J&J loses $417 million in California’s first talc verdict case
In the 2017 case of Echeverria v. Johnson & Johnson, the company was ordered by a Los Angeles jury to pay $417 million to 62-year-old Eva Echeverria.
Echeverria started using Johnson and Johnson’s talc powder products when she was 11 and was diagnosed with ovarian cancer in 2007. According to Echeverria’s attorneys, the lawsuit stemmed from the company's alleged ignoring of studies that linked the baby powder and Shower to Shower talc products to ovarian cancer. Further, they maintain that the company failed to warn customers about the risk.
Today, Johnson and Johnson continues to claim that these allegations do not hold weight when it comes to sufficient scientific evidence. A New Jersey state court tossed out two similar cases set for trial after the judge said that evidence linking talc to ovarian cancer was inadequate. This was a temporary boost in the messaging Johnson and Johnson had attempted to push in fighting related lawsuits.
However, in the end, the $417 million verdict in Los Angeles included $347 million in punitive damages and $70 million in compensatory damages. What’s more, it marked the beginning of clients getting justice in their own Johnson and Johnson lawsuit matters. The trial in Los Angeles was the first before a state jury outside of Missouri. That’s where the company lost four out of five trials over two years, resulting in verdicts as high as $110 million.
Unfortunately, Echeverria passed away shortly after the trial came to an end.
Updates on the Johnson and Johnson baby powder lawsuit
While there was sufficient evidence to uphold the jury’s finding in Echeverria v. Johnson & Johnson, an appeals court granted the company a new trial in 2019. The Los Angeles-based court cited conflicting evidence about the baby powder’s cancer links.
According to California Superior Court Judge Maren Nelson, Johnson and Johnson could not be held liable for failure to warn, only the subsidiary that manufactured the product would have the duty of disclosing any and all risks. The appeals court also made claims that the evidence failed to support a finding of malice, which is a legal requirement for cases involving punitive damages.
Regardless of her death, Echeverria’s attorney has vowed to follow through and continue the fight, and he’s not alone. In June 2020, a Missouri appeals court ordered Johnson and Johnson to pay $2.1 billion to more than two dozen women.
Much like Echeverria’s case, Johnson and Johnson appealed the verdict, requesting the court throw out the decision. Fortunately, the court declined, citing “significant reprehensibility” in the company’s conduct.
Evidence from as far back as the 1960s demonstrated that the company’s talcum products contained asbestos, a known carcinogen. The ruling stated:
“A reasonable inference from all this evidence is that, motivated by profits, defendants disregarded the safety of consumers despite their knowledge the talc in their products caused ovarian cancer.”
The plaintiffs “showed clear and convincing evidence defendants engaged in conduct that was outrageous because of evil motive or reckless indifference,” the court said.
The attorney representing the women noted that several of them passed away before the ruling, as well as immediately after. This has only furthered the mission of attorneys across the U.S. to seek justice for their clients. For those who have suffered from cancer as a result of using these products, each Johnson and Johnson baby powder lawsuit is a critical step in the right direction
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While we were not directly involved in the original Johnson and Johnson baby powder lawsuit, we can assist in a search for class-action lawsuits that may be available to you. Even as related cases come to a close, there are still more victories to be had.
If you have cancer and believe it may be tied to the use of the products discussed here, you may have grounds for filing a Johnson and Johnson lawsuit. Contact us today to learn more.
A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the third case to go to trial out of thousands of lawsuits claiming the drugmakers' blood thinner Xarelto led to severe internal bleeding.
The verdict in U.S. District Court in Jackson, Mississippi, is a blow to thousands of patients with similar allegations against the drugmaker. The jury returned the verdict after just four hours of deliberation.
The companies also won the previous two trials on claims of risks from Xarelto.
In the latest case, plaintiff Dora Mingo claimed she suffered acute gastrointestinal bleeding after she was treated with Xarelto for a month in 2015 to prevent blood clotting following an operation.
Mingo's case is among an estimated 18,600 lawsuits in federal and state courts related to Xarelto. The first three cases were chosen to be tried as so-called bellwethers to help both sides assess similar claims, define legal strategies, damages ranges and settlement options.
Both Johnson & Johnson and Bayer said they would continue to defend against claims related to Xarelto.
