Personal Injury News & Developments

Articles Posted in Dangerous Drugs & Medical Devices

Concerns arise about Invokana and OsteoporosisAt the time of FDA approval for Invokana (canagliflozin) in 2013, the benefits versus risks of the prescription medication to treat diabetes had already become highly questionable. Within the first two years of availability in the United States, serious concerns over the drug turned to reality when clinical studies showed users were experiencing reduced bone density in their hips and lower spine.

Invokana is a glifozin class drug that is prescribed by family doctors to treat Type II diabetes. Developed and manufactured by Mitsubishi Tanabe Pharma, the prescription medication is marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The oral diabetes prescription medication has shown to be highly effective in controlling blood sugar levels by assisting the kidneys in ridding the body of glucose in the bloodstream. The drug marketers claim that with exercise and diet, Invokana can be highly effective at treating and controlling diabetes.

Even before the prescription medication had become available in the United States, the pharmaceutical manufacturer and marketers had already become aware that the drug posed serious problems, even during short-term use. Before its approval in the U.S., many patients in other countries that already suffered serious kidney damage or become victims of heart attacks and ketoacidosis. In some cases, patients were suffering bone fractures in less than 90 days after first taking the drug. The risk of fractures and bone loss seem to be most prominent in women of post-menopausal age.

The FDA Warning

In October 2015, the FDA (Food and Drug Administration) issued a warning advising doctors to consider the high potential risks of bone fractures before prescribing Invokana or generic canagliflozin medications. The FDA is also monitoring similar glifozin drugs that are all SLGT2 (sodium-glucose co-transporter-2) inhibitors. These drugs are designed to lower blood sugar levels by blocking glucose reabsorption in the kidneys. It does this through an increased excretion in urine.

Long before the FDA warning, Mitsubishi Tanabe Pharma and Janssen Pharmaceuticals had begun saturating the market of family doctors with materials promoting Invokana as a wonderful effective drug. However, during this time, experts reviewing the medication showed ambivalence because clinical studies indicated a high risk to patients already suffering with cardiovascular disease, noting that the medication seem to increase heart attack levels.

Opponents of the drug becoming legal in the United States show that the medicine label did not include a warning concerning strokes and heart attacks. As a result, even the most conscientious family doctor would have little to no idea of the exposure to adverse side effects when prescribing the medication to their patients suffering Type II diabetes. In addition, these opponents also showed concerns that the medication has been proven highly dangerous for individuals suffering kidney disease.

Study findings published in Diabetes Care, a well-respected medical journal show that Invokana was helpful for individuals Type I diabetic requiring glycemic control. However, the study showed that the drug also increases potential risk of developing ketoacidosis, or high acid levels in the bloodstream cause significant health complications that often require emergent hospital treatment.

Hiring an Invokana Injury Attorney

As of yet, claims for compensation against the manufacturer and marketer of Invokana have not reached the status of a class action suit. Currently, reputable personal injury attorneys including Rosenfeld Injury Lawyers are filing individual lawsuits and claims for compensation on behalf of their clients. To raise concerns about the development of osteoporosis as a direct result of taking Invokana, other claim for compensation involve:

  • Kidney failure and impairment,
  • Developing kidney stones associated with Invokana use,
  • Fluid imbalance and severe dehydration,
  • Abnormal weight loss,
  • Urinary tract infections caused by the diabetic drug.

The bad drug injury attorneys at Rosenfeld Injury Lawyers can provide you with various legal options to hold Mitsubishi Tanabe Pharma and Janssen Pharmaceuticals financially accountable for your damages, losses and injuries. Our team of skilled, experienced attorneys can help build a case for compensation by showing the marketer and manufacturer’s failure to warn you of potential risk, negligence making and selling a defective medication and misrepresenting the benefits and risks of Invokana. We encourage you to call our law offices today at (888) 424-5757 to discuss your claim for compensation.

Xarelto and its' LawsuitsPrescription drug marketer Janssen Pharmaceuticals has begun a full press marketing blitz to promote a leading blood thinning medication Xarelto (riboroxaban) by using familiar celebrities. The promotional campaign commercials involve golfer Arnold Palmer, professional racer Brian Vickers, Chris Bosh from the Miami Heat and comedian/actor Kevin Neely. The celebrities have all taken the prescription medication for a variety of conditions that require treatment for deep vein thrombosis (DVT), atrial fibrillation, pulmonary embolism and blood clots.

Xarelto is a leading anti-coagulation (blood thinner) prescription medication manufactured by Bayer Pharmaceuticals. The drug is promoted to reduce the potential risk of blood clots and stroke in individuals suffering from atrial fibrillation that is not associated with heart valve problems. In addition, the FDA has approved Xarelto to treat pulmonary embolism and deep vein thrombosis, and help reduce the potential recurrence of these conditions.

