(MASS TORT NEXUS MEDIA) On November 26, 2018 the FDA announced an overhaul of the 510(k) system that is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize the manufacturers and their devices that are based on older products.
The FDA is supposed to protect the interests of the general public and ensure that new devices, as well as existing ones are functioning as designed. More often that is not the case, as the FDA either fails to review medical device failures or simply ignores them.
Pharmaceutical companies and medical device makers, collectively Big Pharma, spend far more than any other industry to influence politicians. Big Pharma has poured close to $2.5 billion into lobbying and funding members of Congress over the past decade.
Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152 million on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the single largest beneficiary, with donations from the industry totaling $228,670.
Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its report findings on November 26, 2018.
The new FDA rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly 9 out of 10 device categories, a recent review found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.
As part of the worldwide scrutiny of medical devices and at times, the affiliated dangers, a massive investigation known as “The Implant Files” was undertaken by a group of journalists around the world. Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete
ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored. This included an analysis of more than 8 million device-related health records, including death and injury reports and recalls.
The Implant Files review encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.
Like the rest of Big Pharma, the medical device manufacturers have created an intricate web of corporate and political influence including at the Federal Drug Administration, where the FDA is charged with oversight of medical devices.
The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the pharmaceutical and medical device industry, which is a massive global business that has existed for years with minimal international scrutiny.
A recent analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.
BUYING A PRESENCE IN WASHINGTON
The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.
But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.
Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.
There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.
The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress and target agencies and offices across the executive branches in D.C., from the FDA to the Center for Medicare and Medicaid and the National Security Council.
Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.
With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.
An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma-pharmaceuticals, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year, more than six times as much as the device industry, according to a Statista market analysis.
The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.
Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.
“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”
Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.
Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.
Three companies that spent the most on lobbying in the past five years were ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”
Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.
In a statement, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”
OBAMA – TRUMP COMPARISON
During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.
Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.
Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.
“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.
During Obama’s final year in office, the FDA banned its first device in more than 30 years, a type of surgical glove and proposed a ban on a home shock collar for behavior modification. That ban is still pending.
The industry successfully pushed for changes in a proposed regulation on unique device identifiers, the identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.
“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”
President Trump vowed to cut regulations across the government by 75 percent when he came into office.
In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. In its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.
“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that the industry gets FDA to agree to and that they’re paying for.”
If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.
“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.
The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”
The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination, and including device identifier codes in insurance claims forms.
MAKING FDA APPROVAL EASIER FOR BIG PHARMA
The changes to how adverse events are reported was seen as an overwhelming industry success.
The FDA database in which surgical complications are entered is known as the Manufacturer and User Facility Device Experience Database (MAUDE), which includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.
Despite its size, it’s widely accepted that the database is only a rather limited record of the full scale of medical device complications and adverse events.
The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.
“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”
Patients are able to report adverse events to the database themselves, but few know to do so. Companies are required to report the events, once they are notified., which they don’t always do. The FDA said thirty-three percent (33%) of all FDA warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.
The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.
Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.
“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”
In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.
“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”
In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”
In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”
But Redberg, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.
“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”
How these changes are affecting medical care in the US, and more importantly the publics right to be informed of adverse events and problems with medical devices, their approval process and who’s lobbying who and for what in the FDA should be open and transparent.
(Certain images and text excerpts in this article were reprinted from third party media sources)
WHY THE MOTTO OF “PROFITS BEFORE PATIENTS” IS STILL THE BANNER:
HERE’S A FULL REPORT
By Mark A. York (November 26, 2018)
(MASS TORT NEXUS MEDIA) For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.
Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.
Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!
The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.
This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.
Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.
In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.
Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.
When makers of medical devices learn that one of their products has malfunctioned in a way that could kill or seriously injure people, they are required to file a report with the Food and Drug Administration (FDA). The reports are meant to alert regulators that patients may be in danger.
However, in the future, under a deal the FDA has negotiated with industry lobbyists, manufacturers could generally wait three months before reporting malfunctions, and they could report malfunctions in “summary” form, according to an FDA document.
This 2017 deal apparently means that the government and the public could receive less detailed and less timely warnings.
Jim Taft listened intently as his pain management doctor described a medical device that could change his life, it wouldn’t fix the nerve damage in his mangled right arm, but a spinal-cord stimulator would cloak his pain, making him “good as new.”
Taft’s stimulator failed soon after it was surgically implanted. After an operation to repair it, he said the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed.
“I thought I would have a wonderful life,” Taft said. “But look at me.” Taft is just one of the thousands of patients who have been injured by an implanted medical device, almost always by a device that was made in the USA.
A recent global investigation has found that hundreds of thousands of unsafe medical devices have been implanted in patients around the world and device failures are considered very normal.
A recent worldwide investigation was carried out by the International Consortium of Investigative Journalists (ICIJ) in coordination with the British Medical Journal and various media outlets including the Guardian newspaper and BBC Panorama.
The probe found that pacemakers, artificial knees, hips and rods to support the spinal cord are among the faulty devices that were implanted in patients and that failed. These unsafe medical devices have resulted in thousands of injuries and deaths and quite often patients are forced to undergo removal or revision surgeries.
The investigation found that many of the unsafe medical devices did not complete patient trials before their commercial launch, adding that some of the pacemakers were implanted when the manufacturers were aware of the problems, while some devices were approved on the basis of a regulatory nod secured in other countries.
Poor regulations across countries, lenient testing standards and lack of clarity allowed these faulty medical devices to reach the market.
In the UK alone, the regulators received 62,000 “adverse incident” reports associated with medical devices between 2015 and 2018. About 1,004 of such cases even resulted in the death of patients.
In the USA, the Food and Drug Administration (FDA) has been notified of 5.4 million ‘adverse events’ over the last ten years. Faulty devices were linked to approximately 1.7 million injuries and 83,000 deaths.
Even though these medical devices are made in the USA, the U.S. Food and Drug Administration had not, and still has not, deemed them good enough for Americans. The FDA has permitted sales overseas of unproven devices and products via an obscure FDA provision in which products are registered as an “export only” device, requiring far less FDA scrutiny than for devices that are sold domestically.
An example is PyroTITAN, by Intergra LifeSciences of New Jersey, among the biggest medical device companies in the world and maker of more than a dozen export-only devices with troubled track records identified as “export only” which is a U.S.-made implant for losing weight that instead led to numerous emergency surgeries, stents that could cut into arteries and heart valves sold in Spain and Italy that, according to the FDA, caused severe infections and may have caused a five-year-old child to die. These items were found by analyzing and comparing databases in 10 countries, and a lack of international standards for identifying devices means it is difficult to know how many other troubled devices exist.
For U.S. companies, exporting medical devices is big business, valued last year at more than $41 billion. Currently about 4,600 devices are registered with the FDA as “export only” devices. Several executives for medical device makers said registering the devices is faster, less expensive and has involved less oversight than getting them approved for sale inside the U.S. The troubled devices identified by NBC News have been sold around the world. The destinations range from the Netherlands to Namibia, Chile to Canada, Japan to Germany.
Recently, NBC probed export-only devices as part of the same global project organized by the International Consortium of Investigative Journalists, a news organization notable for its work on the Panama Papers, to examine the medical device industry. More than 250 reporters in 36 countries worked on stories that began publishing Sunday.
Worldwide US Device Exports are Often Substandard
Zimmer Biomet is one of the big medical device companies named in the investigation. The company has previously had to discontinue sales of a metal-on-metal hip implant system which was cause to flesh-rotting via metallosis poisoning. The company seems to have maintained the tried and true Big Pharma mantra of “we do what the FDA requires, therefor we are excluded from accepting responsibility for defective medical products” which is often pushed as a coverall statement by medical device makers when they are under scrutiny.
“We adhere to strict regulatory standard, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network.
Abbott has also come under scrutiny for its Nanostim pacemaker, which has received complaints about implant battery failures and parts of the device falling off inside patients. The company released the following statement: “In accordance with the European CE Mark approval process, the Nanostim leadless pacing system was approved based on strong performance and safety data.”
Medical device companies and doctors tout spinal-cord stimulators to treat patients suffering from a wide range of pain disorders. But an investigation by AP found the devices rank third in injury reports to the FDA in 10 years.
But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008.
Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.
The FDA data contains more than 500 reports of people with spinal-cord stimulators who died but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.
An animated look at the spinal cord stimulator, its benefits and potential problems. (AP Animation/Peter Hamlin)
Medical device manufacturers insist spinal-cord stimulators are safe — some 60,000 are implanted annually — and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.
Most of these devices have been approved by the FDA with little clinical testing and the agency’s data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.
The AP reported on spinal stimulators as part of a year long joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.
The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.
The investigation also found that the FDA — considered by other countries to be the gold standard in medical device oversight — puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.
Devices are rarely pulled from the market, even when major problems emerge, and the FDA does not disclose how many devices are implanted in the U.S. each year — critical information that could be used to calculate success and failure rates.
The FDA acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death, but it rejects any suggestion of failed oversight.
“There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day,” Dr. Jeffrey Shuren, the FDA’s medical device director said at an industry conference in May. “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”
In response to reporters’ questions, the FDA said last week that it was taking new action to create “a more robust medical device safety net for patients through better data.” ″Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market,” the agency said. In the last 50 years, the medical device industry has revolutionized treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.
Medical device companies have “invested countless resources — both capital and human — in developing leading-edge compliance programs,” said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry’s main trade association.
At the same time, medical device makers also have spent billions to try to influence regulators, hospitals and doctors.
In the United States, where drug and device manufacturers are required to disclose payments to physicians, the 10 largest medical device companies paid nearly $600 million to doctors or their hospitals last year to cover consulting fees, research, travel and entertainment expenses, according to an AP and ICIJ analysis of data from the Centers for Medicare & Medicaid Services. This figure doesn’t include payments from device manufacturers like Johnson & Johnson and Allergan, which also sell other products.
On top of that, lobbying records show that the top four spinal-cord stimulator manufacturers have spent more than $22 million combined since 2017 to try to influence legislation benefiting their overall business, which includes other medical devices.
Some companies have been fined for bribing physicians, illegally promoting products for unapproved uses and paying for studies that proclaim the safety and effectiveness of their products, according to the joint investigation.
In a 2016 case, Olympus Corp. of the Americas, the largest U.S. distributor of endoscopes and related medical equipment, agreed to pay $623.2 million “to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals,” according to the U.S. Justice Department. Olympus said that it “agreed to make various improvements to its compliance program.”
In a case the previous year involving spinal-cord stimulators, Medtronic,Inc. agreed to pay $2.8 million to settle Justice Department claims that the company had harmed patients and defrauded federal health care programs by providing physicians “powerful” financial inducements that turned them into “salesmen” for costly procedures. Medtronic denied wrongdoing. “As a matter of policy, Medtronic does not comment on specific litigation,” the company said in a statement. “We do stand behind the safety and efficacy of our Spinal Cord Stimulators and the strong benefits this technology provides to patients, many of whom have tried all other therapy options to no benefit.”
