s (EPA) review of glyphosate safety.
- Monsanto failed to disclose information about how the human body absorbs glyphosate.
Together, the information in the Monsanto Papers indicates that Monsanto knew Roundup® could be a serious health risk and took steps to hide the risk from government regulators and the public.
Why the Monsanto Papers Matter
The Monsanto Papers may provide valuable evidence in your case if you have developed non-Hodgkin lymphoma from Roundup® exposure. Specifically, the texts, emails, memoranda, and other documentation may show that Monsanto knew of the Roundup® risks and failed to warn the public about those risks.
However, the Monsanto Papers alone will not be enough to prove your case. To recover damages, you will need to prove that Roundup® caused your cancer. Your attorney may use documentation of your history of Roundup® exposure, your medical records, other documentation, and expert testimony to make this critical connection for the court.
Fight for the Recovery You Deserve
Several people with non-Hodgkin lymphoma from Roundup® use have successfully pursued lawsuits, and they have been awarded millions of dollars—or more—in damages.
Now, our lawyers and the public know more about glyphosate safety and Monsanto’s actions than we did a few years ago, and our Roundup® injury lawyers will fight hard to get each of our client’s the fair recoveries that they deserve.
If you have non-Hodgkin lymphoma from Roundup® exposure, then your damages should include compensation for past and future:
- Healthcare costs. All medical costs including but not limited to medications, surgeries, doctors’ appointments, and hospitalizations should be included in your recovery.
- Lost income. Any income that you cannot earn because of your non-Hodgkin lymphoma should be part of your recovery. This includes wages, benefits, bonuses, and income from self-employment.
- Physical pain and emotional suffering. Your physical pain and your emotional suffering are likely among your most significant damages. These damages can be hard to quantify because there are no receipts or pay stubs to present as evidence. However, your lawyer can offer the right evidence to make sure that you are fairly compensated for your pain and suffering.
- Other compensatory damages. Any other out-of-pocket expenses, including things like transportation costs or funeral costs that are directly associated with your injuries, should be compensable.
- Punitive damages. Monsanto should be held accountable for its actions. Punitive damages seek to punish the defendant rather than to compensate the plaintiff for injuries. However, the practical effect of punitive damages is to provide the plaintiff with additional financial damages. Many of the Roundup® non-Hodgkin lymphoma cases have resulted in significant punitive damage awards.
To learn more about your rights and to protect your recovery, please contact our Roundup® injury lawyers today for a free, no-obligation 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.
How long should hip and knee replacements last?
Before you consented to knee or hip replacement surgery, you carefully considered whether the chance to be pain-free and active outweighed the risks of surgery. One of the critical factors that you likely considered was how long the benefits of the replacement surgery would last.
New Study Finds Many Hip and Knee Replacements Last a Long Time
In February 2019, the results of a large study conducted by researchers at the University of Bristol in the United Kingdom were published. The study looked at more than half a million people who had knee or hip replacements over a 25-year period.
The information from the study gave doctors and patients actual information about the amount of time knee and hip replacements truly last compared to how long they are designed to last, and the study’s conclusions were encouraging. Specifically, the study found that:
- 89% of hip replacements, 93% of total knee replacements, and 77% of partial knee replacements lasted 15 years after surgery.
- 70% of hip replacements, 90% of total knee replacements, and 72% of partial knee replacements lasted 20 years after surgery.
- 89% of hip replacements, 93% of total knee replacements, and 77% of partial knee replacements lasted 25 years after surgery.
This data includes patients from Australia, Finland, Denmark, New Zealand, Norway, and Sweden, but not from the United Kingdom or the United States. While U.S. patients were not specifically considered in this study, it is reasonable to conclude that it is possible for U.S. patients to enjoy the benefits of replacement surgeries for many years just like people in other developed countries. U.S patients can enjoy a pain-free and active lifestyle for many years after hip or knee replacement surgery.
Unless the Hip or Knee Replacement Is Defective
The benefits of a long-lasting hip or knee replacement can only be realized if the knee or hip replacement device is safe. Unfortunately, if the manufacturer of the hip or knee replacement was negligent in the design, manufacturing, or marketing of the medical device, then serious injuries could result.
Premature failure of a hip or knee replacement device could result in:
- Serious pain
- Infection or metal poisoning
- Broken bones or joint issues
These problems could require additional surgeries known as revision surgeries. Revision surgeries are often more difficult than initial hip or knee replacement issues because it can be hard to remove the replacement device once it is implanted in the body. In addition to the pain you experience with a defective device and the risks of additional surgeries, you may face lifelong disabilities.
This was not what you signed up for when you consented to surgery. Instead, you expected that the pharmaceutical company would produce a safe product that would allow you to live your life on your terms without worrying about pain.
