Articles Posted in Medical Device Defect

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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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After a trial that lasted over two months, Johnson & Johnson and Imerys Talc America Inc. have been handed down a verdict that sees the companies now responsible for $37 million in compensatory damages and another $80 million in punitive damages to be paid to a New Jersey man and his family.

The lawsuit was brought by Stephen Lanzo III, 46, and his wife. Lanzo claimed that the prolonged use and inhalation of the company’s talc products lead to his cancer of the lungs. It was found that Johnson & Johnson’s popular products, including baby powder and Shower to Shower contained asbestos. At the conclusion of the trial, the New Jersey jurors concurred with the overall claims made by the Lanzo family.

Lanzo had been using the company’s products for over three decades, starting from when he was an infant and his mother would apply it on him. His use of the talc products spanned from between 1972 and 2003. The court reasoned that this exposure to the toxic minerals in Johnson & Johnson’s products contributed a substantial amount overall to Lanzo developing mesothelioma.

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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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Cook Medical is going to soon find themselves in court according to recent court developments. This news comes in the light of thousands of lawsuits that have been filed against Cook Medical and their IVC filters. The first bellwether trial is now on the horizon, after Cook Medical, Inc. was unsuccessful in their motion for summary judgment earlier this month.

According to the Southern District of Indiana, the jury selection process for the first trial will begin on October 23, 2017. Overall, a total of three bellwether trial are slated to take place, which will allow those negatively affected and their representation a range of settlement values regarding IVC filter lawsuits.

The case that has been selected for first bellwether trial is Hill v. Cook Medical, Inc., et al. This case involves Elizabeth Hill, a Florida resident. She was implanted with a Cook Celect IVC filter prior to her scheduled back surgery. Hill has alleged that she was negatively affected by her Cook Medical IVC filter and subsequently required multiple medical corrective procedures.

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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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Last week, the subsidiary of Johnson & Johnson, Ethicon was order to pay Ella Ebaugh an amount that totaled $57.1 million of damages due to receiving defective pelvic mesh implants. As a result of the defective implants Ebaugh claimed that she was in constant pain and left incontinent.

Ella Ebaugh, a 51-year-old resident of York County, Pennsylvania, brought the suit against Johnson & Johnson. She was initially implanted with two Ethicon devices, the TVT and TVT-Secur, in 2007 in order to treat her stress urinary incontience. Both Ethicon devices eroded ultimately traveling to her urethra. Subsequently, Ebaugh had to endure three agonizing corrective surgeries in order to remove the damaged devices. According the lawsuit, her injuries included vast scarring to her urethra, intrinsic sphincter deficiency, chronic urinary tract infections, chronic pelvic pain and dyspareunia, chronic pain during sex. Ebaugh even stated that somedays she can’t even get out of bed.

Ebaugh’s counsel based their argument around the claim that Johnson & Johnson manipulated information that was available to their company and withheld that information from medical professionals and consumers. Ultimately, this decision is the fifth successful suit in Philadelphia related to these devices. The breakdown of Ebaugh’s award is: $7.1 million in compensatory damages and $50 million in punitive 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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