Articles Posted in Product Liability

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This week, a New Jersey jury has handed down another substantial verdict in the most recent pelvic mesh lawsuit. The product liability verdict states C.R. Bard must pay out compensatory damages totaling $33 million and punitive damages totaling $35 million.

The reasoning behind this multi-million dollar verdict was that C.R. Bard overall failed to warn doctors about their mesh product’s potential negative side effects and risks. Accordingly, C.R. Bard’s mesh products were deemed deficient and unsafe.

The plaintiff in this caseMary McGinnis was implanted with the company’s Avaulta Solo Support System and Align Trans-Obturator Urethral Support System in 2009. After undergoing her implant procedure involving the C.R. Bard mesh products she experienced multiple unwanted negative side effects. The unwanted results lead to McGinnis filing a product liability claim against the company in 2011.

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Earlier this month, after a nine-day trial an Indiana federal jury ruled in favor of a women who claimed she was damaged by her pelvic mesh implant. The $35 million jury verdict was handed down after it was ruled that the pelvic mesh implant was negligently designed as well as the failure of the manufacturers to adequately warn patients and medical professional of the negative risks or side effects that accompany their pelvic mesh implants.

The jury verdict in favor of the Indiana resident Barbara Kaiser came two weeks after the trial began. The breakdown of the $35 million verdict is: $10 million in compensatory damages and $25 million in punitive damages.

The injured party, Barbara Kaiser, was implanted with the Ethicon Prolift pelvic mesh in 2009 in order to treat her pelvic organ prolapse. Approximately two years after the procedure, she complained to her doctors of lower pelvic pain, groin spasms, bladder spasms among other issues. Doctors explained that the pain and negative side effects she was experiencing could be tied to the implant from the 2009 pelvic mesh procedure.

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Thousands of individuals have brought, and continue to bring, lawsuits against the manufacturers of defective IVC filters. On March 14th, the first bellwether trial against the manufacturer of defective IVC filters will take place. The results of this bellwether trial will be used by the parties to further gauge how future litigation may fare.

The March bellwether trial is set to be heard in the District of Arizona by U.S. District Judge David Campbell. The plaintiff selected for the first bellwether case is Sherr-Una Booker.

In 2007, Booker underwent a procedure in which a C.R. Bard G2 IVC filter was implanted. As a result of that procedure, she suffered from various health issues when her device migrated and fractured. After enduring multiple intense corrective procedures, it was concluded that one of the struts from her device would not be able to be removed and will remain in Booker’s inferior vena cava.

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Hernia mesh manufacturer C.R. Bard and subsidiary Davol, Inc., are facing a growing number of hernia mesh lawsuits for products that were brought to market through the FDA’s 510(k) program. Plaintiffs in Louisiana and Mississippi are suing Bard and Davol for selling hernia mesh repair products that are incompatible with human tissue; they allege that because of the fast track provided by FDA’s 510(k) approval, human trials were not required.

Numerous hernia mesh devices were brought to market under U.S. Food & Drug Administration’s 510(k) program which is a fast track clearance program that allows products to go to market that are similar to pre-existing market devices. Current claims allege that hernia mesh manufacturers failed to produce a safe product, used unsafe and inferior materials in their products, and that materials are not compatible with human tissue. It is this incompatibility with human tissue that results in corrective surgeries. Complications from these products include extreme pain, abscesses, infection, migration, obstructions, and swelling that often multiple corrective surgeries.

Recently, Randy Roberts and Reginald Sanders sued C.R. Bard, Inc. and its Davol, Inc. subsidiary in Louisiana. Both plaintiffs allege hernia mesh complications, including severe abdominal pain and infections, requiring corrective surgeries. In January, Patrick Dove filed suit in the Southern District of Mississippi after experiencing similar complications from the Bard Ventralex patch device. The complaint alleges that that the material used in the hernia mesh was ultimately incompatible with human tissue and the defendants knew or should have known of this incompatibility.

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This week in Dallas a jury has ordered Johnson & Johnson to pay $247 million to six patients that were negatively affected by the company’s Pinnacle artificial hips. The awarded amount broke down as $79 million in actual damages and $168 million in punitive damages. The patients that brought the claims all had to have their Pinnacle artificial hips surgically removed as a result of a defect. All six patients are residents of New York.

The New York patients that brought this claim included: Uriel Brazel, who is an 88-year-old physician; Karen Kirschner, a 67-year-old elementary school teacher; Ramon Alicea, a 61-year-old chauffeur; Hazel Miura, a 60-year-old housing official; Eugene Stevens, a 53-year-old health-care aide; and Michael Stevens, a 52-year-old financial analyst.

The Depuy unit is the manufacturer of this type of hip replacement for Johnson & Johnson. The jury ruled that Depuy knew that the Pinnacle artificial hip devices were defective and that the metal hip implants were defectively designed, but Depuy failed to properly warn medical professionals and patients about the risk of the device failing prematurely.

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Recently, in the Northern District of Texas, the fourth bellwether trial focused on allegedly defective metal on metal hip replacement devices began. This bellwether trial is concentrated on the DePuy Orthopedics’ Pinnacle Hip Replacement System. The bellwether trial has consolidated six hip replacement lawsuits filed by plaintiffs and their family members who allege that they suffered unwanted complications or serious negative side effects due to the premature failure of their DePuy Pinnacle Hip Replacement System device.

This bellwether trial also focuses on the allegations that Johnson & Johnson, and its subsidiary company DePuy, brought their metal-on-metal hip replacement devices to market albeit knowing the device was or may have been manufactured with defects. Among the alleged defects was the low-level quality equipment used to make the devices. Due to the material used in the production of the devices, many patients suffered the negative side effects, including having toxic metal debris to be allowed into their bloodstream or tissue surrounding their joints.