Some doctors enthusiastically promote spinal-cord stimulators without disclosing to patients they’ve received money from medical device manufacturers. Some experts say doctors are not legally required to disclose such payments, but they have an ethical obligation to do so. Sometimes the money goes to the doctors’ hospitals, and not directly to them.
As for Taft, he said he just wanted to get better, but he has lost hope. “This is my death sentence,” Taft said, stretched out beneath his bed’s wooden headboard on which he’s carved the words “death row.”
“I’ll die here,” he said.
Why Hasn’t The FDA Learned From Past Failures?
A generation ago, tens of thousands of women were injured by the Dalkon Shield, an intrauterine device that caused life-threatening infections. Consumer advocates demanded testing and pre-market approval of medical devices to prevent deaths and injuries associated with defective products.
So in 1976, Congress passed the Medical Device Amendment, a law meant to assure Americans that devices recommended by their doctors would do good and not harm.
“Until today, the American consumer could not be sure that a medical device used by his physician, his hospital or himself was as safe and effective as it could or should be,” President Gerald Ford said when he signed the bill into law.
Charged with carrying out the law, the FDA created three classes of medical devices. High-risk products like spinal-cord stimulators are designated to be held to the most rigorous clinical testing standards. But the vast majority of devices go through a less stringent review process that provides an easy path to market for devices deemed “substantially equivalent” to products already approved for use.
As designed by Congress, that process should have been phased out. Instead, it became the standard path to market for thousands of devices, including hip replacements implanted in tens of thousands of patients that would later be recalled because metal shavings from the devices made some people sick.
The AP found that the FDA has allowed some spinal-cord stimulators to reach the market without new clinical studies, approving them largely based on results from studies of earlier spinal stimulators.
Spinal stimulators are complex devices that send electrical currents through wires placed along the spine, using a battery implanted under the skin. An external remote controls the device.
The four biggest makers of spinal-cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the U.S.; Nevro, in Redwood City, California; and Illinois-based Abbott, which entered the market after its $23.6 billion purchase of St. Jude Medical, Inc.
St. Jude’s application to go to market with its first spinal stimulator contained no original patient data and was based on clinical results from other studies, while Boston Scientific’s application for its Precision spinal-cord stimulator was based largely on older data, though it did include a small, original study of 26 patients who were tracked for as little as two weeks.
Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.
For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design.
“It’s kind of the story of FDA’s regulation of devices, where they’re just putting stuff on the market,” said Diana Zuckerman, president of the National Center for Health Research, who has studied medical devices for nearly 30 years.
Medical device manufacturers have cited multiple industry-funded studies showing the effectiveness of spinal-cord stimulation in the treatment of chronic pain. Experts say treatment is considered successful if pain is reduced by at least half, but not every patient experiences that much pain reduction.
A 2016 study looking at different stimulation systems found “significant evidence” that they were “a safe, clinical and cost-effective treatment for many chronic pain conditions.”
But Zuckerman noted that the more extensive studies came after the devices were being widely used on people. “These patients are guinea pigs,” she said.
FDA said in a statement that it approves, clears or grants marketing authorization to an average of 12 devices per business day and its decisions are “based on valid scientific evidence” that the devices are safe and effective.
Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a “substantial” placebo effect.
“I don’t know of anyone who is happy with spinal-cord technology as it stands,” Koroshetz said. “I think everybody thinks it can be better.”
Every time Jim Taft walked into his pain management doctor’s office, he would glance at the brochures touting spinal-cord stimulators — the ones with pictures of people swimming, biking and fishing.
Inside the exam room, Taft said, his doctor told him the device had been successful for his other patients and would improve his quality of life.
On lifetime worker’s compensation after his right arm was crushed as he was hauling materials for an architectural engineering company, Taft had been seeing the doctor for five years before he decided to get a stimulator in 2014. What finally swayed him, he said, was the doctor’s plan to wean him off painkillers.
Taft said his pain management doctor praised the technology, saying stimulators had improved the quality of life for his patients. But four years later, Taft is unable to walk more than a few steps.
Taft is one of 40 patients interviewed by the AP who said they had problems with spinal-cord stimulators. The AP found them through online forums for people with medical devices. Twenty-eight of them said their spinal-cord stimulators not only failed to alleviate pain but left them worse off than before their surgeries.
Zuckerman, who has worked at the U.S. Department of Health and Human Services and as a senior policy adviser to then-first lady Hillary Rodham Clinton, said no doctor wants to think they’re harming patients.
“But there’s a tremendous financial incentive to downplay, ignore or forget bad patient experiences and just focus on how happy patients are,” she said.
More than half the patients interviewed by the AP said they felt pressured to get stimulators because they feared their doctors would cut off their pain medications — the only thing helping them.
Stimulators are considered a treatment of “last resort” by insurance companies, as well as Medicare and Medicaid. That means doctors must follow a protocol before insurance will pay for the device and implantation.
Physicians must show that conservative treatments failed to help, and patients also undergo psychological assessments to evaluate the likelihood of success. They then typically undergo a trial period lasting three days to a week with thin electrodes inserted under the skin. If patients say they got relief from the external transmitter sending electrical pulses to the contacts near their spines, they have surgery to implant a permanent stimulator.
Taft said his three-day trial helped reduce his pain so, a few days before his surgery, he began preparing for a new life. He ordered lumber to refurbish a patio and deck for his wife, Renee, as thanks for her years of support.
In April 2014, Boston Scientific’s Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room — a common practice, the AP found.
Highsmith would not comment on the payments. Other doctors have defended the practice, saying they do important work that helps the companies — and ultimately patients — and deserve to be compensated for their time.
From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.
Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don’t cause the kind of problems he had.
That runs counter to Boston Scientific’s own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.
That also is not reflected in the AP’s analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators. For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.
In response to questions, the company called infection “unfortunately a risk in any surgical procedure” that the company works hard to avoid. It added that the FDA’s data “shouldn’t be interpreted as a causal sign of a challenge with our device. In fact, many examples of reportable infections include those that were caused by the surgical procedure or post-operative care.”
“In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible in nature,” the company added.
Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked.
“I told them that it feels like the lead is moving up and down my spine,” Taft said. “They said, ‘It can’t move.’” But in July 2014, X-rays revealed the lead indeed had moved — two inches on one side.
Highsmith told the AP the electrode broke from “vigorous activity,” though Taft said that would not have been possible due to his condition. Taft said he was in such bad shape after his surgery that he was never able to redo the patio and deck for his wife or do anything else vigorous.
That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.
Still, Taft’s medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device “seemed to make his pain worse.”
The stimulator was surgically removed in August 2015. The following June, Taft got a second opinion from a clinic that specializes in spinal injuries, which said he had “significant axial and low back pain due to implantation and explantation” of the stimulator.
Highsmith said other doctors have documented severe arthritis in Taft and that, while he has not examined Taft in more than three years, it’s “likely his current condition is the result of disease progression and other factors.”
He did not answer questions about whether he informed Taft of the risks associated with stimulators.
The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief.
“Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain,” he said.
Renee Taft, a paralegal, reached out to Boston Scientific in 2017, but said the company refused to help because her husband’s stimulator had been removed and blamed Taft for his problems, also saying he had engaged in “rigorous physical activity” after surgery.
In the letter from the company’s legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.
In response to questions from investigators, Boston Scientific again blamed Taft’s “activity level” but didn’t elaborate. The company also said other factors could contribute to his problems such as “hyperalgesia, a phenomenon associated with long-term opioid use which results in patients becoming increasingly sensitive to some stimuli.”
Since 2005, there have been 50 recalls involving spinal stimulators, averaging about four per year in the last five years. Roughly half the recalls involved stimulators made by Medtronic, the world’s largest device manufacturer, though none warned of a risk of serious injury or death.
The experience of nearly all the 40 patients interviewed by the AP reflected one common fact. Their pain was reduced during the trial but returned once their stimulators were implanted.
Experts say the answer may be a placebo effect created when expectations are built up during the trial that only the stimulator can offer relief from pain, exacerbated by patients not wanting to disappoint family members, who often have been serving as their caregivers.
“If patients know this is a last resort, a last hope, of course they will respond well,” said Dr. Michael Gofeld, a Toronto-based anesthesiologist and pain management specialist who has studied and implanted spinal-cord stimulators in both the U.S. and Canada.
By the time the trial ends, the patient is “flying high, the endorphin levels are high,” Gofeld said.
Manufacturer representatives are heavily involved during the entire process. Along with often being in the operating room during surgery in case the physician has questions, they meet with patients to program the devices in the weeks following surgery.
Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not.
“People who are selling the device should not be in charge of maintenance,” Gofeld said. “It’s totally unethical.”
In a 2015 Texas case, a former Medtronic sales representative filed suit contending she was fired after complaining that the company trained employees to program neurostimulators without physicians present. She also claimed that a Medtronic supervisor snatched surgical gloves away from her when she refused to bandage a patient during a procedure, pushed her aside and then cleaned and dressed the patient’s wound. Medtronic denied the allegations, and the case was settled on undisclosed terms.
In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs.
“While there have been a few instances where individuals or affiliates did not comply with Medtronic’s policies, we acted to remedy the situation in each case once discovered and to correct any misconduct,” the company said.
Gofeld said he believes stimulators do work, but that many of the problems usually arise when doctors don’t choose appropriate candidates. And he thinks the stimulators are used too often in the U.S.
Nevro, one of the four big manufacturers, has cited estimates that there are as many as 4,400 facilities in the U.S where spinal-stimulation devices are implanted by a variety of physicians, including neurosurgeons, psychiatrists and pain specialists.
It’s a lucrative business . Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.
The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.
In Canada, where Gofeld now works, he said the surgeries are done only by those who specialize in the procedures. He said spinal-cord stimulators should be used when pain starts and not after failed back surgeries.
“By then,” he said, “it’s too late.”
When Surgeries Never Stop
While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists.
“Chronic pain is one of the largest health-care burdens we have in the U.S. It’s more than heart disease, cancer and diabetes combined,” Falowski said in an interview. If they’re used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.
Since 2013, device manufacturers have paid Falowski — or St. Luke’s University Health Network in Fountain Hill, Pennsylvania, where he works — nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.
Falowski said he has conducted research and done other work for manufacturers, adding, “The contracts with industry are with my hospital and not with me.”
St. Luke’s told the AP that it keeps the majority of the payments from device makers, but that Falowski “may receive a portion of these payments through his annual compensation.” AP’s analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words “heat” or “burn.”
Abbott said that many of the “adverse events” reports in the FDA’s data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site “is often a reality for rechargeable spinal-cord stimulation systems,” which is why the company is now concentrating on devices that do not need to be recharged.
Falowski said doctors do important work for medical device companies, and he has been involved in device development, education, clinical trials and research.
“You’re trying to help patients and you realize as a physician by yourself you’re not going to generate $200 million to make the next best implant for a patient and it’s going to take a company to do that,” he said. “So I think the important part in that relationship is transparency and disclosures.”
