| Read Time: 4 minutes | Dangerous Drugs

Average Wrongful Death Settlement in Indianapolis?

Losing a loved one in an accident leaves their family and friends devastated. As they move through the stages of grief, they begin searching for answers and recognize the financial stresses associated with the loss of a loved one. Potential plaintiffs often ask what a wrongful death lawsuit average is when deciding if they want to pursue one. Unfortunately, there is no one average number. No two cases are exactly alike, so there is no way to compare cases to each other. The amount of compensation you can receive will depend on a number of factors. Understanding what a wrongful death claim requires and how damages are calculated can help the family decide how to proceed. Our Indiana wrongful death lawyers will explain. For immediate assistance, please don’t hesitate to send us a message or call (888) 437-5464 today for a free consultation. What is a Wrongful Death Suit? Wrongful death is a civil claim brought by the deceased’s surviving family or personal representative against the negligent party. It is completely separate from a criminal charge, with a different burden of proof. Every state defines wrongful death in its own way, but there are common elements: Duty of Care. The plaintiff must show that the defendant had a responsibility to avoid behaviors that could cause foreseeable harm to the plaintiff (the deceased);  Breach of Duty. The plaintiff must show that the defendant violated their duty of care; Causation. The defendant’s violation/breach caused the person’s death; and Damages. The deceased and their family suffered injury or damage as a result. In these situations, the family has the option to file a wrongful death lawsuit and seek compensation. What Damages Are Available in a Wrongful Death Case? A wrongful death claim covers those losses experienced by the next of kin after the deceased’s death. These can include: Loss of future inheritance, Loss of parental guidance (if they had minor children), Loss of spousal companionship (also called consortium), Loss of the decedent’s benefits such as retirement, and Loss of the decedent’s future income. Depending on your state, you may also be able to pursue a claim for losses suffered by the deceased prior to their death, such as medical expenses and pain and suffering. Your attorney can help you understand the laws that apply to you. How Are Wrongful Death Damages Calculated? Because each case is so different, it’s hard to name a number, or even a range, for damages. However, there are several factors that may affect a typical wrongful death settlement amount. Usually, the main consideration is the decedent’s status and circumstances at the time of death. Factors to consider include: Age of person at time of death; The deceased’s career, education, and earning capacity; Their state of health; Income at time of death; and The age and needs of the deceased’s legal dependents. The final amount of damages cannot be a guess. It must be supported by objective evidence, which can require expert witnesses. Because of this, it is so important to have a personal injury attorney on your side who knows how wrongful death cases work. If a case does reach a jury, the plaintiff can also ask for punitive damages. Punitive damages are intended to punish a defendant whose conduct is considered grossly negligent or intentional. Some states put a cap (limit amount) on this category. In Indiana, punitive damages are capped at the greater of three times compensatory damages or $50,000, whichever is greater. Kentucky and Illinois do not limit punitive damages. Who Can Bring an Indiana Wrongful Death Claim? Each state has its own laws stating who has the standing to bring a wrongful death claim and who can collect damages. Usually, only immediate family members like spouses, children, and parents of unmarried children can recover damages in a wrongful death suit. Often, these individuals also have standing to bring the wrongful death suit. However, many states require a deceased’s personal representative (executor, executrix, or court-appointed administrator) to bring suit on behalf of the family members. Is a Wrongful Death Settlement Taxable in Indianapolis? The IRS considers any portion of a settlement or award that is “compensatory” as non-taxable. Compensatory damages are intended to repay someone for a loss that they have already sustained and are not considered “income” for tax purposes. If the case goes to trial and a jury awards punitive damage, the result may be different. It is possible that any punitive damages in a jury award or settlement may be taxed.  How an Indiana Wrongful Death Lawyer Can Help You Navigating a wrongful death claim can be complicated and overwhelming. You may be grieving and wondering if a claim is in the family’s best interest. Sometimes insurance companies contact family members shortly after an accident and offer an amount that seems substantial. But in most cases, their offer will be significantly less than the family’s actual losses. A wrongful death claim will take an additional toll on everyone involved, so having an attorney is essential. First, they will be your advocate against the responsible party, insurance company, or opposing counsel. They know the law and how to navigate the legal system on your behalf. The loss of a loved one cannot be reclaimed through a wrongful death action. But a claim can compensate a family for emotional and economic harms so that they can begin to move forward. An experienced lawyer can help you negotiate a wrongful death settlement or represent you at trial if necessary. Suffering After the Loss of a Loved One? Did you lose a family member or loved one due to the negligent actions of another? The team at Gerling Law is incredibly sorry for your loss, and we want to help you if we can. Our Indiana wrongful death attorneys are dedicated advocates who will fight hard to get you the compensation you deserve after such a tragedy. We have successfully represented clients in Indiana, Illinois, and Kentucky in wrongful death suits and other personal injury matters...