The drug has also received approval as a treatment to reduce the potential risk of forming blood clots in the lungs and legs of individuals who have recently undergone hip or knee replacement surgery. Despite its widespread use, the drug has caused many patients to suffer with serious adverse side effects.

Serious Side Effects

There are significant health issues associated with taking Xarelto that have the potential of claiming the lives of unsuspecting patients who were not properly warned against its dangers. The anti-coagulant has serious side effects that cause hemorrhaging, embolism, blood clots, internal bleeding and death due to uncontrollable bleeding. This is not the first time that manufacturers and marketers have been sued for failing to warn consumers or inform doctors on the adverse effects of a bad drug that causes internal or uncontrolled bleeding.

Xarelto has been known to increase bleeding in patients who have undergone hip surgery, are acutely ill and require blood thinners to minimize the potential of developing blood clots, or those suffering from ACS (acute coronary syndrome). Patients suffering many of the adverse side effects caused by Xarelto often face extensive hospitalization, enormous medical expenses and considerable time away from work. In some cases, patients have died due to uncontrollable internal bleeding.

Many victims and surviving family members have filed personal injury claims and wrongful death lawsuits in an effort to obtain financial compensation for their damages. By taking action, the victims can hold the marketer and manufacturer liable for making and selling a dangerous drug.

Building a Case for Compensation

Every case involving adverse side effects caused by Xarelto are unique. Even so, many victims of the dangerous drug are eligible to participate in personal injury lawsuits and class-action suits taken against Bayer and Jensen Pharmaceutical companies. However, building a strong case for compensation is complex. Rosenfeld Injury Lawyers have handled many cases against bad drug manufacturers and marketers, including those that produce and promote Xarelto. These cases have been built on legal liability strategies that involved:

  • Failure to provide adequate warning and misleading the public about the drug’s potential risk of causing uncontrollable bleeding.
  • Failure to inform patients that no antidote is available to reverse blood thinning of Faxon hemorrhaging caused by the prescription medication.
  • Showing a direct connection between the death of a loved one and the use of Xarelto that caused the victim to bleed to death.

Hiring an Attorney

Even though the drug has only been available in the United States since 2011, nearly 2000 lawsuits have already been filed by victims suffering injuries from the medication or their surviving family members. Rosenfeld Injury Lawyers offer aggressive, swift legal recourse to hold Bayer and Janssen Pharmaceuticals legally liable for making and promoting the unsafe product. Our team of lawyers demand complete justice for our clients and have ample resources to take on the drug industry.

Our law firm provides compassionate legal counsel through successful negotiation skills and trial advocacy. With years of seasoned experience, we aggressively fight on your behalf against the major drug manufacturers that have caused such profound loss for you and your family. We encourage you to call our law offices today at (888) 424-5757 to schedule a no obligation, free initial consultation. Our team of attorneys will evaluate your case and provide numerous legal options to recover your financial damages so you can heal from your injuries.

Faults with Bair Hugger Warming Blankets3M Bair Hugger manufactures and sells a forced air warming blankets that are used during implant surgeries nationwide. The blanket helps patients who are under anesthesia regulate their body temperature while it prevents hypothermia. Using a surgical hose, the system forces hot air into the disposable blanket draped over the patient’s larger body areas during surgery. The warming blanket has been used by many surgeons during millions of surgical procedures each year as a way to reduce the chance of hypothermia, when the patient loses body heat at a rate faster than it can be produced.

While designed to reduce the potential risks of developing an infection, the device might actually cause an infection by blowing highly contaminated bacteria-laden air from the tainted floor area into the patient’s opened surgical site. The potential risk of developing an infection is especially severe for individuals undergoing artificial heart valve implant surgery or joint replacement surgeries including knee and hip replacements.

The Inventor Speaks Out

The potential risks of developing infections are so severe that even the inventor of the device is warning health care providers and surgeons of the potential serious problems the device could cause during orthopedic and heart surgery. The inventor of the Bair Hugger warming blanket, Dr. Scott Augustine first introduced the device in 1988 through his privately owned company. However, the doctor now claims the device creates significantly higher risk than once believed. This is because studies now show how the patient is exposed to dangerous contaminants transferred from the floor into their opened surgical site.

The warming blankets were first marketed through the Augustine Medical Company before its name was changed to Arizant. In 2002, the doctor resigned his Arizant positions as chief executive and chairman of the board. By 2010, Arizant was purchased by 3M.

In response to claims made by Dr. Augustine, 3M stated that they believe “Mr. Augustine’s allegations against forced air warming stand from a personal vendetta and are baseless.” However, there are at least 14 lawsuits filed in U.S. federal courts alleging serious complications involving infections by patients who would undergone surgery using the Bair Hugger warming blanket system.