Experts interviewed by the AP said doctors are not legally required to tell their patients about financial relationships with medical device manufacturers, but that it would be the right thing to do.
“The patient should be fully informed before consenting to a procedure,” said Genevieve P. Kanter, an assistant professor at the University of Pennsylvania who specializes in internal medicine, medical ethics and health policy.
Abbott Issues Warning After Surgeries For Thousands of Patients
In October 2016, Abbott notified physicians and patients that a subset of ICD and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured between January 2010 and May 2015 could potentially experience premature battery depletion due to short circuits from lithium clusters.
The potential for premature battery depletion in the affected devices is low. The new Battery Performance Alert can be used as a tool to further assist in identifying the potential for these devices to experience premature battery depletion.
It’s a voluntary recall, so patients are being told to consult with their doctors before coming in for the procedure — which thankfully consists of a simple 3-minute wireless firmware update (using a wand, according to the pamphlet) instead of anything invasive.
The FDA-approved firmware update actually includes a pair of important-sounding fixes. In addition to some enhanced security, the update also comes with a way to detect if a device’s battery drains abnormally quickly and alert the patient.
The FDA and Abbott say they haven’t had issues with any of the 50,000 firmware updates they’ve installed on devices like this so far.
Based on historical results as well as litigation related to adverse events with medical device FDA approvals and disclosures by device makers, it would seem that the reality of the dangers related to this device and thousands of other FDA approved devices, we may never know the truth on how dangerous these products really are.
(Images and text excerpts have been taken from NBC News and Associated Press media releases)
(MASS TORT NEXUS MEDIA) The National Vaccine Injury Compensation Program (VICP or NVICP) was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine. Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared the loss of herd immunity.
The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as “vaccine court“, administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.
“In the vaccine court, the burden is on a plaintiff to show a biological theory of harm, demonstrate a logical sequence of events connecting the vaccine to the injury, and establish an appropriate time frame in which injury occurred. The petitioner must also show that there is not another biologically plausible explanation for the injury.
The ZOSTAVAX vaccine is not a vaccine listed in the Vaccine Injury Table
The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 et seq. does not preempt a Plaintiff from filing a civil complaint in federal court.
No Special Tax Was Paid By Zostavax
Merck & Co. did not pay the 75 cent tax per dose to the vaccine court, to have Zostavax included on the “Vaccine Injury Table” see 42 CFR 100.3 Vaccine Injury Table, that lists which drugs are under the “Vaccine Court” jurisdiction and not the normal courts of civil procedure in the United states.
Merck & Co. have taken the position that there is no overriding public interest in Zostavax being available, as there is with vaccines for contagious viruses that could potentially cause a public health epidemic.
The 75 cent excise tax on each vaccine administered to children and others, routinely gets routed to the Vaccine Injury Compensation Trust Fund, which is collected by the U.S. Department of the Treasury.
CDC Shingles Vaccine Warning of Feb. 12, 2018
Women should avoid getting pregnant for at least 1 month after getting a shingles vaccine. Have a weakened immune system due to disease (such as cancer or AIDS) or medical treatments (such as radiation, immunotherapy, high-dose steroids, or chemotherapy).Feb 12, 2018
Why is Varicella Vaccine on the Vaccine Court List?
Some confusion may exist due to the fact that Varicella vaccines are listed on the Vaccine Court list, this reference however does not refer to Zostavax. The Varicella Vaccines subject to vaccine court are related to the Chickenpox vaccines and not the Shingles vaccine.
Only vaccines that have been determined to be in the public interest despite being unavoidably unsafe are on the vaccine court list. No Vaccine Act preemption arguments arise from the Vaccine Act. for Zostavax. Zostavax was not permitted to be unsafe as drugs listed on the Vaccine Injury Table are classified.
The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines. The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. The VICP uses a no-fault system for resolving vaccine injury claims. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $250,000 for pain and suffering; a death benefit of up to $250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims.
Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award, a claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare.
John Ray and other speakers will cover the Zostavax MDL 2848 case criteria and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”
November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.
Althen v. Secretary of Health and Human Services (Fed. Cir. July 29, 2005). Text This decision, which is binding upon the United States Court of Federal Claims, clarified the standing for proving “causation in fact” absent a “Table Injury” under 42 U.S.C. 300aa-11(c)(1)(C)
(MASS TORT NEXUS MEDIA) Tens of thousands of infants born in the U.S. each year now have NAS, and a recent Centers for Disease Control report said the rate of NAS deliveries at hospitals quadrupled during the past 15 years. The period of hospitalization for NAS infants averages 16 days and hospital costs for a typical newborn with NAS are $159,000-$238,000 greater than those of healthy newborns, according to the attorneys representing the NAS (neonatal abstinence syndrome) babies.
With the filing of a New Motion to Consolidate Opiate Addicted Infant Case as MDL 2872 with the Joint Panel on Multidistrict Litigation, the fire may be lit to move the most vulnerable victims of the opioid crisis into the forefront of the litigation. Will this force Opiate Big Pharma to pay for 20 years of bad conduct in pushing opiate prescriptions on American commerce? See MDL 2872 Motion to Consolidate Infant-NAS Addicted Opiate Litigation
In West Virginia, home of the highest overdose rates in the nation, the foster care population has increased by 42 percent since 2014. Federal Centers for Disease Control and Prevention data, from 2013 and released in 2016, suggested West Virginia had the highest rate of neonatal abstinence syndrome (NAS) of 21 states analyzed.
Later data collected by the state showed the state’s rate was higher than the CDC report indicated, said Christina Mullins, director of the state Department of Health and Human Resources’ Office of Maternal, Child and Family Health.
The 2016 CDC report, which said NAS “occurs primarily among opioid-exposed infants,” showed that as of 2013, West Virginia’s NAS rate was 3.34 percent of all hospital births, a hair higher than Vermont’s 3.33 percent.
After those two states, the rate plummeted significantly, with Kentucky’s 1.5 percent being the next highest – although Maine, which had no data reported in 2013, did have a 3.04 percent rate in 2012, lower than Vermont’s then-No. 1 rate of 3.05 percent and higher than West Virginia’s then-No. 3 rate of 2.17 percent.
Mullins said the data previously came from hospital discharge data, and it’s not easily comparable across all states. She said that when the state began collecting real-time data in October 2016, it got a rate of about 5 percent of all births.
Mullins presented Monday to a legislative interim committee that heard several reports regarding likely impacts of the opioid crisis on kids and education.
The reports indicated that the state was No. 1 or No. 2 in the country in removing children from their homes; the number of youth in state custody increased 46 percent from October 2014 to October of last year; there’s been a 22 percent increase in accepted abuse/neglect referrals over three years; and 85 percent of open child abuse/neglect cases involve drugs.
The number of children in state or foster care hit a record low in Massachusetts earlier this decade. Since then, that number has risen by a quarter, and there are now more children in state care than ever before.
Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.
In Canada, during the past decade, the number of babies exposed to opioids in the womb has increased 16-fold in Ontario. And according to Ontario’s Provincial Council for Maternal and Child Health (PCMCH), more than 950 infants were born to opioid-addicted mothers last year. Just over half of them will live the toughest days of their lives in their first week outside the womb.
Until the governments at the federal, state and local levels can all agree on a long-term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.
In Ohio, the number of children in state custody has grown by 28 percent since 2015. Foster care populations are up more than 30 percent in Alabama, Alaska, California, Idaho, Indiana, Minnesota and New Hampshire since 2014. States like Illinois, Oklahoma, Massachusetts, Pennsylvania, Colorado and New Jersey now adopting new approaches to help keep parents and children together, even as parents are receiving treatment for their addictions.
The opioid epidemic plaguing the nation is taking a catastrophic toll on our most vulnerable group, the children of the opiate addicts and those with substance use disorders. Many children are sent to live with grandparents or other family members, often due to a parent overdose or other addiction displays other problems but tragically, a growing number are being placed in the foster-care system, with many states unable to keep up with the demand from both a budget as well as staffing overload.
From 2013 to 2015, the number of children in foster care nationwide jumped almost 7 percent to nearly 429,000, according to the U.S. Department of Health and Human Services’ Administration on Children and Families, the 2016 to 2018 numbers have moved that number closer to 550,000. Parental substance use was cited as a factor in about 32 percent of all foster placements. From 2000 to 2015, more than half a million people died of an overdose, and currently 91 people a day die from opiate overdoses.
Unfortunately, many children, the indirect victims of the crisis, are not getting the care and services they need. “This is a neglected subpopulation,” says John Kelly, PhD, associate professor of psychiatry in addiction medicine at Harvard Medical School, and the founder and director of the Massachusetts General Hospital. “Because we’re trying to put out the fire in terms of stopping overdose deaths, we haven’t really been attending to other casualties, including kids most importantly.”
To lessen the long-term effects on children, psychologists are treating children in the foster-care system in outpatient, inpatient and residential treatment programs and in school-based mental health programs.
[STUDY OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]
Drug users’ children flooding to foster care
In Washington state, this number is alarming but not widely known, 10,000 high-school seniors said they used heroin or gotten high on opioid-derived painkillers in 2016, those numbers were about the same as two years prior, but foster care placements have surged.
Between 2011 and 2017, the state took children from drug-abusing parents nearly 14,000 times. Last year’s rate was the highest for drug-related causes since 2010 — up 16 percent over 2015 — while state hospitals report a steady increase in substance-exposed newborns.
Child-welfare workers hear complaints about increasingly severe problems in school — more physical violence toward peers, or kids who need to be taught separately — from students whose parents are staggering through addiction, said Jenna Kiser, who oversees intake at the state Children’s Administration.
Jenny Heddin, a state agency supervisor stated, “These numbers are very concerning, when children from these homes come into foster care, they can be very difficult to serve.”
This represent one corner of a national wave. More than 37 states report unprecedented numbers of kids entering foster care, many of them for reasons related to a parent’s substance abuse, according to the federal Department of Education.
Damaging children’s futures
By the time Child Protective Services is knocking on someone’s door, the problem is already severe. And so far efforts to respond might best be described as triage — focused more on addiction treatment than prevention, both in Washington and across the country.
As in many other states, political infighting prevents treatment, earlier this year Washington Gov. Jay Inslee proposed spending $20 million on a multipronged effort to combat opioid addiction. The bill never made it to the floor for a full vote, and it contained little funding for prevention. (But $1.7 million targeted for youth did get funding.)
Yet researchers warn that ignoring that aspect of the crisis virtually guarantees costly problems to come as the children of addicts grow into adulthood. Kevin Haggerty, a professor at the University of Washington who studies risk factors for drug abuse, authored one of the few peer-reviewed studies tracking life outcomes for these young people.
In the early 1990s, Professor Haggerty identified 151 elementary and middle-school children in Washington who were growing up with heroin-addicted parents. Fifteen years later, 33 percent had dropped out of high school. The vast majority were addicts themselves, and half had criminal records. Only 2 percent had made it through college. (Nationally, 33 percent of all kindergartners in 1992 grew up to earn a college degree.)
