Product Liability

March 5, 2016

Talcum Powder Ovarian Cancer Victims

Medical experts have warned that women who regularly powder their genitals with talc have a one-third higher risk of being diagnosed with ovarian cancer.

Those women who routinely apply talc to their genitals, sanitary napkins, tampons and underwear were found to have a 33 per cent higher risk of ovarian cancer.

Lead study author Dr Daniel Cramer, of Brigham and Women’s Hospital in Boston, noted that there must be warning labels on talcum powder.

According to Cramer, “Talc is a good drying agent, but women should know that if it’s used repeatedly, it can get into the vagina and into their upper genital tract.”

Dr Cramer first linked genital talc to ovarian cancer in 1982. The current study, in the journal Epidemiology, is the first to limit the association to premenopausal women and postmenopausal women who used hormone therapy.

What is Talc?

Talc is a naturally occurring mineral that absorbs moisture, and is made of magnesium, silicon and oxygen. It may contain asbestos – a known carcinogen – in its natural form. But, all consumer talc products in the US have been free of asbestos in the US since the 1970s.

Ovarian Cancer

Almost 20,000 women in the US are diagnosed with ovarian cancer each year – and almost 14,500 die from the disease annually, according to the Centers for Disease Control and Prevention (CDC).

The World Health Organization’s International Agency for Research on Cancer classified genital talc as possibly carcinogenic in 2006.

St Louis Talc Powder Ovarian Cancer $72 Million Verdict

The St. Louis jury in the latest J&J talc powder lawsuit to go to trial, was hammered and ordered to pay $72 million to the family of a woman who died from ovarian cancer. The family of Jackie Fox filed a wrongful death claim for ovarian cancer caused by talcum powder that she used throughout her life.

Fox used J&J talcum powder products for feminine hygiene, and she alleged that the company failed to warn that the talc migrates through the vagina and increase the risk of ovarian cancer.

$62 Million In Punitive Damages

The jury in the Missouri Circuit Court in St. Louis, found that J&J should pay the family $10 million in compensatory damages, for causing her wrongful death. The jury also found that J&J acted with gross negligence and wanton disregard for the plaintiff’s health and safety, and awarded $62 million in punitive damages. Punitive damages are awarded when the jury finds egregious behavior and is designed to punish the company for wrongful acts.

The jury noted that internal documents showed that the company knew about increased risk of ovarian cancer from talc for years, but hid the vital information from talc powder users.

Smoking Gun Internal Documents

According to the jury the company’s internal documents that were presented during the trial, swayed the jury towards for finding for the plaintiffs. A 1997 internal memo from a company medical consultant said “anybody who denies” the risk of using hygienic talc and ovarian cancer is “denying the obvious in the face of all evidence to the contrary,” AP reported.

Shower-to-Shower and Baby Powder Under Fire

Johnson’s Baby Powder is the most popular talcum powder product sold by the company. The talc is usually used in infants to prevent diaper rashes and it is also marketed to adult women for general hygiene purposes, as the Shower-to-Shower product.

Johnson & Johnson, based in New Brunswick, N.J., is expected to appeal. It issued a statement Tuesday insisting the products are safe.

1,200 Talc Ovarian Cancer Lawsuits Pending

There are about 1,200 Baby Powder lawsuits and Shower-to-Shower body powder lawsuits pending against J&J, with similar allegations that the company failed to warn that the talcum-based powders may increase the risk of ovarian cancer when applied to the female genitals.

According to medical experts, pathological evidence reveals that the talc may migrate through the vagina and into the fallopian tubes, uterus and ovaries, causing inflammation leading ovarian cancers. Microscopic evidence of talc particulate infiltration is found in the ovaries of affected women.

2nd Jury Talc Ovarian Cancer Verdict

In October 2013, a South Dakota jury found that J&J failed to warn about the risk of ovarian cancer from talcum powder, but no damages were awarded. In that South Dakota case, Deane Berg, aged 56 was diagnosed with ovarian cancer, and three doctors found that her cancer tissue had evidence of talc in the ovaries.