Bair Hugger Litigation

Most lawsuits filed in U.S. District Court for the District of Minnesota have made claims that patients develop serious infections after implant replacement surgeries. Many of the lawsuits claim that the device interfered with operating air flow and caused contaminants and bacteria to spread into the patient’s surgical site. Some of the patients had to undergo an additional surgery involving removal and replacement of the affected implant.

Lawsuits filed against Arizant and 3M claim that the device manufacturers were negligent during the design, manufacturing and promotion processes of all Bair Hugger devices. Many of the plaintiffs have filed a lawsuit to seek financial compensation to cover past, current and future damages that involve hospitalization, medical expenses, lost earnings and loss of earning capacity along with pain, suffering, grief and mental anxiety.

Even though there have been repeated warnings and escalating scrutiny involved in Bair Hugger warming blankets, many hospitals and surgeons still use the devices for orthopedic surgeries nationwide. In all likelihood, there will be many more Bair Hugger infection lawsuits and claims filed against the manufacturer and distributors of the product.

Filing a Lawsuit for Compensation

The medical device recall attorneys at Rosenfeld Injury Lawyers are currently evaluating potential claims for compensation from patients who have suffered life-threatening infections after implant surgery. Our team of lawyers are working on behalf of our clients injured by Bair Hugger forced air warming blankets during their hip or knee replacement surgery or heart valve replacement surgery that cause complications involving:

  • Sepsis (septic knee or hip infection)
  • Methicillin Resistant Staphylococcus Aureus (MRSA)
  • Amputation
  • Deep joint infections that require additional surgery or antibiotic spacers
  • Wrongful death

Our reputable, experienced attorneys encourage you to call our law offices today at (888) 424-5757 for a case review to determine your eligibility for an individual injury claim or involvement in a Bair Hugger class-action suit. You might be entitled to receive financial compensation to cover your losses, damages and injuries. We accept these types of cases on contingency so no upfront fee is required.

Bair Hugger Infections post surgeryMany patients have developed serious life-threatening infections after hip and knee replacement surgeries from using temperature management systems developed and sold by 3M Bair Hugger. Many of these individuals have filed lawsuits against the manufacturer of the device claiming negligence of its potential risks and safety hazards. This is because many studies have indicated that the Bair Hugger warming system could potentially increase the risks of infection during orthopedic surgeries.

These warming devices are used during surgical procedures as a way to regulate body temperature. Currently, more than 50,000 warming systems sold by the device manufacturer are used in nationwide hospitals and have warmed millions of patients since the products were first brought to the medical marketplace.

Many personal injury attorneys, including Rosenfeld Injury Lawyers, have claimed that the forced air warming blankets have design defects that cause a disruption of laminar flow during surgeries in operating rooms nationwide. The defects allow bacteria and other dangerous contaminants to transfer from the floor and enter the patient’s surgical site. The defect increases the potential risks of knee and hip implant patients to develop a life-threatening joint infection after surgery.

Consolidation through Multidistrict Litigation (MDL)

Currently, there are at least 14 knee and hip replacement lawsuits filed by victims in U.S. courts. These lawsuits allege that the victims have developed life-threatening joint infections caused by the forced air warming blankets that are designed, manufactured and sold by Bair Hugger. In August 2015, a plaintiff in one case filed a motion with the Judicial Panel of Multi-District Litigation (JPML) to consolidate all Bair Hugger infection-associated federal claims filed in the United States District Court (Minnesota) to create a class action suit against all parties considered at fault. Multidistrict litigation (MDL) consolidation of the cases through JPML provides plaintiffs and defendants an opportunity to:

  • Reduce the amount of duplicate discovery in every case,
  • Avoid any conflict involving pretrial rulings,
  • Provide a level of convenience to the court system, witnesses and all parties involved.

A Risk of Infection

More than eight out of 10 hospitals in the United States use temperature management systems designed, developed and manufactured by Bair Hugger. However, numerous studies have indicated that this type of therapy increases the potential risk of patients developing serious life-threatening infections during orthopedic high-risk surgery. Many of these surgeries involve implants including artificial heart valves, hip implants and knee implants. The increased risk of contamination and infection is significantly higher for these types of procedures compared to other surgeries.

Why File a Bair Hugger Lawsuit?

The manufacturers of medical devices have a legal responsibility to design, develop and promote medically safe products to consumers that are used by health care professionals. Many of the lawsuits that have already been filed accuse 3M Bair Hugger of failing to thoroughly and properly test their devices, failing to conduct substantial testing after the product was brought to market and failure to surveil their products after becoming aware of the products’ numerous life-threatening adverse effects.