“The results are astounding at how poor the outcomes are, when having a drug-addicted parent,” said Caleb Banta-Green, principal research scientist at the Alcohol and Drug Abuse Institute at the University of Washington’s School of Public Health.
“We need to be doing a lot more for kids being parented by opiate-addicted parents — and we’re not.”
“Families literally bring their problems to our door now to help them navigate their lives,” Harrington-Bacote said. “Public schools are doing things that fall way outside of regular academic education. But if they don’t, it’s not going to get addressed at all.”
OHIO EXAMPLES – HOW BIG PHARMA OPIOID MONEY DESTROYS LIVES
Way before social workers showed up in his living room this March, Matt McLaughlin, a 16-year-old with diabetes, had taken to a routine not of his doing, trying to scrounge up enough change for food while his mom, Kelly, went out to use heroin. On a good night, the high school junior would walk his neighborhood in Andover, Ohio to pick up frozen pizza from the dollar store, and on bad nights, he’d play video games to keep his mind off his hunger and unknown blood sugar levels.
When Matt was little, his mom Kelly was a Head Start caseworker who taught parents how to manage their autistic children and who hosted potlucks and played Barbie with Matt’s sister, Brianna. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”
Kelly had neck surgery and got addicted to OxyContin, and by 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, food became scarce, life changed for the worse, “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”
Ashtabula County Children Services answered a tip when someone called the police and urged them to check on the family.
She’d been to detox several times over the years, trying to rid herself of what felt like a demon that had taken over her brain. Last year, she managed to stay clean for 63 days, until a friend came over “and laid out a line—and that was all it took.” There are five heroin dealers within a five-mile radius and all are more than willing to provide an addict the opiate of choice, which is the norm for rural Ohio anymore.
Her kids were once again forced to pack their bags as Kelly would go to detox another time, they were lucky to have relatives nearby. The spiraling opioid epidemic has disrupted so many families that all the foster homes in Ashtabula County are full, with this story being repeated across the country every day.
The scourge of addiction to painkillers, heroin, and fentanyl sweeping the country has produced a flood of bewildered children who, having lost their parents to drug use or overdose, are now living with foster families or relatives. In Ashtabula County, in Ohio’s northeast corner, the number of children in court custody quadrupled from 69 in 2014 to 279 last year. “I can’t remember the last time I removed a kid and it didn’t have to do with drugs,” says a child services supervisor. Her clients range from preschoolers who know to call 911 when a parent overdoses to steely teenagers who cook and clean while Mom and Dad spend all day in the bathroom. Often, the kids marvel at how quickly everything changed—how a loving mom could transform, as one teenager put it, into a “zombie.”
The pattern mirrors a national trend: Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.
More Broken Families, Less Funding
Ohio also has one of the nation’s highest overdose rates. In 2016, at least 4,149 Ohioans died of drug overdose—a 36 percent jump from the year before, according to the Columbus Dispatch. In 2015, 1 in 9 US heroin deaths occurred in Ohio.
It’s hard to overstate just how pervasive the epidemic feels here. Detective Taylor Cleveland, who investigates drug cases in Ashtabula, told me, “I’m dealing with ruined homes two and three times a day.” Cleveland, who coaches youth soccer and recently adopted a 17-year-old player whose mom overdosed, leads a task force that responds to every overdose in the county. Once, he arrived at an overdose scene only to realize that the victim slouched over in the motel room was his cousin, whose young daughter had called 911. “Every OD that happens, I get a text. I’ve gotten two texts while we’ve been talking.” We’d been talking for less than an hour.
Given the scale of the crisis, it’s not hard to understand why, when Donald Trump promised Ohioans on the campaign trail to “spend the money” to confront the opioid crisis and build a wall so drugs would stop flowing in, locals in this historically blue county took notice. In late October, Trump became the first presidential candidate since John F. Kennedy to visit Ashtabula County. He promised to bring back jobs, to open the long-shuttered steel plants, to build the wall. Twelve days later, Ashtabula residents voted for a Republican president for the first time since Ronald Reagan in 1984.
WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER
But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.
“I think some people felt as though nothing else is working,” said one Ashtabula resident when I asked why so many in a Medicaid-dependent area would vote for Trump. Now, she says, “I’m really, really scared. You don’t get it until you live in a small town and you see people die every day.”
Like so many other Midwest Rust Belt counties, Ashtabula, Ohio has seen better days. Locals proudly tell me that the Port of Ashtabula used to be one of the biggest in the world, where barges unloaded iron mined from Minnesota’s Mesabi Range onto trains headed for the steel mills of the Ohio River Valley. Today, once-bustling streets have given way to vacant storefronts and fast-food chains; the surrounding countryside is made up of farm fields, trailer parks, and junkyards. One in three kids now live below the federal poverty line, less than half of adults have a high school education. The financial downturn accelerated in the ’90s when manufacturing jobs started disappearing.
Then Opiate Big Pharma and their marketing campaigns introduced newer “less addictive” painkillers like OxyContin and others like Vicodin were liberally prescribed in communities wrestling with dwindling economic opportunity and rife with workplace injuries common to mines, lumberyards, and factories. As authorities started to tighten the rules on prescribing drugs like OxyContin, the use of heroin, which is chemically nearly identical to opioid painkillers, crept up. But the tipping point, for Ohio and the country, came over the past couple of years, when illicit fentanyl, an opioid up to 100 times more powerful than morphine, started making its way into the heroin supply. Since then, says Dr. Thomas Gilson, the medical examiner for nearby Cuyahoga County, the deaths have been coming “like a tidal wave.”
About five years ago, Ohio noticed a major uptick in the number of parents using heroin. More recently, elected officials have learned more about the parasitic way that opioids co-opt the brain and the complex pull of addictions attitudes have softened, with most realizing there is no good guy or bad guy, once addiction takes hold. The long-term problems are often multiplied many times over by lack of short-term treatment.
Gov. John Kasich, a notorious budget hawk, made national news when he pushed Medicaid expansion through Ohio’s conservative Legislature. “When you die and get to the meeting with St. Peter,” he told one lawmaker, “he’s probably not going to ask you much about what you did about keeping government small, but he is going to ask you what you did for the poor.” He made news yet again last week, when he signed a 2018 budget that will, for the first time in years, increase the state’s funding for children’s services. Yet the $30 million boost in funding over two years, which will pay foster parents and provide counseling for the kids, won’t make up for the $55 million increase in child placement costs over the past three years. Other than county pilot programs, “No policy or state investment has focused specifically on the children flooding into county agency custody as a result of the opioid epidemic,” concluded a report by the Public Children Services Association of Ohio this spring.
Meanwhile, federal funding for children’s services decreased by 16 percent between 2004 and 2014. That’s due in part to an arcane law stipulating that the largest pot of federal money for children’s services applies only to kids from below a certain income threshold. In many states, that threshold is about half the poverty level—in Ohio, it’s roughly $14,000 per year for a family of four. But the opioid epidemic has afflicted families of all stripes. “A few years ago, I was constantly just in homes that were clearly in poverty,” says Mongenel. Now she’s struck by her new clients’ well-kept houses: “You pull up to it and it’s like, ‘Really?’”
The director of one Ohio county stated “that more caseworkers are quitting than ever before, unable to reconcile the overwhelming caseload with the paltry salary, which starts at $28,500..’”
CPS and affiliated social services agencies across the United States are now becoming much more familiar with the latest addiction research on ACEs and impacts on young children. They know that a child with four or more ACEs is twice as likely as other kids to develop cancer and ten times more likely to inject drugs themselves. When they encounter someone like Lisa, they are torn between mitigating one ACE, exposure to parental substance abuse, and catalyzing another: separating a child from her parents, which is what makes these conversations so heart-wrenching.
For county and state professionals, one of the most difficult things about managing opioid cases is how unpredictable they can be, never knowing how a client’s drug-addicted parent will do after detox. Some thrive and are quickly reunited with their families. Others can’t pull themselves out of the black hole of addiction.
Every 19 minutes, an opioid addicted baby is born in America, while many of us are well aware of the repercussions of addiction in adults, but very little is understood about the impact it has on infants. After months of being fed opioids through the mother, these babies suffer through excruciating pain.
Imagine, then, how it feels for a baby. Infants who have been exposed to opioid painkillers like morphine, codeine, oxycodone, methadone treatment or street drugs such as heroin while in utero are literally cut off from the drugs when they are born. Within their first 72 hours of life, about half of the babies who have been exposed begin having withdrawal symptoms.
The medical term for this is neonatal abstinence syndrome, or NAS, and rates of babies born with it are rising along with the exponential increase of painkiller use and abuse.
A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.
In Tennessee which is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, the penalty is punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.
Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions.
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Philadelphia Court of Common Pleas Is Now The Venue for Filing “Essure” Cases
By Rosemary Pinto, Esq. Feldman & Pinto
And Mark A. York, Mass Tort Nexus
(September 27, 2018)
(MASS TORT NEXUS MEDIA) Bayer Corp. and its entities, the makers of Essure, a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators ,said recently that it will stop selling the device in the U.S., the only country where it remains available.
On July 23, 2018, U.S. District Senior Judge, John R. Padova of the Eastern District of Pennsylvania,ruled that the federal court did not have jurisdiction over the cases against Bayer Healthcare Pharmaceuticals Inc., and the legal claims over the Essure contraceptive device.
The cases were originally filed in Philadelphia court but were removed by Bayer with the company claiming the removals were proper because the plaintiffs’ claims involved an interpretation of federal law, including Food and Drug Administration regulations.
The company cited a 2017 ruling by a U.S. District Court in North Carolina in another Essure case, Burrell v. Bayer, in which it found that it had federal question jurisdiction because “the labeling of FDA-approved medical devices is governed by the FDA under the MDA, and [the] state law is generally pre-empted under 21 U.S.C. Section 360k.”
But Padova instead followed the lead of courts in the Eastern District of Kentucky and the Eastern District of Missouri, finding that “Congress intended for the state courts to resolve cases such as this one, which ask whether a defendant violated state laws that parallel federal requirements applicable to Essure.”
Bayer argued that the cases were of federal concern because the Essure devices were subject to “stringent federal scrutiny” as Class III medical devices.
“We certainly agree with Bayer that Congress has a significant interest in the regulation of Class III medical devices,” Padova said. Nevertheless, Padova added, the Medical Device Amendments of 1976 “permit individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. It would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”
Padova also said Bayer failed to identify any disputed federal issue, noting that “the central claims in the complaints are that Bayer violated state law and the complaints merely reference federal law to rebut any argument that their state law claims are preempted.”
Feldman Pinto In Philadelphia Provides Insight
Essure Litigation Survives Preemption Challenge, Cases Remanded to State Court
Essure is a birth control device composed of two metal coils implanted in a patient’s fallopian tubes. Women injured by the device have filed more than 16,000 lawsuits against Bayer Healthcare, alleging, among other things, that Bayer failed to provide adequate warnings of severe Essure complications suffered by plaintiffs from device breakage, migration, and / or expulsion. Complications include perforation of fallopian tubes, uteri, rectums, colons, and other organs; severe and chronic pelvic or abdominal pain; and autoimmune diseases.
