Preview Newsletter
Opioid Litigation Daily Media Report - 11/22/17
-
Two Escambia County hospitals sue pharmaceutical companies over opioid epidemic
Nov 21, 2017 | Pensacola News Journal (FL)
By Emma Kennedy
Two Escambia County hospitals have filed a lawsuit against national health care and pharmaceutical companies in an effort to recoup the costs of treating opioid-addicted patients. -
Escambia County hospitals suing Big Pharma over opioid distribution
Nov 21, 2017 | WEAR TV (FL)
By Candice Zamora
Two Escambia County hospitals join the list of hospitals suing big pharmaceutical companies, retailers, and distributors over opioid epidemic and opioid diversion. -
Fla. Hospitals Launch Wide-Ranging Opioid Liability Suit
Nov 21, 2017 | Law360
By Dani Kass
Two Florida hospitals on Monday sued a group of pharmacies, drug manufacturers and drug distributors for allegedly contributing to the nation’s opioid crisis by filling suspicious orders or prescriptions and downplaying the risks of the painkillers. -
Yadkin County plans to sue opioid manufacturers
Nov 21, 2017 | WXII 12 News (NC)
By Jarred Hill
Yadkin County is looking for financial compensation for the cost of the opioid epidemic to the country, blaming drug manufacturers and distributors for possibly violating state and federal laws for practices they said eventually created the opioid epidemic. -
Yadkin Co. Joins Lawsuit Against Prescription Opioid Distributors, Manufacturers
Nov 21, 2017 | WFMY News 2 (NC)
By Staff
Yadkin County is joining a lawsuit to fight against the manufacturers and distributors of prescription opioid pain relievers. -
Yadkin County joins in civil litigation over opioid drug crisis
Nov 21, 2017 | The Yadkin Ripple (NC)
By Staff
Following closed session at its Monday night meeting, the Yadkin County Board of Commissioners voted unanimously to pass a resolution declaring the opioid crisis a public nuisance which must be abated for the benefit of Yadkin County and its residents and citizens. The commissioners also signed a contract with a large number of law firms throughout the southeastern United States to file civil litigation in the courts against the manufacturers and distributors of prescription opioid pain relievers. -
W.Va. counties file suits against drugmakers
Nov 21, 2017 | Herald Mail Media
By Matthew Umstead
Federal lawsuits filed Friday on behalf of Berkeley and Jefferson counties in the Eastern Panhandle accuse several pharmaceutical drugmakers and distributors of fueling the region's opioid problem by illegally marketing and distributing the highly addictive substances. -
Detroit plans to sue drugmakers, distributors over opioid crisis
Nov 21, 2017 | Crains Detroit Business (MI)
By Chad Livengood
Detroit is gearing up to sue major pharmaceutical companies over their marketing tactics and sale of highly addictive opioid pain killers, following a litigation strategy being pursued by Oakland and Wayne counties and other major cities across the country. -
County to sue drug companies
Nov 21, 2017 | Echo Press (MN)
By Celeste Edenloff
Douglas County will be following suit with more than 60 other state, county and city governments around the country and suing opioid drug manufacturers and distributors. -
Saginaw County Joining Legal Action Battling Drug Problems
Nov 22, 2017 | WSGW (MI)
By Bill Hewitt
After nearly a half hour debate, Saginaw County commissioners voted Tuesday to join a federal lawsuit against the drug industry. -
Opioid Insurance Litigation Is Mounting With Mixed Results
Nov 21, 2017 | Law360
By Scott Seaman
The opioid epidemic has been describe as “the deadliest drug crisis in American history. Overdoses, fueled by opioids, are the leading cause of death for Americans under 50 years old — killing roughly 64,000 people last year, more than guns or car accidents.”[1] Estimates place the costs of the epidemic in excess of $75 billion and growing. -
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse (PRESS RELEASE)
Nov 21, 2017 | US FDA
By Scott Gottlieb, M.D.
As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence. -
The NIH is seeking a way to objectively measure pain. Could it help solve the opioid crisis?
Nov 22, 2017 | USA TODAY
By Gregory Korte
Every year, millions of Americans will go to their doctors complaining of pain, and their doctors will ask them to rate their degree of discomfort on a zero-to-10 scale, or using a range of smiley-face symbols. -
WXII 12 News at 11
Nov 21, 2017 | WXII (NBC)
By Greensboro, NC
Video Link: http://app.criticalmention.com/app/#/report/bb6103eb-deb3-4989-87f5-e152f3568359 -
3 in the Morning at 4:30AM
Nov 22, 2017 | WEAR (ABC)
By Mobile, AL
Video Link: http://app.criticalmention.com/app/#clip/view/30919619?token=13dcacfd-0e76-4354-9d5c-d957a447610a
Escambia County Hospitals
Yadkin County, NC
Other Litigation Coverage
Commentary and FYIs
Broadcast Media Coverage
-
Two Escambia County hospitals sue pharmaceutical companies over opioid epidemic
Nov 21, 2017 | Pensacola News Journal (FL)
By Emma Kennedy
Two Escambia County hospitals have filed a lawsuit against national health care and pharmaceutical companies in an effort to recoup the costs of treating opioid-addicted patients.
Baptist Hospital and Jay Hospital, both owned by Baptist Health Care, are named as plaintiffs in the federal lawsuit filed Tuesday that alleges the 23 companies or subsidiaries have played a part in the increased need to treat patients for opioid addictions in Escambia County.
Many of the companies refute the claims, saying the role of pharmaceutical companies in the nationwide opioid epidemic is misunderstood.
Many municipalities across the country have started suing pharmaceutical companies for the strain and cost that treating opioid-dependent patients takes on paramedics, ambulances and other resources.
Escambia County commissioners discussed the option of suing pharmaceutical companies in August, citing the increasing popularity of "Big Pharma" lawsuits and the need to hit companies financially to spur action.
Commissioner Grover Robinson said at the time that he didn't know precisely how much the opioid epidemic was costing Escambia County, but he said he did know expenses were rising.
The hospitals' lawsuit claims the defendants profited by allowing the geographic area the facilities serve to "become flooded with prescription opioids."
"The drug distribution industry is supposed to serve as a 'check' in the drug delivery system ... . Defendants woefully failed in this duty, instead consciously ignoring known or knowable problems and data in their supply chains," the suit states.
The hospitals claim the companies created conditions in which innocent patients became opioid abusers and drug dealers, and they were "economically incentivized" to ignore red flags in distribution orders.
The lawsuit cites a series of marketing campaigns by several of the companies, including an OxyContin advertisement by defendant Purdue Pharma that allegedly implied taking the substance would help a writer with osteoarthritis work more effectively. Purdue and another company, Endo Pharmaceuticals, agreed to stop running those ads in New York by 2016, the suit claims, but continued to show them in Florida.
Another example was a patient education guide released by Janssen Pharmaceuticals that described the claim that opioids are addictive as "myth," the lawsuit states.
