June 22, 2016 — San Diego, CA. Two controversial medical devices that have harmed thousands of women nationwide are the subjects of two new pieces of legislation introduced to the House of Representatives earlier this month.
Essure permanent birth control and power morcellators have been the topic of conversation among doctors, consumers, federal regulators, lawyers and, most recently, federal legislators. Two new bills, introduced to the House of Representative’s Committee on Energy and Commerce June 8 by Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY), were inspired by the controversial medical devices.
The first bill, known as Ariel Grace’s Law (H.R. 5403), would allow patients harmed by class III medical devices to file lawsuits against the manufacturers. Currently, class III medical devices approved by the Food and Drug Administration (FDA) through its pre-market approval program, or PMA, are shielded from litigation, both at the federal and state level.
The second bill, known as Medical Device Guardians Act (H.R. 5404), would expand the current requirement for hospitals and manufacturers to report adverse events to the FDA to include doctors and doctor’s offices.
Both bills seek to put power back into the hands of consumers, but in slightly different ways.
A stillborn baby could upend federal preemption
Ariel Grace’s Law was filed in response to a 2008 decision by the Supreme Court in Riegel vs. Medtronic which protected medical devices approved through the FDA’s PMA process from litigation challenging the device’s effectiveness and safety. This protection is called federal preemption. Essentially, the decision stripped consumers of their power to fight the makers of potentially dangerous medical devices in the courtroom.
“While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences for patients,” said Rep. Fitzpatrick in a statement June 8. “I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price.”
Essure permanent birth control has garnered much attention in the past few years – mainly for the harm it allegedly caused thousands of women across the country. Once hailed as a quick and easy non-surgical option for female sterilization, Essure soon proved to be anything but for a large percentage of women who had the device implanted.
Essure, which consists of two metal coils, is inserted into a woman’s fallopian tubes where it creates scar tissue that closes the tubes and blocks sperm from getting in or eggs from getting out. The insertion is performed in a doctor’s office without the need for anesthesia (in most cases) or surgical incisions. Women would be back to their normal routine in no time – or so they thought.
Within a few days to years after insertion, thousands of women started noticing the horrific side effects of the “quick and easy” sterilization device: migration of the coils out of the tubes into the abdominal cavity, fragmentation of the device, auto-immune reactions, hair and teeth loss, weight gain, bloating, severe and chronic abdominal pain, rashes, heavy and consistent bleeding, and unintended pregnancies to name just a few of the hundreds of reported side effects.
Nearly 10,000 adverse event reports were submitted to the FDA regarding Essure by 2015 – 13 years after the FDA first approved the device.
Angie Firmalino was just one of the many women harmed by Essure. She helped create an online resource group on Facebook, called Essure Problems, for women like her – her E-sisters. Today, the group has more than 30,000 members.
Through her support group, Firmalino helped bring the potential problems of Essure to the forefront and gained support from Congress members who helped introduce not only Ariel Grace’s Law, but also the E-Free Act. Introduced to the House in November 2015, the E-Free Act calls on the FDA to withdraw its approval of Essure and take it off the market. The act is still pending in the House of Representatives.
Both Ariel Grace’s Law and the E-Free Act speak to the barriers the E-sisters have faced while fighting Bayer Health – the maker of Essure – and its flagship sterilization device. While most product liability litigation takes place in the courtroom, the E-sisters have had to fight to get their day in court thanks to Essure’s federal preemption status. Essure is shielded from liability.
Ariel Grace’s Law would seek to change that. Named for Ariel Grace, who was stillborn after her mother’s Essure birth control device failed, the law would remove the litigation shield from dangerous devices like Essure. It would once again give consumers an avenue for recourse.
Ariel Grace’s mother, Kristiana Burrell, spoke of the change she hopes her daughter’s death might inspire in a statement on Rep. Slaughter’s website:
“My hopes are that Ariel Grace’s Law will save many other women from going through what my family, and hundreds of others, had to endure. Ariel Grace was called ‘our perfect instrument for change’ at her memorial service and I wholeheartedly believe that. She is not the only baby that has been born sleeping due to Essure, however, I believe she can be the face for this change. If she can save one woman or one baby, I know she did not die in vain,” said Burrell.