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| Read Time: 2 minutes | Defective Medical Devices

Three New Lawsuits Come Forward Against Paragard IUD

July 14, 2020 – Three new lawsuits alleging that Paragard is defective and causes severe complications and injuries were filed against Teva Pharmaceuticals.   The first lawsuit, a ten-count complaint, was filed on May 11, 2020 in the US District Court for the Eastern District of California.  As of July 14, 2020, the case was before Magistrate Judge William B. Shubb.   Notable claims were negligence, strict liability design defect, strict liability manufacturing defect, and strict liability failure to warn.  In her lawsuit, the plaintiff reported that she had the Paragard IUD for approximately two years after its implantation before she requested for its removal.  Her doctor removed the IUD following the manufacturer’s instructions to find one arm of the device gone, which then required the doctor to search and recover the part via a hysteroscope.   The second lawsuit was filed on May 26, 2020, in the US District Court for the Southern District of New York. As of July 14, 2020, the case was before Judge Gregory H. Woods.  Notable claims were negligence, design defect, and manufacturing defect.  The second plaintiff had the Paragard IUD for approximately five years after its implantation before she experienced uterine pain.  Similar to the first plaintiff, the second plaintiff requested for the IUD to be removed only for the doctor to find that it was missing an arm when they removed it.  The plaintiff claimed that Teva Pharmaceuticals “knew or should have known that Paragard can and does cause serious harm to individuals who use it, due to the risk of the Paragard’s arm breaking upon removal.” The third lawsuit, an eleven-count complaint, was filed on May 28, 2020, in the US District Court for the Southern District of Illinois in the East St. Louis Division. As of July 14, 2020, the case was before Judge J. Phil Gilbert after being reassigned to him on June 24, 2020. Notable claims were negligence, failure to warn, violation of consumer protection laws, and gross negligence. The plaintiff was implanted with the Paragard IUD in 2008. In 2018, when her doctor attempted to remove the device according to Teva’s instructions, the device was missing an arm. The plaintiff underwent two procedures before the device was successfully removed. The plaintiff claims that “Paragard is inherently dangerous and defective, unfit and unsafe for its intended use.” All three plaintiffs claim that they were in good health when the Paragard IUD was implanted. When the IUD broke off while inside each plaintiff, they all required invasive procedures to remove the fragments. The plaintiffs allege that Teva Pharmaceuticals was aware of the dangers of the Paragard device and failed to warn the public about its risks. No trial date has been set in any of the three cases, yet they clearly depict the need for justice in the lives of those consumers who were burdened with serious injuries from their Paragard IUDs. Reference: “Paragard IUD Alleged to Cause Serious Injuries.” The National Law Review, www.natlawreview.com/article/paragard-iud-alleged-to-cause-serious-injuries.

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| Read Time: 2 minutes | Defective Medical Devices

