Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label Bayer. Show all posts
Showing posts with label Bayer. Show all posts

Tuesday, July 24, 2018

BAYER Essure sterilization device: FAILED globally.

Bayer to phase out Essure birth control device in U.S.



NEW YORK (Reuters) - Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device that made the business no longer sustainable.

The decision followed an announcement by the company in September 2017 that it would discontinue the sale of the contentious sterilization device in all countries outside the United States.
Bayer said in a statement that the decision was not related to safety concerns. The company, based in Leverkusen, Germany, is facing some 16,000 U.S. lawsuits over Essure, and it said it was expecting more.
“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” Bayer said.
It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers.

Essure will be gradually phased out and U.S. sales halted by the end of this year. Doctors will be able to perform Essure procedures until the end of next year when they will be asked to return unused devices.
FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure’s safety, and added, “We expect Bayer to meet its postmarket obligations concerning this device.”
Early in 2016, the FDA put its strongest safety warning label on the device after thousands of complaints and asked the drugmaker to conduct a post-market study.
The agency said it received nearly 12,000 reports in 2017 related to Essure.
Bayer said extensive research by the company and independent medical researchers showed Essure was safe.
Women have claimed in lawsuits that Essure, which is implanted in a woman’s fallopian tubes to permanently block the passage of eggs to the uterus, could pierce the tubes, and that metal parts of the device could become dislodged and migrate to other parts of the body, causing pain, injuries and severe bleeding.

They also claimed that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.
Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn sellers, doctors and regulators.
Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons.
Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.
The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.
In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and “inaccurate and misleading publicity about the device.”

Reporting by Tina Bellon; Editing by Clive McKeef, Toni Reinhold

Thursday, December 21, 2017

Spain Bans Bayer Essure Sterilization Coils




After civil proceedings were opened against pharmaceutical company Bayer all over the world because of the higher risks of serious adverse reactions associated with its contraceptives (see HERE), now, under the authority of the Ministry of Health of Spain, has called for pharmaceutical giant Bayer to stop marketing the contraceptive Essure and to withdraw it from the market, ” as it does not have a valid CE marking certificate”. Thus, as a precautionary measure to avoid birth control implant risks, the Spanish Agency for Medicines and Medical Devices (AEMPS) has ordered health centers and professionals who have Essure to stop using it.

The AEMPS note explains that “Essure® is a permanent contraceptive system, designed to be used as a micro-insert to block the Fallopian tubes and that acts mechanically by causing a foreign body reaction that causes blockage of the tube”. It adds that “it is not advisable to remove the device or modify the follow-up guidelines of users.” Suspension of the certificate was effective from 3 August 2017 for a period of 90 days until 2 November 2017. On 4 August, the European Union took the decision to suspend the marketing of these sterilization implants for three months, after the body responsible for renewing the certification required additional elements before reaching a decision (see further information HERE)

Wednesday, September 27, 2017

Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!



September 26, 2017 Press Release
WASHINGTON, DC (September 26, 2017) Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).
”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”
“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.
###


2413 Rayburn House Office Building
Washington, DC 20515
Phone: (202) 225-3661
Fax: (202) 225-4890

59 Elm Street
New Haven, CT 06510
Phone: (203) 562-3718

Fax: (203) 772-2260

Thursday, June 8, 2017

FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.

Updated: JUNE 6, 2017 — 7:38 PM EDT


by Marie McCullough, Staff Writer mmccullough@phillynews.com
The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.


Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.
More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.


Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook
“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?
Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure
This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.




Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.
Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”
But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.
“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.
The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”
Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Tuesday, May 9, 2017

No Objective Patient Outcome Data: Sacrificial Lambs




Updated: May 07, 2017 9:51 AM CDT

By Kent Luetzen

MISSOULA -
Women from around the country who have been harmed by medical devices such as Essure --  a type of birth control -- used their voices to rally on Saturday. One rally was held in Missoula in hopes of raising awareness about what they call "hidden dangers" of some FDA-approved products. 




The group says women deserve better communication from doctors on the side effects of products and for manufacturers to not hide behind the FDA's pre-market approval certification.
For some of these women, products which were said to be safe have caused serious health issues including autoimmune diseases such as eczema, lupus and celiac disease.
Ray Curtis, who’s wife died from hysterectomy complications, is hoping Montana legislators will continue their work to protect women.
"They're (treated) almost like human guinea pigs. These devices are being used for purposes they weren't intended to be used for," Curtis said.  "Legislation can bring about awareness to begin with, but also get government to protect woman who are unsuspected like my wife and me... we didn't know.."

Missoula's rally was just one of over 20 throughout the United States.

Thursday, March 3, 2016

FDA Commissioner Dr. Califf: The Fox is in the Henhouse!

F.D.A. Asks If Faulty Blood Monitor Tainted Xarelto Approval

By KATIE THOMAS FEB. 22, 2016
The Food and Drug Administration is investigating whether a faulty blood-testing device may have compromised the results of a clinical trial that led to the approval of Xarelto, a blockbuster anticlotting drug that has been prescribed to millions of Americans since it arrived on the market in 2011.

The agency has asked the drug’s manufacturer, Johnson & Johnson, detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.

