Thousands of Artificial Knees and Hips Wear Out Prematurely

By Fred Schulte, KFF Health News

Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.

Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants.

Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.

RON IRBY

Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”

A KFF Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.

In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”

“I think they were cutting corners to improve their bottom line,” Irby told KFF Health News.

Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”

‘Trailblazing’ Implant

Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.

Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.

Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.

Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company.

Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.

Optetrak knee implant

Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”

Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.

“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.

“There was no disclosure or transparency.”

Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”

Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.

‘Popping Out Right and Left’

In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.

One knee implant gave out in just nine months, Moody told the group, according to the minutes.

In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.

Moody “probably had 50-something revisions. … They’re just popping out right and left,” the sales agent said, according to Farley’s suit.

Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.

Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.

The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.

Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.

Late Reporting to FDA

The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.

Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.

KFF Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.

FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.

In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.

The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.

The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.

Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.

Cutting Corners

In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.

Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities.”

Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.

His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.

Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.

In advertising directed at surgeons, Exactech boasts about the long life of its implants.

One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.

The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.

The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.

Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.

How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.

Consulting Fees

Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.

Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.

In promoting the Optetrak in sales materials, Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.

Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”

Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.

One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”

A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.

The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.

The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.

James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.

In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”

‘Dear Patient’

Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.

Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.

Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.

In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.

Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.

Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.

In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.

Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.

In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.

But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.

In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.

Total Recall

Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.

Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”

Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.

In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.

The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An FDA “safety communication” issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.

Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.

In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.

“So every case is different,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Lawsuits Accuse DEA of ‘Incompetence’ in Regulating Drug Supply

By Pat Anson, PNN Editor

Two federal lawsuits accuse the Drug Enforcement Administration of incompetence and heavy-handed regulation of the nation’s drug supply, which could worsen shortages of ADHD medication and drive a drug manufacturer and specialty pharmacy out of business.

At issue is the DEA’s enforcement of the Controlled Substances Act (CSA), a federal law that gives the agency broad authority to limit the production and sale of opioids, ADHD drugs and other controlled medications that have the potential for abuse. Under the CSA, the DEA decides who can write and dispense prescriptions for hundreds of controlled substances and the amount that drug makers can produce.   

“They shouldn't be playing God with people's medications. And really, that's what's happening here,” says attorney Jim Walden, who recently filed a lawsuit in the Second Circuit Court of Appeals on behalf of Ascent Pharmaceuticals, a leading producer of generic drugs used to treat attention deficit hyperactive disorder (ADHD), a condition that primarily affects children.

By its own estimate, Ascent produces about 20% of the nation’s supply of generic ADHD medication. In its 12-year history, Ascent had never been accused of a regulatory violation or faced any sanctions, so it was surprised to learn on September 29 that DEA would not renew its production quota for ADHD drugs because it has doubts about the company’s record keeping.

“After reviewing these records, DEA lacks confidence in the data provided by Ascent in its quota requests,” the agency said in its denial.

Ascent’s lawsuit disputes that claim, saying DEA investigators spent 18 months “bumbling about” its business records, without ever making clear what they were concerned about or why the quota was denied.

“The Quota Denial nowhere explains the basis for DEA’s alleged confidence gap. If that detail resides in the administrative complaint served alongside the Quota Denial, DEA should be embarrassed: the errors in it reveal a fundamental inaptitude with DEA’s own recordkeeping requirements,” the lawsuit alleges.

“This case highlights the perils of a hapless administrative agency, which (ironically) acknowledged the scarcity of ADHD medications on the very day it effectively sought to shutter Ascent, a company with a time-proven capability of quickly getting medicine to children in need. Ascent and patients have been victimized by DEA’s incompetence, having rendered an arbitrary, capricious, and unsubstantiated quota denial based on erroneous conclusions.”

Before going into private practice, Walden spent 10 years as a federal prosecutor, often handling DEA cases. He’s asking the federal appeals court to issue an emergency injunction that forces DEA to approve Ascent’s quota application.

“We're in the middle of a national scarcity crisis that is really putting children at risk. So it's very, very hard to understand what could possibly be motivating DEA, because they're obviously not alleging that there are quality control problems with the drugs or that there's a threat of diversion,” Walden told PNN. “So, by definition, their decision is arbitrary and it should be reversed.”

