Product Liability

March 7, 2016

Bad Things Can Happen With Bard IVC Filters

If there was ever a medical device that was rushed to market and continued to be marketed after the company knew that the device was defective, look no further. Bard and other Inferior Vena Cava filter device makers are under fire for selling a grossly defective medical device that is responsible for at least 27 deaths with the Bard Recovery filter over the past 10 years.

South Dakota Bard IVC Filter Injury

Amber Nordin, from South Dakota earlier this year filed a personal injury and defective product liability lawsuit against C.R. Bard, because of the company’s Eclipse blood clot filters broke apart and embedded inside her internal organs.

March 6, 2016

Laparoscopic Hysterectomy Uterine Cancer Lawsuit Battle

by Dr. Shezad Malik

Babette Davis from Wisconsin filed a morcellator product liability lawsuit in the U.S. District Court for the Eastern District of Wisconsin against Johnson & Johnson’s Ethicon unit after being diagnosed with leiomyosarcoma, a deadly aggressive form of uterine cancer. According to Davis, the Johnson & Johnson’s Ethicon Gynecare power morcellator that was used during the laparoscopic hysterectomy caused the undiagnosed uterine cancer to be spread throughout her abdomen and pelvis.

Davis has to take expensive oral chemotherapy drugs to keep the leiomyosarcoma cancer from spreading further and she knows that beating the uterine cancer is going to be a tough battle that she may not win.

Increased Risk of Cancer Spread After Morcellator Use

March 5, 2016

Talcum Powder Ovarian Cancer Victims

by Dr. Shezad Malik

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.