Bayer Pays Roundup Plaintiff To Appeal Case

In an attempt to get a case to the Supreme Court, Bayer AG has entered into a deal with Georgia doctor John Carson where he is required to appeal his Roundup case and continue fighting against the company. Carson sued Bayer in 2017, and after Judge R. Stan Baker in Savannah did not throw the case out at the company’s request, litigation moved forward.  Baker decided in December 2020 that Bayer had no duty to warn Roundup users about its cancer risk because the Environmental Protection Agency (EPA) had approved the product’s label.  Other U.S judges have rejected this type of claim, known as a preemption claim. For Judge Baker’s decision to impact other  Roundup lawsuit cases, Bayer needs a federal appeals court to agree.  The company entered into a settlement with John Carson’s lawyer, Ashleigh Madison, in order to ensure that Carson appeals.  Bayer will be paying Carson as long as he follows through with appealing the preemptive question to the U.S. Court of Appeals in Atlanta.  Carson must also surrender any claims that he won. Bayer defends its settlement, explaining in a statement that it will pay Carson an undisclosed sum.  However, Carson will receive more money if he wins on appeal according to court records. “The parties have reached an agreement to resolve the Carson case on confidential terms contingent on the outcome of future appellate review of the district court’s dismissal of his failure-to-warn claims on federal preemption grounds,” Bayer said. If Bayer succeeds in Atlanta and then has a case heard by the Supreme Court, the company could potentially save hundreds of millions of dollars.  The Supreme Court is likely to only hear Bayer’s case if there is a contradictory decision in a different appeals court.  Before any of this can occur, Bayer must first win in Atlanta.  The company has shown confidence in its argument, stating in a legal brief that laws and regulations “make clear” that the EPA’s approval of a Roundup label without a warning should decide the case. A Loyola Law School professor, Adam Zimmerman, also agrees that a favorable Supreme Court ruling on preemption could curb the steady stream of Roundup lawsuits. “If you win on preemption, and you win at the Supreme Court, that’s a win that works in federal court, in different circuits and across the state courts in a way that can finally bring an end to a significant piece of the litigation,” Zimmerman said. Madison has declined to comment, and Carson has not returned calls to his office. Reportedly Madison has shared with other lawyers that the settlement is the “best possible outcome” for Carson and that, under the deal’s terms, the appeal is in his “best interest.” Reference:  Joel Rosenblatt. “Bayer Deal Pays Roundup Plaintiff to Keep Fighting in Court.” Bloomberg, www.bloomberg.com/news/articles/2021-04-21/bayer-deal-pays-roundup-plaintiff-to-keep-fighting-it-in-court.

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| Read Time: < 1 minute | Defective Medical Devices

Paragard Faces Lawsuits for Misinforming Patients of IUD Risks

Paragard is facing a growing number of lawsuits related to its IUD. In 2019, the U.S. F.D.A. informed the pharmaceutical company that its advertising was misleading and did not accurately inform patients of side effects. Multiple women have filed lawsuits against Paragard for not informing them of potential health issues, including: Uterine perforation, Ectopic pregnancy, and Pelvic inflammatory disease. Many of these lawsuits were consolidated into multidistrict litigation in 2020. Source: Legal Examiner

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| Read Time: < 1 minute | Defective Medical Devices

Hernia Mesh Lawsuits Resume As COVID-19 Restrictions Loosen

As COVID-19 restrictions begin to ease, court is resuming. Hernia mesh lawsuits against Bard, Ethicon, Atrium, and Covidien are moving forward in courts across the country. The lawsuits are focused on multiple product lines, including: Bard’s PerFix, 3DMax, Marlex, Kugel, Composix, Ventralex, Ventrio, Sepramesh, and Ventralight; Ethicon’s Proceed and Prolene; Atrium’s C-Qur; and  Covidien’s Parietex and Gore-Tex. Although the products and claims vary, progress in these cases will be telling for future hernia mesh lawsuits. Source: The National Law Review

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| Read Time: < 1 minute | Defective Medical Devices

Paragard Facing Lawsuits Over IUD Breaking Apart Inside Patients

More than 3,000 women have filed lawsuits against Paragard over their IUD. Many of the complaints detail the contraceptive breaking apart inside the woman’s uterus, resulting in the need for surgery and causing other complications. The F.D.A. has collected voluntary reports from Paragard IUD users since 2013. Their database shows that: 3,186 women reported broken devices, 1,910 of those reports resulted in “serious” complications, and More than 100 of those complications required hospitalization. While awaiting settlement, the plaintiffs are speaking out on social media about their experiences with the IUD.   Source: WJLA

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| Read Time: < 1 minute | Defective Medical Devices

Hip Implant Manufacturer Demands New Trial After Jury Rules Against It

Zimmer Biomet is filing for a new trial after a jury ruled they owed plaintiffs $3.55 million for a metal-on-metal hip implant. Lawyers for Zimmer Biomet state there are many missteps that opposing counsel and the court took to warrant a new trial, including Admittance of general evidence, Misrepresentation of the law, Allowing application of irrelevant law, and Submitting punitive damages to the jury. Metal-on-metal hip implant lawsuits are becoming more common. There are multiple other outstanding lawsuits against Zimmer Biomet that have been consolidated into a multidistrict litigation. Source: Mass Device