Even before Ariel Grace’s Law was introduced, a Philadelphia judge allowed Essure litigation against Bayer to proceed in federal court, despite the device’s PMA status. U.S. District Judge John R. Padova allowed two of 12 claims against Bayer to move forward in March 2016, including claims that Bayer used misleading advertising and that it failed to warn about the risks of Essure.
In response to Ariel Grace’s Law, Bayer said lifting the protection FDA’s PMA program gives medical devices would stifle innovation. The company said the bill “upends the very carefully crafted balance established by Congress to promote medical device research and innovation, and could potentially delay or stifle significant health benefits such devices provide,” as reported by Drs. Amy Reed and Hooman Noorchashm in an opinion column published by the Philadelphia Inquirer’s online news source, philly.com.
Drs. Reed and Noorchashm said Bayer’s response was “self-serving,” and the “notion that a balanced free-market equation would ‘stifle’ innovation and health benefits in the medical device space is an inappropriate corporate smoke screen.”
“[Ariel Grace’s Law] is about recognizing that no medical device can possibly be perfect. That unreasonable harm is possible in the realm of medical technology, even after FDA approval. That American citizens are guaranteed access to the court. And that without liability signals from the marketplace, via the court system, industry will not have an adequate incentive to improve and eliminate hazards,” wrote the husband and wife doctor duo in their column.
Drs. Reed and Noorchashm have been outspoken critics of dangerous medical devices and the companies and regulators that protect them for years. The couple was personally impacted by one such device which became the inspiration for another bill introduced to the House on June 8: the Medical Device Guardians Act.
Lawmakers: Doctors should report adverse events to FDA
In 2013, Dr. Amy Reed reported an adverse event to the FDA after being diagnosed with cancer. Dr. Reed had a hysterectomy at Brigham and Women’s Hospital in Boston in which surgeons used a power morcellator. The morcellator inadvertently spread undiagnosed cancer throughout her body.
Dr. Reed was the first to report such a case to the FDA – despite medical studies and literature that have highlighted the device’s potential risk to spread undetected cancer since it first deputed in the 1990s, an article published by the Wall Street Journal reported.
“After that initial report from Amy, hundreds of other safety reports began to flow into the FDA,” Reps. Fitzpatrick and Slaughter wrote in a letter to colleagues introducing the bill. “In retrospect, it should not have fallen on patients to get the FDA’s attention.”
Onto whose shoulders does that obligation fall? Currently, hospitals and device manufacturers are required to report adverse events to the FDA by law. The Medical Device Guardian Act of 2015 seeks to change that.
If passed, the bill would require doctors and doctor’s offices to report adverse events to the FDA, as well as hospitals and manufacturers.
Why is this so important? Just ask the husband of Linda Interlichia, who died at the age of 55 after battling uterine cancer spread by a power morcellator. Frank Interlichia told the Wall Street Journal that requiring clinicians to sound alarms is a crucial start to keeping others safe from potentially dangerous medical devices.
“Would [the doctor] have advised Linda differently? Maybe,” Mr. Interlichia said of the doctor’s decision to use a power morcellator during his wife’s surgery. “I’m deeply in favor of changing the current system.”
Asking doctors to report adverse events is especially critical since the current agents required to report such events don’t seem to be doing such a good job of it.
Johnson & Johnson was the largest supplier of power morcellators before suspending sales of the devices in April 2014 and ultimately pulling them from the market the following July. The company is under investigation by the Government Accountability Office, which is looking into whether Johnson & Johnson knew of adverse events long before it actually reported them to the FDA.
Retired pathologist Robert Lamparter said he contacted J&J as far back as 2006 regarding the possibility of its power morcellator spreading undiagnosed cancer. Yet the first adverse event was reported to the FDA not by J&J or the hospital where the surgery took place, but by a patient: Dr. Amy Reed.
“It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety,” said Rep. Fitzpatrick in his June 8 statement. “Agencies, physicians and lawmakers should all be committed to this common cause, and open to these bipartisan solutions.”
Essure and Power Morcellator Litigation
There is currently litigation pending against Bayer, the maker of Essure, and Johnson & Johnson, the maker of power morcellators. If you or a loved one were harmed as a result of either of these medical devices, you may be entitled to compensation. Call the Hood National Law Group today at 1-800-214-1010 for a free case evaluation and to speak with a member of our legal team.