Articles Posted in Defective Products

Hernia mesh is a medical device that is used to repair hernias, which occur when internal organs bulge out through a weak spot of muscle. The only way to permanently fix a hernia is with surgery. However, hernias often return and need another surgery. To reduce this risk, surgeons implant hernia mesh inside the body to reinforce weak tissue. Most of the mesh devices are made from synthetic materials like polypropylene, a kind of plastic.  Some type of hernia mesh product is used in more than half of all hernia surgeries in the United States.

Unfortunately, patients that have had a hernia repaired with mesh are experiencing a number of complications including:

  • Pain

On December 1st, jurors in Dallas Texas returned a verdict against Depuy Orthopedics for more than a billion dollars.  There were more thanDePuy Pinnacle 40 witnesses that testified during the 10 week trial. The jury deliberated for nearly eight hours before returning the verdict that awarded $32 million in actual damages and $1.009 billion in punitive damages.

The six plaintiffs involved in the trial suffered serious medical complications caused by defective metal-on-metal Depuy Pinnacle hip implants. The jurors found that DePuy Orthopaedic misled doctors and patients about the safety of its Pinnacle hip implant, and the device can deteriorate bone and tissue leading to severe pain and the need for revision surgery.

Depuy, a subsidiary of Johnson & Johnson, is still faced with more than 8,600 Pinnacle-related lawsuits, which have been consolidated in federal court in Texas.

The Australian Therapeutic Goods Administration (TGA), similar to the United States Food and Drug Administration (FDA), issued a Hazard Alert on September 27, 2016 for Stryker LFIT Anatomic CoCr V40 femoral heads. The LFIT V40 is a femoral head that orthopedic surgeons utilized in hip replacement surgeries. The Stryker LFIT V40 can be used interchangeably with Stryker’s entire product line of modular total hip replacement devices and is designed to offer a large range of offsets based on a patients’ needs. According to the Australian TGA, some LFIT Anatomic CoCr V40 femoral heads have a “higher than expected incidence of taper lock failures.” The taper lock connects the femoral head and femoral neck of the hip prosthesis. If the taper lock fails, the patient can suffer severe complications including catastrophic disassociation and metallosis, resulting in the need for emergent revision surgery. These conditions can lead to the destruction of tissue in the area of the implant, causing all sorts of complications. Stryker has recently notified orthopedic surgeons who have implanted the LFIT V40 of the increased incidence of taper lock failure and ensuing complications.

The Defective Medical Product attorneys at Suthers Law Firm are investigating the Stryker LFIT CoCr V40 femoral head cases on behalf of patients who were implanted with these devices and have suffered complications. These attorneys previously prosecuted cases successfully against Stryker on behalf of  many patients who were surgically implanted with Stryker Rejuvenate hip replacement products, which products were recalled by the FDA because of similar complications.

Since reports of deaths and injuries linked to a defect in Takata airbags, nearly 70 million Takata airbags have been recalled in the U.S.  That means that almost one out of every five cars has a potentially defective airbag.  More and more automobiles equipped with Takata airbags have been the subject of recalls on an ongoing basis.

Takata’s use of a volatile chemical, ammonium nitrate, has been cited as one of the major reasons the Takata airbags are dangerous.  Because ammonium nitrate is a volatile substance, it can become unstable when exposed to sudden changes in temperature or humidity.  Typically, there is a metal housing surrounding the airbag.  When the ammonium nitrate explodes with enough force, the metal housing cannot contain it, resulting in the airbag exploding and metal shrapnel being propelled through the air.

To date, the Takata airbags in approximately 9 million automobiles have been repaired.  However, it was reported recently that Takata is using several of the same parts and materials which were used in the faulty airbags.  This has caused significant concerns among many experts.  Takata claims that it has added a substance to the ammonium nitrate that is intended to keep the ammonium nitrate dry, even in conditions of high temperatures and humidity.  However, some industry experts believe that Takata’s solution does not adequately address the problem of ammonium nitrate becoming unstable during temperature changes.  Because Takata is responsible for the repairs, and due to the recent discovery that Takata continues to use some of the same methods and components that were used in the manufacture of the defective airbags, consumers should be concerned.

AndroGel1The Suthers Law Firm continues to investigate alleged claims of serious and sometimes fatal side effects suffered by patients who were prescribed “Low T” drugs for testosterone therapy.  The drugs, including AndroGel, AndroDerm, Axiron, Foresta, Testim and others, have been heavily prescribed over the past several years as a safe way to treat men with low testosterone. However, numerous recent studies suggest that men taking AndroGel have a far greater risk of suffering a heart attack, stroke, congestive heart failure, or other adverse cardiovascular event.