Defendants in the lawsuit include pharmacies, distributors and pharmaceutical companies. The suit claims they contributed to the hospitals' influx of opioid-dependent patients.
McKesson Corporation, one of the defendants, claims the lawsuit "defies common sense and lacks understanding."
"As distributors, we understand the tragic impact the opioid epidemic has on communities across the country," McKesson spokesman John Parker said in an email. "We are deeply engaged in the issue and are taking our own steps to be part of the solution — but we aren't willing to be scapegoats."
Parker said distributors work with the logistics, transport and delivery of medicines from manufacturers to pharmacies, hospitals and long-term care facilities, but he said they don't make, market, prescribe or dispense medicines.
Mark Marmur, a spokesman for another one of the defendants, Allergan, said the company's two branded opioid products — Norco and Kadian — came to the company through legacy acquisitions and have not been promoted since 2003.
"Allergan has a history of supporting — and continues to support — the safe, responsible use of prescription medications," he said in an emailed statement. "This includes opioid medications, which when sold, prescribed and used responsibly, play an appropriate role in pain relief for millions of Americans."
The hospitals' lawsuit asserts negligence, nuisance, unjust enrichment, deceptive and unfair trade practices act violation, civil conspiracy and common law fraud.
The hospitals ask for injunctive relief, penalties, damages, restitution, attorneys' fees and costs and a trial by jury, but do not stipulate a financial amount they are seeking.
Baptist Health Care was not able to make a representative available to comment on the lawsuit on Tuesday. A lawyer for Baptist Health Care did not respond to a phone call requesting comment.
-
Escambia County hospitals suing Big Pharma over opioid distribution
Nov 21, 2017 | WEAR TV (FL)
By Candice Zamora
Two Escambia County hospitals join the list of hospitals suing big pharmaceutical companies, retailers, and distributors over opioid epidemic and opioid diversion.
Channel 3 News obtained a copy of the federal lawsuit on Tuesday.
The plaintiffs, Baptist Hospital, Inc. and Jay Hospital, Inc., state pharmaceutical companies, retailers, and distributors are responsible for “extraordinary damages, substantial loss of resources, employee disability, and a myriad (of) human and capital costs”.
The National Institutes of Health said opioids kill twice as many people in the United States as heroin.
The two hospitals claim the defendants listed on the lawsuit below failed to control opioid distribution and manufacturing and instead ‘profited greatly’.
They claim their inaction or “wrongful conduct” has pushed opioids from legitimate channels to the black market.
Both hospitals state the economic damage has gone “un-reimbursed and un-recouped”.
Baptist Hospital, Inc. and Jay Hospital, Inc. filed this civil action for injunction relief, compensatory damages, statutory damages, and any other relief allowed by the law against the pharmaceutical companies, retailers, and distributors.
Link to Complaint: https://www.scribd.com/document/365123702/Escambia-County-Hospitals-Sue-Big-Pharma#from_embed
-
Fla. Hospitals Launch Wide-Ranging Opioid Liability Suit
Nov 21, 2017 | Law360
By Dani Kass
Two Florida hospitals on Monday sued a group of pharmacies, drug manufacturers and drug distributors for allegedly contributing to the nation’s opioid crisis by filling suspicious orders or prescriptions and downplaying the risks of the painkillers.
Baptist Hospital Inc. and Jay Hospital Inc. are the latest in a long line of parties to try to hold those in the drug industry responsible for the nationwide epidemic, with their suit targeting distributors McKesson Corp., Cardinal Health Inc. and AmerisourceBergen; pharmacies CVS Health, Walgreens Boots Alliance Inc. and Wal-Mart Stores Inc.; and manufacturers Purdue Pharma, Teva Pharmaceutical Industries Ltd. and its unit Cephalon Inc., Johnson & Johnson and its unit Janssen Pharmaceuticals Inc., Endo Health Solutions Inc., and Actavis Inc. and its units Allergan PLC and Watson Laboratories.
“Defendants thus intentionally and negligently created conditions in which vast amounts of opioids have flowed freely from drug manufacturers to innocent patients who became addicted, to opioid abusers, and even to illicit drug dealers — with distributors regularly fulfilling suspicious orders from pharmacies and clinics, who were economically incentivized to ignore ‘red flags’ at the point of sale and before dispensing the pills,” the complaint states.
The combined alleged misconduct has led to the hospitals having to pay for medical costs which couldn’t be reimbursed, along with expenses tied to handling overdoses, deaths, counseling, rehabilitation, security, public safety, regulatory compliance and other areas, according to the complaint.
As has been alleged in many related lawsuits, the drug companies allegedly marketed their opioids as safe for long-term use, without having proper scientific backing, and downplayed the addiction risks of opioids. They’re also accused of using sources that represented themselves as unbiased to push their products.
The hospitals say the distributors are at fault for allegedly filling orders of opioids that are suspicious, such as being disproportionately large for a community or that fall outside a pharmacy’s normal ordering pattern. These distributors have been investigated or penalized by law enforcement and other agencies, but the alleged misconduct has continued, the suit says.
“The drug distribution industry is supposed to serve as a ‘check’ in the drug delivery system, by securing and monitoring opioids at every step of the stream of commerce, protecting them from theft and misuse, and refusing to fulfill suspicious or unusual orders by downstream pharmacies, doctors, clinics, or patients,” the complaint says. “Defendants woefully failed in this duty, instead consciously ignoring known or knowable problems and data in their supply chains.”
The pharmacies are also accused of ignoring red flags that they’re trained to catch, like when a stolen prescription pad is used. Pharmacists should also catch when prescriptions are written too frequently, when one doctor prescribes opioids too often, when patients come from a distance to fill opioid prescriptions or when a patient gets a combination of opioids and other strong drugs, among other concerns, the suit says.
“Pharmacies are the ‘last line of defense’ in keeping drugs from entering the illicit market,” the hospitals said. “They are meant to be the drug experts in the healthcare delivery system and as such have considerable duties and responsibility in the oversight of patient care. They cannot blindly fill prescriptions written by a doctor, even one registered under the [Controlled Substances Act] to dispense opioids, if the prescription is not for a legitimate medical purpose.”
The suit names alleged violations of the Florida Deceptive and Unfair Trade Practices Act, nuisance, negligence and gross negligence, unjust enrichment and civil conspiracy. The drug companies are also accused of common law fraud.
While the pharmacies didn’t respond to requests for comment Tuesday, the drug companies and a representative for the distributors offered their standard statements for opioid litigation, denying the allegations and outlining how they work to combat the crisis through, for example, education and abuse-deterrent drug formulations.
“We are deeply troubled by the opioid crisis and we are dedicated to being part of the solution ...” Purdue said in a statement. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”
“Teva is committed to the appropriate use of opioid medicines, and we recognize the critical public health issues impacting communities across the U.S. as a result of illegal drug use as well as the misuse and abuse of opioids that are available legally by prescription,” the company said in a statement.