Take Action If Your Knee or Hip Replacement Fails Prematurely
A full investigation will need to be done to determine the cause of the hip or knee replacement’s premature failure. If the device failed because a pharmaceutical company, such as DePuy, Zimmer, or Stryker, was negligent, then you may have the right to pursue legal action.
It can be challenging to pursue a successful legal case against a large pharmaceutical company. The pharmaceutical company has the information that you need to prove your claim in its control, and it will likely fight hard to keep that information from you. Pursuing a case on your own can be expensive, frustrating, and time-consuming, but you don’t have to do it alone.
Instead, you have the right to contact a lawyer who will fight for you. If other people have suffered similar injuries from the same hip or knee replacement, then you may be able to join together in a mass tort lawsuit to gather evidence and pursue legal action. However, even in a mass tort case, your recovery is unique and yours alone.
To learn more, please contact us via this website or by phone to schedule a free consultation.
Are there different types of IVC filters?
Different kinds of inferior vena cava (IVC) filters are designed to do the same thing. An IVC filter is supposed to prevent a blood clot from entering your lungs and causing a potentially fatal pulmonary embolism. However, while IVC filters serve the same purpose, they are not all the same.
Permanent IVC Filters
The United States Food and Drug Administration (FDA) approved the first permanent IVC filter several decades ago. Since then other permanent IVC filters have been approved. Some examples of permanent IVC filters include:
- Vena Tech LP made by B. Braun
- Vena Tech LGM by B. Braun
- Titanium Greenfield made by Boston Scientific
- Trap Ease made by Cordis
- Simon Nitinol made by Bard Peripheral Vascular Inc
- Bird’s Nest Made by Cook Group
- Recovery by C.R. Bard
- G2 by C.R. Bard
- SafeFlo vena by Rafael Medical Technologies
Retrievable IVC Filters
Retrievable IVC filters may be permanently implanted in a person’s body even though they are designed by the manufacturer to be retrievable. Over the years, there has been a higher rate of complications associated with retrievable IVC filters than with permanent IVC filters. Some examples of retrievable IVC filters include:
- Celect made by Cook Medical Inc
- Gunther-Tulip made by Cook Medical Inc
- Option made by Argon Medical Devices
- ALN made by ALN Implants
- Denali made by Bard Peripheral Vascular Inc
- Crux made by Volcano Corp
- Eclipse made by C.R. Bard
- Meridian made by C.R. Bard
Lawsuits have been filed against retrievable IVC filter manufacturers such as C.R. Bard and Cook Medical. Some of the alleged complications include:
- Device migration. IVC filters may move from their implanted location and migrate to the heart, lungs, or other parts of the body.
- Device erosion. IVC filters have fallen apart. This can result in a blood clot traveling to the lungs and causing the pulmonary embolism that it was supposed to prevent. Additionally, the broken pieces of the IVC filter can pierce internal organs and cause dangerous, potentially life-threatening injuries.
Since 2010, the FDA has reminded doctors that retrievable IVC filters are meant to be temporary and that they should be removed as soon as the risk for a pulmonary embolism has passed and the procedures can be safely performed.
IVC Filter Injuries and Lawsuits
If you have an IVC filter and you experience shortness of breath, pain, abnormal heart rhythm, or hemorrhaging, then it is important to get immediate medical treatment. A doctor can determine whether the IVC filter is still intact and whether it is still located in its original implantation location. If it has moved or broken apart, then your doctor can suggest treatment options.
Even if you get prompt treatment, however, you may have already suffered a serious injury. You may suffer temporary or permanent physical problems, you may be unable to work, you may incur high medical expenses, and you may suffer emotionally.
Our experienced IVC filter injury lawyers can evaluate your claim and help you get the fair recovery that you deserve if a defective IVC filter caused your injury. If Cook Medical, C.R. Bard or another pharmaceutical was negligent in the design, manufacturing, or marketing of their product, then we may be able to pursue a mass tort action on your behalf.
A mass tort action allows you to join with other people who have been hurt by the same type of IVC filter to pursue legal action. Together, you can share in the discovery requests and litigation costs so that you have the resources necessary to fight a large pharmaceutical company for damages. However, in the end, your recovery will be based on your own injuries, and you will decide whether or not to take any proposed settlements.
If you would like to learn more about your rights or about the possibility of joining an IVC filter mass tort action, please contact Keefe Disability Law today to schedule an initial consultation. We welcome your inquiry by phone or via this website at any time.
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.
Can I still recover damages for Essure-related injuries if it is no longer sold in the United States?
As of December 31, 2018, Essure is no longer sold or distributed in the United States. Bayer, the company that makes and distributes Essure, announced its decision in July 2018. The decision came after several actions by the Food and Drug Administration (FDA), including an April 2018 order that restricted the sale and distribution of Essure.