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| Read Time: 5 minutes | Car Accident

Examples of Wrongful Death Cases

Losing a loved one is a difficult thing for anybody. Losing a loved one due to someone else’s negligence can be even harder. Lives are cut short every day for many reasons, but losing a loved one in an accident caused by someone else’s negligent actions is especially tragic. When such an event happens, the family of the person who died is entitled to compensation. Wrongful death suits occur when someone who has lost a loved one due to someone else’s negligence files a claim against the individual responsible for the death. In 2019 more than 170,000 people lost their lives in the US from accidents or unintentional injuries. In fact, such accidents are the third leading cause of death in the US. While accidents happen in an almost infinite number of different ways, some wrongful death causes are more common than others. Here are some examples of wrongful death causes. Car Accidents There is no way to ignore the fact that driving a vehicle can be dangerous. While many of us may go years without getting into a car accident, others are not so lucky. Many wrongful death lawsuit cases happen each year after fatal car accidents. Generally, if a driver’s negligent actions cause a death on the road, they are liable for the wrongful death.  The number of car accident fatalities each year may surprise you. More than 38,000 people die in car accidents each year. In 2020, while there was less traffic volume than normal due to the COVID-19 pandemic, the number of vehicle fatalities rose. Some experts say that the increase in fatalities was due, in part, to increased rates of speeding in the US. If a loved one dies after a car accident that someone else negligently causes, you are entitled to compensation through a wrongful death claim. Some of the most common causes of death after car accidents stem from things like: Brain injuries, Neck injuries, and Internal bleeding. The two best things you and your loved ones can do to avoid suffering a fatal injury in a car accident are wearing your seatbelt and avoiding distractions while driving. Defective Products Defective products lead to numerous wrongful death claims each year. Most consumer products producers are responsible for ensuring consumer safety as long as their products are used as intended. Some products are inherently dangerous, but other times, a consumer product can have a fatal defect. For example, a cooking utensil that leaches deadly chemicals into food as it is used as intended can lead to a wrongful death claim against a manufacturer. Similarly, a safety feature in a vehicle that doesn’t work properly, like a seatbelt that comes unbuckled easily in an accident, can easily cause fatal injuries and leave the manufacturer liable for wrongful death claims. Even an inherently dangerous consumer product, such as a gun, comes with an assumption of safety with proper use. A defective part in a gun that causes a chambered round to go off without the user pulling the trigger can easily lead to a wrongful death claim.  When a manufacturer of goods is made aware of a dangerous defect in their product, they are responsible for notifying the public of that defect and recalling any defective products. They are also responsible for replacing those products free of charge. Boeing became responsible for numerous wrongful death claims after a design flaw caused some of their 737 Max commercial aircraft to crash in 2018. Since then, in addition to settling wrongful death claims, Boeing has recalled and replaced all of the affected 737 Max airplanes. If you want to keep track of any consumer product recalls to help ensure your safety, the US Consumer Product Safety Commission (CPSC) is the best place to do so. The CPSC website contains a database of all consumer product recalls. You can even subscribe to the CPSC to get a newsletter of product recalls relevant to you. Workplace Accidents Unfortunately, many accidents happen in the workplace. While all employers must provide their employees with a safe workspace, some employers fail to do so. Even an employer who takes all necessary precautions can have a fatal accident occur at their workplace. In addition, some jobs and workspaces are more dangerous than others. For example, a construction site will typically be more dangerous than an average office.  While the vast majority of workplace injuries are nonfatal each year, the number of fatal injuries is still significant. Employers in the US reported 2.8 million nonfatal injuries in 2019. During the same period, however, a total of 5,333 workers died due to workplace injuries. If a loved one dies after a workplace accident, you can file a claim through their employer’s workers’ compensation program. Most employers in the US are required to maintain workers’ compensation insurance. However, if a loved one dies due to negligence by someone other than their employer or coworker, or if the employer did not carry workers’ compensation insurance, you may be able to seek additional compensation through a wrongful death claim. Medical Malpractice Medical malpractice commonly gives rise to wrongful death claims. Medical malpractice is estimated to take roughly 250,000 lives each year. Generally speaking, medical malpractice occurs when an error in medical treatment leads to injury. If the patient dies due to a medical error, their loved ones are entitled to compensation through a medical malpractice wrongful death claim. To file a successful wrongful death claim based on medical malpractice, one must prove that the death was caused by a medical provider’s mistake that amounts to a violation of the medical standard of care. Pedestrian Accidents Another common source of wrongful death claims is pedestrian accidents. Unlike when a car strikes another vehicle, when a car strikes a pedestrian, the pedestrian does not have the protection that a vehicle offers. Thus, a pedestrian receives the full force of impact when a car strikes them. As a result, it is not uncommon for injuries to a pedestrian after being struck by...