Janssen said, “Responsibly used opioid-based pain medicines give doctors and patients important choices to help manage the debilitating effects of chronic pain. At the same time, we recognize opioid abuse and addiction is a serious public health issue that must be addressed. We believe the allegations in lawsuits against our company are both legally and factually unfounded. Janssen has acted in the best interests of patients and physicians with regard to its opioid pain medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label.”
“At Endo, our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options,” the company said. “We share in the [U.S. Food and Drug Administration’s] goal of appropriately supporting the needs of patients with chronic pain while preventing misuse and diversion of opioid products.”
Lastly for the drugmakers, Allergan said its opioids make up a tiny portion of the market — .08 percent of opioid prescriptions in 2016 — and that its products were ones it acquired through acquisitions.
“Allergan has a history of supporting — and continues to support — the safe, responsible use of prescription medications,” the company said. “This includes opioid medications, which when sold, prescribed and used responsibly, play an appropriate role in pain relief for millions of Americans.”
For the distributors, John Parker, senior vice president of the Healthcare Distribution Alliance, said in a statement that distributors are only middlemen and their role is being overstated.
“We don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers,” Parker said. “Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated.”
The hospitals are represented by J. Nixon Daniel III of Beggs & Lane RLLP.
Counsel information for the defendants was not immediately available.
The case is Baptist Hospital Inc et al v. McKesson Corporation et al, case number 3:17-cv-00816, in the U.S. District Court for the Northern District of Florida. -
Yadkin County plans to sue opioid manufacturers
Nov 21, 2017 | WXII 12 News (NC)
By Jarred Hill
Yadkin County is looking for financial compensation for the cost of the opioid epidemic to the country, blaming drug manufacturers and distributors for possibly violating state and federal laws for practices they said eventually created the opioid epidemic.
n a closed session on Monday, the county's Board of Commissioners unanimously voted to declare the opioid epidemic a public nuisance and signed a contract with more than half a dozen big law firms to sue distributors of prescription pain killers.
The board cites a report from the National Institute on Drug Abuse that said pharmaceutical companies told doctors that patients wouldn't become addicted to prescription opioids, leading doctors to prescribe them at a higher rate and presumably leading to the current crisis.
The county manager said they're still working to figure out exactly how much the crisis has impacted Yadkin County, economically speaking, but it includes things like paying for more people in jail or children in foster care because of opioid abuse.
"In Yadkin County, we've certainly seen our share of the opioid crisis," chairman Kevin Austin said. "And it has not only cost the county a great deal, but it has extremely impacted families and individuals here, so we wanted to get involved and do whatever we can to resolve this hopefully."
The actual lawsuit will be filed in the next few weeks. The county said the lawsuit will not be paid with taxpayer dollars.
-
Yadkin Co. Joins Lawsuit Against Prescription Opioid Distributors, Manufacturers
Nov 21, 2017 | WFMY News 2 (NC)
By Staff
Yadkin County is joining a lawsuit to fight against the manufacturers and distributors of prescription opioid pain relievers.
The Yadkin County Board of Commissioners voted unanimously to pass a Resolution declaring the opioid crisis a public nuisance at its Monday meeting. County leaders signed a contract with a large number of law firms throughout the southeastern United States.
Kevin Austin, Yadkin County Commissioner Board Chairman, said, “Our Board of Commissioners has decided to take action in behalf of our citizens to do all that we can to put an end to the opioid abuse that daily affects the lives of all of our residents. We believe and have resolved as a Board that it is critically necessary that we do all that is possible to abate the nuisance that we see increasing daily from the illegal diversion and abuse of opioid drugs. We know this will not be an easy or quick process, but we feel it is paramount to do so if there is any way to end this crisis that is impacting so many individuals and families. We have retained experienced professionals who have already filed litigation in behalf of numerous counties and cities in West Virginia, Ohio, and Kentucky and other areas. In addition, we have been able to agree with our attorneys that there will be absolutely no expenditure of any taxpayer money for attorney fees or any expenses of the lawsuit.”
-
Yadkin County joins in civil litigation over opioid drug crisis
Nov 21, 2017 | The Yadkin Ripple (NC)
By Staff
Following closed session at its Monday night meeting, the Yadkin County Board of Commissioners voted unanimously to pass a resolution declaring the opioid crisis a public nuisance which must be abated for the benefit of Yadkin County and its residents and citizens. The commissioners also signed a contract with a large number of law firms throughout the southeastern United States to file civil litigation in the courts against the manufacturers and distributors of prescription opioid pain relievers.
“Our board of commissioners has decided to take action on behalf of our citizens to do all that we can to put an end to the opioid abuse that daily affects the lives of all of our residents,” said Commissioner Kevin Austin, chairman of the county board, in a press statement sent following Monday’s meeting. “We believe and have resolved as a board that it is critically necessary that we do all that is possible to abate the nuisance that we see increasing daily from the illegal diversion and abuse of opioid drugs.
“We know this will not be an easy or quick process, but we feel it is paramount to do so if there is any way to end this crisis that is impacting so many individuals and families. We have retained experienced professionals who have already filed litigation in behalf of numerous counties and cities in West Virginia, Ohio and Kentucky and other areas. In addition, we have been able to agree with our attorneys that there will be absolutely no expenditure of any taxpayer money for attorneys fees or any expenses of the lawsuit,” Austin added.
The board of commissioners found that the National Institute of Drug Abuse, a division of the National Institute of Health, reports that every day more than 90 Americans die after overdosing on opioids and found that the misuse of and addiction to opioids, including prescription pain relievers, heroin and synthetic opioids, are a serious national crisis that affects public health as well as social and economic welfare.
In addition, the board of commissioners found that they have the authority to abate or cause to be abated any public nuisance that interferes with the public health, safety, peace and convenience of their citizens. The board signed a contract to retain national law firms, Baron & Budd, PC from Dallas, Texas; McHugh Fuller Law Group from Hattiesburg, Mississippi; Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, PA from Pensacola, Florida; Hill, Peterson, Carper, Bee & Deitzler, PLLC from Charleston, West Virginia; Greene, Ketchum, Farrell, Bailey & Tweel, LLP from Huntington, West Virginia and local North Carolina law firms, Pinto, Coates, Kyre & Bowers, PLLC, Greensboro, North Carolina; Donald R. Vaughan and Associates, Greensboro, North Carolina; and Garry Whitaker Law, P.C., Winston-Salem, North Carolina.
-
W.Va. counties file suits against drugmakers
Nov 21, 2017 | Herald Mail Media
By Matthew Umstead
Federal lawsuits filed Friday on behalf of Berkeley and Jefferson counties in the Eastern Panhandle accuse several pharmaceutical drugmakers and distributors of fueling the region's opioid problem by illegally marketing and distributing the highly addictive substances.
The lawsuits, filed on behalf of the counties by attorney Stephen Skinner, contend that the drugmakers "knew that to expand their market and profits, they needed to change the perception of opioids to permit and encourage the use of opioids long term for widespread chronic conditions, like back pain, migraines and arthritis."