Essure Claims for Negligent Misrepresentation and Negligent Failure to Warn Survive Preemption Challenge
All of the approximately 16,000 Essure lawsuits in state and federal court exist as individual legal actions rather than class actions or multidistrict litigation. Five such cases were consolidated in the U.S. District Court for the Eastern District of Pennsylvania. Defendants filed motions in all five cases, requesting dismissal of plaintiffs’ claims on the basis of express or implied preemption, failure to state a plausible claim, or failure to plead fraud with particularity.
In March 2016, the court denied defendants’ motions to dismiss plaintiffs’ claims of negligent misrepresentation and negligent failure to warn, holding that the state law claims set forth plausible claims for relief and were not preempted by federal law.
Consolidated Essure Cases Remanded to State Court
In July 2018, the Eastern District of Pennsylvania remanded 19 Essure injury cases to the Philadelphia Court of Common Pleas. The district court found that it lacked both diversity of citizenship and federal question subject-matter jurisdiction over the consolidated individual actions and remanded them to state court.
Essure Statute of Limitations
Defendants in Essure personal injury cases may argue that the statute of limitations period in all Essure cases should begin on November 18, 2016, the date the FDA approved a black box warning (its strongest warning level) for Essure. In reality, the dates triggering Essure limitation periods will vary. The beginning of each plaintiff’s limitation period will depend on the plaintiff’s individual claims and state law applicable to the particular case.
Bayer Stops USA Sales
Bayer announced in June 2018 that it would voluntarily discontinue U.S. sales of Essure by the end of this year “for business reasons” but earlier this month affirmed the safety profile of the device. Last week, Bayer took Netflix to task over the accuracy of its medical device documentary “The Bleeding Edge.” The tide was turning for Bayer at that point, sales were already down 70% after the 2016 FDA warning and the public became aware of the risks of using Essure.
Bayer received FDA approval to sell Essure in 2002 and promoted it as a quick and easy permanent solution to unplanned pregnancies. Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman’s eggs.
Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study. FDA Commissioner Scott Gottlieb said Friday, the agency would work with Bayer to continue the study, but noted “Bayer will not be able to meet its expected enrollment numbers” for new patients. The study was designed to follow patients for three years to better assess complications.
Gottlieb said the FDA will continue to monitor adverse events reported to its database after Essure is removed from the market. He stated “I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so,” and added “Those who think it’s causing problems, such as persistent pain, should consult with their doctors,” with Gottlieb further noting that device removal “has its own risks.”
Essure’s original label warned that the device’s nickel can result in allergic reactions. Its current labeling lists hives, rash, swelling and itching as possible reactions.
But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. Those problems are listed in the current FDA labeling for the device, with the qualifier: “It is unknown if these symptoms are related to Essure or other causes.”
Informational material Bayer supplied to doctors and patients lists potential problems and states the devices are meant to be permanent. It also says removal may require complicated surgery, including a hysterectomy, that might not be covered by insurance.
Non-Profit Weighs In
Diana Zuckerman, president of the nonprofit National Center for Health Research, said Essure is among medical devices approved without “clear evidence of safety or effectiveness. As a result, when thousands of women reported serious complications from Essure, there was no unbiased long-term research to refute or confirm those reports” she also stated, “If patients had been listened to when the first clinical trials were conducted on Essure, better research would have been conducted to determine exactly how safe and effective Essure is.”
Feldman & Pinto is Representing Plaintiffs in Essure Litigation
The Philadelphia personal injury firm of Feldman & Pinto concentrates its practice in plaintiffs’ drug and medical device injury litigation. Each of the firm’s attorneys has more than 20 years’ experience trying personal injury and wrongful death cases in state and federal court. Feldman & Pinto currently represents plaintiffs in approximately 20 Essure injury cases in the Philadelphia Court of Common Pleas. Attorney Rosemary Pinto can be contacted at email@example.com.
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THE JPML HAS BEEN REQUESTED TO CONSOLIDATE A NEW ADDICTED INFANT MULTIDISTRICT LITIGATION
By Mark A. York (September 21, 2018)
Have the most vunerable plaintiffs in the opiate litigation been underserved by firms primarily focused on representing governmental entities in Opiate MDL 2804 and state court consolidations? What about the epidemic of NAS affected babies who have been born addicted to prescription opiates?
Plaintiffs lawyers have also filed class actions in nine states on behalf of infants, and other “individuals” affected by opiate use and subsequent addiction, with very limited input into the federal litigation process. On May 21, 2018 a coalition of nine law firms filed court papers asking MDL 2804 Judge Dan Polster (USDC ND Ohio) for permission to request a separate discovery and litigation track for the baby cases, which was summarily denied without comment by the court on June 28, 2018.
Lawyers and public health officials have estimated that there could be more than 1 million babies diagnosed with “neonatal abstinence syndrome,” which occurs when infants are born to mothers who used opioids. There is a request seeking a trust of more than $1 billion to help pay for medical monitoring of the children over the next few decades.
“There has been no large-scale attempt to find out what happens to these children, and there are thousands at this time, perhaps over 1 million, progressing now through the school system and growing up,” said Scott Bickford, a principal at Martzell, Bickford & Centola in New Orleans. “Theoretically, these kids are born addicted and may stay addicts for life.”
Treatment and Prognosis for Opioid Addicted Newborns
The course of treatment will be determined by factors such as:
Baby’s gestational age, medical history, and health
Severity of the disorder and expectation of the effects it will have
Baby’s tolerance of the therapies, procedures, or medications
Immediate treatment for withdrawal effects focuses on comfort and thriving. Babies suffering from opioid withdrawal often have trouble resting and eating, so treatment involves:
Swaddling for comfort
Adding extra calories to account for energy used through restlessness and increased activity
Intravenous fluids for dehydration
Medication to relieve discomfort and eliminate symptoms like seizures
Long-term treatment involves treating physical and behavioral effects and can involve:
Monitoring and treating vision and hearing impairments
The vast majority of plaintiffs are cities and counties seeking to recoup the costs of medical treatment and law enforcement, but Native American tribes, hospitals and others have elbowed into the case. New plaintiffs are emerging, such as class actions—including eight filed this week—filed on behalf of individuals alleging the opioid epidemic caused their health insurance premiums to skyrocket.
At least 11 cases have been brought on behalf of babies, many of whom suffer from addiction and learning disabilities. Bickford said the cases are in states that have medical monitoring laws, which include New York and California. According to the case filed in New York Supreme Court for Niagara County, for instance, lifetime medical costs could include treatment of developmental, psychiatric, emotional or behavioral disorders associated with addiction.
THIS IS A MUCH BIGGER PROBLEM
Dr. Shawn Hollinger, neonatologist at Niswonger Children’s Hospital, cradled baby Jayden’s head in an effort to comfort him. After 35 days in the neonatal intensive care unit, Jayden was ready to go home.
The number of children needing intensive treatment for NAS has become so overwhelming that the hospital opened a new ward this year just to care for them. Since 2009, hospital staff have treated over 1,800 babies with NAS. In the past 12 months, Hollinger has seen 351 infants with NAS come through the NICU.
After birth, children exposed to drugs in the womb experience a multitude of symptoms, including tremors and seizures. Even after being released from the hospital, some children may still have to be treated with medication and physical therapy. It can cost upwards of $60,000 to treat one baby.
“The intent would be to construct a trust that would deliver financial assistance directly to the custodians of these children,” he said. Custodians could include other family members, foster parents or birth parents who have kicked the habit, he said.
The defendants in all the baby cases include opioid manufacturers Purdue Pharma, Johnson & Johnson, Endo Health Solutions and Teva Pharmaceuticals, as well as distributors McKesson Corp., AmerisourceBergen Corp. and Cardinal Health Inc. The New York complaint also named Insys Therapeutics Inc.
Johnson & Johnson spokeswoman Wanda Moebius wrote in an email: “Our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated. In fact, our medications have some of the lowest rates of abuse among this class of medications.”
Endo spokeswoman Heather Zoumas Lubeski said, “We deny the allegations contained in these lawsuits and intend to vigorously defend the company.”
Representatives of the other defendants either did not respond or declined to comment.
It’s not the first time the coalition of law firms tried to get Polster to create a separate “baby track.” On June 28, the judge denied an earlier request.
“We’ve asked the court to reconsider our motion for a separate baby track for babies with neonatal abstinence syndrome,” Bickford said. “We don’t think the present MDL and the people in it who essentially represent state and local governments really have the children’s interests at heart.”
The plaintiffs’ executive committee in charge of the opioid MDL has refused to provide information about discovery and depositions, he said. His request described the discovery process as operating under a “cloak of secrecy” and included an attached email exchange in which executive committee member Jayne Conroy of Simmons Hanly Conroy called his request to monitor depositions “not necessary” and “burdensome.”
Conroy said in a statement: “All our legal efforts are directed at the companies who caused the opioid epidemic. Any success will benefit all victims.”
Earlier this summer, the Judge charged with control over the federal MDL involving government entities’ claims against opioid manufacturers and distributors rejected a request for the inclusion of NAS baby cases within a special litigation track. The request would create a nationwide medical monitoring trust fund for NAS babies within the existing MDL litigation regarding prescription opioid
On May 31, 2018 counsel for the baby/NAS addicted plaintiffs filed a Motion for Leave to Establish a Separate Track for Opioid Baby Claims, with the court denying the request via text order entry below.
Order [non-document] denying Motion for leave to File Motion for Order to Establish Separate Track for Opioid Baby Claims filed by Melissa Ambrosio, Darren Flanagan, Elena Flanagan, Ceonda Rees, Deric Rees, Virginia Salmons, Walter Salmons, Roxie Whitley, Rache l Wood(Related Doc # 540 ). Judge Dan Aaron Polster (MDL 2804) on 6/28/18.(P,R) (Entered: 06
Court Response to Previous Attempt to Get a Baby Track in Opiate MDL 2804
Tens of thousands of infants born in the U.S. each year now have NAS, and a recent Centers for Disease Control report said the rate of NAS deliveries at hospitals quadrupled during the past 15 years.
The period of hospitalization for NAS infants averages 16 days and hospital costs for a typical newborn with NAS are $159,000–$238,000 greater than those of healthy newborns, according to the attorneys representing the NAS babies.
Dr. Kanwaljeet J. S. “Sunny” Anand, the nation’s foremost expert on opioids in infants and a Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine at Stanford University School of Medicine, is a medical expert to the legal team. “There is an unprecedented epidemic of opioid addiction sweeping across the U.S.,” said Dr. Anand. “Newborn babies are the most vulnerable citizens, their lives and developmental potential are disrupted by NAS, but arrangements for their short-term and long-term care have been ignored until now. These babies need strong advocacy and legal action to ensure that their rights are protected, and that they urgently receive essential medical care and rehabilitation. On average, one infant with NAS is hospitalized every hour in the U.S.”