In fall 2006, Berg began noticing signs of ovarian cancer. Berg had both ovaries removed when her doctors found a hemorrhagic ovary. In January 2007 Berg was diagnosed with stage 3 ovarian cancer with a life expectancy of less than five years. Berg’s oncologist suggested a linkage between talcum powder and ovarian cancer. Berg had “dusted” her groin daily with J&J’s talcum powder since the age of 18.

New Jersey Talc Powder State Court Mass Tort

The New Jersey Supreme Court in November 2015, consolidated all talcum powder lawsuits filed on behalf of women diagnosed with ovarian cancer.

All talc cancer cases filed throughout New Jersey state court are centralized before Judges Julio L. Mendez and Nelson C. Johnson in Atlantic County, as part of a Multi-County Litigation (MCL). There are more than 100 ovarian cancer lawsuits over talcum powder pending throughout the state.

February 10, 2016

J&J Ethicon Vaginal Mesh Injury Claims Beginning to Settle

by Dr. Shezad Malik

According to a recent Bloomberg news article, Johnson & Johnson (J&J) has begun to settle thousands of personal injury and product liability lawsuits filed by women who blame the company’s vaginal-mesh inserts for causing severe injuries.

First of Many Johnson and Johnson Ethicon Settlements

The world’s largest medical-device maker has agreed to pay more than $120 million to settle an initial round of about 3,000 lawsuits where women suffered serious organ damage from erosion of their popular line of vaginal mesh surgical inserts.

February 9, 2016

Xarelto Uncontrollable Brain Bleed Lawsuits Increasing

by Dr. Shezad Malik

Oren Fells from Georgia recently filed a Xarelto uncontrollable intracranial or brain bleeding lawsuit in the U.S. District Court for the Eastern District of Louisiana. The lawsuit was filed against Bayer Healthcare, Johnson & Johnson, and its Janssen subsidiary, the manufacturers of Xarelto.

Catastrophic Xarelto Brain Bleeding Allegations

Fells began taking the newer anticoagulant or blood thinner Xarelto in 2013, for the treatment of atrial fibrillation, a common heart rthym problem. Fells suffered a brain bleed in January, 2014, causing him to develop life long permanent injuries.

February 8, 2016

FDA Launches Uterine Cancer Death Morcellator Investigation

by Dr. Shezad Malik

Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery.

Brigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center are implicated in failing to report these surgical deaths, that were likely related to the use of morcellators at the hospital as part of surgical procedures there.

What are Power Morcellators?

February 5, 2016

FDA Ups Transvaginal Mesh Warning Label as “High Risk Devices”

by Dr. Shezad Malik

According to the U.S. Food and Drug Administration (FDA), the popular plastic transvaginal mesh device that has been used to repair pelvic organ prolapse (POP) transvaginally, or through the vagina, will have to undergo rigorous safety studies before being available to be used in patients.

The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.

FDA Classifies Plastic Vaginal Mesh as High Risk

February 4, 2016

AndroGel Pulmonary Embolism Side Effect Lawsuit Filed

by Dr. Shezad Malik

Timothy Wilkes from Ohio, filed a testosterone drug personal injury and product liability lawsuit in the U.S. District Court for the Northern District of Ohio. According to Wilkes, the side effects of the popular testosterone replacement medication, AndroGel caused a deep vein thrombosis or a blood clot in his legs that traveled to the lung, causing a pulmonary embolism.

AndroGel Used as “Lifestyle” Low T Testosterone Replacement

There are almost 3,500 testosterone lawsuits filed in the federal court system, alleging injuries caused by the side effects of testosterone drugs, including AndroGel, Testim, Axiron, Androderm and other variations of gels, patches, pills and injections.

February 3, 2016

J&J Ethicon Prolift Vaginal Mesh $12.5M Verdict

by Dr. Shezad Malik

Recently, a Philadelphia jury found for the plaintiff Patricia Hammons, who suffered serious internal injuries from the Ethicon Prolift vaginal mesh. Johnson and Johnson, the manufacturer is exposed to at least fifty thousand similar claims, with hundreds of lawsuits fast tracked for early trial in 2016.