The DEA’s actions do seem puzzling. Shortages of ADHD drugs began in the early stages of the pandemic and have steadily worsened, as more children and adults sought mental health treatment. Yet in December of last year, when the DEA issued its quotas for 2023, the agency said there was no need to increase production because the supply of Adderall and other stimulants was sufficient to meet demand.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase.”

A few months later, DEA and FDA officials changed their tune. In an unusual joint letter,  FDA commissioner Dr. Robert Califf and DEA Administrator Anne Milgram admitted there was an ADHD shortage, blamed drug makers for not making enough medication, and washed their hands of the problem.

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

DEA production quotas may also be partially responsible for shortages of opioid pain medication. In recent years, the agency has aggressively cut the supply of many opioids, leading to current shortages of hydrocodone and oxycodone.     

Judge, Jury and Executioner

The second lawsuit against DEA involves Simfa Rose Pharmacy, a Pembroke Pines, Florida pharmacy that specializes in making drugs for seniors, palliative care, and cancer patients.

Simfa Rose came under scrutiny nearly three years ago when investigators saw it was filling an unusual number of high-dose, immediate release opioid prescriptions, often in combination with stimulants and muscle relaxants. Some of the prescriptions were paid for in cash.

As far the DEA is concerned, these were signs of “multiple red flags of abuse or diversion” that posed “an imminent danger” to public health. On May 2 of this year, DEA suspended the pharmacy’s license to dispense controlled substances, a move that severely impacts its ability to continue operating.

“It’s affected them greatly. It’s a miracle they are still open at this point,” says Vittorio Penza, a lawyer for Simfa Rose.

Under DEA rules, there is only one recourse for a pharmacy or doctor to challenge a license suspension – an appeal to a DEA Administrative Law Judge. Such appeals are not only time consuming; they are rarely granted. The few that are granted are referred back the DEA Administrator, who then has the final say on whether the license is restored or permanently revoked.

The Simfa Rose lawsuit alleges this is an “unconstitutional administrative process” that denies the pharmacy due process.

“It’s totally nuts what they are doing. You have a judge, jury and executioner system. It’s all in secret. They don’t publish anything until it’s a decision that’s favorable to them. You’re kept in the dark by it,” Penza told PNN. “All you have to do is take someone's license, whether they need it or not. You're still screwed and you're going to go down. Because once your reputation is tainted, you lose your customers and you lose the patients.”

Penza says the expert witness hired by DEA to review the pharmacy’s practices made outrageous claims.

“Their expert says you can't fill immediate release opioids more than two times. If you are a cancer patient or someone on their deathbed, it doesn't matter. It's an unresolvable red flag if you give someone an immediate release opioid,” he said. “And the kicker is he doesn't even look at what the patient's diagnosis is. One of the patients was shot was shot in the back, the bullet is still lodged in there. The other one was wounded overseas in the Gulf War.”

Perhaps the biggest challenge faced by someone seeking to reverse a DEA decision is that federal agencies have sovereign immunity – they can’t be sued for monetary damages. All they can do is challenge the DEA’s statutory authority under the Controlled Substances Act and its use of an in-house “kangaroo court” to keep pharmacies, doctors and drug makers in line.        

“I've come to realize that this is a nationwide issue. I've been getting calls ever since we filed from around the country. It pains me to hear some of these stories of doctors and nurses and pharmacists that have just been stripped of their livelihoods because of what the DEA is doing,” Penza said.  

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Judge Finds ‘No Evidence’ Pain Relievers Caused Opioid Crisis

By Pat Anson, PNN Editor

In a major victory for the pharmaceutical industry, a California judge has ruled that four opioid manufacturers did not use deceptive marketing to promote pain relievers and are not liable for the state’s opioid crisis.

Three California counties and the city of Oakland filed suit against Johnson & Johnson, Allergan, Endo and Teva Pharmaceuticals, claiming they used false and misleading marketing to increase sales of prescription opioids.

But in Monday’s ruling, Orange County Superior Court Judge Peter Wilson said there was no evidence that “medically appropriate prescriptions” fueled the opioid crisis.

"There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need," Judge Wilson wrote in a 41-page ruling. "Any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.''

Plaintiff law firms representing local governments across the nation have filed over 3,000 lawsuits against drug companies for their role in the opioid crisis. Several cases have already been settled out of court.