Named as defendants in the class actions are an array of pharmaceutical manufacturers, distributors and retailers, all of whom netted billions of dollars due to unfair and deceptive trade practices that preyed on all Americans, including the unborn, say the attorneys.
“Legal precedent recognizes the difference between present and future claims in negotiations of this magnitude,” said Mr. Bickford. “Without being at the table, the legal representatives of NAS babies and children will not be heard and the due process rights of these infants and children will be denied.”
The filing says only government, hospital and third-party payors are at the table in negotiating a settlement through the MDL, though no agreement has yet been reached. The attorneys representing the NAS babies have raised concerns that outcomes similar to the Tobacco MDL settlement, where money was diverted to state budget deficits instead of the intended victims, might happen here.
Born to women addicted to drugs, newborns suffer through withdrawal
Babies suffering through opioid withdrawal have a distinct way of crying: a short, anguished, high-pitched wail, repeated over and over. It echoes through the neonatal therapeutic unit of Cabell Huntington Hospital in Huntington, West Virginia. A week-old girl has been at it, inconsolably, since six o’clock this morning. At 10 o’clock Sara Murray, the unit’s soft-spoken, no-nonsense nurse manager, sighs. “This may be a frustrating day,” she says.
The opioid epidemic in the United States is painfully evident in hospital newborn units across the country. In 2012 nearly 22,000 babies were born drug dependent, one every 25 minutes, according to the most recent federal data. As the opioid crisis has escalated dramatically over the past five years, those numbers have surely climbed.
West Virginia, at two and a half times the national average, has the highest rate of deaths from drug overdose—mostly from opioids. Cabell County, which averaged about 130 overdose calls to 911 annually until 2012, received 1,476 calls last year and is on pace to reach around 2,000 this year. Emergency workers saved many of those people, including an 11-year-old, but inpatient treatment programs have long waiting lists. At Cabell Huntington Hospital, one in five newborns has been exposed to opioids in the womb.
“What you’re seeing here is the tip of the iceberg of substance use,” says neonatologist Sean Loudin, the unit’s medical director.
In 2012 the neonatal intensive care unit became so overwhelmed by drug-dependent babies that it had to turn away newborns with other medical needs. The hospital opened this specialized unit to treat withdrawal. It typically has 18 babies. On this day there are 23.
The babies shake, sweat, vomit, and hold their bodies stiff as planks. They eat and sleep fitfully. Swaddled, they lie in bassinets or in the arms of nurses, parents, or volunteers. The place doesn’t have the hustle or beeping machinery of an ICU. Instead there are dim lights and hushed conversations because the babies need calm and quiet. Many also need methadone or other medication to relieve their symptoms. They are weaned from it over days or weeks.
“OK,” Murray whispers to a bleating 41-day-old boy. She gently lifts him to her chest, cradles him firmly, and places a green pacifier in his mouth. He sucks it fast and hard, like a piston.
Opioids pass readily from a pregnant woman’s bloodstream through the placenta and across the fetal blood-brain barrier. When birth abruptly shuts down the flow of the drug, the baby’s nervous system can trigger the agitating symptoms of withdrawal. Studies show that 55 percent to 94 percent of newborns exposed to opioids develop symptoms. Prenatal exposure to other widely used drugs, including benzodiazepines and certain antidepressants, also can lead to withdrawal shortly after birth.
The condition is called neonatal abstinence syndrome (NAS). Experts don’t consider it to be addiction, which, by definition, means a person persists in compulsive drug use despite terrible consequences. By the same logic, NAS is also a misnomer—abstaining, or just saying no, is different from experiencing the physical anguish of withdrawal. But medical experts have come to accept the NAS label because it’s less fraught with stigma than words like “addiction” and “withdrawal.”
In some cases the mothers themselves are in recovery. They didn’t misuse opioids during pregnancy but took methadone or buprenorphine, the frontline medications for treating opioid addiction. The American Congress of Obstetricians and Gynecologists recommends their use during pregnancy despite the risk of NAS, for the obvious reason that sobriety is safer and healthier for a woman than shooting heroin or popping painkillers or trying to go cold turkey on her own. It’s also much better for her child. But encouraging as it is, the growing use of medication-assisted addiction treatment means that even when the opioid crisis eases, hospitals like Cabell Huntington will continue to be swamped with babies in withdrawal.
To manage the condition, most hospitals use an assessment tool developed at the height of the heroin outbreak in the 1970s. Babies are rated every four hours on the severity of 31 symptoms, including excessive crying, sweating, tremors, and frequent yawning. The scores help doctors determine whether to put babies on methadone or other medication. In most cases the scores support drug therapy. Now some researchers are challenging that approach.
“It’s archaic,” says Elisha Wachman, a neonatologist at Boston Medical Center and an assistant professor of pediatrics at Boston University School of Medicine. “What ends up happening is that babies get overmedicated.” Too often, she says, they experience withdrawal from their treatment, which prolongs their misery and their hospital stay.
A handful of researchers around the country are revamping NAS treatment to rely less on medication and more on parental bonding. Wachman has abandoned the old score sheet for assessing the babies. “I couldn’t care less how many times they yawn,” she says. Instead, she evaluates them on just three measures: eating, sleeping, and being consoled. Rather than transfer babies to an ICU or a specialty unit, Boston Medical Center keeps them with their moms throughout their stay. Wachman encourages the women to breastfeed and clutch their babies skin to skin. One hundred fifty volunteers—most of them medical students and hospital employees—put in two-hour shifts as cuddlers. The waiting list to hold babies has 200 names.
Before the hospital changed its approach, 86 percent of the babies with NAS it treated received medication. Now it’s 30 percent. The babies generally spend nine days in the hospital, down from 19 days under the old protocol. The average cost of a hospital stay for a baby with NAS is $19,655 at Boston Medical Center, compared to a national average of $67,000.
Wachman says sound treatment for the babies must go hand in hand with compassionate, comprehensive care for their mothers. The medical center runs a prenatal clinic for women with addiction. The obstetricians prescribe buprenorphine and prepare women for the possibility that their babies will have NAS. The clinic also offers counseling, social services, psychiatric help, peer support, and education about infant care. “When the moms come in to deliver, they’re in the best shape they can be,” Wachman says. In July the medical center opened a clinic that provides pediatric care for babies born with NAS and addiction services for their mothers.
It’s not clear how opioid exposure affects long-term brain development. Surprisingly little research has been done, and most of it predates the current crisis and the widespread use of highly potent synthetics, such as fentanyl. Some studies show subtle cognitive and behavioral differences among children who were exposed to opioids before birth, but the problems are less severe than the intellectual and attention deficits associated with fetal alcohol exposure. The studies don’t answer a key question: Do the neurodevelopment issues stem from drug exposure or poverty or other chronic stresses? Some researchers believe that social factors and a stable environment are bigger influences on a child’s future than NAS.
“We keep hearing about the babies, and that it is important, but there needs to be much more of a focus on women and making sure they’re taken care of well,” says Uma Reddy, a maternal-fetal medicine expert at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Mass Tort Nexus will provide updates on the Infant NAS MDL request to the JPML as well the Opiate Prescription MDL 2804 on a daily basis.
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IS MEDICAL CANNABIS AN ALTERNATIVE TREATMENT FOR OPIOID ADDICTION?
By Mark A. York (September 20, 2018)
(MASS TORT NEXUS MEDIA) More and more medical treatment professionals, politicians and others have joined in the quickly emerging role of medical marijuana to help in treatment by patients struggling with opioid addiction. Now, two studies are reflecting this emerging treatment to be viable.
Recent studies, published journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.
Additionally, three states have approved Medical Cannabis for alternative treatments related to both pain management and substance abuse disorders, where cannabis has been determined as an appropriate treatment. Pennsylvania, New Jersey and Illinois are at the forefront of using changes to state laws regarding medical cannabis in the most effective clinical settings when possible.
PENNSYLVANIA CANNABIS BASED OPIOID ADDICTION TREATMENT
The Pennsylvania Department of Health approved major changes to the state’s medical marijuana program, when the health department added opioid addiction to the list of conditions eligible for treatment with medicinal cannabis. With that decision, Pennsylvania joins New Jersey and Illinois as the only states that have done so.
Pennsylvania Secretary of Health Dr. Rachel Levine told local media that marijuana won’t be the first treatment for addiction to opioids. Instead, doctors will try more traditional therapies first.
“It’s important to note that medical marijuana is not a substitute for proven treatments for opioid use disorder,” Dr. Levine said. “In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”
A related positive note by Pennsylvania is the Department of Health has approved cannabis research licenses for five Philadelphia area medical schools on Monday. With one topic of research at the institutions being the potential role of cannabis in addiction treatment as a normal treatment protocol.
The schools that received approval to study cannabis are Drexel University College of Medicine, Lewis Katz School of Medicine at Temple University, Sidney Kimmel Medical College at Thomas Jefferson University, Perelman School of Medicine at the University of Pennsylvania, and Philadelphia College of Osteopathic Medicine.
JAMA STUDY RESULTS
The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.
“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.
“And for pain patients in particular, our work adds to the argument that cannabis can be effective.”
Medicare Part D, the optional prescription drug benefit plan for those enrolled in Medicare, covers more than 42 million Americans, including those 65 or older. Medicaid provides health coverage to more than 73 million low-income individuals in the US, according to the program’s website.
“Medicare and Medicaid publishes this data, and we’re free to use it, and anyone who’s interested can download the data,” Bradford said. “But that means that we don’t know what’s going on with the privately insured and the uninsured population, and for that, I’m afraid the data sets are proprietary and expensive.”
Earlier this year, the National Academy of Sciences, in a 395-page report, refuted the official US Department of Justice position that cannabis is a “gateway drug” and that using marijuana can lead to opioid addiction and instead found evidence of cannabis having therapeutic and health benefits. Joe Schrank, a social worker who worked at various detox centers and clean houses, is now practicing the report’s findings at High Sobriety treatment center in Los Angeles, where he offers clients medical and therapeutic sessions, and daily doses of marijuana to treat a variety of addictions.
The Opioid Crisis Is Here
The new research comes as the United States remains entangled in the worst opioid epidemic the world has ever seen. Opioid overdose has risen dramatically over the past 15 years and has been implicated in over 500,000 deaths since 2000 — more than the number of Americans killed in World War II.
“As somebody who treats patients with opioid use disorders, this crisis is very real. These patients die every day, and it’s quite shocking in many ways,” said Dr. Kevin Hill, an addiction psychiatrist at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School, who was not involved in the new studies.
“We have had overuse of certain prescription opioids over the years, and it’s certainly contributed to the opioid crisis that we’re feeling,” he added. “I don’t think that’s the only reason, but certainly, it was too easy at many points to get prescriptions for opioids.”
Like opioids, marijuana has been shown to be effective in treating chronic pain as well as other conditions such as seizures, multiple sclerosis and certain mental disorders, according to the National Institute on Drug Abuse. Research suggests that the cannabinoid and opioid receptor systems rely on common signaling pathways in the brain, including the dopamine reward system that is central to drug tolerance, dependence and addiction.