Personal injury attorneys and wrongful death law firms, including Rosenfeld Injury Lawyers, have filed lawsuits against 3M for failing to provide adequate warning to health care professionals who use circulating air inside operating rooms using devices that have a defect that could lead to infection. In addition, the lawyers have claimed misrepresentation by the design manufacturers because they recklessly and knowingly disregarded their duty to inform consumers of known defects that cause unsafe conditions.

Hiring an Attorney

The attorneys at Rosenfeld Injury Lawyers are currently handling Bair Hugger lawsuits and claims for compensation on behalf of individuals who have developed serious life-threatening infections including sepsis and MRSA after knee or hip replacement surgery involving forced air warmer systems. If you, or your loved one, have suffered serious harm as a result of these procedures, you are likely able to obtain financial compensation to cover all injury related damages, injuries and harm.

We invite you to call our law offices today at (888) 424-5757 for a no-obligation, free legal review of your case. Our team of successful attorneys can ensure you receive adequate payment for your hospitalization, medical expenses, doctor fees, prescription medications, physical therapies and rehabilitation costs associated with your injuries caused by negligence of others. Call today to learn about protecting your legal rights for financial compensation.

Uncontrollable Bleeding Caused by XareltoIn 2011, the FDA (Food and Drug Administration) approved the blood thinner Xarelto (rivaroxaban) for prescription as an effective anticoagulant. The prescription medication is manufactured by Bayer and marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

Almost immediately, many patients suffered its dangerous side effects including uncontrolled bleeding. While bleeding is not uncommon when taking anticoagulants, many personal injury attorneys, including Rosenfeld Injury Lawyers, allege that Xarelto is significantly more dangerous compared to other blood thinners because it lacks an antidote for reversing many of the effects of blood thinning.

That means during emergent situations, the individual might be at risk for a life-threatening irreversible bleeding issue including gastrointestinal or internal hemorrhaging. As a result, many patients prescribed the drug have filed lawsuits against the manufacturer and marketer on the grounds that they did not receive adequate warning against the dangers of using the blood thinning medication.

Marketed as Better Than Warfarin

Janssen Pharmaceuticals have marketed Xarelto as easier and better to use than other anticoagulants including Coumadin (warfarin). The manufacturer and marketer say the medication does not require routine blood monitoring like all other dangerous anticoagulants as a way to ensure that the patient’s blood levels remain in a therapeutic range.

Holding the Drug Company Accountable

Xarelto, like all other dangerous drugs, can cause significant harm and death to patients. When the pharmaceutical companies, doctors and other healthcare providers fail to adequately warn the patient about the drug’s associated risks, all parties involved can be held legally accountable.

In many incidences, filing a Xarelto lawsuit is the only sure way to obtain financial recompense for losses, harm and emotional injuries. Today, nearly 2,000 individuals have filed lawsuits against the manufacturer and marketer of Xarelto for numerous reasons including a failure to warn. These individuals receive compensation to cover their damages that include:

  • Financial hardship associated with emergency room visits, lost wages and ongoing care.
  • Mental and emotional distress of dealing with severe medical issues.
  • The associated expenses of a Xarelto wrongful death lawsuit including funeral costs and financial losses directly associated with uncontrolled bleeding.
  • Holding both Bayer and Janssen Pharmaceuticals financially accountable for manufacturing, marketing and releasing the extremely dangerous prescription medication to the public.

Common Complications and Side Effects

The most severe side effects that can potentially claim the life of the victim using Xarelto is internal bleeding that causes death. Many of the injured or killed patients were never told there was no cure (antidote) to reverse internal bleeding caused the prescription medication.

Other potential harm directly associated with using Xarelto include:

  • Life-threatening infections after knee or hip replacement surgery,
  • Swelling of the lower limbs (peripheral edema),
  • Cerebrovascular accident that involves cerebral hemorrhaging,
  • Decreased hemoglobin is required to carry oxygen in the patient’s red blood cells, and/or
  • Difficulty in breathing (dyspnea).

If your doctor has currently prescribed Xarelto for your condition, it is essential to avoid any activity where you could be bruised, cut or suffer internal/external bleeding. Sustaining any of these injuries could be life-threatening especially if you experience severe headaches, dizziness, weakness, confusion, persistent bleeding, bruising, vision changes and swelling. Pregnant women are especially susceptible to serious injury, complications and side effects of Xarelto.

Receiving Compensation

Nearly 2000 patients have filed lawsuits to seek financial compensation from the Xarelto manufacturer and marketer to cover their past, current and future medical expenses, lost wages, other financial losses and damages including pain and suffering. In some cases, surviving family members have filed a Xarelto wrongful death lawsuit as a way to punish the defendants and deter any other pharmaceutical manufacturer or marketer from acting similarly.