"The manufacturer defendants spent millions of dollars funding, assisting and encouraging doctors and front groups that would pioneer a new, far broader market for the potent and highly addictive opioids — the chronic pain market," according to the lawsuit.
The civil actions seek an unspecified amount of compensatory and punitive damages, as well as money for an "abatement" fund to address the opioid problem.
Among other claims, the lawsuit noted that the success of the drugmakers' marketing efforts resulted in 207 opioid-related overdoses in Berkeley and Jefferson counties between 2007 and 2012.
"In West Virginia, heroin-related overdose deaths (523) have been second only to oxycodone-related deaths (582) in the past three years," the lawsuit said.
The lawsuit contends that the defendants engaged in a campaign of deception that misrepresented the intended result of opioids, trivialized or obscured serious risks and adverse outcomes, overstated the drugs' superiority compared with other treatments, provided no limitation or oversight on the volume of prescription opioids available in a given community, and encouraged use of prescription opioids that didn't conform to the drugs’ authorized uses.
Regarding the claims against the distributors, the lawsuit contends that the diversion of opioid drugs into the counties was made possible by the "negligent and illegal actions" of the companies, including wholesale-drug distributors and sellers who bring prescription opioids into West Virginia.
Skinner said Friday in a news release that he will travel next week to St. Louis to represent the two counties in a pending application to the Judicial Panel on Multidistrict Litigation that, if approved, will consolidate hundreds of lawsuits by counties and municipalities filed against the drugmakers and distributors for the first part of the litigation.
Among those named in the lawsuit are Oxycontin manufacturer Purdue Pharma, Teva Pharmaceuticals, Janssen Pharmaceuticals, Endo Pharmaceuticals and Allergan.
Distributors named in the lawsuits, which alleged violation of federal and state law, include Amerisourcebergen, Cardinal Health and McKesson.
Skinner said in his announcement that lawsuits possibly are the first federal actions in West Virginia that name both distributors and manufacturers in a single action.
-
Detroit plans to sue drugmakers, distributors over opioid crisis
Nov 21, 2017 | Crains Detroit Business (MI)
By Chad Livengood
Detroit is gearing up to sue major pharmaceutical companies over their marketing tactics and sale of highly addictive opioid pain killers, following a litigation strategy being pursued by Oakland and Wayne counties and other major cities across the country.
The Detroit City Council on Tuesday approved hiring The Sam Bernstein Law Firm PLLC in Farmington Hills and the Detroit office of Weitz & Luxenberg P.C. to represent the city in forthcoming litigation against opioid manufacturers, distributors and retailers.
Last month, Wayne and Oakland counties became the first Michigan municipalities to file suit against a dozen drugmakers and distributors over how they market and sell opioids.
Attorney Mark Bernstein said his family law firm also is representing the city of Lansing as well as Delta, Saginaw and Grand Traverse counties in similar litigation against pharmaceutical companies and distributors of opioid prescription drugs.
Melvin "Butch" Hollowell, the city's corporation counsel, said he hopes to file Detroit's lawsuit by the end of the year.
Opioids include prescription drugs such as OxyContin and Fentanyl, as well as illegal drugs such as heroin. They're a highly addictive and sometimes lethal class of painkillers. Drugmakers have come under increased scrutiny as the opioid crisis has gained more public attention.
The proliferation of opioids has added costs to Detroit's public health services and emergency medical care and contributed to the deaths of an unknown number of Detroiters, Hollowell said.
Opioid-related deaths in Wayne County totaled 817 in 2016, up from 506 in 2015 — a 61 percent increase, according to Wayne County Executive Warren Evans' office.
By filing suit, Hollowell said, Detroit could become part of a possible settlement with drugmakers. There's no guarantee such a settlement will be reached, and getting there is likely to take years.
"I wanted to make sure that we were represented in this case as an independent party in light of the devastating damages that are being suffered in our community," Hollowell told Crain's.
Hollowell told City Council that Detroit "made a strategic error" by not becoming an individual plaintiff in the 1990s nationwide litigation against tobacco companies over the harmful effects of cigarettes.
Detroit repeated the mistake following the Great Recession by not joining state and local government lawsuits against banks and mortgage companies over "predatory lending" practices that preceded the housing foreclosure crisis, Hollowell said.
"There is no cost to the city of Detroit — it's all on contingency basis," Hollowell told council members.
-
Nov 21, 2017 | Echo Press (MN)
By Celeste Edenloff
Douglas County will be following suit with more than 60 other state, county and city governments around the country and suing opioid drug manufacturers and distributors.
"We have a crisis in our country," Chad Larson, Douglas County attorney, told the commissioners at the board meeting Tuesday morning. "Those drugs (opioids such as OxyContin, morphine, fentanyl) are marketed to physicians for pain management, but they were developed for end of life care."
Larson said the opioid epidemic has affected Douglas County. Citing numbers from the Centers for Disease Control and Prevention, he said Douglas County was No. 2 in the state for retail opioid prescriptions dispensed per 100 residents in 2016. Larson said that there were 91 opioid prescriptions for each 100 residents over the course of the year.
According to the CDC website, the highest county in the state is Wadena, which is at 145.6 prescriptions per 100 residents. Here are the rates in surrounding counties, according to the CDC:
• Grant: 47.2
• Stevens: 57.5
• Pope: 68.6
• Todd: 25.3
"This is ridiculous," said Larson. "These companies have to be held accountable."
Last year, there were 153 accidental opiate-related deaths in Minnesota, compared with 97 in 2015, Larson shared in a memo to the county commissioners and Carl Vaagenes, CEO of the Douglas County Hospital.
Government agencies within Douglas County, across Minnesota, and across the United States have implemented different strategies to address opioid use and misuse. These strategies include emergency responses by local law enforcement, such as the Douglas County Sheriff's efforts to distribute naloxone, also known as Narcan, that can be used to try to save overdose victims. There also are intervention and treatment programs; prevention; and public health efforts. An example of those efforts is the recent work of the state Medical Examiner's office in identifying carfentanil, a powerful opioid, as the cause of multiple overdose deaths.
Also in the memo, Larson explained that the opioid litigation has important similarities to the tobacco lawsuit by state attorneys general in the mid-1990s, "in that it seeks to hold manufacturers responsible for their misconduct related to opioid marketing and to hold distributors responsible for their misconduct related to improperly over supplying portions of the market."
He said unlike the tobacco litigation, however, any relief obtained would directly serve Douglas County and its residents.
"We, the county, need to have control," Larson said. "We need to have a say in the settlement, as I am anticipating a settlement."
Commissioner Jerry Rapp asked how the funds would be used. Larson replied that the idea is to steer reimbursements toward treatment for patients.
To date, as far as Larson knows, no lawsuits have been filed yet by any governmental entity in Minnesota, although several Minnesota counties and cities are currently considering such action.