“All drugs of abuse operate using some shared pathways. For example, cannabinoid receptors and opioid receptors coincidentally happen to be located very close by in many places in the brain,” Hill said. “So it stands to reason that a medication that affects one system might affect the other.”
But unlike opioids, marijuana has little addiction potential, and virtually no deaths from marijuana overdose have been reported in the United States, according to Bradford.
“No one has ever died of cannabis, so it has many safety advantages over opiates,” Bradford said. “And to the extent that we’re trying to manage the opiate crisis, cannabis is a potential tool.”
Comparing states with and without medical marijuana laws
Researchers compared prescription patterns in states with and without medical cannabis laws
States with medical marijuana had 2.21 million fewer daily doses of opioids prescribed per year
Opioid prescriptions under Medicaid dropped by 5.88% in states with medical cannabis laws
In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.
Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use — Alaska, Colorado, Oregon and Washington — saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study.
“We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon,” Wen said. “And in Alaska and Washington, the magnitude was a little bit smaller but still significant.”
The first state in the United States to legalize marijuana for medicinal use was California, in 1996. Since then, 29 states and the District of Columbia have approved some form of legalized cannabis. All of these states include chronic pain — either directly or indirectly — in the list of approved medical conditions for marijuana use, according to Bradford.
The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.
The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries — regulated shops that people can visit to purchase cannabis products — had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.
“We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on — and that was statistically significant — and about a 7% reduction in any opiate use when home cultivation only was turned on,” Bradford said. “So dispensaries are much more powerful in terms of shifting people away from the use of opiates.”
The impact of these laws also differed based on the class of opioid prescribed. Specifically, states with medical cannabis laws saw 20.7% fewer morphine prescriptions and 17.4% fewer hydrocodone prescriptions compared with states that did not have these laws, according to Bradford.
Fentanyl prescriptions under Medicare Part D also dropped by 8.5% in states that had enacted medical cannabis laws, though the difference was not statistically significant, Bradford said. Fentanyl is a synthetic opioid, like heroin, that can be prescribed legally by physicians. It is 50 to 100 times more potent than morphine, and even a small amount can be fatal, according to the National Institute on Drug Abuse.
“I know that many people, including the attorney general, Jeff Sessions, are skeptical of cannabis,” Bradford said. “But, you know, the attorney general needs to be terrified of fentanyl.”
MAKING CANNABIS AVAILABLE
This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state’s upward trend in opioid-related deaths.
“There is a growing body of scientific literature suggesting that legal access to marijuana can reduce the use of opioids as well as opioid-related overdose deaths,” said Melissa Moore, New York deputy state director for the Drug Policy Alliance. “In states with medical marijuana laws, we have already seen decreased admissions for opioid-related treatment and dramatically reduced rates of opioid overdoses.”
Some skeptics, though, argue that marijuana legalization could actually worsen the opioid epidemic. Another 2017 study, for example, showed a positive association between illicit cannabis use and opioid use disorders in the United States. But there may be an important difference between illicit cannabis use and legalized cannabis use, according to Hill.
“As we have all of these states implementing these policies, it’s imperative that we do more research,” Hill said. “We need to study the effects of these policies, and we really haven’t done it to the degree that we should.”
The two recent studies looked only at patients enrolled in Medicaid and Medicare Part D, meaning the results may not be generalizable to the entire US population.
But both Hill and Moore agree that as more states debate the merits of legalizing marijuana in the coming months and years, more research will be needed to create consistency between cannabis science and cannabis policy.
“There is a great deal of movement in the Northeast, with New Hampshire and New Jersey being well-positioned to legalize adult use,” Moore said. “I believe there are also ballot measures to legalize marijuana in Arizona, Florida, Missouri, Nebraska and South Dakota as well that voters will decide on in Fall 2018.”
Hill called the new research “a call to action” and added, “we should be studying these policies. But unfortunately, the policies have far outpaced the science at this point.”
There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.
The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.
Opioid overdose, which claimed celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.
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THE RECENT FAILURE OF TWO XARELTO STUDIES STOPPED BAYER AND JOHNSON & JOHNSON ATTEMPTS TO INCREASE BLOOD THINNER MARKET-SHARE
By Mark A. York (August 28, 2018)
Two recent Xarelto studies fail to show additional benefits when Bayer and Johnson & Johnson’s attempted to expand the patient group for their heart drug Xarelto.
The recent Xarelto blood thinner “Commander HF” study, (see https://clinicaltrials.gov/ct2/Bayer/J&J (Commander AF Study), could not show any statistical improvements in helping heart failure patients after an acute decline in their condition, results from the so-called study showed on Monday. The primary study goal of reduction in the risk of death, heart attack and stroke was unsuccessful.
A second Bayer/J&J study known as “Mariner” also failed to produce clear evidence that Xarelto is able to reduced the rate of blood clots in certain high-risk patients after a hospital release.
Bayer earned $3.84 billion in sales of Xarelto revenues last year, primarily from stroke prevention in the elderly, with projected annual sales to rise above $5 billion in 2019 and beyond.
Bayer retains marketing rights for Xarelto outside the United States while partner J&J sells Xarelto in the U.S., with Bayer being eligible for royalties on U.S. sales of 20 to 30 percent.
Both Bayer and J&J’s Janssen R&D are facing thousands of lawsuits across the country over failure to warn and disclose the significant dangers of being prescribed Xarelto and the inability to stop the bleeding as there hasn’t been an antidote for Xarelto until 2018.
XARELTO MDL 2804 AND PHILADELPHIA COMPLEX LITIGATION DOCKET
Between the Xarelto MDL 2804 federal docket of 25,000 plus and the 1,700 in Philadelphia Court of Common Pleas there seems to be significant concern for the use of Xarelto when a comparison is made to the pre-Xarelto blood thinners i.e. Coumadin and Warfarin which required additional monitoring, are not known as a drug that can kill you.
Xarelto was first approved by the FDA July 2011, representing a major advancement in blood thinning (anticoagulant) medication according to Bayer and Johnson & Johnson, developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE, DVT and atrial fibrillation.
More than one study has shown Xarelto can cause a higher rate of internal bleeding, than other anticoagulant drugs and there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding, but there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have to wait it out and hope it stops on its own.
MAYO CLINIC XARELTO STUDY RESULTS NOT POSITIVE
In the journal Gastroenterology, a team of physicians and researchers from the Mayo Clinic studied thousands of patients who took Xarelto (rivaroxaban), Pradaxa (dabigatran), and Eliquis (apixaban). The goal was to figure out which of these three anticoagulant drugs had “the most favorable GI safety profile,” which is medical-research-speak for “which one of these drugs is least likely to hurt patients.”
This is how the study worked: The researchers studied health insurance administrative claims information on thousands of patients between October 1, 2010 and February 28, 2015. These patients had atrial fibrillation, or Afib, which is a heart arrhythmia, a quivering or irregular heartbeat. Afib can lead to serious health problems such as stroke, blood clots, heart failure and other health complications. The researchers looked at the incidents of gastrointestinal bleeding among the thousands of patients who took Xarelto or Pradaxa or Eliquis.
MAYO STUDY SHOWS NEGATIVE RESULTS
Patients who took Xarelto had a higher incidence of gastrointestinal (GI) bleeding patients who took Pradaxa or Eliquis. The statistics show that patients taking Xarelto may have a 20% greater risk of internal bleeding than with those taking Pradaxa or Eliquis, with the rates of GI bleeding increased in patients over seventy-five (75) years old. Turns out, Eliquis “had the most favorable GI safety profile among all age-groups.” While clearly showing Xarelto, unfortunately, had the “least favorable” safety profile among the three prescription anticoagulant drugs.
FDA Investigation of Xarelto Trials
The approval history for Xarelto was actually pretty controversial. FDA reviewers originally said that they recommended against approval, then there was an FDA advisory committee (independent group of key opinion leaders) and they voted in favor, so the FDA approved the drug. Their concern was with how the Phase III trials were run and whether Xarelto had really proved its efficacy. The tests compared patients on warfarin to patients on Xarelto, but the patients on the warfarin run had poor TTR. That means the patients weren’t well controlled on warfarin to begin with, which skews the data in favor of Xarelto.
During the approval process, Xarelto actually wanted a superiority label, which would say that the drug was better than warfarin and other blood thinners. Because of the concerns with the Phase III data, the FDA only gave them a non-inferior label, which says they’re essentially the same in terms of effectiveness.
One of the clinical trials that played a key role in its approval for stroke prevention in patients with atrial fibrillation is now under investigation by the FDA. This trial compared Xarelto’s performance to warfarin’s, but it used a device called INRatio to test the warfarin patients.
The INRatio device was the subject of two FDA warning letters about inaccurate readings just as the trial was starting in 2005 and 2006. In 2014, the device was recalled. The use of the INRatio device may have skewed the results with inaccurate readings, making Xarelto look better in comparison with warfarin.
The FDA’s medical experts originally recommended against improving the drug due to concerns about its efficacy. They found that Xarelto was not as effective as warfarin. However, a review board eventually approved the drug over the objections.
The FDA has issued a number of warnings about Xarelto and has required the makers of the drug to change its labeling multiple times. Specifically, the FDA warned about the risks of uncontrolled bleeding. It also added a black-box warning, its most serious kind of warning, about the increased risk of stroke when patients prematurely stop taking Xarelto and about the increased risk for swelling and damage associated with the use of epidural anesthesia while taking Xarelto.
The makers of Xarelto recently applied to the FDA to expand the approved uses of the drug to include treatment for acute coronary syndrome (ACS). For the third time, the FDA unanimously denied the expansion. Johnson & Johnson and Bayer are expected to continue to apply for approval due to the high value of that market. More than 1 million patients are hospitalized with ACS each year. That offers serious potential for growth for Xarelto, which already earns almost $1 billion in sales annually.
Johnson & Johnson also is claiming that Xarelto helps patients with peripheral artery disease (PAD) in reducing their heart attack and blood clot risks.
WHAT THE VETERANS ADMINISTRATION SAYS ON XARELTO USE
“The good news is you now have an alternative to warfarin … The bad news is you can kill a patient as easily with the new drug as you could with the old drug.”Dr. Alan Jacobson, Director of anti-coagulation services at the VA in Loma Linda, Calif.
The makers of Xarelto say it takes time for doctors to get up to speed on new types of treatments and how to best administer them outside the controls of clinical trials.
“This is a shift in medical practice,” said Dr. John Smith, senior vice president for clinical development at Boehringer. “Individual physicians have to determine what the follow-up plan will be, to use common medical-sense judgment.”
XARELTO MAKERS SAY NO FOLLW-UP CARE REQUIRED
Dr. Peter Wildgoose, a senior director of clinical development at J&J, said the company has not provided special advice on follow-up care for patients on Xarelto.
“There’s nothing more than for any other drug that people regularly take,” he said, adding that most atrial fibrillation patients probably see their doctors on a regular basis. “These drugs have been tested long term, for several years at a time, with very good outcomes.”