"We will continue to defend against the allegations made in this litigation," J&J's Janssen Pharmaceuticals unit said in a statement.
Bayer in a statement, said, "Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it."
Andy Birchfield, one of Mingo's lawyers, in a statement said health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.
"We will continue fighting for the thousands of innocent victims injured or killed by this drug," Birchfield said.
Xarelto is Bayer's best-selling drug and in 2016 contributed 2.9 billion euros ($3.41 billion) in revenues to the German group's pharmaceutical business.
J&J in 2016 reported $2.2 billion in revenues from Xarelto.
The U.S. Food and Drug Administration approved Xarelto in 2011. The drug is prescribed for people with a common heart rhythm disorder known as atrial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
Original story by Tina Bellon of Reuters.
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The U.S. Food and Drug Administration said it will require a new “black box warning” label for the Essure birth control, an implantable permanent contraceptive device. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.
Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths, and severe pain and bleeding after an Essure implantation.
Approved by the FDA in 2002, Essure birth control is a permanent form of birth control in which a coil is non-surgically placed into a woman’s fallopian tubes. Scar tissue is supposed to form around the device to prevent sperm from reaching eggs and fertilizing them, thus preventing pregnancy.
The FDA also called upon Bayer, which makes and markets Essure, to conduct surveillance that will assess “risks of the device in a real-world environment,” and said the agency will use the results of that study to “determine what, if any, further actions related to Essure are needed to protect public health.” The company is required to follow more than 2,000 women for at least three years. The study will not be limited to women being implanted with Essure but will be comparing women with Essure to women who select other methods of sterilization, such as surgery.
The FDA expects Bayer to submit a study protocol within 30 days and the company is required by law to begin the study within 15 months, according to Dr. William Maisel, FDA deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health. If Bayer does not, the FDA can declare the device misbranded.
The company will also be required to submit interim reports on the study including data and analysis. The FDA expects the first such report will be available within a few months of when the trial begins.
When reached for comment, Bayer provided the following response: “Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work closely with the FDA to support the continued safe, effective, and appropriate use of Essure.”
‘The FDA truly failed these women’
Reaction to the FDA announcement was swift and uncomplimentary.
“We are outraged that it appears as if the FDA is going to leave Essure on the market,” said Essure Problems, a support group for women who say they have been damaged by the device. “Take the device OFF the market and revoke PMA [premarket approval]. Do not continue to allow more women to be harmed.”
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” said Rep. Mike Fitzpatrick, a Republican from Pennsylvania who has called for the FDA to revoke its approval of Essure. “It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”
“I feel as if the FDA truly failed these women,” said Madris Tomes, a former FDA contractor whose business, Device Events, analyzes FDA public data. “My hope was that they would recommend a recall. How can we trust the FDA to make good decisions regarding safe and effective devices?”
Last week, Fitzpatrick and Tomes provided the FDA with raw data showing a total of 303 fetal deaths among women who used the device. The FDA said Monday that it put the number at 294. Previously the agency said that number was only five.
Tomes said she found the additional cases by using a different method of analysis than the FDA.
“Most of the story of what happened and all the side effects, those are going to be in the narrative,” Tomes said. “So we searched for keywords in that narrative that women and their doctors would use, such as fetal death, miscarriage, stillbirth, stillborn and ectopic pregnancies.”
“I actually think the 303 number is conservative,” Tomes added, “because some of these women have had multiple miscarriages, they’ve had multiple pregnancies, after confirmation, but I only counted them once.”
Fitzpatrick said, “I believe Congress must.”
He vowed to present a number of legislative actions to the House and Senate, including working to block government agencies, such as the U.S. Department of Veterans Affairs, from purchasing the device; introducing new legislation that would remove “blanket civil liability protections” that keep women from suing Bayer and seeking passage of an act that would revoke Essure’s FDA approval.
In its press release, the group Essure Problems also called for Congress to act. “While we continue to encourage women to file their adverse event reports with the FDA, our focus will be on Congress and the E-Free Act. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”
“The FDA continues to believe that this should remain available,” Maisel of the FDA said Monday.