Rosenfeld Injury Lawyers have filed lawsuits and claims on behalf of many injured victims suffering damages and losses through bad prescription medications including Xarelto. Our attorneys accept Xarelto uncontrollable bleeding lawsuits on a contingency fee basis. This means we are only paid once we have provided you a favorable outcome by resolving your case through an out-of-court settlement or jury verdict in your favor.

Call our law offices today at (888) 424-5757 to schedule a free case review. Our personal injury attorneys working on your behalf can offer you various legal options to seek financial compensation and hold those legally responsible accountable for your losses.

IVC Filter LawsuitsThe Chicago IVC filter attorneys of Rosenfeld Injury Lawyers have been investigating numerous claims on behalf of clients who believe that the devices were directly responsible for severe bodily harm. In response to a mounting number of cases against C.R Bard on behalf of those who were injured by the Recovery and G2 IVC filter product lines, a multidistrict litigation has been formed to hear facts that are common to all of the cases involved. The result of this multidistrict litigation will have an impact on the cases currently being heard as well as any that will be filed in the future.

Clients Allege IVC Filters Cause Bodily Harm

The devices produced by C.R Bard and other IVC filter manufacturers are designed to prevent pulmonary embolism and other events that are the result of blood clots moving from the leg to other areas of the body. They work by trapping the clots and then holding them in place until they dissolve or break into smaller pieces that are able to pass through the bloodstream safely. C.R Bard is the largest manufacturer of these devices, and the first to be named in lawsuits that claim a new line of recoverable filters have been released with numerous defects that pose significant risks and that those risks were not communicated properly to patients.

Among the complications resulting from the defects are the tendency for the filters to splinter, puncture the vein wall and migrate to other areas of the body. Internal bleeding caused by the perforation of major blood vessels pose a fatal risk due to blood loss or the development of life threatening infections. The most serious injuries have resulted from the puncture or perforation of major organs due to the fracture or migration of the devices and victims have cited the need for emergency operative procedures to address the injuries.

What Multidistrict Litigation Means for Your Case

A multidistrict litigation is a means that courts take both to condense multiple cases against a common defenses into one pretrial hearing and to ensure that the end result of individual cases are more consistent. The C.R Bard MDL involves 22 cases to be heard in the U.S District Court of Arizona and will evaluate all of the common questions of fact between each case before sending the litigation back to each individual court. It is important to understand that while an MDL establishes facts to be heard in individual cases; those cases are still returned to the courts where they originated for a final verdict.

Our Chicago medical device liability attorneys are monitoring the ongoing multidistrict litigation and will be able to answer any questions that you have about how current facts and litigation may impact your own IVC filter case. If you have not taken advantage of our free case review yet, now is the time to contact us as we are currently reviewing and accepting cases while this mass tort continues to grow.

Damages Sought in Current Litigation

Current victims are seeking compensation in the form of the value of medical bills, wages lost due to the inability to work throughout their physical recovery, out of pocket expenses, pain and suffering and punitive damages. When evaluating your case, we will consider the current value of your injuries in addition to the long term impact on your finances. If the multidistrict litigation favors the plaintiffs, it may be possible that C.R Bard will make attempts to settle the matter outside of court. It is important that you never accept a settlement offer without first having it reviewed by an attorney, as the offers may affect your legal rights in the future, should you choose to accept them.

Rosenfeld Injury Lawyers is the leading personal injury firm in Illinois and we have successfully recovered compensation for thousands of clients who have been injured due to defective medical devices. Contact us today to learn more about how we can maximize your chance of a successful claim and your legal options in light of current developments with this mass tort. Our consultations and case reviews are completely risk free and if you are unable to travel to us, we will gladly meet you at your location of choice.

Our Chicago IVC filter attorneys only collect attorneys’ fees when we’ve successfully secured damages on your behalf and you are ensured that you will never be required to pay a fee at any point prior to receiving compensation. If you don’t receive compensation, neither will we.

IVC Filters and their RisksIn the five year span between 2005 and 2010, the FDA investigated 921 claims by patients receiving IVC filter implants and their families, stating that the devices were responsible for serious injuries due to fragmentation, migration, and punctured organs. In light of the sea of litigation that followed the FDA’s warning regarding the risks associated with the devices, a study was conducted to determine the efficacy of the IVC filter and how well it compares to the traditional treatment options involving anticoagulants to shrink and break up the blood clots without the need for surgical intervention. The results of the study were surprising and suggest that IVC filters are not worth the risk.

Evaluation of Recurrent Pulmonary Embolism

In a study conducted by French physicians, four hundred patients were monitored to determine whether IVC filters were more effective than blood thinning medications at preventing pulmonary embolism, which results when a blood clot reaches the lungs. The general consensus among the researchers was the hypothesis that anticoagulants— which come with risks of their own, such as uncontrolled bleeding— would be far less effective in the reduction of recurrent pulmonary embolism and mortality. At the conclusion of the study, it was revealed that both treatment options had the same level of impact.

