Personal Injury News & Developments

Articles Posted in Dangerous Drugs & Medical Devices

Warnings on Birth Control DeviceWomen looking for a simple alternative to traditional methods of sterilization have turned to the Essure Permanent Birth Control System, which is marketed and sold by Bayer. The contraceptive device was originally developed by Conceptus Inc. and approved in 2002. Bayer purchased Conceptus and the rights to the Essure System in 2013 and is now under fire for numerous complications that women using the system have suffered. These complications are so severe that the FDA has implemented a black box warning for the devices— which requires patients to sign a waiver stating that they have been notified of the risks associated with the devices prior to use.

How the Essure System Works

The Essure Permanent Birth Control System is a non-hormonal birth control method that prevents pregnancy through sterilization. Two flexible coils are inserted into the fallopian and over time, scar tissue develops around the coils and causes permanent infertility by creating a barrier that prevents eggs from reaching the uterus. The simple outpatient procedure has made the system an attractive alternative to tubal litigation and the devices can be inserted without any need for anesthesia.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.