Moreover, through examination of their marketing process, emails and commissioned studies counsel for the plaintiffs has argued it may be shown that Johnson & Johnson, and DePuy took part in deceptive behavior. That highlighted conduct was allegedly aimed toward deceptively encouraging the use of their metal on metal hip replacement devices in hip implant surgeries.

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Earlier this month, Johnson & Johnson found itself in the courtroom again due to another female’s claim that after using Johnson & Johnson’s talc-based products for feminine hygiene purposes, over a significant period of time, she developed ovarian cancer. This marks the fifth case against talc-based Johnson & Johnson products to be heard, albeit the first case to be heard in California.

Eva Echeverria, a 62-year-old California resident, brought this claim against Johnson & Johnson. The claim, similar to recent lawsuits against Johnson & Johnson, alleged that the company failed to warn consumers of their talc-based product’s risks and encouraged women to engage in the use of their talc-based products; even though they were aware of multiple years’ worth of scientific studies that linked ovarian cancer deaths and diagnoses to the genital use of talc-based product such as the ones produced by Johnson & Johnson.

Last week, a Los Angeles Superior Court jury’s verdict ultimately found in favor of Echeverria. This came after a four-week trial and two-day’s worth of deliberation. As a result, Echeverria was awarded the largest verdict to date against Johnson & Johnson, $417 million. This was due to their failure to adequately warn consumers of the risks and unwanted negative side effects to be linked to talc-based product use. The breakdown of the verdict is as follows: $347 million in punitive damages and $70 million in compensatory damages.

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On August 7, Endo International Plc agreed to a settlement amount of an additional $775 million that will allow the company to settle the remaining 22,000 mesh suits brought against them. This additional settlement agreement has now brought the settlement figure to a staggering $2.6 billion. The lawsuits brought against the company alleged that the company’s vaginal-mesh implants left some women incontinent and in extreme pain due the mesh implants eroding.

The August settlement agreement comes only a year after Endo International was slammed with over thousands of complaints due the devices produced by the company. As a result, the company chose to close and shut down one of the units that was based on producing mesh implants. Paul Campanelli, Endo’s CEO and president issued a statement last week in which he called this settlement an “important milestone” for the company. He also made a point to express that this settlement also allowed the company to “resolve virtually all known U.S. mesh product liability claims” against the company.

On the other hand, other companies that are producers of mesh devices, such as Boston Scientific Corporation and Johnson & Johnson, are still facing thousands of complaints from women who had one of their mesh products inserted/implanted and as a result suffered painful or unwanted negative side effects. Overall, mesh based lawsuits are showing to be one of the main mass tort claims in history with the total number of transvaginal mesh lawsuits currently rising to over 100,000 filed complaints.

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3M’s Bair Hugger surgical blanket is at the center of nearly 2,000 lawsuits due to allegations of the device causing unwanted side effects, including serious infections in patients that used the device. A set of eight bellwether trials have been selected, from the proposed trial pool which consisted of 16 potential lawsuits, according to the May 2017 pretrial order. The first Bair Hugger trial is set to begin in February 2018.

The 3M Bair Hugger is a device that may be placed over an individual after an orthopedic implant or replacement surgery in order to warm their body temperature in order to assist in speeding the recovery process. Ultimately, the surrounding area’s warm air is facilitated through a hose into the blanket and then onto the patient, this is known as “forced air warming.” Almost 80% of the leading hospitals across the United States use the Bair Hugger surgical blanket to assist in the prevention of patient’s hyperthermia. There are 25 different designs, shapes and sizes in order to meet the individual patient’s body and type of surgery. These blankets are also known as one-use blankets because they are disposed of after being used in the patient’s overall procedure.

Individuals have brought lawsuits against the 3M, and its subsidiary Arizant Healthcare, due to the negative side effects that are allegedly caused by the device’s defective design. Many have made claims that the device’s design allows for contaminated air from the surround area, such as the operating room floor, to travel towards the sterile area that the patient just received surgery. If these contaminants or bacteria do reach the sterile surgical site the risk for infection, whether it in the form of sepsis (blood infection), deep joint infection, septic hip or knee or MRSA, is significantly increased for patients. Plaintiffs have also seen unwanted or negative side effects including, but not limited to:

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In two separate federal litigations, the number of lawsuits filed against C.R. Bard and Cook Medical has reached nearly 4,000. According to the U.S. Judicial Panel on Multidistrict Litigation May report, Cook Medical’s Gunther Tulip and Celect IVC filter blood clot filters are at the center of 1,918 current product liability claims. While C.R. Bard is the named defendant in 1,851 claims due to alleged complications and negative side effects involving their IVC filters, including Recovery, G2, Meridian and Denali.

IVC filters are used to intercept blood clots before they are able to reach an individual’s heart or lungs. The filter is implanted into the inferior vena cava, the body’s largest blood vessel. The filter is most commonly used to prevent a blood clot in the lung, known as pulmonary embolism.

The FDA issued an alert in 2014 to the public that explained the risk of injury outweighed the potential benefits of having the IVC filter implanted and that the devices should be removed as soon as the risk of pulmonary embolism is no longer at issue. The device is meant to be retrievable, but if it migrates into the vein it may become impossible or extremely painful and difficult to remove. Other complications related to the device include the device: breaking; moving or migrating of the filter or pieces of the filter into the lungs or heart; tilting within the inferior vena cava after being implanted; perforation of the inferior vena cava vein.