The clinical trial, known as Rocket AF, was led by Dr. Robert M. Califf, currently President Obama’s nominee for head of the Food and Drug Administration. It involved more than 14,000 patients worldwide and took place from 2006 to 2010.
Xarelto, which is also known by its scientific name, rivaroxaban, is one of a new class of drugs that are seen as a replacement for warfarin, a cumbersome 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that is working. If patients receive too little of the drug, they could experience a stroke. But if they receive too much, their lives could be threatened by catastrophic bleeding.
Questions about the trial have been stirring since last fall, when Johnson & Johnson and Bayer, which sells Xarelto overseas, notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding. The device, the INRatio sold by Alere, was used in the trial to help doctors gauge whether patients were getting the right dose of warfarin. The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto to those of patients who were given warfarin.
Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.
This month, researchers with the Duke Clinical Research Institute, which oversaw the trial, published their own analysis in the New England Journal of Medicine and concluded that the faulty device did not affect the trial’s outcome. A few days later, an analysis by the European Medicines Agency, the F.D.A.’s European counterpart, came to the same conclusion.
But rather than settling the matter, the analyses have raised additional questions and have come under harsh criticism from some medical experts. The Duke researchers, for example, never mentioned the existence of central laboratory tests — taken at two points during the trial — that could have been used to assess whether the device’s readings were accurate. And the analysis released by the European drug agency, while it did include those readings, was done by the companies themselves and not by independent statisticians.

“There are so many questions that are yet unaddressed,” said Dr. Harlan M. Krumholz, a cardiologist and director of the Yale University Open Data Access Project, which has an agreement with Johnson & Johnson to make the company’s data from clinical trials available to outside researchers. He has asked the company for access to the trial data, he said, and the company has agreed — but Bayer has refused.
Dr. Krumholz called on Alere to release more information about its device. “We do not know why the device did not work well,” he said.
In a statement, a spokeswoman for the F.D.A. said that while the agency was looking into the issue, it had not changed its recommendations for the drug, which “provides an important health benefit when used as directed.”
A spokeswoman for Alere declined to comment, and a representative for Duke referred to an earlier statement detailing the results of its reanalysis.
Johnson & Johnson said the INRatio device was selected because it was F.D.A.-approved and easy to use. It said it was not informed of the device recall until last September, when it and Bayer “acted with urgency, diligence and in the best interests of patients and prescribers.” The company said that it has provided answers to the questions the F.D.A. asked and that the analysis published in the New England Journal of Medicine confirmed the safety and efficacy of the drug.
A spokesman for Bayer said the company was confident in the results of the trial and dismissed the issue as being driven by plaintiffs’ lawyers, saying, “They have cherry-picked testimony and documents divorced from any context.”
Dr. Califf is the former director of the Duke Clinical Research Institute, which conducted the trial, and served as the study’s co-chairman. He has since left Duke and is now a deputy commissioner of the F.D.A. Dr. Califf, who did not respond to an email, has no role in the inquiry into the Rocket AF trial, the F.D.A. has said. The Senate was expected to vote Tuesday on whether to confirm his nomination as head of the agency.
Just as the trial was getting underway in 2006, the INRatio was facing scrutiny by the F.D.A. In 2005 and 2006, the agency sent warning letters to HemoSense, then the manufacturer of INRatio, claiming that the devices were generating “clinically significant” erroneous values and that the company, which was later acquired by Alere, was not properly investigating the complaints.
In 2014, Alere recalled the INRatio monitors, saying that they might provide inaccurate results.
However, the connection to the Rocket trial was not made public until this past fall, when a journalist for the British Medical Journal began asking the companies about it. A spokesman for Johnson & Johnson told the journal that the company had been unaware of the recall. The revelation led to the reanalysis by the Duke researchers as well as inquiries by the European Medicines Agency and the F.D.A.
But while the European agency concluded that the trial outcome was not affected by problems with the device, the F.D.A. appears to be taking a closer look, asking pointed questions about whether the company had evidence that the device was malfunctioning during the trial and what actions it took, according to the legal document, which was filed with Judge Eldon E. Fallon in the Eastern District of Louisiana.

The legal motion filed on Monday also cited internal emails that, the lawyers said, showed that some doctors were questioning the accuracy of the device while the trial was underway. The lawyers said so many concerns were raised about the device that a special program was set up to investigate the malfunctions, but none of these details were provided to the F.D.A. when Johnson & Johnson responded to the agency this month.
The Rocket trial has previously come under criticism. In 2011, the F.D.A.’s medical reviewers recommended against approval of Xarelto, citing concerns that the patients receiving warfarin during the trial were being poorly managed, which could give an unfair advantage to Xarelto.
An outside advisory committee later voted to approve the drug — although several members cited reservations — and the agency allowed it to go on the market. It has since become the best-selling drug in its class, bringing in $1.9 billion in the United States in 2015, according to Johnson & Johnson.
Some said the fact that Xarelto has been on the market since 2011 gave them faith in the safety of the product. “The real world has already made the case for this drug,” said Dr. Jürgen vom Dahl, a German cardiologist who served as an investigator in the trial, who said he did not recall encountering any problems with the device.
Dr. vom Dahl also said that he and his German colleagues have wondered whether Dr. Califf’s F.D.A. nomination was playing a role in the renewed questions about the trial. “We don’t know what is real science, and what is more politics,” he said.
But others say that plenty of questions remain, and that they are disheartened by a seeming reluctance by Duke, Johnson & Johnson and Bayer to be forthright about the problem.
“It depends on where you put the flashlight,” said Robert Powell, a clinical pharmacologist who has worked in the drug industry, as well as for six years at the F.D.A. “I think they were directing people away from the problem.”

Sabrina Tavernise contributed reporting.

Wednesday, March 2, 2016

Any COI? Dr. Robert Califf: FDA Commissioner and former Duke University researcher.