FDA requires new checklist
In addition to the black box warning, the FDA is requiring a patient decision checklist to be signed by patients and doctors before the device is implanted. This will include agreeing to a test three months after implantation to make sure the device is properly in place and functioning as intended. A checkup at that time is already recommended by the device maker, Bayer.
In the past, Bayer has said the device is 99% effective at permanently preventing pregnancy. It blames the unintended pregnancies on patient error, suggesting patients may have been lax in following up with their doctors for three-month checkups to make sure the device was working, or lax at using backup birth control during the first three months.
In September, the agency held a hearing in which some of those who filed complaints described what they went through. The FDA also heard from Bayer and health care providers about the existing body of safety data for Essure birth control.
On a call with reporters Monday, Maisel said the agency review of all available information on the device, which was conducted to support Monday’s announcement, also assessed possible clinical trial misconduct in the original clinical trial data. However, he said no misconduct was found and any allegations of that are unfounded.
The FDA said its actions will increase understanding of the risks associated with the device for patients and doctors.
“They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications,” Maisel said.
The new warning label requirement announced Monday has a 60-day comment period to incorporate feedback from patients and the industry before finalizing it and adding it to the packaging.
Original story by CNN.
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Jacqueline Fox passed away in the fall, but her voice recently came alive in a St. Louis courtroom.
In an audio deposition, the Birmingham, Ala., native who died at age 62 recounted 35 years of using Johnson & Johnson products containing talcum powder, including the manufacturing giant’s trademark baby powder and its Shower to Shower body powder. Fox had used them for feminine hygiene, and she believed they were what ultimately killed her.
More than three years ago, she was diagnosed with ovarian cancer that proved fatal. Fox was among more than 1,200 women from across the country who were suing Johnson & Johnson for failing to warn consumers of the dangers associated with talc, the mineral used in baby powder.
On Monday, her case became the first in which monetary compensation was awarded.
A Missouri jury has ordered Johnson & Johnson to pay Fox’s family $72 million in actual and punitive damages. One of Fox’s lead attorneys, Jim Onder, told the St. Louis Post-Dispatch that $31 million will go to the Missouri Crime Victims’ Compensation Fund.
The suit’s other defendant, talc producer Imerys Talc America, has not been faulted.
“We have no higher responsibility than the health and safety of consumers and we are disappointed with the outcome of the trial,” Johnson & Johnson said in a statement Tuesday. “We sympathize with the plaintiff’s family but firmly believe the safety of the cosmetic talc is supported by decades of scientific evidence.”
Johnson & Johnson is expected to appeal the verdict. The award — which is made up of $10 million in compensatory damages and $62 million in punitive damages — will probably be lessened in appellate courts, Stanford University law professor Nora Freeman Engstrom told the Associated Press.
According to the St. Louis Post-Dispatch, one male juror and nine female jurors voted in Fox’s favor; two men voted against her.
One juror, 50-year-old Jerome Kendrick, told the Post-Dispatch that he was swayed by internal company memos presented at trial.
“They tried to cover up and influence the boards that regulate cosmetics,” he said, adding “They could have at least put a warning label on the box but they didn’t. They did nothing.”
One memo from a company medical consultant likened ignoring the risks associated with “hygenic” talc use and ovarian cancer to denying the link between smoking cigarettes and cancer — in other words, “denying the obvious in the face of all evidence to the contrary,” the Associated Press reported.
Another document noted that sales were declining as more people became aware of the health risks, and included strategies for making blacks and Hispanics the highest users of talcum powder, Onder said, as the Post-Dispatch reported.
Fox was African American.
The New Jersey-based company faces many more lawsuits related to talcum products it has made household names.
Marvin Salter, Fox’s son, told the AP that using Johnson & Johnson “became second nature, like brushing your teeth.”
But a routine act eventually became insidious, Fox’s attorneys argued.
A pathologist found that Fox’s ovaries were inflamed from talcum powder, which then turned into cancer.
While studies have associated regular talc use with ovarian cancer for decades, the American Cancer Society notes that there is no definitive research on whether asbestos-free talc — the kind widely used in consumer products — causes ovarian cancer:
Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase. Many case-control studies have found a small increase in risk. But these types of studies can be biased because they often rely on a person’s memory of talc use many years earlier.
Story by Yanan Wang of the Washington Post.
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