Larson also explained that he will be seeking outside counsel to help in the litigation process and asked the board to approve using Lockridge Grindal Nauen, a law firm in Minneapolis.
He said Lockridge would pay all costs up front and they would get 25 percent of any settlement.
"We are not out anything by getting on board," Larson said. "It's a no-brainer."
In his memo, Larson said that on Oct. 30, the Hennepin County Attorney's Office coordinated a meeting with city attorneys from Minneapolis and St. Paul, along with county attorneys from Anoka, Carver, Dakota, Isanti, Mower, Olmsted, Otter Tail, Ramsey, St. Louis and Steele counties to hear presentations from four different law firms that specialize in this type of litigation.
On Nov. 8, Larson participated in a conference call with a number of county attorneys to discuss each of the law firms and Larson said he felt the team from Lockridge looked like the best team.
The next step, he said, is to prepare the complaint and file the lawsuit.
Larson will update the commissioners as the lawsuit progresses.
-
Saginaw County Joining Legal Action Battling Drug Problems
Nov 22, 2017 | WSGW (MI)
By Bill Hewitt
After nearly a half hour debate, Saginaw County commissioners voted Tuesday to join a federal lawsuit against the drug industry.
Commissioner Cheryl Hadsall says the growing drug problem is a big expense for Saginaw County, especially with jail inmates. A successful lawsuit would help the county cover the cost of treating drug addicts.
Commissioners supporting the lawsuit said drug companies encourage their sales representatives with big bonuses to push drugs with doctors and drug stores. The lawsuit includes several other Michigan counties and cities.
Commissioner Kathy Dawn voted against the lawsuit. She agrees there’s an opioid addiction problem, but some street drugs are made in clandestine labs and not controlled by the drug industry.
-
Opioid Insurance Litigation Is Mounting With Mixed Results
Nov 21, 2017 | Law360
By Scott Seaman
The opioid epidemic has been describe as “the deadliest drug crisis in American history. Overdoses, fueled by opioids, are the leading cause of death for Americans under 50 years old — killing roughly 64,000 people last year, more than guns or car accidents.”[1] Estimates place the costs of the epidemic in excess of $75 billion and growing.
Suits are pending across the country against manufacturers, distributors, pharmacies and others. With defendants looking to insurers to defend and indemnify them, the number of opioid coverage actions and decisions are mounting with mixed results depending upon a variety of factors, including: whether the issue being decided relates to defense or indemnity; the allegations and theories asserted in the underlying litigation; the policy language; and the court deciding the issue.
We are in the early stages of the opioid insurance coverage war. So far most decisions address three sets of issues: (1) accident/fortuity issues; (2) application of product exclusions; and (3) whether or not the claims involve damages “because of” or “for” “bodily injury.”
California Here We Come
The California Court of Appeal is the most recent court to rule against coverage for opioid addiction lawsuits. The court ruled in The Traveler’s Property Casualty Company of America v. Activis Inc., No. G053749 (Cal. Ct. App. Nov. 6, 2017) that a CGL insurer is not obligated to defend opioid-related lawsuits.
The Claims Alleged
Alleging that an “epidemic of addiction, overdosing, death, and other problems brought on by the increasing use and abuse of opioid painkillers” has placed a financial strain on state and local governments, the county of Santa Clara and the county of Orange brought a lawsuit against various pharmaceutical manufacturers and distributors. The California action alleges various pharmaceutical companies collectively referred to here as Activis or Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute and noncancer pain for which Watson allegedly knew its opioid products were not suited. The city of Chicago brought a similar lawsuit in Illinois. Both actions were brought in 2014 and the decision involved the most recent amended complaints in those actions.
The California action asserts causes of action for false advertising in violation of Business and Professions Code section 17500, unfair competition in violation of Business and Professional Code section 17200, and public nuisance under Civil Code section 3479. The counties sought injunctive relief, restitution and civil penalties and an order of abatement. The Chicago action asserted counts for consumer fraud — deceptive practices, consumer fraud — unfair practices, misrepresentation with sale or advertisement of merchandise, false statements to the city, false claims, conspiring to defraud by getting false or fraudulent claims paid or approved by the city, recovery of city costs of providing services, insurance fraud, civil conspiracy, and unjust enrichment. The complaint seeks injunctive relief, restitution, treble restitution, civil penalties, disgorgement of profits, treble damages and costs incurred by the city of Chicago.
Travelers denied Activis’ demand for a defense and brought this lawsuit to obtain a declaration that it has no duty to defend or indemnify. The trial court — after a bench trial based on stipulated facts conducted in March 2016 — found that Travelers had no duty to defend because the injuries alleged were not the result of an “accident” within the meaning of the primary CGL policies in effect from 2006 to 2010 and that the claims alleged fell within a policy exclusion for the insured’s products (and warranties and representations made about those products). The Court of Appeals in a decision certified for publication, affirmed, holding Travelers has no duty to defend the pharmaceutical companies under the policies.
It Ain’t No Accident
The existence of unexpected and unintended injury or damage is a central component of liability occurrence coverage whether stated in the definition of “accident” or “occurrence,” whether stated in an intentional acts exclusion, or whether embodied in the concept of fortuity. This is another recent coverage decision in which a court returned to this fundamental concept.
The Court of Appeals affirmed the trial court’s ruling that neither the California action nor the Chicago action create a potential for coverage for an “accident” because they are based, and can only be read as being based, on the deliberate and intentional conduct of Watson that produced injuries — including a resurgence in heroin use — that were neither unexpected nor unforeseen. According to the court:The injuries alleged by the California Complaint and the Chicago Complaint are: (1) a nation ‘awash in opioids’; (2) a nationwide opioid-induced ‘public health epidemic’; (3) a resurgence in heroin use; and (4) increased public health care costs imposed by long-term opioid use, abuse, and addiction, such as hospitalizations for opioid overdoses, drug treatment for individuals addicted to opioids and intensive care for infants born addicted to opioids.
None of those injuries was additional, unexpected, independent, or unforeseen. The complaints allege Watson knew that opioids were unsuited to treatment of chronic long-term, nonacute pain and knew that opioids were highly addictive and subject to abuse, yet engaged in a scheme of deception in order to increase sales of their opioid products. It is not unexpected or unforeseen that a massive marketing campaign to promote the use of opioids for purposes for which they are not suited would lead to a nation ‘awash in opioids.’ It is not unexpected or unforeseen that this marketing campaign would lead to increased opioid addiction and overdoses. Watson allegedly knew that opioids were highly addictive and prone to overdose, but trivialized or obscured those risks.
It also is not unexpected or unforeseen that promoting the use of opioids would lead to a resurgence in heroin use. The California Complaint alleged: ‘The pain-relieving properties of opium have been recognized for millennia. So has the magnitude of its potential abuse and addiction. Opioids, after all, are closely related to illegal drugs like opium and heroin.’ Both the California Complaint and the Chicago Complaint allege: ‘Defendants had access to scientific studies, detailed prescription data, and reports of adverse events, including reports of addiction, hospitalization, and deaths—all of which made clear the significant adverse outcomes from opioids and that patients were suffering from addiction, overdoses, and death in alarming numbers.’