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| Read Time: 3 minutes | Dangerous Drugs

Who Can File a Wrongful Death Lawsuit in Kentucky?

When you lose a loved one due to someone else’s actions, you may experience many emotions. Naturally, you feel grief and anger. You may also wonder how you can achieve justice for your loved one and prevent others from experiencing similar harm. At Gerling Law, we can’t take away your pain. However, we can help you pursue justice. We can help you hold the person who caused your pain accountable for their actions. Our compassionate attorneys have been representing victims and their families for decades. If you would like to speak with one of our knowledgeable lawyers, call anytime for a free consultation. When many clients initially speak with us, they’re not sure if they can sue for their loved one’s death. Here, we provide an overview of who can file a lawsuit for wrongful death and what such legal action involves. What Is a Wrongful Death Lawsuit? The goal of a wrongful death lawsuit is to compensate the surviving family for the harm they have suffered. Before considering a Kentucky wrongful death lawsuit, you should know what the term actually means. Wrongful death is the death of a person caused by the negligent or wrongful act of another. This wrongful act could be unintentional or purposeful. In other words, someone does not have to intend to kill your loved one for it to be a wrongful death. A person or company might be responsible for your loved one’s death. For instance, if a drunk driver hits your loved one, that individual should be held responsible. However, if a sober driver hit your loved one after her brakes malfunctioned, the auto manufacturer may be liable. Who Can File a Kentucky Wrongful Death Lawsuit? In Kentucky, the personal representative (executor) of the deceased’s estate can file a wrongful death lawsuit. The probate court names a personal representative based on the instructions in the deceased’s will or the preference of the judge. While the personal representative files the wrongful death lawsuit, most of the lawsuit proceeds go to the deceased’s estate and surviving family members. Funeral and burial expenses, as well as attorney fees, go to the estate. But then the remainder of the award goes to the deceased person’s surviving family members. Payment is awarded according to these rules: All to the surviving spouse if there are no surviving children; If there are a surviving spouse and surviving children, half to the spouse and half divided among the children; If there is no surviving spouse, all divided among the children; or  If there is no surviving spouse or children, all to the surviving parents. If there is no surviving spouse, children, or parents, the wrongful death award goes to the estate. After paying debts, the award will be distributed according to the deceased’s will or intestate succession rules. What Damages Are Available? A wrongful death lawsuit compensates family members for the harm they have suffered as a result of their loved one’s death. You can sue for these damages in a wrongful death case: Pain and suffering, Loss of companionship, Loss of support, Loss of care, Funeral and burial expenses, and Attorney fees. You may also be able to request punitive damages for intentional harm or gross negligence. These damages go beyond compensating your family for the harm suffered. Instead, they serve the goal of punishing the person for their wrongful actions. The State may choose to criminally prosecute the defendant, but that is a separate legal action. A criminal prosecution punishes a wrongdoer by taking away their freedom. A wrongful death lawsuit is a civil action that will not put the defendant behind bars but seeks to financially compensate your family for the death of your loved one. If you think you might have a Kentucky wrongful death claim, you should contact an experienced attorney. At Gerling Law, we have helped grieving family members with wrongful death claims in Kentucky for decades. We have the experience to get the results you deserve while showing you compassion and respect. Contact our law firm for a free consultation. You’ll have the opportunity to ask questions and get to know our knowledgeable legal team. If we think we can help you, you should know that we work on contingency. This means you owe us nothing until we win your case. Review our decades of winning cases here, and call us when you’re ready to talk. Don’t trust the fight for justice and your family’s financial future with just anyone. Remember: Go with Experience. Go with Gerling.®

