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On July 20, 2018 Bayer announced that it would stop selling Essure, a hysteroscopic sterilization procedure for women. Bayer’s decision to pull Essure from the market comes on heels of an FDA black box warning for the device. A black box warning is the FDA’s highest warning that a drug or device may cause death or serious injury.

Essure is a metal spring like device with synthetic fibers that is implanted into a woman’s fallopian tubes in order to prevent eggs from fertilization. The device was marketed as a form of tubal sterilization that did not involve a surgical procedure.

Since its approval by the FDA in 2002, the agency received more than 27,000 adverse event reports related to Essure.  In addition to death, complications from the Essure procedure include; chronic pelvic pain, fetal death, organ puncture, ectopic pregnancies, device migration, expulsion, and perforation of pelvic organs requiring hysterectomies.

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In May, after a three-week trial a Texas jury handed down a verdict that will see Cook Medical paying out over a million dollars to a Texas resident. The jury awarded Jefferey Pavlock, a Houston firefighter, $1.2 million for his claims that his Cook Celect IVC filter caused serious injuries, specifically organ and blood vessel perforation.

Pavlock had a surgery in March of 2015 where a Cook Celect IVC filter was implanted in order to avoid blood clots from traveling to his heart and lungs. Medical professionals intended the implant to be temporary, but surgeons ran into complications and struggled to remove the implant weeks later. After attempting to retrieve the Cook Celect IVC filter doctors learned that they would be unable to do so after it was found the Celect IVC filter had migrated and tilted from its intended location.

As a result of the migration and tilting, the Cook Celect IVC filter had embedded itself within Pavlock’s blood vessel and the legs of the device had punctured his aorta and small intestine in the duodenum. The Houston firefighter underwent a second surgery to remove the filter, but that was also unsuccessful. According to the claims made by Pavlock, he must now undergo continued medical monitoring for the rest of his life.

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There have been over 100,00 lawsuits filed nationwide against manufacturers of transvaginal mesh devices and nearly half of those lawsuits, more than 48,000, involve the Boston Scientific manufactured mesh. Boston Scientific, a Marlborough based company, is widely recognized as one of the leading gynecological mesh implant device manufacturers in the country.

The use of transvaginal mesh implant devices has been seen as common practice by doctors in order to treat women, mostly after childbirth, for incontinence and pelvic organ prolapse. Unfortunately, the negative side effects that accompany the initial mesh procedures as well the subsequent removal procedures of mesh implants can be even more devastating.

At the center of the claims against Boston Scientific, are that the company knowingly used improper and unstable materials, most notably polypropylene, in production of their implant products. According to a recent report, Boston Scientific was made aware by their original polypropylene supplier that Marlex polypropylene must not be used in any “permanent implantation in the human body.” Even after obtaining this information, Boston Scientific wished to continue use of that polypropylene in their devices.

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In Phoenix, a woman that was injured by her defective C.R. Bard G2 filter has been awarded $3.6 million. This was the first bellwether multidistrict litigation of its kind regarding a Bard device. The injured party, Sherr-Una Booker, was implanted with a defective C.R. Bard G2 filter in 2007. Booker experienced a range of negative side effects when her IVC filter fractured and as a result migrated from its initial location and perforated her vena cava.

As it was explained at the onset of this trial there were two phases of litigation. In the first phase, the federal jurors ultimately ruled for $2 million in compensatory damages, Bard being deemed 80 percent ($1.6 million) at fault and an unnamed party doctor 20 percent at fault. In the second phase, the injured party was also awarded $2 million in punitive damages.

At the end of April, C.R. Bard moved for a new trial regarding this decision.

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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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