Document Claims Drug Makers Deceived a Top Medical Journal

By KATIE THOMAS MARCH 1, 2016
It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?
Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.

Duke and Johnson & Johnson contend that they worked independently of each other. Bayer declined to comment. And top editors at The New England Journal of Medicine said they did not know that separate laboratory data existed until a reporter contacted them last week, but they dismissed its relevance and said they stood by the article’s analysis.

But the claim — that industry influence led to the concealing of data — carries echoes, some experts said, of an earlier era of drug marketing, when crucial clinical data went missing from journal articles, leading to high-profile corrections and a wave of ethics policies to limit the influence of drug companies on medical literature.
“It just feels like it’s a real ethical breach,” said Dr. Lisa Schwartz, a professor of medicine at Dartmouth, of the failure to include the lab data in the letter. “If you know the direct answer to this question, then how can you not provide it to be able to give insight?”
Xarelto, which is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace warfarin, an older blood thinner. The two companies hired the Duke Clinical Research Institute to run a three-year clinical trial involving more than 14,000 patients that led to Xarelto’s approval by regulators. But those results have come under scrutiny since September, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.
The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those of patients using warfarin. The concern is that the faulty results may have led doctors to give patients the wrong dose of warfarin, which could have favored Xarelto.
Last month the Duke researchers published an analysis in The New England Journal of Medicine and concluded that the problems with the device did not change the trial’s results.
But some in the medical community questioned their findings because their method required them to essentially guess which groups of patients were more likely to be affected by the malfunctioning device.
A better way to evaluate the device, other researchers said, would be to compare the device readings with test results that were done at a central laboratory. Investigators did that at two points in the trial, drawing blood from more than 5,000 of the patients who took warfarin and sending the samples for testing. The blood was taken 12 and 24 weeks after patients enrolled in the trial.

But the Duke researchers made no mention of the lab data in their letter. In an interview, journal editors said they did not know about the lab data until last Tuesday, when a reporter for The New York Times asked them about it.
“At the time we published the letter, we didn’t know that it existed,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal of Medicine.
Dr. Drazen disputed the lawyers’ claim that the editors had been misled about the data, and said it was not relevant to the letter that was published.
Last week, lawyers in the case against Johnson & Johnson and Bayer filed a legal brief in federal court in New Orleans, asking a judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.
In a footnote, the lawyers said that during the process of vetting the Duke researchers’ letter, a peer reviewer asked about the existence of lab data that would allow a comparison with the device’s readings.
“Despite being provided this opportunity to respond to the peer reviewers,” the lawyers said, the “defendants remained silent on this point, thereby misleading the NEJM.”
Dr. Drazen confirmed that a peer reviewer, whose identities are kept confidential, had asked about such data, but said the editors had rephrased the question to ask whether such data was available throughout the course of the trial. Duke then answered no, he said.
The letter’s three authors, two from Duke and one affiliated with the University of Edinburgh in Scotland, declined to comment, as did a spokesman for Duke.
Dr. Drazen questioned the value of comparing lab results taken at only two points during the trial, noting that people’s blood-clotting levels can vary greatly over time. “There’s so much variation among people that it probably wouldn’t be clinically informative,” he said.
However, he said, the Duke researchers had since agreed to conduct an analysis of the lab data.
Dr. Drazen also said that the editors had not been in contact with either Johnson & Johnson or Bayer. A spokeswoman for Johnson & Johnson said the analysis by Duke was conducted independently of the company. Although a company employee serves on the trial’s executive committee, she said he recused himself “from the conduct of the reanalysis, the drafting of the research letter, and provided no feedback before it was submitted.” Bayer declined to comment.
In a previous statement, Duke said it had conducted its research separately from the two companies. But this fall, Bayer submitted an analysis to the European Medicines Agency that was nearly identical to the approach used by the Duke researchers, comparing the outcomes of patients who had specific medical conditions with outcomes of those who did not. And the legal document filed last week cites a document obtained from one of the companies that describes the peer-review process.

Some experts say this case is reminiscent of other instances in which drug companies concealed or altered drug-trial data in medical journals. In 2005, for example, The New England Journal of Medicine published a rare Expression of Concern after it learned that researchers had failed to include three heart attacks in a study of the painkiller Vioxx, made by Merck, which has since been withdrawn from the market. In that case, editors learned that data had been deleted from the trial manuscript two days before it was submitted to the journal.
Such controversies led to changes in the way that journal articles are published. Authors are now required to disclose their outside financial interests and the role that drug companies played in articles’ publication.
Several researchers said they were surprised that Duke and the editors at the journal did not see value in comparing the lab data, especially since Bayer and Johnson & Johnson have submitted such information to regulators in Europe and the United States.
“I think it’s always important to make sure that you have all the information to answer the scientific question before publication,” said Dr. Rita F. Redberg, a cardiologist who is also editor of the medical journal JAMA Internal Medicine.
Less than a week after the Duke letter was published, the European Medicines Agency released its own report, which contained analyses using the independent lab comparisons. The agency concluded the device most likely did not affect the trial’s outcome, but it did find that the device was highly inaccurate.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

Wednesday, February 17, 2016

Safety and Suicide: Karen Langhart, J&J NuvaRing, Bayer and FDA


OVERVIEW
How direct-to- consumer advertising, corporate malfeasance, and conflicts of interest at the FDA have given rise to a false sense of security for women who use some forms of hormonal birth control.
PUBLISHED 3 HOURS AGO  20160216
This Dan Walter story was funded directly by readers like you.
It's free to read because it was shared on Facebook. Back Dan Walter, and your funding directly supports his future work — You can impact the stories that get told.