Watson argues the alleged injuries are not the ‘normal consequences of the acts alleged’ and, for its opioid products to end up in the hands of abusers, it was necessary for doctors to prescribe the drugs to abusers. The test, however, is not whether the consequences are normal; the test is whether an additional, unexpected, independent, and unforeseen happening produced the consequences. The role of doctors in prescribing, or misprescribing, opioids is not an independent or unforeseen happening. The California Complaint and the Chicago Complaint allege: ‘Nor is Defendants’ causal role broken by the involvement of doctors, professionals with the training and responsibility to make individualized medical judgments for their patients. Defendants’ marketing efforts were ubiquitous and highly persuasive. Their deceptive messages tainted virtually every source doctors could rely on for information and prevented them from making informed treatment decisions.’Complaints In Other Actions Allege Facts Potentially Implicating The Duty To Defend
Other courts have concluded insurers have a duty to defend pharmaceutical companies in opioid-related lawsuits as Activis pointed out. However, the California Court of Appeals in Activis distinguished the underlying complaints in the matter before it from those in Liberty Mut. Fire Insurance Co. v. JM Smith Corp.[2] and Cincinnati Insurance Co. v. Richie Enterprises LLC,[3] where courts concluded the insurer had a duty to defend the pharmaceutical companies. According to the court, the allegations in the other lawsuits were appreciably different from those in the California complaint and the Chicago complaint inasmuch as they allege claims based on negligence and did not allege intentional harm. Secondarily, the court distinguished South Carolina law and Kentucky law that supplied the rule of decision in those cases from California law. It pointed out that, under South Carolina law a deliberate act is an accident if the resulting injury is unintentional. Under Kentucky law, a loss or harm is fortuitous/accidental if unintended by the insured. In contrast, under California law, a deliberate act is not an accident, even if the injury is unintentional, unless the injury was produced by an additional, unexpected, independent and unforeseen happening. Under California law “the term ‘accident’ does not apply where an intentional act resulted in unintended harm.”
It’s A Nuisance
The California Court of Appeals rejected Activis’ argument that its liability under the public nuisance cause of action of the California Complaint can be based on negligent conduct or omissions.A ‘nuisance’ is ‘[a]nything which is injurious to health’ (Civ. Code, § 3479), and a ‘public nuisance’ is ‘one which affects at the same time an entire community or neighborhood, or any considerable number of persons’ (id., § 3480). Both are remediable by civil suit or abatement. (Id., §§ 3491, 3493, 3494.) The public nuisance statutes do not require a finding that the nuisance was created or furthered by intentional acts. However, ‘it is not the form or title of a cause of action that determines the carrier’s duty to defend, but the potential liability suggested by the facts alleged or otherwise available to the insurer.’ [Citations Omitted.] The duty to defend is triggered by allegations on the face of the complaint and from extrinsic information available to the insurer and whether those allegations and facts create a potential for coverage under the terms of the policy. ... The facts alleged in the California Complaint and the Chicago Complaint suggest potential liability based only on Watson’s intentional conduct. But to the extent the complaints create a potential for liability against Watson based on unintentional conduct, the claims fall within the Products Exclusions.
The court’s reasoning with respect to the lack of an “accident” is sound and has broad application among general liability policies. It always is encouraging when courts pay attention to fundamental elements of insurance coverage in deciding coverage matters. Given the breadth of the duty to defend, courts sometimes strain to find allegations or imagine facts that simply were not asserted and this court properly refused to do so. It is difficult to determine the overall impact of this ruling because plaintiffs wanting to implicate insurer defense obligations often employ creativity and alternative pleading to assert negligence with respect to at least one count of a complaint.
Barred By Product Exclusions
Following the trial court’s lead, the Court of Appeal adopted a “belt and suspenders” approach ruling that the claims fall within the products exclusions of the policies. The subject policies contained product exclusions. As described by the court,The Products Exclusions exclude coverage for bodily injury “arising out of” (Travelers Policies) or that “results from” (St. Paul Policies) “[a]ny goods or products ... manufactured, sold, handled, distributed or disposed of by: [¶] ... [y]ou.” The Products Exclusions also exclude coverage for bodily injury that arises out of or results from “[w]arranties or representations made at any time, or that should have been made, with respect to the fitness, quality, durability, performance, handling, maintenance, operation, safety, or use of such goods or products.” Thus, the Products Exclusions bar coverage for bodily injury that arises out of or results from (1) goods or products manufactured, sold, handled, distributed, or disposed of by Watson and (2) warranties or representations made with respect to the fitness, quality, durability, performance, handling, maintenance, operation, safety, or use of those goods or products.
The trial court found the allegations of the California complaint and the Chicago complaint fell within the scope of the products exclusions because “[a]ll of the harm that is asserted in the lawsuits — narcotics addiction, the public nuisance in the California action and the public health costs, etc. highlighted in the Chicago [Action] — stem from [Activis’] products and what [Activis] said and did not say about the products.” In finding the exclusion bars coverage for both actions, the Court of Appeal stated:
The ‘bodily injury’ alleged by the California Complaint and the Chicago Complaint falls into two categories. The first category relates to use and abuse of opioid painkillers and includes injuries such as overdose, addiction, death, and long-term disability. The second category relates to use and abuse of heroin, the resurgence of which is alleged to have been triggered by use and misuse of opioids.
As the Court of Appeals recognized, the Eleventh Circuit, applying California law, held that products exclusions barred coverage for opioid addiction related claims in Travelers Property Casualty Co. of America v. Anda Inc.[4] It also referenced other public nuisance decisions such as the Florida Supreme Court’s decision in Taurus Holdings v. U.S. Fidelity,[5] which addressed whether CGL policies excluded coverage for lawsuits brought by municipalities against gun manufacturers to recover the costs of medical and other services incurred as a result of gun violence. The court held there was no coverage because the claims fell within exclusions for “‘bodily injury and property damage ... arising out of your product.’”
The ruling that there is no duty to defend because coverage is barred by the products exclusions is significant with respect to opioid claims against pharmaceutical manufacturers and distributors because many policies issued to such companies contain general products exclusions or exclusions for pharmaceutical products.
Public nuisance claims have taken on greater significance in recent years. For example, in the area of lead abatement, a billion dollar plus judgment against lead paint manufacturers was reversed in part and remanded last week by the California Court of Appeal.
Damages “Because Of” Or “For” “Bodily Injury”
The California Court of Appeals did not have occasion to address another common issue in opioid coverage litigation concerning whether insurance policy requirement of damages “because of bodily injury” or “for bodily injury” are satisfied. Compare Cincinnati Insurance Co. v. Richie Enterprises [6] (holding no obligation to defend suit against the opioid distributors seeking reimbursement for public expenditures due to the defendants’ distribution of drugs in excess of legitimate medical need as claims against distributors do not seek damages “because of bodily injury”) with Cincinnati Insurance Co. v. H.D. Smith[7] (holding insurer has a duty to defend West Virginia claim seeking to recover its healthcare expenditures as such expenditures were no different than a mother’s lawsuit to recover money spent to care for her injured son as both payments were “because of bodily injury”).