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| Read Time: 2 minutes | Defective Medical Devices

Bard To Pay $3.6 Million In IVC Filter Bellwether

March 30, 2018 – An Arizona jury unanimously ruled in favor of Plaintiff who claimed that she suffered injuries after receiving a G2 IVC filter device which later fractured in her body. Visit our IVC filter lawsuit page for more information. Please don’t hesitate to call us today if you think you need help with a similar case. References: Silvestrini, Elaine. “$3.6 Million Awarded in First Bard IVC Filter Case.” Drug Watch, 30 March 2018, https://www.drugwatch.com/news/2018/03/30/3-6-million-awarded-first-bard-ivc-filter-case/. “Bard Hit With $35M Punitive Damages In NJ Mesh Case.” Law360, 13 April 2018,  https://www.law360.com/articles/1033164/bard-hit-with-35m-punitive-damages-in-nj-mesh-case. “Class 1 Device Recall OptEase Vena Cava Filter.” U.S. Food and Drug Administration, 29 March 2013, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119066. “Class 3 Device Recall Gunther Tulip Vena Cava Filter Sets”. U.S. Food and Drug Administration. 19 March 2019, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=171163. “Compensation for IVC Filter Patients”.  Consumer Safety Watch, https://www.consumersafetywatch.com/compensation-ivc-filter-lawsuit/?gclid=Cj0KCQiAqdP9BRDVARIsAGSZ8AlPudcVEUnp1J7fZ2qrJkMsyt7PIhRz4ZIIW5FZmqb9cxvtM3oe_hYaAsbdEALw_wcB. Deso, Steven E., et al. “Evidence-Based Evaluation of Inferior Vena Cava Filter Complications Based on Filter Type.” Thieme Medical Publishers, June 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC4862854/. “IVC Filter Lawsuit – Legal Claims for Complications and Injuries”.Shouse California Law Group, https://www.shouselaw.com. Morales, JP, et al. “Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.” Journal of Vascular Surgery. Venous and lymphatic disorders 1(4):376-84, https://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM396384.pdf. “Multidistrict litigation”. 28 USC 1407, ttps://www.law.cornell.edu/uscode/text/28/1407. Polemenakos, Lori. “$1.2 Million Verdict Reached In Cooke Celect IVC Filter Trial.” Leading Response, 30 May 2018, https://leadingresponse.com/ivc-filter-verdict/. Ray, John. “Will $33.7 Million IVC Filter Verdict Expedite Mass Settlement?” Mass Tort Nexus, 30 October 2019, https://www.masstortnexus.com/News/5406/Will-337-Million-IVC-Filter-Verdict-Expedite-Mass-Settlement#:~:text=Rex%20Medical)-,The%20Jury%20awarded%20Tracy%20Reed%2DBrown%20%241%2C045%2C764%20million%20in%20future,presided%20over%20the%20Reed%20case. Shah, Rena, MD et al. “Appropriate Use of Inferior Vena Cava Filters.” American College of Cardiology, 31 October 2016, www.acc.org/latest-in-cardiology/articles/2016/10/31/09/28/appropriate-use-of-inferior-vena-cava-filters. Silvestrini, Elaine. “$3.6 Million Awarded in First Bard IVC Filter Case.” Drug Watch, 30 March 2018, https://www.drugwatch.com/news/2018/03/30/3-6-million-awarded-first-bard-ivc-filter-case/. Teicher, Erica. “Johnson & Johnson hit with over $1 billion verdict on hip implants.” Reuters, December 2016, https://www.reuters.com/article/us-johnson-johnson-verdict-hipimplants-idUSKBN13Q5XF. Turner, Terry. “IVC Filter Lawsuits, Verdicts & Settlements”. Drugwatch, 7 July 2020,  https://www.drugwatch.com/ivc-filters/lawsuits/. Turner, Terry. “IVC Filter Removal”. Drugwatch, 17 November 2020, https://www.drugwatch.com/ivc-filters/removal/. “Warning Letters – C.R. Bard, Inc. 7/13/15.” U.S. Food and Drug Administration, 13 July 2015, https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm455224.htm

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