SUBSCRIBE TO DAN MAKE A ONE-TIME PLEDGE

“By the time you receive this note I will have joined Erika,” a letter obtained by the Durango Herald reads. “I consider it an honor to give my life to help save the lives of others.”
___________
There’s a video, made last summer, in which 56 year old Karen Langhart approaches a podium in a conference room in San Antonio, Texas. She takes the microphone and, with a heavy sigh, faces the audience. She drops her hands to the edges of the lectern, takes a deep breath and lets it go. It is clear that what she is doing is an effort, and that she has done it many times before. She is weary - very weary - and you can tell that she is willing herself to go on. She raises her eyes from her notes and looks out at the room, sweeps her blonde hair behind her ears and puts her reading glasses on.
She sighs heavily again and sets a grim smile.
She thanks her hosts and says that she and her husband cannot convey how much they appreciate that the film which is about to premier is dedicated “to my beloved daughter Erika and all of the other women who have lost their lives to these dangerous drugs.” She is all but crying; not actually crying because she is all cried out and has been for a long, long time.
The independent film, Natural Love Stories, is about alternatives to hormonal contraception. It was dedicated to Erika Langhart because she died at the age of 24 from massive pulmonary embolisms. In November 2011, a blood clot traveled from Erika’s leg to her lungs and cut off the blood supply, causing a series of cardiac arrests that left her brain-dead by the time her parents made it to the hospital. The doctor told them that she died because of a contraceptive she was using called NuvaRing.
Karen Langhart has told the story so many times to so many audiences since then that you’d think the rawness of it would subside. But it never did, it got worse with each telling and you can see from the video that this woman is coming apart, disintegrating before your eyes.
Without grasping the irony, Karen tells her audience that her daughter’s spirit was best captured in the Durango High School Yearbook dedication, which urged graduates to “Care more than others think wise, risk more than others think safe…”
Risk and safety, our perceptions of it as consumers, are at the core of this American family tragedy.
Karen, sniffling back the sadness that will soon drag her under, says that she appreciates the film because it gives women the information they need in order to make well-informed choices about birth control, and that she and her husband believe that if Erika had access to that information, she would be alive today.

***
As often happens with people whose lives are precipitously sheared in half by some sudden, incomprehensible and unacceptable tragedy, Karen became obsessed with righting the injustice of it all. The loss of a loved one through the carelessness or cunning of those entrusted with their health and safety is dealt with by taking action, transforming one’s life into a crusade. It is an effort - not to find “closure” because there can never be any such thing - but to do something with it, to channel the unstoppable flood of grief, pain and anger toward something else so that one can at least endure.
But it turns out to be less a crusade than an odyssey, with disorienting twists and turns that some people just aren’t equipped to survive.
The Langhart’s introduction to the Alice in Wonderland world of post-traumatic patient advocacy began with the discovery that the Food and Drug Administration would be holding scheduled hearings about the dangers of certain hormonal contraception within weeks of Erika’s death, but there would be no discussion about NuvaRing, nor would the Langharts be allowed to speak.
Wise counsel to their reflexive reaction that this is crazy, unfair, and makes no sense would have been to just get used to it, because you have entered a world where fairness, justice and common sense are more the exception than the rule.