In Travelers Property Casualty Co. of America v. Anda Inc.[8] the district court concluded that the policies did not afford coverage because the state’s amended complaint in the West Virginia Action asserted claims “for” and “because of” economic harm to the state rather than “bodily injury.” The Eleventh Circuit declined to reach the question, stating “the better conclusion is that the ... policies do not afford coverage because of the policies’ Products Exclusions.”
Other Coverage Issues on the Horizon
Opioid coverage actions will present numerous other coverage issues as the types of claims and entities embroiled in opioid-related litigation expand. For starters, other issues may include: trigger; allocation, exhaustion and reallocation; coordination of coverage among different lines of coverage; intentional acts fortuity, occurrence, known loss and knowledge-based defenses; number of occurrences; claims made issues; compliance with policy conditions, including notice; applicability of product and various other exclusions; whether a particular matter constitutes a “suit” for duty to defend purposes; whether the particular relief sought constitutes “damages” for indemnity purposes; and whether the claim involves damages “because of” or “for” “bodily injury.”
These and other coverage defenses and issues are likely to be litigated vigorously in view of the high stakes and complexities presented. Sufficit to say, in many cases general liability insurance will not provide financial “pain relief” to pharmaceutical companies for their opioid-related liabilities.[1] “The Opioid Epidemic: A Crisis Years in the Making” New York Times (Oct. 26, 2017).
[2] 602 Fed.Appx. 115 (4th Cir. 2015).
[3] 2014 U.S.Dist Lexis 27306 (W.D. Ky. 2014).
[4] 658 Fed.Appx. 955 (11th. Cir. 2016).
[5] 913 So.2d 528 (Fla. 2005).
[6] 2014 WL 3513211 (W.D. Ky. July 16, 2014).
[7] 2016 WL 3909558 (7th Cir. July 19, 2016).
[8] 658 Fed.Appx. 955 (11th. Cir. 2016). -
Nov 21, 2017 | US FDA
By Scott Gottlieb, M.D.
As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.
Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.
Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.
These efforts also include the development of new tools for expediting the generic development of complex products. The same features that make drugs hard to manipulate and abuse also make these formulations more complex, and therefore harder to develop generic versions of. To provide a more efficient pathway for the generic entry of these and other complex formulations, the FDA is advancing new review policies. For example, the new guidance will now assist generic drug developers who meet with the agency to discuss scientific and regulatory issues before submitting their applications. These meetings will enable the FDA to clarify the agency’s expectations early in the development process with the goal of reducing the time it takes to obtain approval. We’ll be taking additional steps to facilitate the efficient entry of complex generic drugs in the near future.
Together, all of these efforts are aimed at creating a more robust path for applicants who plan to develop and seek approval of generic ADF opioids. Our goal is, when the use of any opioid drug product is appropriate, to make prescribing of these new formulations more commonplace. But let us be clear on one point. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose, or death. To address these issues, among other steps, we’re currently conducting a study to evaluate whether the nomenclature we use to describe these drugs, by labeling them “abuse deterrent,” is accurately conveying their benefits.
We also recognize that the science of abuse deterrence is relatively new. Both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. That’s why we’re also focusing our efforts on determining how effective the current abuse-deterrent products are in the real-world setting and better understanding the attitudes and beliefs of health care professionals and those who are prescribed these products.
Further, all of these steps shouldn’t be mistaken as an effort that will encourage more opioid use. Our goal is to decrease the rate of new addiction, and thus any unnecessary legitimate and especially illicit use of opioids. Rather, this is an effort designed to encourage the shift – only when opioids are clinically appropriate ‒ from existing, easily abused products to those that are harder to manipulate.
This final guidance is one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis. This effort must include treatments for those who are already addicted. That’s why we are also focusing new efforts on the development and promotion of medication-assisted treatments for addiction. As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
-
The NIH is seeking a way to objectively measure pain. Could it help solve the opioid crisis?
Nov 22, 2017 | USA TODAY
By Gregory Korte
Every year, millions of Americans will go to their doctors complaining of pain, and their doctors will ask them to rate their degree of discomfort on a zero-to-10 scale, or using a range of smiley-face symbols.
The doctor will have to take their word for it. And then, all too often, the doctor will prescribe a powerful and addictive opioid painkiller.
It's a longstanding — if imprecise and subjective — way of measuring and treating pain. And it's at least partly responsible for starting an opioid addiction crisis that killed 64,000 people last year.
"One of the things we heard from many physicians is that the pain-specific indicator contributed to this crisis," said White House Counselor Kellyanne Conway, President Trump's top adviser on the opioid crisis.
"We don’t think health care by emoji is good idea," she said.
So the Trump administration, which has declared the opioid crisis a public health emergency, is backing efforts to find better ways of measuring and treating pain in the hope of developing precise treatments that would be more effective than opioids — and without the often catastrophic side effects.
Next month, the National Institutes of Health will open proposals for $4 million in small business grants to develop a device or technology to objectively measure pain. That could take the form of a blood test, a device to measure pupil dilation, or software to interpret facial expressions.
NIH Director Francis Collins calls it the "pain-o-meter."
It's not entirely clear what the pain-o-meter would look like, or exactly how it would work. It hasn't been invented — yet.
But the pain-o-meter isn't meant to be the end game. It's actually the first step in understanding the measurable indicators — or "biomarkers" — that can indicate pain. And that, in turn, could pinpoint causes and treatments, bringing precision medicine to pain management.
"There is this issue about whether we'll ever really get where we want to go in terms of developing effective pain management if we just consider pain to be one thing," Collins told the National Advisory Council for Complementary and Integrative Health last month. "Because we know that it's not."
The current tools of measuring pain don't take into account individual pain thresholds, which can be influenced by genetics, past experiences and other conditions. They often don't distinguish different causes of pain, or different pain sensations.
To understand how a pain-o-meter could lead to advances in preventing opioid abuse, it's important to understand how the opioid crisis began two decades ago.
In 1995, the American Pain Society began to promote the idea that pain was "the fifth vital sign" — after temperature, pulse, respiration and blood pressure. Health care professionals were encouraged to actively monitor patients' pain. But unlike the other vital signs, pain could only be measured by asking.
Then in 1996, as more patients began to report pain, Purdue Pharmaceuticals introduced Oxycontin, a time-release formulation that it said could kill pain with the power of an opioid but less danger of addiction.
Twenty years later, the overuse of prescription painkillers has grown into a national epidemic of opioid addiction that now includes heroin and its deadly synthetic cousin, fentanyl. Various federal surveys suggest how how that evolution took place:
► About 38% of U.S. adults have taken a prescription painkiller in the past year.