On May 29, 2014, an order was issued that established a federal testosterone multidistrict litigation (MDL) before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois. The purpose of creating an MDL is to facilitate faster progression of a large number of lawsuits that have certain allegations of fact in common. An MDL is designed to eliminate inconsistent court rulings among these cases, as well as expensive and unnecessary duplication of discovery. All of the lawsuits that were transferred to the Northern District of Illinois allege that drugs such as AndroGel, AndroDerm, Axiron, Foresta, Testim and others caused serious, and sometimes fatal, cardiovascular problems in men. There are currently more than 5000 cases pending in the MDL.

In the near future, bellwether trials will begin in the Testosterone Replacement MDL.  Bellwether trials are cases that the court and the parties select to test their arguments.  These bellwether cases, are typically representative of issues that will arise in every injured person’s case. The goal of a bellwether process is to give all interested parties a good indication of what is likely to happen in future trials and to advance the litigation in a timely manner.  In the Testosterone Replacement MDL, a series of six cases are expected to go to trial beginning in June 2017.  While the outcomes of these early trial dates are not binding on other cases, they may influence eventual Androgel settlements or other negotiations to resolve cases and avoid the need for hundreds of individual trials to be scheduled in courts throughout the country.

A second trial out of more than 1,000 lawsuits alleging Johnson & Johnson products containing talcum powder caused cancer began this week in Missouri.  The Plaintiff, Gloria Ristesund, age 62, developed ovarian cancer in 2011 after having used Johnson & Johnson’s Baby Powder in her genital area for several decades.  Ms. Ristesund alleged that her cancer was caused by the talcum powder that is in the Baby Powder product.  She also alleged that J&J continued to sell its Baby Powder product despite being aware of the link between talc and ovarian cancer.

In his opening remarks, Ms. Ristesund’s attorney told the jury that J&J was aware of studies connecting talcum powder use and ovarian cancer, but the corporate giant continued to sell Baby Powder containing talc, unlike other manufacturers who switched to corn starch-based powder.  The Plaintiff’s attorney also argued that J&J employed a strategy designed to prevent Government regulation of talc and at the same time, disregarded the Government’s requests that J&J either remove talc from its Baby Powder product or issue warnings to its customers.  J&J’s attorneys contended that the studies linking talcum powder use and ovarian cancer are not conclusive and that the medical and scientific community still does not know what causes ovarian cancer.

This is the second case pending in State Court to go to trial over the alleged link between ovarian cancer and use of Johnson & Johnson’s Baby Powder.  In February of 2016, jurors returned a $72 million verdict for the family of a Missouri woman who had used J&J’s Baby Powder for more than 35 years and died from ovarian cancer.  Roughly 1,000 similar cases are pending, and a growing number of lawsuits are being filed regularly throughout the U.S.

J&J Powder-2Last week we wrote in this blog about the family of a woman from Birmingham, Alabama, Jackie Fox, who successfully sued Johnson & Johnson after linking her use of their talcum powder products to her ovarian cancer.  The family of Ms. Fox obtained a 72 million dollar verdict.  However, Ms. Fox and her family were not the first in the United States to bring a lawsuit alleging these products caused ovarian cancer.   That distinction belongs to a South Dakota woman named Deanne Berg.

Ms. Berg, wrote a very interesting story this week in the New York Post that detailed her struggle after being diagnosed with ovarian cancer in January of 2007.  You can access the full story here.  Ms. Berg had used Johnson & Johnson Talc powder for more than 30 years.  She recalled the marketing for Johnson & Johnson’s Baby Powder and Shower to Shower as a feminine hygiene product when she first began using the products as an 18 year old.  Tag lines such as “A sprinkle a day helps keep odor away,” and another that stated, “Your body perspires in more places than just under your arms.”  She, as millions of others, felt that the use of these products to be perfectly safe.  However, once she was diagnosed with ovarian cancer, she began to do research, and, to her surprise, found several studies that had long linked talcum powder use and ovarian cancer.  Some going back decades.

In the article, she discusses the struggles that she went through on a daily basis dealing with her ovarian cancer:

On Monday, a St. Louis jury awarded the family of an Alabama woman $72 million in a civil suit against Johnson & Johnson.   The jury found Johnson & Johnson liable for the plaintiff, Jackie Fox’s ovarian cancer, which she claimed in the lawsuit was the result of using the company’s Baby Powder and Shower to Shower powder, both of which contained talcum powder.

According to the lawsuit, Ms. Fox, of Birmingham, Alabama, was diagnosed with cancer in 2013.  She died last fall at age 62 after her ovarian cancer returned. The jury awarded $10 million for compensatory damages and $62 million for punitive damages to Ms. Fox’s estate.  Deliberations lasted four hours, following a three-week trial.  Jurors found Johnson & Johnson liable for fraud, negligence and conspiracy.