***
Because clinical trials can only test products on a limited number of subjects, you really can’t get an idea of the full range or seriousness of unintended consequences of drugs or devices until they are used by hundreds of thousands of people.
The process of vetting a new medical product through the general public generally goes like this: If there is some latent defect, various dreadful side effects will be revealed over a period of several years with reports of hundreds of injuries and scores of deaths. At some point it starts to dawn on the medical community and the public that there’s a problem, a downside to the miracle drug. There will be news stories, lawsuits and government hearings. There will be protestations from the manufacturer that the risks are well-known and the product “has been shown to be safe and effective,” even as they settle lawsuits (stipulating confidential payouts and no admission of wrongdoing).
If they find a way to tinker with the product to reduce their legal exposure by eliminating undue risk, all the better. But as long as the legal fees, settlements, and government fines can still be figured into the overhead and the product still turns a profit, it’s business as usual. (Ford Motor Company famously set the American standard for using cost-benefit analysis in deciding that the bottom line justified the immolation of a modest number of its customers.)
This is how it unfolded for pharmaceutical birth control - except that the profit motive has engendered a repeat of the whole cycle. And this time, in the era of deregulation and direct-to-consumer advertising, Big Pharma is in a much better position to deflect criticism and responsibility - and to keep selling the products.
***
Dr. Frits Rosendaal is a Professor at Leiden University Medical Center in the Netherlands. He heads the Department of Clinical Epidemiology, as well as the Department of Thrombosis and Hemostasis, and has written nearly 500 papers for international journals - which qualifies him as the world’s leading expert on the self-sealing aspects of the circulatory system.  
“Coagulation is a complex system consisting of some 20 or more proteins, for it has to happen rapidly and be localized when necessary as in the case of a wound - but not otherwise - and it has to stop quickly afterwards,” Rosendaal says. “So, these proteins keep each other in a dynamic balance. This balance varies between people, and as with eye color there is variation. Some people are a bit tilted one way; they bleed more easily and clot a bit less easily, and some people tilt the other way. Those who tilt towards clotting will be more prone to develop thrombosis when they encounter a risk factor like cancer, extended air travel or hormonal contraception.”
Birth control drugs generally consist of a combination of an estrogen hormone and a synthetic form of progesterone. While this works to prevent conception, any tinkering with hormones is bound to effect other delicate systems of the body. The main repercussion of chemical contraception is its effect on the cascading factors that trigger the clotting action of blood.
The original pill, Enovid, loosed on a grateful generation of women in 1960, was launched with what turned out to be dangerously high doses of estrogen and progestin, which caused some women to develop serious blood clots. After more than ten years of side effects, deaths, corporate denials and FDA hearings, manufacturers finally reduced the amount of hormones in what became known as the second generation of pills.
The problems diminished and all was well, more or less, for a decade or so until two looming factors prodded drug manufacturers to mess with a good thing. For one thing, the market was pretty well saturated. There was a good-enough pill out there and those who wanted it took it, with little room for individual companies to increase market share. More importantly, while estrogen was not proprietary, patents on various versions of progestin would eventually expire, depriving companies of exclusive control for premium brands. This prompted development of third and fourth generation contraceptives. These were based on the same basic formula, but the progestin component was altered to include patentable derivations of the synthetic hormone. The other innovation made with an eye toward marketability was in delivery systems; the transdermal patch and the hormone-secreting vinyl ring.
The numbers, as usual, are contentious and undecipherable to all except practitioners of the dark art of statistical analysis, but they generally point to at least a doubling of the chances for dangerous blood clots for users of the third and fourth generation contraceptives, such as NuvaRing, the Ortho Nuva patch and pills such as Yaz and Yasmin.
As with the original version of the pill in the 1960’s, the adverse effects of the newer generation contraceptives have been revealed over several years as reports of injuries and deaths continued to mount.
***
With the intervention of their senator, John McCain, the Langhharts were given leave to speak at the FDA hearings about the dangers of the newer contraceptives.
The hearings were spread over two days. The first day’s discussion was given over to decide whether the benefits of pills which contained the fourth generation synthetic hormone drospirenone (DSRP) outweighed the risks. In other words, the question was whether birth control pills like Yaz and Yasmin, which pulled in $1.6 billion for Bayer Pharmaceuticals the year before, were too dangerous to stay on the market. The second day would be devoted to risks and benefits of the Ortho Evra contraceptive patch, which contains a third generation hormone, and what, if any, action was to be taken regarding that product.
The Yaz and Yasmin question was debated in the light of studies that had been submitted to the panel.
Three of the studies, funded by Bayer, found no additional risk from their product. Seven other studies, which had not been paid for by Bayer, all showed that the risks were indeed higher - significantly higher.