On July 20, 2018, the FDA confirmed that Bayer had notified the government that Essure sales would stop at the end of 2018. In the FDA’s press release, the agency mentions explicitly that the postmarket safety of Essure will continue to be a top priority of the FDA and that Bayer will be expected to meet its postmarket obligations with regard to Essure. FDA Commissioner, Scott Gottlieb, M.D. specifically included the following language in the press release, “I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources.”
The FDA Revises Essure Postmarket Study Requirements
On December 20, 2018, the FDA issued another press release about Essure. This time FDA Commissioner Gottlieb announced new steps to “…revise and strengthen the manufacturer’s postmarket study…” including:
- Following the women in the study for five years rather than three years.
- Requiring additional blood tests for women involved in the study to learn more about their inflammatory markers.
- Requiring Bayer to continue to enroll women in the study who decided to get Essure before it was fully discontinued in the United States.
- Requiring Bayer to submit more frequent reports to the FDA.
While the FDA is continuing to monitor adverse reports about Essure, the agency cannot provide a financial recovery for women who have been hurt.
Individual Women Hurt by Essure Can Pursue Legal Recoveries
Essure is a form of permanent birth control. The device consists of small flexible coils that were inserted into a woman’s fallopian tubes during a relatively quick and simple office procedure. About three months later, scar tissue should form around the coils and prevent sperm from reaching eggs.
Unfortunately, this form of permanent birth control came with many risks. After receiving Essure, some women experienced:
- Significant pain in the pelvis, abdomen, or back.
- Excessive bleeding.
- Unintended pregnancies.
- Migration of the Essure device into the pelvic or abdominal cavities.
- The uterus or fallopian tubes being perforated by the Essure coils.
- Allergic reactions.
- Significant and long-term mood changes or clinical conditions such as depression.
Thousands of women have pursued legal action against Bayer and against Conceptus, the pharmaceutical manufacturer that made Essure until Bayer bought the company in 2013. These women allege that the pharmaceutical companies failed to warn them about the risks of Essure and instead marketed Essure as a safe product.
Take Action Today If You’ve Had an Essure-Related Injury
If you have suffered a serious complication from Essure, then it is not too late to take action. Your legal rights have not changed just because Bayer decided to discontinue sales of Essure in the U.S.
Instead, if you have suffered a serious long-term complication from this form of birth control, then you may be able to pursue or to join a mass tort lawsuit with other women in Massachusetts, New Hampshire, and Rhode Island who have suffered similar injuries.
Essure claims, like other pharmaceutical injury claims, can be complicated. Bayer has the resources to defend itself against your claim and to make it very difficult for you to be successful unless you have an experienced lawyer on your side.
The legal team at Keefe Disability Law will protect your rights and your potential recovery if you have suffered an Essure injury. We want you to recover for the past and future medical expenses, lost income, out-of-pocket costs, pain, suffering, and other damages that you’ve suffered. Call us or reach out to us via this website today to schedule a free, no-obligation consultation to learn more about your rights and about what you can do next to protect your recovery.
How do I know if my knee replacement has been recalled?
It can be confusing and scary to hear about a knee replacement recall. You immediately want to know whether the recalled knee replacement device was used during your surgery and is currently in your body.
Find Out If Your Knee Replacement Was Recalled
You can find out about specific knee replacement recalls by:
- Searching the Food and Drug Administration (FDA) website. The FDA maintains a medical device recall database. You can search here to find out if your knee replacement has been subject to a recall.
- Calling your surgeon’s office. You may be notified directly by your doctor’s office if there is an urgent recall that you need to know about. However, if you have any question about whether your knee replacement has been recalled or if you aren’t sure exactly which knee replacement you received, then you can call your doctor’s office for this important information.
If you know that you have a recalled knee replacement device, then it is important to watch for signs and symptoms that it is failing. Generally, this may include physical pain, signs of infection, swelling, or difficulty standing or walking. Your doctor may be able to provide you with more specific symptoms to watch for based on the particular knee replacement device and the reason for its recall.
Take Action If You’re Hurt by a Defective Knee Replacement Device
You do not have a lawsuit simply because the knee replacement device that was implanted in your body has been recalled. However, if the device fails prematurely and you suffer a physical injury or require additional surgery, then you may have a claim against the pharmaceutical company that designed, made, or marketed the knee replacement device.
Our Massachusetts knee replacement lawyers are here to help you if you’ve been hurt. Contact us today for a free, no-obligation consultation about your rights and about how we may be able to help you get the full and fair recovery that you deserve.
I think my knee replacement is failing. What should I do?
You went through knee replacement surgery with the hope and expectation that your pain would decrease and your quality of life would improve. However, now you are experiencing concerning symptoms such as:
- Fever or signs of infection
- Lack of stability or mobility
These could be signs that your knee replacement is failing.
