Defective Medical Device Frequently Asked Questions
Here, we have answered some of the most commonly asked questions we receive about defective medical device injuries. Please browse the questions and answers in this section to learn more about your legal rights and potential recovery.
- Page 1
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.
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.
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.
Is it financially beneficial for me to pursue a mass tort lawsuit after being hurt by a defective medical device?
We understand your question. Filing or joining a mass tort lawsuit is an important decision. Like all of life’s important decisions, it is important to consider the pros and cons, or benefits and costs, before you decide what course of action to take. Even if you were hurt by a medical device and your injury was caused by the pharmaceutical company that made the medical device, it only makes sense to pursue legal action if the potential benefits of a legal action outweigh the costs.
Possible Damages in a Defective Medical Device Mass Tort Lawsuit
The benefits of a medical device injury case are the damages that you may recover if your case is successfully settled or if the court returns a verdict in your favor. We can’t tell you the value of your potential damages in the answer to a frequently asked question—and you should be wary of any lawyer who claims to be able to give you a fast online quote. The simple reason for this is that each recovery is based on unique circumstances such as:
- The extent of your injury.
- The quality of the evidence that you have that links the design, marketing, or manufacturing of the medical device to your injury.
- The strength of the arguments that you make to the insurance company or the court.
These factors will impact the dollar value of your recovery. In general, however, you should be able to recover for your past, current, and future:
- Medical expenses. All of your health care costs including, but not limited to, hospitalizations, surgeries, doctors’ appointments, medications, physical therapy, and other rehabilitation therapies should be part of your recovery.
- Lost income. If you are unable to work because of your medical device injury, then you should be able to recover for the income that you were or will be unable to earn. This may include wages, benefits, bonuses, and income from self-employment, for example.
- Out-of-pocket costs. Any bills that you have that you would not have had but for your medical device injury should be part of your recovery. Depending on your unique circumstances, this could include things like modifications to your home or help around the house.
- Physical pain and emotional suffering. The physical pain and emotional suffering that you experience from your medical device injury may be your most significant damages. While it is impossible to put a precise price tag on these damages, an attorney can help you value them based on your unique injuries and the impact of those injuries on your life.
- Other damages. In some cases, for example, punitive damages that are designed to punish the pharmaceutical company may also be possible.
Additionally, you may feel a moral obligation and a sense that justice has been done by holding the pharmaceutical company accountable for its negligence. Your action will hopefully prevent the pharmaceutical company, and other pharmaceutical companies, from acting without due care for patient safety in the future.
What About the Costs of a Mass Tort Lawsuit?
While every lawsuit has costs—such as court costs, discovery expenses, and lawyer fees—mass tort actions are typically more financially efficient than individual lawsuits. You will be able to share in the costs with other people who join you in the mass tort action. At the same time, you retain control of your own individual claim, and you won’t have to divide or share the settlement or verdict with other plaintiffs the way you would have to do in a class action case.
Call a Mass Tort Lawyer for a Free Personal Case Evaluation
Since every medical device injury case is unique, it is important to understand what you have at stake so that you can weigh your own benefits and costs and decide whether or not to pursue a mass tort action.
Our experienced lawyers can help you with that. We can review your claim and your injuries and advise you of your rights so that you can make an educated decision. Call us or contact us via this website at any time to schedule your free, no-obligation consultation with us.
What should I do if I’ve been injured by a medical device?
Many of the actions that you take after suffering a defective medical device injury can impact your potential recovery. Some of the actions may help your recovery while other actions may hurt your recovery. You need to know about both the actions that can help you and the actions that can hurt you so that you can make sure your rights and potential financial damages are protected.
Four Things You Should Do If You Suffer a Defective Medical Device Injury
As soon as you notice a symptom, side effect, or medical condition that could be related to your medical device it is important to take action. Your actions may include:
- Seeing a doctor as soon as possible. The primary purpose of seeing a doctor whom you trust is to get an accurate diagnosis and to begin medical treatment. However, seeing a doctor may also have a significant impact on your potential recovery because it will document your injury and your attempts to recover from your injury.
- Documenting your symptoms and how they impact your life. Right now you might think that you will remember every bit of pain and every way in which your injury impacts your everyday life. However, as time goes on, the details may become fuzzy. Accordingly, it is important to keep a journal or calendar that documents how you are feeling and how your injury impacted your daily activities.
- Doing a little research. A simple internet search with the name of your medical device and the word injury may reveal whether or not other people are suffering similar injuries because of the same device and whether a mass tort action has been filed.
- Contacting a medical device injury lawyer. An attorney can review your claim with you and advise you of all of your legal options so that you can make an informed decision about protecting your rights.
These actions can help you better understand what happened to you, manage your medical condition, and protect your financial recovery.
Four Things You Should Not Do If You Suffer a Defective Medical Device Injury
The actions that you don’t take are just as important as the actions that you take. Accordingly, it is important that you do not:
- Try to treat your symptoms yourself. This can interfere with both your physical recovery and your legal recovery. You may end up making your injury worse or failing to make it better. Likewise, you may complicate issues of liability if you do make your physical condition worse by failing to get medical care.
- Negotiate directly with the pharmaceutical company or its lawyers. The pharmaceutical companies do not want to accept liability nor do they want to pay you for your injuries. Accordingly, they may try to deny or minimize your claim to protect themselves. Anything that you say to the pharmaceutical company may be misconstrued and may make your fair recovery more difficult.
- Post on social media. Anything that you put on social media may also be misunderstood and used against you when you pursue a recovery. For example, if you post a picture of yourself at a party, then it may be interpreted to mean that you are not as hurt as you claim.
- Wait too long to do anything. You only have a set amount of time to pursue a legal claim. If you file a lawsuit after the statute of limitation expires then you should expect the pharmaceutical company to file a motion to dismiss the lawsuit.
Any of these mistakes could interfere with the recovery that you deserve.
Let a Defective Medical Device Injury Lawyer Advise You on Your Next Steps
You shouldn’t have to guess about what to do, or not to do, after you suffer an injury. The potential consequences of your actions are complicated, and the potential impacts of your actions are serious.
Our experienced medical device injury lawyers can advise you every step of the way. We can weigh the pros and cons of each action you might take with you and provide you with valuable advice about protecting your rights after a defective medical device injury. To learn more about whether you may have a claim, please contact us today for a free, no-obligation consultation.