Two hundred patients were treated with retrievable IVC filters such as the C.R Bard and Cook filters that have been subjected to such expansive litigation over the last decade. The other two hundred were treated solely with anticoagulants. Three months later, six of the patients receiving the IVC filters had exhibited recurring pulmonary embolism compared with three patients who had been treated with blood thinners. The difference was negligible and revealed that both treatments had similar success rates and while blood thinners come with their own risk of adverse health events, their risk to patients is far less significant than that of the IVC filters.

IVC Device Manufacturers Coming Under Fire

It is a common misconception that the IVC filter is a recent invention because it was not until the mid-2000s that reports began to surface following serious injuries and fatal events associated with devices manufactured by Cook and C.R Bard. In reality, the IVC filter has existed since the 1960s and about 100,000 people have undergone treatment in which the devices were used. The recent onslaught of injuries and lawsuits is a referendum primarily on the current manufacturers of the device and the living victims and families of those who have died from their injuries allege that the devices are defective and that the manufacturers did not provide adequate warnings to patients about their risks.

Common injuries that occur when an IVC filter migrates or fractures are internal puncture wounds and perforations of internal organs and migration of the devices into critical organs including the heart and lungs. Prior to the development of retrievable IVC devices, the filters were permanently implanted and there may be a connection between the first retrievable filters being brought to market and the resulting injuries. None of the retrievable devices received approval in the United States and made it to market through the 510(k) provision that clinical trials and research would not be required for products that are similar to those which have received past approval.

In cases currently being heard across the country, the argument is being made that Bard knew as early as in 2003 that its Recovery IVC filter could break apart, migrate or puncture the vein wall or major organs. Its decision to continue marketing the product and failure to warn doctors or patients of the uncovered risks are grounds for a medical negligence lawsuit and some of the plaintiffs are seeking punitive damages on the basis that Bard knowingly allowed the devices to be sold after the risks were revealed.

To learn more about your rights as well as the status of current IVC litigation and how it may impact your case, contact the Chicago IVC attorneys of Rosenfeld Injury Lawyers. We would be happy to perform a free case review to determine whether you are entitled to compensation and to prepare a legal strategy that will maximize your recovery as we’ve done for thousands of our clients in the past. You will not be required to pay any legal fees or other costs for our services upfront and we will only collect payment once we’ve secured compensation on your behalf. If we fail to collect for you, our services are free.

Use of Drug Linked to PancreatitisThe latest report to surface regarding Invokana and other SGLT2 inhibitors in the same drug family has added yet another serious side effect to the growing list. The FDA has already launched an investigation into reports that have linked the medicines to ketoacidosis, which results when ketone levels create excessive acids in the blood. Now we can add pancreatitis to the list of side effects, and this one is serious as it is a rare and very deadly condition that results from the inflammation of the pancreas. This latest news will not bode well for the maker of Invokana, which is already the subject of numerous lawsuits.

The Current Side Effects Associated with Invokana

To understand the side effects associated with Invokana, you need to understand the mechanics of hyperglycemia (high blood sugar) and how the medication works to reduce blood sugar in type-2 diabetics. One of the ways in which glucose is eliminated from the body is through our urine and Invokana prevents the kidneys from reabsorbing excess glucose, thus passing it through the urine instead of back into the blood stream. Due to these mechanics, the following side effects are now suspected and linked to the medication.

  • Development of urinary tract infection or yeast infection. Bacteria and yeast both feast on sugar for survival and growth, so it is not surprising that diabetics have a greater risk of developing either form of infection. Invokana increases the chance of infection through increased glucose in the urine. Studies have also shown that those taking Invokana urinate more frequently, which only exacerbates these risks.
  • Diabetic ketoacidosis. This condition is the result of abnormal ketone levels in the blood. When the body does not have access to sugar due to insulin resistance or low blood sugar, it breaks down its fat and protein stores instead. You may think that this would be a good thing, but when the liver and kidneys are unable to regulate the resulting ketone levels in the blood it results in increased blood acidity, which has the potential for fatality.
  • Kidney failure. The diuretic property of Invokana places a great deal of strain on your kidneys, liver and pancreas. An excessive work load can have an impact on your kidneys, ultimately resulting in infections or sudden kidney failure.
  • Acute pancreatitis. The latest report indicates that the cause of acute pancreatitis in patients taking Invokana may be linked to its diuretic qualities. Forcing the kidneys to eliminate glucose through urine also forces them to dump more water, increasing the toxic load of the liver and pancreas. This may cause the pancreas to become inflamed or infected and is a very rare and serious condition that requires immediate medical attention.