See Your Doctor for a Diagnosis and Treatment Plan
If you notice any sign that your knee is giving way or that you have developed an infection, then it is important to see your doctor as soon as possible. Your doctor will determine whether or not your knee replacement is failing. If your doctor finds that your knee replacement is failing, then revision surgery may be recommended.
Revision surgery can be more complicated and have a more significant impact on your life than your original knee replacement surgery.
Schedule a Free Consultation With a Defective Knee Replacement Lawyer
You consented to surgery and expected your DePuy Synthesis Attune knee replacement, Zimmer Persona Knee System, Zimmer High Flex Knee Implant, or other knee replacement device to last you for many years. If the knee replacement was defective, however, then it may fail much sooner than expected and require you to have a complicated and costly surgery.
The manufacturer of the knee replacement device may be responsible for your injury. With the help of an experienced attorney, you may be able to recover damages for your defective knee replacement. These damages may include compensation for past, current, and future medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other losses.
To learn more about your potential recovery and about how to protect your rights, please contact our defective knee replacement lawyers today for a free, no-obligation consultation. You can be confident that the pharmaceutical company is going to try to find a reason not to pay for the damages caused by its defective product. Let us convince the pharmaceutical company of its legal obligation to compensate you while you concentrate on your physical recovery.
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.
Is my employer required to have workers’ compensation insurance?
State law requires that almost all Massachusetts employers carry workers’ compensation insurance. A Massachusetts employer is defined as an employer who does business in the Commonwealth regardless of whether the employer’s headquarters is located in Massachusetts.
For the vast majority of Massachusetts employers, the requirement to carry workers’ compensation insurance applies regardless of the number of employees or the number of hours that the employees work.
Exceptions to the Massachusetts Workers’ Compensation Requirement
While almost all Massachusetts employers must have workers’ compensation, there are a few exceptions to the law. Specifically:
- Employers of domestic employees only need to carry workers’ compensation insurance if the domestic employee works at least 16 hours a week.
- Members of a limited liability company (LLC) or limited liability partnership (LLP) do not need to have workers’ comp insurance if they are the only ones working for the LLC or LLP and they do not have any other employees.
Additionally, corporate officers may request an exemption for themselves if they own at least a 25 percent interest in the corporation. This exemption would apply only to the qualifying corporate officers and not to any employees of the corporation.
How to Verify Your Employer’s Workers’ Compensation Insurance
As an employee, you likely want to know whether your employer carries workers’ compensation insurance. In Massachusetts, you can do this easily. All you need is the name of your employer’s business, the city or town where it is located, and the zip code. You can then check for workers’ comp insurance:
- Online. You can search for your employer’s insurance coverage online. However, your employer may have insurance, and it may not show up in an online search in some cases. If it does not show up, then you should verify coverage in another way.
- By phone. You can call the Office of Insurance, Department of Accidents at (617) 626-5480 or (617) 626-5481.
- By mail. You can download the insurance inquiry form and mail it to the Office of Insurance, Department of Industrial Accidents, 19 Staniford Street, 5th Floor, Boston, MA 02114.
- By fax. You can fax your insurance inquiry form to the Office of Insurance, Department of Accidents at (617) 624-0985.
- In person at the Department of Industrial Accidents in Boston. You will need to do this if you are searching for proof of insurance from 1986 or earlier.
Penalties for Employers Who Do Not Have Workers’ Compensation
Whether or not someone is hurt on the job, the Commonwealth of Massachusetts may impose penalties on any employers who do not have the required workers’ compensation insurance. The Department of Industrial Accidents (DIA) Office of Investigations may:
- Issue a stop work order (SWO) to the employer.
- Impose a fine of $100 a day (including weekends and holidays) beginning on the date the SWO was issued and ending on the date that workers’ compensation insurance starts and the fine is paid in full.
Employers who receive an SWO have a choice to make. They may appeal the SWO and remain open during the appeal. However, employers who choose this option will have their fine increased to $250 a day.
Further penalties may include being excluded from consideration for public contracts for three years and criminal penalties that include up to one year in prison and a fine of up to $1,500.
What to Do If You are Hurt at Work
There are specific steps that you should take if you’ve been injured at work in Massachusetts. In addition to checking to see if your employer carries workers’ compensation insurance, you should seek immediate medical attention and you should promptly report your injury to your employer. Your time to report your injury is limited and if you fail to make the report then your claim could be denied.
Additionally, it is important to consult with a Massachusetts workers’ compensation lawyer. Whether or not your employer had the required insurance, an attorney can make sure that all of your rights and your workers’ compensation benefits are protected. Call us or reach out to us via this website today to schedule a free and confidential consultation and to learn more about getting your medical expenses paid and a portion of your lost income reimbursed.