Currently, there are more thJJ-baby-powder-shower-shower-crop-300x270-300x270an 1,200 civil suits against the company related to its talcum-containing products. Several studies have been conducted which link talc powder to ovarian cancer and talc is a common ingredient in many Johnson & Johnson products. In 23 case-controlled studies, conducted by the International Journal of Gynecological Cancer in May of 2015, the researchers found that talc use increased the risk of ovarian cancer by 30-60 percent. While studies had been previously unable to determine conclusively whether talc played a role in ovarian cancer, the International Journal of Gynecological Cancer concluded that their results “suggest that talc use causes ovarian cancer.” Several other recent studies, including one conducted by the Journal of the National Cancer Institute, confirmed those same results. The connection between talc powder and ovarian cancer was reinforced when scientists discovered talc minerals inside the cancerous tumors they were removing from women’s bodies.  Ovarian cancer is the most lethal gynecological cancer there is and it is most often detected in the later stages of the illness when it is too late to effectively treat the cancer.

JJ-baby-powder-shower-shower-crop-300x270-300x270Talc is a naturally occurring mineral that is one of the primary ingredients in products like Johnson & Johnson’s Baby Powder and Shower-to-Shower body powder.  Manufacturers of products containing talc have promoted these products for decades, claiming that talcum powder eliminates friction, is gentle on the skin, and provides a fresh scent.  They created ads with smiling, bare-bottomed babies, promoting the use of baby powder to reduce diaper rash, and other ads, promoting the use of talcum powder by women as a personal hygiene product.  However, a large number of studies published in scientific and medical journals concluded that the use of talcum powder in the genital area increases a woman’s risk of developing ovarian cancer.  This alarming information has been known by the manufacturers of products for many years, but the manufacturers chose not to put warnings on their products or in their ads.

Talc is a mineral that shares some similarities with asbestos, another mineral that causes deadly cancers.  Just as asbestos fibers were found in the lungs of workers who breathed them, talc particles have been found in the ovaries of women who used baby powder containing talc in the vaginal area and developed ovarian cancer.  When baby powder containing talc is applied to the genital area, talc particles can move up the vagina, into the fallopian tubes, and into the ovaries, where the talc particles can remain for decades.  Scientific studies have shown that talc causes inflammation in healthy tissue.  This inflammation may, in turn, contribute to the development of cancer.

Dr. Daniel Cramer is a gynecologic oncologist and Harvard Medical School professor.  In 1982, Dr. Cramer published the first study that linked talcum powder use in a woman’s genital area with an increased risk of ovarian cancer.  In a recent interview, Dr. Cramer said “I have always advised gynecologists that if they examine a woman and see that she is using talc in the vaginal area, tell her to stop.”  The association between talcum powder use and ovarian cancer was the subject of numerous epidemiological studies published throughout the 1980s and 1990s, which reinforced Dr. Cramer’s findings.  As early as 1992, manufacturers were urged to put warning labels on talcum powder products because of this serious health threat to women.

Medical device manufacturer, C.R. Bard, Inc., is back in the news and back in Federal Court.  On August 18, 2015, the Judicial Panel on Multidistrict Litigation (JPMDL) announced that the lawsuits pending currently against C.R. Bard, Inc. and Bard Peripheral Vascular involving the IVC filter will be consolidated and transferred to the U.S. District Court for the District of Arizona.  More than 200 pending cases will be transferred immediately, and it is believed that many more will follow.

An inferior vena cava (IVC) filter is a small medical device that is surgically implanted inside the body to capture blood clots before they migrate to other areas of the body, causing serious conditions such as a pulmonary embolism or stroke.  However, a number of studies have shown that pieces can break away from the filter and migrate to other areas of the body, causing serious injuries and deaths.  The New England Society for Vascular Surgery conducted a study, which concluded that the IVC filters fractured in 31% of the cases.  These shards or splinters often migrated to the patients’ right ventricles of the heart.  Another study found that in 25% of the patients studied, there were splinters that broke off, many of which migrated to the heart, lungs and the hepatic vein.

Before introducing these filters on the medical market, Bard knew that IVC filters were associated with serious side effects.  However, this information was not conveyed to doctors.  Bard knew the filters were prone to fracture, which could lead to perforations of the vena cava, surrounding vessels and organs, necessitating serious and life-threatening open surgical procedures.  On July 13, 2015, the U.S. Food and Drug Administration (FDA) cited Bard for failing to report adverse events associated with the IVC filters and for illegally selling a device that was designed to retrieve the filters.  It is believed that Bard has sold more than 500,000 IVC filters.  With failure rates approaching 40% after five years of implantation, there are far too many patients with IVC filters who are at risk.