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The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, 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 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, still birth, 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 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.
On a call with reporters Monday, Maisel said the agency review of all available information on the 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.
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 an 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 & Johnsonsaid in a statement Tuesday. “We sympathize with the plaintiff’s family but firmly believe the safety 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 talc, 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.
Officials in Florida, Alabama, Mississippi and Louisiana announced an $18.7 billion settlement with BP on Thursday that resolves years of litigation over the 2010 Gulf of Mexico oil spill.
According to Louisiana Attorney General Buddy Caldwell, more than $6.8 billion will be paid to the state of Louisiana. He said $5 billion would be for natural resource damage, $1 billion would be for economic losses, $787 million in Clean Water penalties via the Restore Act, and he said Louisiana would receive total reimbursement for attorneys’ fees and other expenses.
The settlement announcement comes as a federal judge was preparing to rule on how much BP owed in federal Clean Water Act penalties after millions of gallons of oil spewed into the Gulf. Individual states also were pursuing litigation. Most of those penalties were to be distributed among the states for environmental and economic restoration projects along the Gulf Coast.
The settlement money will be used to resolve the Clean Water Act penalties; resolve natural resources damage claims; settle economic claims; and resolve economic damage claims of local governments, according to an outline filed in federal court Thursday morning.
In arguing against such a high penalty, BP has said its spill-related costs already were expected to exceed $42 billion – even without the Clean Water Act fine. It’s also unclear how much BP will end up paying under a 2012 settlement with individuals and businesses claiming spill-related losses.
Costs incurred by BP so far include an estimated $14 billion for response and cleanup and $4.5 billion in penalties announced after a settlement of a criminal case with the government.
In 2012, BP reached the settlement with plaintiff’s lawyers over economic and property damage claims arising from the spill. In its first-quarter earnings report for 2015, BP said it could estimate at least a $10.3 billion cost. But it also stressed that the cost could be higher, depending on how many legitimate claims were filed by a recently passed deadline.
Earlier this year, a federal judge in New Orleans concluded the third phase of a civil trial pitting the oil giant against the federal government. He had already made two key rulings: that BP acted with “gross negligence” in the rig explosion that resulted in the spill; and that 3.19 million barrels of oil – nearly 134 million gallons – spewed into the Gulf as a result. BP had appealed both those rulings, which set the stage for the a possible multibillion-dollar Clean Water Act penalty.
Article originally published on WWL 870.
WASHINGTON, April 14 (UPI) — The U.S. government said it’s proposing new rules to prevent a repeat of the Deepwater Horizon tragedy, though the industry said it’s ahead of the curve.
The Interior Department proposed dozens of new rules for offshore drilling equipment in order to ensure the series of failures that led to the 2010 rig disaster and subsequent oil spill won’t happen again.
“Both industry and government have taken important strides to better protect human lives and the environment from oil spills,” Interior Secretary Sally Jewell said in a statement.
“These proposed measures are designed to further build on critical lessons learned from the Deepwater Horizon tragedy and to ensure that offshore operations are safe,” she added.
A district court in Louisiana ruled in September that BP’s activities at the Macondo well, beneath the Deepwater Horizon rig in the Gulf of Mexico, amounted to willful misconduct. In its 152-page ruling, the court found a series of BP failures at the well “created the catastrophic situation” that led to the 2010 spill.
The incident left 11 rig workers dead and led to the worst offshore oil spill in U.S. history.
BP leased the Deepwater Horizon from Transocean. In 2012, oil services company Halliburton was accused by BP of destroying test results on the cement used to seal the well beneath the rig.
The federal rules, if approved, would require companies to offer records up to third-party reviews and require backup equipment to close off any failed infrastructure.
The American Petroleum Institute, which represents the business interests of the oil and gas industry, said it’s already created and revised more than 100 standards meant to ensure safe exploration and production.
“We are reviewing the proposed rules and hope they will complement industry’s own efforts to enhance safety,” API director for exploration and production Erik Milito said in a statement. “Improved standards for blowout preventers are one of the many ways industry has led the charge to make offshore operations even safer.”
Original story by Daniel Graeber of UPI.
It’s been almost five years since the Deepwater Horizon oil rig exploding, sending gallons upon gallons of oil into the Gulf of Mexico. Now, scientists have assessed the wildlife in the Gulf, and have found that it’s still suffering from the oil spill.
“Five years later, wildlife in the Gulf are still feeling the impacts of the oil spill,” said Collin O’Mara, president and CEO of the National Wildlife Federation, in a news release. “The science is clear that this is not over-and sea turtles, dolphins, fish and birds are still suffering from the fallout. Holding BP fully accountable and using all fines and penalties to restore the Gulf of Mexico must be a national priority.”
In this latest study, the researchers examined wildlife populations. They found that dolphins on the Louisiana coast were found dead at four times historic rates in 2014, and there is increasing evidence that ongoing deaths are connected to the oil spill. In addition, endangered Kemp’s ridley sea turtle nests have declined after the spill, even though they were increasing before it. Exposure to oil also has been shown to cause abnormal development in many species of commercially valuable fish, including mahi mahi and the yellowfin tuna.
“Wildlife from sperm whales to marsh ants are still feeling the effects of the disaster,” said Ryan Fikes, a NWF restoration scientist. “But BP seems to prefer attacking scientists over accepting responsibility. It’s time for BP to quit stalling so we can start restoring the Gulf.”
These latest findings show how the Gulf is still being impacted by the spill, years after it occurred. More specifically, it shows how not only wildlife is being impacted, but how the Gulf states may be affected as well as commercial species continue to fare poorly.
Originally posted by Catherine Griffin here.