Off Label Prescriptions

Invokana received approval solely for use to lower blood glucose levels in type-2 diabetics, but reports indicate it has also been prescribed off label to type-1 diabetics as well. Doctors are allowed to prescribe medications for unapproved use at their own discretion, but this can lead to cases in which drug manufacturers dodge the approval process by offering doctors incentives to prescribe medications off label. Because of key differences in the two forms of diabetes, it is extremely important that considerations are taken to tailor treatment to the specific form of diabetes a patient suffers from and Invokana can pose serious risks to type-1 diabetics who have been prescribed the medication despite lack of FDA approval. Off label prescriptions are one of the many ways pharmaceutical companies avoid seeking approval for medications and the only way to hold them accountable seems to be through civil action.

The Chicago Invokana attorneys of Rosenfeld Injury Lawyers are currently reviewing cases involving injuries resulting from the use of Invokana and other SGLT2 inhibitors. If you were prescribed one of these medications and suffered from adverse conditions such as ketoacidosis, acute pancreatitis or kidney failure, contact us today to arrange a free consultation with one of our award winning attorneys. We’ve recovered compensation on behalf of thousands of clients across Illinois and can help you recover the cost of your medical treatment, out of pocket expenses and compensation for your pain and suffering. Once we’ve had the opportunity to review your case, we can discuss your legal options and decide upon the legal recourse that is most appropriate.

We never collect an attorney fee until the successful recovery of compensation and if we cannot collect on your behalf, our services will be free of charge.

Vaginal Mesh ComplicationsTransvaginal mesh products became extremely popular around 2005 as alternatives for the treatment of conditions that include pelvic organ prolapse and incontinence but evidence later surfaced questioning the safety of the devices and whether they could cause serious injuries to the patients implanted with them. By October of 2008, the FDA needed to issue a warning to surgeons conducting transvaginal mesh procedures due to over a thousand reports of significant complications associated with the devices. At the moment, we are on the brink of a wave of litigation being brought against major transvaginal mesh manufacturers due to the damage that has been caused and the failure of the manufacturers to provide sufficient warnings about their risks.

Types of Transvaginal Mesh and Uses

The primary purpose of transvaginal mesh products is to treat pelvic organ prolapse and stress urinary incontinence which are caused when pressure is placed against the bladder from reproductive organs which have fallen into the pelvis. In both cases, the mesh products are used to return the affected organs to their correct positions and reinforce the pelvic floor to keep them there. There are two different forms of mesh cited in transvaginal mesh litigation.

  • Transvaginal mesh— this is used to hold organs into place after that have been pushed back into their intended position. It also holds the pelvis in the desired position.
  • Transvaginal sling/bladder sling— this device is similar to a hammock that supports the bladder and its primary function is in the treatment of incontinence.

Complications Caused by Mesh Erosion

Mesh erosion is the main cause of the complications which have been reported by thousands of women and the damage that is caused may be severe enough to warrant additional surgeries to remove the mesh, repair the damage or address medical concerns brought on by the complications. These complications include but are not limited to the following.

  • Organ perforation— when the mesh erodes, it becomes sharp and cuts into the surrounding flesh. This becomes a serious concern when the mesh cuts into organs nearby such as the bowel or the bladder, which can cause severe pain, infections and septic shock.
  • Stress urinary incontinence— while the transvaginal mesh devices are designed to prevent and treat this condition, they can actually become the source of new and more severe incontinence.
  • Loss of consortium— mesh erosion can make intercourse extremely painful and the damage can result in the inability of a couple to continue normal sexual relations either due to the pain, embarrassment or a combination of both.
  • Internal bleeding and infection— the sharp edges created by eroding mesh can result in internal bleeding, which may result in a serious infection if the bleeding is undetected or untreated.
  • Recto-vaginal fistula— this is the result of a hole in the vaginal wall leading to the rectum and way result in bowel matter being excreted from the vagina, which is a horrifying and embarrassing condition for any woman to need to endure.
  • Abscess— usually caused by inflammation or infection, an abscess is a pus filled sore where the flesh has begun to necrotize.
  • Pain and discomfort— the pain associated with mesh erosion can be debilitating and make it difficult for victims to live normal lives or enjoy the things they once did.

Warnings Required of Surgeons

By 2011, the FDA had received over 2,800 reports of complications associated with transvaginal mesh products and surgeons are now required to receive special training prior to performing procedures using the products as well as to provide specific warnings and aftercare. Women must be notified that the mesh is a permanent device and that it made erode, potentially resulting in infections, organ perforate and other complications. Surgeons must monitor patients for signs of these complications after patients have undergone the procedures and patients must be aware that revisionary surgery may be required to remove the devices or to repair damage caused by erosion.