► About half of people over 12 who misused prescription painkillers said they obtained the pills for free from a friend or a relative.
► An estimated 4% to 6% who misuse prescription opioids transition will transition to heroin, often because they no longer have access to prescription painkillers.
► About 80% of people who use heroin started out by misusing prescription opioids.
Conway says that's what's different about this epidemic: It often starts in a household medicine cabinet.
"Over-prescribing has been problematic, as has the default notion that pain management means pain medicine. That is not true of everyone," she said.Eliminating trial-and-error
The final report of President Trump's opioid commission identified a number of factors that contributed to the crisis. The pharmaceutical industry aggressively marketed opioids to doctors. Health insurance policies favor opioids over other painkillers and non-medicinal treatments like acupuncture. Hospital patient satisfaction ratings often higher when patients are prescribed opioids.
But also, they work.
Opioids are cheap. They act quickly. And they take a lot of the guesswork out of trying to diagnose and treat pain.
"We think of them as painkillers, but they don’t quote-unquote 'kill' all pain," said Dr. Sean Mackey, chief of pain medicine at the Stanford University Medical Center. "They often have a very short-term, immediate response that helps a large number of people."
Other pain treatments, he said, are the result of a "very long and time-consuming and frustrating trial of treatment after treatment."
"It’s literally trial and error," he said. "I'm pretty decent at it, and I bat about .400 in getting it right the first time. If you’re a baseball player and batting .400, you're making millions. If you’re a physician, you're not bragging about that."
With opioids, many doctors were batting 1.000.
Part of the problem, Mackey explains, is that doctors have no reliable way of predicting how any particular patient will respond to painkillers.
"Wouldn’t it be great if we had a way of determining who was going to run into problems with opioids?" he said. "That’s where this ties into the opioid epidemic."
Mackey sees the Trump administration's research into pain and addiction as a logical outgrowth of President Barack Obama's Precision Medicine Initiative — using the power of big data to help develop targeted treatments to diseases like cancer or Alzheimer’s.
But that pain data won't exist unless scientists find a way to effectively measure it.
"In the olden days, people use to think that things like pain were outside the scope of scientific inquiry. It was in your head. It was subjective. But pain is real, your brain changes, your body changes," said Dr. Dave Thomas, who manages NIH's pain and opioid research efforts.
"To conduct science, you have to have good measurements," he said. "If you were trying to study chemistry and try to determine reactions based on heat, would you stick your finger in the beaker to see how hot it was?"
But even as scientists work to develop the pain-o-meter, they've voiced concerns about how to use it ethically. Until the science of pain is better understood, it would be a mistake to assume that every patient's pain can be measured in the same way, they said.
"How do you know that a patient who comes to you saying he has severe pain asking for an opioid — how do you know he is not feigning?" said Dr. Nora Volkow, the director of NIH's National Institute on Drug Abuse. "That's one of the concerns that has been voiced by the public."
And indeed, that's one possible use of the pain-o-meter — and a potentially a promising tool in combating opioid abuse. But it's not what most excites pain researchers.
"I have had that argument, that it would be used for people who are claiming they're in pain for workman's comp, or try to get drugs. That's not my intent," said NIH's Thomas. "You could use a lie detector, come to think of it, and you’d have better precision than any pain-o-meter."
"I'm not a big fan of the pain-o-meter," said Mackey, whose research into pain has led to some of the biggest advancements in the technology. "The vast majority of my patients are not lying to me. They’re not trying to cheat to get opioids."
For years, Mackey has tried to tamp down expectations for objective pain measurement. He's still not ready to use his research to testify in court that someone is or isn't experiencing pain, for example.
"I want to put the appropriate cautionary messages out there, that this is going to take a lot of hard science to do this right," he said.
But now he says he's more optimistic than ever. "If you would have asked me in 2007, I would have said we wouldn’t be able to do this. I think 10 years from now, we’re going to have something really cool."
The opioid crisis is a top priority for NIH, but there's more urgency behind ways to better save the lives and treat people already addicted: opioid reversal agents (and auto-injectors that can sense when someone has overdosed), medication-assisted treatments for addiction, and longer-term addiction treatments.
"Those projects that can bring solutions right away are getting priority because we don’t have the luxury of time," said Volkow. On projects like the pain-o-meter, "We cannot put the same emphasis, even though they may be more transformative," she said.
-
Nov 21, 2017 | WXII (NBC)
By Greensboro, NC
Video Link: http://app.criticalmention.com/app/#/report/bb6103eb-deb3-4989-87f5-e152f3568359
Rough Transcript: yadkin county is taking a unique approach in the opioid 11:03 PMepidemic. the county is suing drug manufacturers and distributors for possibly violating state and federal laws for practices they -- for practicing what they say eventually created the opioid epidemic. the county manager said they're still working to figure out exactly how much the crisis has impacted yadkin county economically, like jail time and foster care. >> we have certainly seen our share of the impact of the opioid crisis. it has cost not only the county and the taxpayers a great deal, but it has tremendously impacted families and individuals here. nicole: the county says none of this lawsuit will be paid for with taxpayer dollars. meanwhile today, rockingham county officials talked about the opioid crisis and how to fight it. they feel their biggest issues include heroin and detox. one thing they want to use to help combat this issue, prescription drug drop boxes. >> we can get the drugs out of our medicine cabinets that we don't need that are incredibly addictive. they are like a magnet to people with addiction or young people looking to full around. nicole: those drop boxes are open 24 hours a day, seven days a week.
-
Nov 22, 2017 | WEAR (ABC)
By Mobile, AL
Video Link: http://app.criticalmention.com/app/#clip/view/30919619?token=13dcacfd-0e76-4354-9d5c-d957a447610a
Rough Transcript: placing blame for the opioid risis -- on big pharma... two northwest florida hospitals have joined the growing list of plaintiffs suing pharmaceutical companies, retailors, and distributors over the opioid epidemic. baptist hospital and jay hospital assert that the entire pharmaceutical production and distribution system -- has contributed to the high rate of opioid abuse in our local area. a recent state report found that the highest number of drug related deaths in northwest florida -- were related to the use of prescription pills. the hospitals claim they have been forced to treat a flood of patients who are addicted -- costing the healthcare facilities unknown millions of dollars. in the filing, defendants are accused of failing to ??responsibly manage opioid distribution. like many other plaintiffs -- the two local hospitals say big pharma has ??only been interested in profit. they are seeking injunctive relief, damages, penalties, restitution, or any other relief allowed by law. and they also want a trial by jury. this is the latest in a growing trend ??across the u-s. many plaintiffs are suing in much the same way -- hoping to hit big pharma where it hurts -- in the pocket book. they all believe it could help create change --- and curb the nationwide opioid problem.
Escambia County Hospitals
Yadkin County, NC
Other Litigation Coverage
Commentary and FYIs
Broadcast Media Coverage
Add recipients
Suggested