Johnson & Johnson officials stressed there was far less evidence in trials of brain bleeding – the most worrisome side effect of anti-coagulants – in patients taking Pradaxa and Xarelto than those taking warfarin.
WAS XARELTO EVEN NEEDED?
Even though warfarin (Coumadin) has been the standard in anticoagulant (blood thinner) drugs for more than 50 years, it lacked perfection, making way for a new generation of blood thinners, including Xarelto. In clinical studies, Xarelto was shown to be more effective than warfarin in treating patients with atrial fibrillation (AF) who are at an increased risk for stroke. And while Xarelto had less cranial hemorrhage (bleeding in the brain) incidents than warfarin, it was shown to have a similar overall number of bleeding incidences when compared to the number of bleeding events in patients taking warfarin.
Despite this finding, and – until recently – its lack of antidote (reversal agent) for serious bleeding, Xarelto rose to popularity, making up a significant portion of the billion-dollar anticoagulant drug industry in the United States. Even after an investigation into into the clinical trial ROCKET-AF study, upon which its U.S. Food and Drug Administration (FDA) approval hinged, the drug continues to be prescribed by doctors to patients with AF and as a prophylaxis for deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) after total hip and knee replacement surgeries.
But as more evidence surfaced regarding the drug risks for patients taking Xarelto, including an increased risk of wound complications following surgical procedures, severe bleeding with no easily available antidote to stop its serious consequences, as well as reports of platelet deficiencies, hepatitis and Stevens-Johnson syndrome (SJS) (a severe skin reaction), some heart doctors are becoming a bit more cautious with the blood thinner.
Xarelto and Internal Bleeding?
Janssen and parent company Johnson & Johnson market its anticoagulant drug Xarelto as a safe and more convenient choice in blood thinners compared to warfarin. But pre-market clinical studies and post-marketing reports have shown that taking Xarelto leaves many patients vulnerable to internal bleeding that can result in death for some users.
In a 2017 annual report issued by the Institute for Safe Medication Practices (ISMP), it was stated that oral anticoagulant drugs, including Xarelto (rivaroxaban), showed “unacceptably high risks,” according to two government data sources, the FAERS adverse events reports for 2016 and a new systematic study by the Centers for Disease Control and Prevention (CDC).
XARELTO ACCOUNTS FOR 75 PERCENT OF ALL AE’s IN ANTI-COAGULANTS
Of the 22,000 reports of serious injuries resulting from anticoagulant drugs, Xarelto accounted for 15,043 cases alone, the FDA said.
“According to an analysis of 2016 FDA adverse event data conducted by the ISMP, anticoagulant (blood thinner) drugs accounted for nearly 22,000 reports of serious injuries in the United States, led by Xarelto, which accounted for 15,043 cases alone. These numbers also included 3,018 reported deaths, with most injuries being the result of hemorrhages, making bleeding one of the most adverse events.”
Gastrointestinal hemorrhages made up the MOST INJURIES, followed by cerebral hemorrhages. From early testing, hemorrhage has always been an apparent increased risk associated with lowering the risk of strokes from blood clots.
In late 2016, the CDC released a separate study that found that “anticoagulant drugs accounted for more emergency department visits for outpatient adverse effects than any other class of drugs currently in therapeutic use, including opioids (non-abuse visits), antibiotics and diabetes drugs.” Most of these adverse events were severe, with nearly 50 percent requiring a hospital stay. The ISMP estimated in its QuarterWatch report that just over 6 percent of patients using anticoagulants for one year will need to visit the emergency room, with about half of those patients requiring hospitalization. That is a major number of injuries that can be attributed to a drug that is advertised as life saving and designed to prevent injuries.
Overall, the CDC found in its systematic study that the FDA’s FAERS voluntary reporting underestimates anticoagulant drug-related injuries. The CDC discovered that approximately 228,600 emergency department visits occur each year due to the use of blood thinner drugs, including Xarelto, which is 10 times more than the FAERS total number of voluntary reports.
The Symptoms of Internal Bleeding
At its onset, unless it’s a severe hemorrhage, internal bleeding may not cause any symptoms apparent to the patient taking Xarelto. However, dependent on where the bleed is located in the body, the patient will soon begin exhibiting signs and symptoms that will be their indication to seek immediate medical attention. Patients who are in poor health or are over the age of 64 and the targeted audience seem more likely to suffer serious, potentially life-threatening bleeding complications.
The end result of Bayer and J&J’s attempts to secure the blood thinner market may continue unabated until the more than 25,000 lawsuits over the injuries and deaths that are affiliated with taking Xarelto will force both companies to come to either the settlement table or begin trying the Xarelto MDL 2592 lawsuits being remanded back to original courts for trials and blocks of 1200 cases at a time. Xarelto MDL Judge Eldon Fallon, USDC Eastern District of Louisiana has already started the remand process for 23,000 cases pending in his federal court, due to the lack of progress in settlements and cooperation by Bayer and Johnson & Johnson.
Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children
By Mark A. York (August 3, 2018)
Employers spent $2.6 billion on opioid addiction in 2016
$1.5 billion+ was spent on children with opiate addiction issues
(MASS TORT NEXUS MEDIA) The now commonly known costs associated with employers treating opioid addiction and the affiliated issues have increased eight hundred percent since 2004 to an eye-watering $2.6 billion in 2016, a new report reveals.
The latest analysis shows that half of the cost was spent covering employees’ children.
A recent Kaiser Family Foundation report found that prescription use of addictive painkillers among people with employer offered health coverage is now at the lowest levels in 10 years.
This comes shortly after a CDC study revealed there was been a nearly 30 percent increase in overdoses between 2015 and 2016.
According to the Centers for Disease Control and Prevention, opioids killed more than 42,000 people in 2016, more than any year on record.
With 40 percent of those deaths involving a prescription opioid such as Oxycontin and Vicodin and other widely prescribed opiates. This has also resulted in the multi-billion lawsuits filed against Opioid Big Pharma drug makers and distributors by cities, counties and states across the country, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”with the drug makers and distributors scrambling to defend the opiate marketing strategies that have caused billions and billions of dollars in costs, medical damages and loss of productivity annually in the United States.
The Kaiser Family Foundation found that the $2.6 billion spending cost companies and workers about $26 per enrollee in 2016, which now appears to be a “man-made” healthcare cost increase associated with the widely accepted Opiate Big Pharma marketing practices over the last 20 years. This include telling doctors and the healthcare industry that “opiates are not as addictive as they used to be” and “we’ve altered the drug compound to control opiate release” which was the widely used Purdue Pharma marketing strategy.
Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report found that spending on opioid prescriptions falling 27 percent from a peak in 2009 – when 17.3 percent of large employer plan enrollees had at least one opioid prescription during that year. However, by 2016, that number dropped to 13.6 percent.
These drugs relieve pain by attaching to specific proteins called opioid receptors, which are found on nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs in the body. When they attach to these receptors, they reduce the perception of pain.
[STUDY OBJECTIVES:The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]
Prescription opioids and illicit drugs have become incredibly pervasive throughout the US, and things are only getting worse.
In the early 2000s, the FDA and CDC started to notice a steady increase in cases of opioid addiction and overdose. In 2013, they issued guidelines to curb addiction.
However, that same year – now regarded as the year the epidemic took hold – a CDC report revealed an unprecedented surge in rates of opioid addiction.
Overdose deaths are now the leading cause of death among young Americans – killing more in a year than were ever killed annually by HIV, gun violence or car crashes.
Preliminary CDC data published by the New York Times shows US drug overdose deaths surged 19 percent to at least 59,000 in 2016.
That is up from 52,404 in 2015, and double the death rate a decade ago.
It means that for the first time drug overdoses are the leading cause of death for Americans under 50 years old.
The data lays bare the bleak state of America’s opioid addiction crisis fueled by deadly manufactured drugs like fentanyl.
These drugs also effect the brain regions involved in reward, so it can also produce a sense of pleasure by triggering the same processes that make people feel good when they are having fun or sex.
Experts say many people’s first contact with opioids is through some form of social contact: either a friend who was sent home with Oxycontin after a surgical procedure or a relative who received an opioid prescription for chronic pain.
‘Opioids are not infectious in terms of [being] an agent,’ Columbia University epidemiologist Dr Guohua Li previously told Daily Mail Online.
‘Opioids, are not a bacteria virus, but the drug, in this case, spreads through social networks…even in some ways a virus, like HIV, is spread to a great degree through social networks,’ he added.
Due to the link between hospitals and the opioid crisis, doctors have been coming up with innovative ways to curb the epidemic.
However, hospitals have been doing their part in trying to curb the opioid epidemic.
For instance, the ER department at St. Joseph University Medical Center in New Jersey managed to halve the rate of opioid prescriptions by using dry needles and laughing gas to treat chronic pain.
In 2016, the department launched an Alternative to Opiates program that uses trigger point injections and a local anesthetics in lieu of opioids to relieve pain. Other alternative pain relieving methods they used was warm compressors and music – they have a harpist roam the halls playing tunes to soothe the patients.
Dr Mark Rosenberg, chair of emergency medicine, said he and his colleagues founded the program after they realized chronic pain was one of the reasons most patients came to their emergency department.
‘We wanted to develop an aggressive acute pain management program that focused on evidence based principles but avoided opioids,’ Dr Rosenberg said.
St. Joseph University Medical Center isn’t the only hospital to implement this program, Kaiser Permanente has implemented an Integrated Pain Service, an eight-week course designed to educate high-risk opioid patients about pain management.
Some experts have stated that the beginning of the end of the epidemic may be near due to tightened regulations on opioid prescription monitoring, local-level efforts to make naloxone, an anti-overdose drug, and drug-assisted rehabilitation more accessible to high-risk populations. Then there are many more “experts” who state that the opioid crisis and the future affiliated issues are going to be on the healthcare, insurance and socio-economic forefront of America for at least the next generation.
Broken Families, Less Funding
The patterns of parent addiction that overflows into child addiction is something that wasn’t part of the opiate equation until fairly recently, where employer issues now mirror a national trend of multiple generations being addicted to opiates. Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.
In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.
Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.
Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions
Local efforts are now seen as the primary way to address the opioid crisis in children- the attempt to secure federal intervention and support to help curb the opioid crisis has not been a priority of the Trump Administration..
WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER
But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.
Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.
(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.
Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.
This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.
To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.
When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.
In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.
Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.
The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses. The FDA will receive comments on this proposal through February 5, 2018.
Here is the official FDA publication of January 16, 2018:
Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”
The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”
J&J RISPERDAL MARKETING ABUSE
In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”
The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.
The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.
In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.
The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.
In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.
NURSING HOME PATIENT ABUSES BY J&J
The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”
J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.
“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”
OFF-LABEL USE OF HEART DRUG NATRECOR
The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.
In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.
The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.
As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.
“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”
Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement
In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.
“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”
FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS
This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.
The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.
One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.
The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.
The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability
With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States. The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.