Thousands of women have surfaced, the first fruits of what may be an expansive wave of future lawsuits against the manufacturers of transvaginal mesh devices, citing the lack of proper warnings of potential complications and the marketing of the products without any evidence to suggest that they are more effective than traditional means of treating pelvic organ prolapse or stress urinary incontinence. The companies involved in the initial onslaught of lawsuits include Johnson and Johnson, Boston Scientific Corp, American Medical Systems and C.R Bard, Inc. There are over forty companies that manufacture the devices, however, and these companies are simply the most high profile plaintiffs to date.

Representing the Victims of Transvaginal Mesh Products

If you have suffered serious medical complications, pain and suffering and the inability to enjoy a reasonable quality of life because of adverse events following a transvaginal mesh procedure, you are not alone and you have the right to receive compensation for your injuries, including the cost of medical treatment, loss of income, pain and suffering, out of pocket expenses and other financial considerations. The Rosenfeld Injury Lawyers have a special team of lawyers specializing in and dedicated to representing those who have claims for medical device liability and medical negligence. Contact us to arrange a risk-free consultation to receive answers to all of your questions regarding how current litigation affects your own case, your rights and legal options and how the legal process works.

Following a deep and thorough investigation of your case, our attorneys will have a greater understanding of the value of your case, the chances of its success and how best to proceed with a lawsuit, if it is in your best interest. In order to allow all people to have access to our services regardless of their financial concerns, we promise only to receive payment upon successfully securing compensation on your behalf. If we are unable to negotiate a settlement in your best interest or win your case in court, our services, time, resources and advice will all be free of charge.

Recall of Ventilators for Not WorkingYou’ve probably felt a sense of frustration if you ever purchased a device that suddenly failed to work and demanded a prompt refund or exchange from the manufacturer. You may be able to forgive the manufacturer if the device is an IPod or a cellphone, but imagine that your ability to breathe rested squarely on the device in question. CareFusion recently announced the global recall of nearly 16,000 ventilators citing that the devices may spontaneously stop working, causing “adverse health consequences or death.” It is purely terrifying to imagine that a device which you or a loved one may rely on for survival could simply stop working.

Recall Designated as Class I by the FDA

Avea ventilators mechanically control respiration in patients that are unable to breathe or have difficulty breathing without assistance. They are most frequently used during medical transport, as a component of home care or nursing care and during critical care. The Avea product line monitors oxygen levels and delivers a predetermined quantity of oxygen during ventilation. CareFusion highlighted the ability of Avea ventilators to monitor and regulate oxygen levels its ability to provide detailed information to medical professionals in its advertising of the devices.

Every one of the Avea ventilator models produced by CareFusion was found to contain a defect which may cause the device to stop operating. The defect in question is a faulty pressure transducer which may register a false extended high Ppeak or circuit occlusion alarm. When these alarms are triggered, the device stops performing its intended function and it could result in the death of the patient by asphyxiation.

In the statement released by CareFusion, it suggested “turning the machines off and then on again” to fix the issue and then sending them back if the devices fail repeatedly. The FDA classified the recall of the ventilators as a Class I recall, which means that the FDA has determined that the failure of the ventilators poses a significant risk of severe injury or death. You might think that it wouldn’t take an FDA ruling to reveal that you might die when your ventilator stops helping you breathe.

CareFusion Initiated the Recall and is cooperating with the FDA

When CareFusion was made aware of the potentially deadly defect in the Avea product line, it responded by promptly issuing warnings to its customers. It soon recalled nearly 16,000 of the devices internationally. Most of the machines that are affected were distributed abroad but there are still over 5,600 units within the United States. The ventilators that were included in the recall were manufactured between July of 2011 and March of this year and CareFusion sent out a letter to its customers making them aware of the issue and providing instructions on how to assess or return the devices.

A surprisingly piece of good news resulting from this recall is that, so far to date, no reports have surfaced of any fatal incidents involving the Avea product line of ventilators. What is more concerning, however, is that the FDA has issued 22 different Class I recalls of ventilation devices since 2011— the year that the Avea product line reached market. Six of the recalls were of ventilators manufactured by CareFusion, which suggests that there is an underlying design issue causing the failures of the devices.

In regard to transducer failure, however, there have only been eleven reports of this event in the FDA’s record of adverse events. Thankfully, the manufacturers have detected this issue quickly in the past and pulled the devices responsible to protect patients. This is a deviation from the norm when considering the historical behavior of medical device manufacturers and pharmaceutical companies in general.

If you find that you’ve been injured because of a medical device failure or lost a loved one in such an incident, it is understandable to be overcome with feelings of anger and to demand vindication for what has occurred. For more information about similar medical device product liability lawsuits or to learn about how these cases are handled, contact us for more information. We would be happy to answer any questions that you have about pending litigation and how it affects you, your personal rights and legal options and the chances you have of succeeding if you choose to file a claim.