***
Dr. Diana Zuckerman went to Yale and did research at Harvard. She is President of the National Center for Health Research and a fellow at the University of Pennsylvania Center for Bioethics. She pointed out to the panel that the Bayer-funded studies had fraudulently misrepresented the dangers that Yaz and the other drugs posed from Venous thromboembolism (VTE) - which is what killed Erika Langhart. The panel, Zuckerman said, had been shown “some very specific examples where Bayer was misleading and misrepresenting” the risks of DSRP drugs relative to earlier generations of hormonal contraceptives.
Zuckerman was referring to a report by former FDA Commissioner Dr. David Kessler which had been provided to the panel earlier in the week, but which the panel decided not to include in the discussion on technical grounds relating to a supposed missed deadline. Kessler’s report included excerpts from internal Bayer documents:
Compared to the three other OCs [oral contraceptives], Yasmin has a several fold increase in the reporting rates for DVT [deep vein thrombosis], PE [pulmonary embolism] and confirmed VTEs [venous thromboembolism].…When considering only serious AEs [adverse events], the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude. [Emphasis added]
The panel heard from Cindy Rippe, whose daughter, Elizabeth, died from pulmonary embolisms after two months on Yasmin. Rippe gave the panel a little lecture about American exceptionalism when it comes to alerting women to the risks of DSRP drugs. “Australia warns, Canada warns, England warns. England tells their daughters that the totality of available evidence now clearly shows that the risk of venous thromboembolism for Yasmin is higher,” Rippe pointed out. “Higher. Not the same, not questionable, not unclear – higher.”
“If Elizabeth had been clearly warned that Yasmin had more risk – maybe twice as much risk as other pills – she never would have switched to Yasmin. Never,” she said. “And she would be alive today.”
They heard from Diane Ammons, a retired fifth grade teacher, who said “I am speaking for my daughter Anne today, since she is dead. She died because she trusted the U.S. medical system. She died because she took her FDA-approved medication as prescribed. DRSP killed our healthy, athletic daughter.”
Anne Ammons was a healthy, athletic young woman who died, not from blood clots, but dehydration and increased potassium levels, another risk of consuming DSRP. But her mother told the panel that “talking with anyone who would listen after Anne’s death, most women or someone they know has had a blood clot problem with drospirenone. It is not rare. That shocks us.”
The panel heard this from Joan Cummins:
“My daughter Michelle was an amazing young woman, vivacious, beautiful, accomplished. She was looked up to by her peers and cherished by her family. Michelle was extremely intelligent and was an exceptional student. At 18, she was just starting her freshman year at Elon University in North Carolina when she collapsed on her way to one of her morning classes on a day I will never forget, September 24, 2010. She was rushed to the hospital by paramedics, but died from cardiac arrest from a pulmonary embolism. My daughter was on Yaz.”
That these pills are on the market when older generation pills are available and just as effective “is worse than insanity,” Cummins said. “It is a sickness called greed. My daughter did not need Yaz. Bayer needed Yaz.”
***
There were 26 FDA panel members voting. The official in charge of such things declared that none of the voting members had a conflict of interest.
Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, was a panel member. Wolfe had called on the FDA to pull these drugs off the market in 2007 because of research showing that while the risk of these drugs is worse, they offer no clear advantage over earlier generation pills. He was not allowed to vote due to “an intellectual conflict of interest.”
The panel voted 15 to 11 that the benefits of Yas, Yasmin and other DSRP contraceptives outweighed the risks.
It was subsequently revealed that four of the voting members who voted “yes” had conflicts in the form of dealings with Bayer. In voting “no”, Dr. Peter Kaboli said “I wouldn’t recommend this to my patients and I wouldn’t have my daughter take it.”
It is important to note that those who voted “yes” did so mainly on the basis that even with these deaths and injuries, the overall risks of using hormonal contraceptives in general is relatively low. According to birthcontrolsafety.org, out of the nearly 11 million women who use the drugs, about 20,000 of them will develop blood clots and about 600 of these women will die. This, according to the medical establishment, means that hormonal contraceptives are “safe enough.”
Groups like Planned Parenthood and The American College of Obstetricians and Gynecologists are OK with those odds as well. They and other proponents of leaving the newer generation drugs on the market often cite a statistic that the risks of VTE’s during pregnancy and the weeks post-partum are actually higher than when using contraceptives. So, from that perspective, you’re much better off taking your chances with hormonal birth control than getting pregnant.
But Dru West, whose 29-year old daughter Julia died in the same way as Erika Langhart, says this reasoning is faulty. She and Joe Malone, whose daughter Brittany was 23 years old when she died after using NuvaRing, did some research and discovered that in 2011, according to the Centers for Disease Control and Prevention, more U.S. women died from pulmonary embolisms while using a combined hormonal contraceptive than while pregnant or postpartum.
Most of those who voted “no” on the newer drugs said they did so because of the reasons Dr. Wolfe laid out; that the newer contraceptives pose a greater risk compared with the older generation drugs - with no appreciable benefit. Michele Orza, a policy analyst at George Washington University and the consumer representative on the panel, said she “voted no because I could not perceive any additional benefits only with these drugs. And so any additional risk, even small - and I don’t think the risk is potentially as small as some people are suggesting; -even only a 50 percent increase would represent thousands of unnecessary VTEs.”
• • •