$12.5M Verdict and Punitive Damages Awarded

Hammons, was awarded $5.5 million in compensatory damages and $7 million in punitive damages against Johnson & Johnson’s Ethicon subsidiary. Punitive damages are rarely awarded in product liability and personal injury lawsuits, and are designed to punish the company for gross negligence and reckless disregard for the safety of patients.

January 4, 2016

Wright Conserve Metal on Metal Hip Replacement Verdict

by Dr. Shezad Malik

The manufacturers of the Wright Conserve metal on metal hip implant were hammered in a recent personal injury and defective product liability trial. The Georgia federal jury awarded $11 million to Robyn Christiansen, in the first bellwether Wright Conserve hip replacement lawsuit to go to trial.

$10 Million Punitive Damages

The jury awarded $1 million in compensatory damages and $10 million in punitive damages, which is designed to punish the Wright Conserve hip replacement manufacturer for gross negligence for recklessly disregarding the safety of hip patients.

Over 500 Wright Conserve Hip Implant Lawsuits

Wright Conserve hip replacement manufacture is exposed to more than 530 personal injury and product liability lawsuits. Plaintiffs claim that patients suffered serious and catastrophic hip failures from the metal-on-metal design was unreasonably dangerous and defective.

Wright Conserve Hip Lawsuit Allegations

According to the lawsuits, the metal-on-metal hip leads to metallic debris to be released during the grinding action between the metal cup and metal ball, which causes early implant failure. Some complications include premature device failure, loosening, metal poisoning and metallosis and severe pain.

Artificial hip replacements are expected to last at least 15 to 20 years, but Christiansen’s Wright Conserve hip implant failed after only six years, resulting in the need for major revision surgery.

December 29, 2015

Risks of Cancer Spread After Laparoscopic Hysterectomy

by Dr. Shezad Malik

In the United States, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically.

What is Laparoscopic Hysterectomy?

Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.

Recently, many personal injury and wrongful death lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.

What Are Power Morcellators?

Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.

How Morcellator Increases the Risk of Uterine Cancer Spread

According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die shortly after diagnosis and there are no curative treatments.

There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.

Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors and hospitals have stopped the use of power morcellators over the past year.

Morcellators Approved Under the 510(k) Program

The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.

J&J Ethicon Morcellator Recall

All Ethicon power morcellators were recalled by the manufacturer, in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.

FDA Morcellator Black Box Warning

The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.

Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.

This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.

Power Morcellator Litigation Centralized

Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.

The U.S. District Court for the District of Kansas was recently approved for the centralization and consolidation in a multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon morcellator manufacturer.

This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.

All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.

December 23, 2015

Kansas Zofran Heart Defect Lawsuit

by Dr. Shezad Malik

A Kansas woman, Samantha Brosseau, filed a personal injury and product liability lawsuit against GlaxoSmithKline (GSK), the manufacturer of the blockbuster drug Zofran. Brosseau took the drug to treat pregnancy-associated morning sickness.

Allegations: Zofran Caused Hole in the Heart

According to Brosseau, Zofran caused her daughter to be born with an atrial septal defect or a hole in the heart. Atrial septal defect can be a serious life threatening heart condition, which can only be corrected by invasive cardiology procedures or in severe cases, open heart surgery.

Brosseau alleges that GSK failed to warn pregnant mothers about the congenital heart defect risks with Zofran. Brosseau claims that her daughter, K.C., was born with hole in the heart from intra-uterine exposure to Zofran during the first trimester of pregnancy.

What is Zofran?

Zofran is a drug developed by GSK, and approved by the FDA in 1991, only for the treatment of nausea and vomiting in cancer patients after chemotherapy, and radiation therapy. GSK through aggressive marketing aimed at pregnant women and their doctors, has made Zofran the single most popular drug for the treatment of morning sickness.

Pharmaceutical companies are not allowed to promote or market drugs to patients beyond their approved use by the FDA. This is known as “off-label” marketing.