Dr. Zuckerman later told NPR that “In my opinion, absolutely, these drugs should not be on the market because there are safer alternatives.”
The panel did vote (21 to 5) to strengthen the label. The warning was buried in a 33 page document that was less than emphatic, advising users that “the FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”
***
The next day’s hearings were devoted to the Ortho Evra contraceptive patch, sold by a subsidiary of the notoriously corrupt Johnson & Johnson corporation. The patch does not contain DSRP, but does deliver a much higher level of hormones. A year before this meeting, NBC reported that “the company knew that users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than pill takers.”
It was after this discussion the the Langharts finally got to speak about their daughter and NuvaRing.
Rick Langhart spoke first: “On the Monday before Thanksgiving, we received a phone call from Erika’s boyfriend that something had happened to Erika and that he EMTs were at her apartment. She was heard screaming down the hall, screaming with the last breath she ever took on her own. The EMTs gave her CPR over the next hour and a half. She suffered three heart attacks, bringing the total to four. Unfortunately, the blood clot was so massive that it clogged her lungs. She never had a chance.”
It seems like Karen Langhart’s time expired just as she started to speak, but she was granted an additional two minutes, which she used to ask the panel: “Why are these third and fourth generation contraceptives prescribed to young women when they are known to have risks and there are safer second generation contraceptives out there? We believe that our daughter would still be alive had the third generation contraception not been prescribed to her. Why would you allow third and fourth generation contraception that shows no additional benefits when second generation contraception provides the ability for young women to not become pregnant as they desire?”
The experts weighed in pro and con, with Dr. Sidney Wolfe again restating that these newer generation contraceptives were much more risky and no more effective than existing birth control products and methods.
The panel voted 19-5 that the benefits of the patch outweighed the risks.
As with Yaz and Yasmin pills, they did vote to strengthen the warning label, which the J&J sales team took as yet another sharp blow. The new label changes were to be added to the dreaded “Black Box” warning which had been mandated in 2005 after reports of about two dozen deaths and thousands of injuries. Contraceptives reaped more than $1 billion for Johnson & Johnson in 2005, but the salad days for the patch were effectively over. The following year’s bottom line would suffer, the company announced, due to “labeling changes and negative media coverage concerning product safety.” (J&J made up for the loss with a twenty-fold increase in the price of contraceptives for Medicaid patients, throwing many Red States into a budget crisis.)
***
The purveyors of NuvaRing fully understood the effect of scary warning labels on sales. The ring was developed by the Netherlands-based pharmaceutical company Organon, which was later bought by Schering-Plough, which was subsumed by Merck shortly afterward.
When the FDA assessed the product in 2001, a clinical trial reviewer flagged the risk of thromboembolism, citing the fact that three young women had to drop out of the study because they developed blood clots. The reviewer recommended that the product label include that information.
Organon executives were having none of that. Email exchanges recovered in the course of lawsuits reveal the executives’ reluctance to convey VTE risks to consumers. “We should really try to get it out of the text,” reads one missive from headquarters. There followed months of negotiation, in which various bits of clinical information were used as “bargaining chips.” Organon cited conflicting studies and pointed out to the FDA that the clinical trials were really designed to test efficacy - not safety. Regulators acquiesced and agreed to a label that proclaimed that it was “unkown” whether there was an increased risk of developing blood clots with NuvaRing.
The folks at Organon were still not satisfied and wondered internally “What are the chances that this section can be removed altogether?”
Dr. Susan Allen, the officer who oversaw the weakening of the label in negotiations for the FDA, later left the government and joined Merck, advising the company as to the best way to head off further efforts to strengthen it. Indeed, Merck succeeded in actually having the clot risk warning weakened even more in 2013.
***
All that hard work paid off for shareholders of Nuvaring’s various parent companies. In 2005, when the FDA mandated the black box warning for the Ortho Evra patch, Organon made sure that the people who wrote prescriptions knew all about it, and enthusiastically touted the supposed superior safety of the ring.
Because Organon was able to dodge the Black Box warning, sales of NuvaRing currently rake in $1 billion a year for Merck, while the Ortho Evra patch has faded from the marketplace. The NuvaRing carries about the same risk for deep blood clots as the patch.
***
“I don’t understand why a company in the United States would allow that kind of product on the market,” Rick Langhart told CNN. “It’s not the way Americans do business. And for them to do what they do in total disregard for what’s going on. It’s criminal to me.”
Unfortunately, Rick Langhart was learning that a lot of American medical and pharmaceutical companies do business this way.
For one thing, the entire commercial infrastructure of life-altering American medical goods and services begins with clinical trials, which are generally rigged when it comes to reporting results of what’s safe and/or effective. The New York Times recently reported on how drug makers often hide negative data on side effects. Organon, it was discovered during lawsuits, hid negative data from the FDA concerning spikes in the amounts of hormones delivered by the NuvaRing, which is at the center of many of the safety complaints. Johnson & Johnson likewise hid data regarding the dangers of the Ortho Evra patch.
All this is really nothing new, since it’s pretty much an open secret that most published research findings are false anyway.
Who is supposed to protect us? The FDA, which is riddled with conflicts. You can find out why by reading this 2013 paper, Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs.
Those are just the nefarious doings on the R&D side of Big Pharma. The selling of the drugs constitutes its own catalog of crimes.
Organon USA’s sales force, for example, proved to be just as agile with ethics as its executives and scientists when it came to pushing NuvaRing. Journalist Ed Silverman reported that Organon defrauded Medicaid by lying about prices and sales figures in an attempt to generate profits and corner the market.
They sold the NuvaRing to Planned Parenthood for $3 a piece, the price they reported to Medicaid. This enabled them to appear to be complying with Medicaid’s best pricing rule and avoid paying rebates. All other wholesalers paid $34.
In short, Organon essentially gave away NuvaRing and its other contraceptives hoping that young women who went to Planned Parenthood facilities would initially be given a low-cost form of birth control. And if the gambit worked, NuvaRing or any of the three pills could become the contraceptive of choice for countless women who could be expected to engage in family planning for the next 20 years or so.
Unlike in the United States, pharmaceutical price gouging is illegal in Canada, so authorities there were not amused by Organon’s charging about $25 for NuvaRing instead of the $20 calculated by the government to be a fair price according to international standards. (The retail price in the US at the time was roughly double the international standard. Today, one NuvaRing will cost a young woman without insurance about $135 at Target.)
Perhaps the great irony in this story is that the Langharts come from solid Republican stock. Erika, who interned for Sen. John McCain on her way to earning a degree in Political Science from American University, would surely have opposed the presidential efforts of Sen. Bernie Sanders, who recently said of drug companies, “They are getting away with murder, and in some cases they are committing murder.”
***
Having won the battle with the FDA to eliminate the negative, NuvaRing’s makers launched an advertising campaign to accentuate the positive. If they held true to form, they would spend up to twice as much money marketing the product than they did on research and development.
A big part of that effort would have gone to lavishing attention on obstetricians and gynecologists - providing free samples and pamphlets as well as recruiting some doctors as “consultants” or “advocates”. Dr. Paula Hillard, professor of obstetrics and gynecology at Stanford University School of Medicine, was cultivated by Bayer, the makers of Yaz, as “a Key Opinion Leader” and “Yasmine Advocate.” Why all the attention? Hillard was a member of the FDA panel that voted to keep Bayer’s products on the market in 2011. Dr. Julia Johnson, Dr. Anne Burke and Dr. Elizabeth Raymond are also OB/GYNs with ties to Bayer who determined that - to them at least - the benefits of Yaz and Yasmin outweighed the risks.
The following year, American College of Obstetricians and Gynecologists (ACOG) officially took a dim view of such goings on in the form of an updated ethics statement, in which they note that “interactions with industry carry some expectations of reciprocity” and physicians “are unable to remain objective.”
Writer Carolyn Thomas puts it this way in her blog Ethical Nag:
The reasons that doctors give out these samples seem obvious: about 94% of the ACOG docs who distributed drug samples to their patients told researchers that they did so because of patients’ financial need and for convenience (76%). Some doctors cite the usefulness of letting a patient try out a short trial of a new drug to observe potential side effects or efficacy. “But fewer docs list the reason as “physicians’ knowledge about the drug” – in other words, they did not know whether or not the sample product was the most appropriate treatment (63%).”
Further bolstering ACOG’s position was a study funded by Merck which was presented at their 60th Annual Clinical Meeting in 2012, which ran with the headline “NuvaRing Users Have No Enhanced Risk for Blood Clots.”
***
NuvaRing’s maker was also a shameless practitioner of product placement, positioning NuvaRing posters in the backgrounds of scenes in popular television shows like Grey’s Anatomy and Scrubs.
The commercials that ran between such shows were carefully designed to portray images of upbeat, carefree young women liberated from the burden of having to take a pill everyday, while potential downsides of the drug were artfully camouflaged.
This is how the Media Literacy Project deconstructs one NuvaRing Ad:
“- Rhetorical question: The ad begins with the question “Tired of your old birth control routine?”
- Symbols: The black and white scenes, one piece swimsuits, and swim caps are all used to symbolize “old” birth control, while color scenes, two piece swimsuits, and freed hair are used to symbolize “new” birth control.
- Beautiful People: The commercial uses female models.
- Simple Solution: This product can transform someone’s life simply by its use.
- Maybe: The narrator lists a series of health risks associated with the product and says the product “might not be right for everybody.”
- Diversion: While the health risks are being presented verbally, strong, colorful images and symbols are used visually to draw attention away from what some viewers may be hearing, and possibly even override what some viewers may be hearing.
The marketing is a stark illustration of how the risks of the product are downplayed to young women, who of course are invincible and much more receptive to the overwhelming choice, convenience, and lifestyle pitches.
The message which is not conveyed to the users of NuvaRing and other contraceptives that use later generation progestens is that while the risks are relatively small, they are real and they do happen - and by choosing this product over that one, you are doubling or tripling that risk.
Dr. Frits Rosendaal compares it to using seat belts. There’s always a risk when you get on the road, and the chances are on any given day that you will not be involved in an accident. But why would you not choose the behavior that carries the lowest risk?
In the Netherlands, birthplace of the NuvaRing, the Dutch College of General Practitioners advises using a pill with second generation hormones. Across Europe, where direct-to-consumer advertising of pharmaceuticals is banned, 2nd generation contraceptives are the most widely prescribed.
***
The Langharts channeled their energy toward educating the public about the dangers of NuvaRing and the other late generation hormonal contraceptives. They started a foundation, Informed Choice for Amerika. They gave interviews, made the rounds on Capitol Hill and spoke to various groups. In addition to working to prevent the deaths of other young women, Karen and Rick were determined to seek justice for Erika. In suing Merck for the wrongful death of their daughter, they were not interested in monetary damages. They wanted to hold the company accountable, to have them admit responsibility and to remove the product from the market.
“That’s what we are going to do the rest of our lives. That’s kind of what we’ve got left,” Rick Langhart told AZFamily.com.
As the number of lawsuits mounted, they were consolidated into a class action suit, which Merck agreed to settle in 2014 for $100 million. About 3,800 women who were injured by the NuvaRing agreed to the settlement, which came to about $10,000 per person after legal fees. The Langharts rejected the settlement, as Merck would not have to admit to any wrongdoing and NuvaRing would stay on the market. Merck, said Rick Langhart, would be “literally getting away with murder.”
One hundred million dollars is really nothing compared to most settlements made by pharmaceutical companies that are sued for causing deaths and injuries. Fines can run into the billions of dollars.
Experts say that one of the reasons the case against Merck was not stronger was because of the warning label change in 2013. If they had been forced to put a black box warning on the label concerning the risk of clotting after so many adverse events, the legal case of the victims would have been that much stronger.
The Langharts pressed on - without their erstwhile crusading lawyer who had crunched the cold hard numbers and realized that, under the circumstances, with the class action suit settled, he had taken the case as far as it would go. Their lawyers, whom they believed would get their story before a jury, had effectively stopped working on the case after they refused the settlement offer. Their lawyers officially withdrew on July 25th, 2015, four days after Karen took the podium in San Antonio to thank the makers of Natural Love Stories for dedicating the film to Erika.
She told the group then that she knew that her case was over.
***
Last year, Karen told the Durango Herald that pursuing justice was painful, and she was nearly out of hope.
In September 2015, about six weeks after the talk at the Natural Love Stories premier, a San Francisco Superior Court dismissed their case. Through four years of heartbreak, anger and grief, Karen Langhart had looked toward that day when her dead daughter would have her day in court. But it was now officially not to be.
“To have that happen to our daughter, and have this happen on top of it, it’s hard to get up in the morning,” Karen Langhart told the Herald.
She posted on a blog: “It is our greatest hope, with what remains of our lives, to fulfill our goal of making a difference in the lives of others by helping to inform women about the dangers of not only the NuvaRing; but all hormonal contraceptive drugs — the pill, patch, ring and implants. We believe women deserve to be informed of the full truth about these powerful drugs.” What remained of Karen’s life was 98 days.
On January 7, 2015, she took her own life.
In 2011, the year that Erika Langhart died, Dr. Graham Dukes wrote in an essay about hormonal contraceptives that “It would seem that the move to the third generation was a matter of patents, profits and prices, no more than that.”
###
https://www.beaconreader.com/dan-walter/safe-enough

• • •

This is reader-supported journalism. Be a part of it.This is reader-supported journalism. Be a part of it.

Dan Walter8 stories
Back my work 31 backers
$895 raised
$80 recurring
Your pledge will directly support Dan's work
This Dan Walter story was funded directly by readers like you.
Our lives are at risk when corporate-driven medical care puts profits before patient safety. My stories get behind the corporate hype to expose the real risks involved when your health and well-being isn't necessarily the doctor’s first priority.
Popular pledges

• • •