Los Angeles, Orange and Santa Clara counties and the city of Oakland wanted the four drug companies to pay over $50 billion in damages. The law firm of Motley Rice filed the initial lawsuit in 2014 on behalf of Santa Clara county, and the case snowballed from there into nationwide litigation against opioid makers, distributors and pharmacies. If successful, plaintiff law firms stand to make billions of dollars in contingency fees.

Judge Wilson’s tentative ruling – which only applies to the California case -- was the first big win for drug companies involved in opioid litigation. The plantiff law firms said they would appeal.

“The people of California will have their opportunity to pursue justice on appeal and ensure no opioid manufacturer can engage in reckless corporate practices that compromise public health in the state for their own profit,” the lawyers said in a statement.

Addiction Claims Debunked

Anti-opioid activists have long claimed that “overprescribing” of opioid medication fueled the U.S. drug abuse crisis, an argument that Wilson rejected. 

“Plaintiffs made no effort to distinguish between medically appropriate and medically inappropriate prescriptions. Mere proof of a rise in opioid prescriptions does not, without more, prove there was also a rise in medically inappropriate prescriptions,” Wilson said in his ruling.

Wilson also disputed claims made by Dr. Anna Lembke, a Stanford psychiatrist and board member of Physicians for Responsible Opioid Prescribing (PROP). As a paid expert witness testifying for the plaintiffs, Lembke said one in four patients prescribed opioids become addicted.

“As Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support it. The more reliable data would suggest less than 5%, rather than 25%. Under either number, addiction based solely on the patient having been prescribed opioids does not occur in ‘most of these patients,’” Wilson said.

Johnson & Johnson issued a statement calling Wilson’s ruling “well-reasoned.” It said the company’s “marketing and promotion of its important prescription pain medications were appropriate and responsible and did not cause any public nuisance.”

In 2019, an Oklahoma judge ruled J&J was liable for $465 million in damages for its marketing of opioids, a case that is still under appeal. The company recently proposed a nationwide settlement of $5 billion and agreed to stop making opioid medication. It voluntarily halted sales of prescription opioids last year.

(Update: On November 10, the Oklahoma Supreme Court overturned the ruling against J&J.)

Although opioid prescribing has fallen significantly over the past decade, overdoses have risen to record highs. The vast majority of drug deaths involve illicit fentanyl and other street drugs, not prescription opioids.      

The DEA recently issued a public safety alert warning of a surge in counterfeit pills made with illicit fentanyl. The agency has also proposed further cuts in the legal supply of prescription opioids in 2022.

Did Pacira Lie to Investors or a Federal Judge?

By Pat Anson, PNN Editor

The war of words between Pacira BioSciences and the American Society of Anesthesiologists (ASA) continues to escalate, with new allegations that the drug company either lied to its investors or a federal judge.

New Jersey-based Pacira filed a lawsuit in April over three articles in the ASA journal Anesthesiology that disparaged Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain. An editorial and two peer-reviewed research articles said Exparel worked no better than other bupivacaine products, even though it costs 100 times more.

Pacira filed a libel complaint against the ASA in federal court seeking a retraction and damages for “significant pecuniary harm.” The company said “multiple existing customers” had either stopped using Exparel or were considering it because of the journal articles.

If true, that would be a significant blow to Pacira, since Exparel accounted for 96% of the company’s revenues in 2020.

The ASA filed a motion last week asking a federal judge to dismiss the case, calling the lawsuit “an egregious and unjustified public relations campaign that seeks to chill scientific research and debate.”

‘Nothing to Worry About’

The ASA motion quotes a statement from a May 4 earnings call, in which Pacira CFO Charlie Reinhart told analysts that “we don’t have anything to worry about” and “actually things are going very, very well,” despite the negative reviews of Exparel in the medical journal.

In a preliminary report released last week, Pacira even boasted about sales of the drug. “Exparel sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales,” the company said in a statement that didn’t mention the lawsuit.

“In other words, Pacira is lying either to a federal judge or its investors,” the ASA said in a press release Monday.  

A Pacira spokesperson declined to respond to the ASA statement, telling PNN that “our corporate policy is not to comment on pending litigation.”

Exparel was first approved by the FDA in 2011 as a local anesthetic for post-operative pain in adults.  Its use has since been expanded to include children and as a nerve blocking agent.  Pacira says over 8 million patients have been treated with Exparel. The drug is primarily sold to hospitals and ambulatory surgical centers. One of the biggest purchasers is the U.S. Department of Defense.

In the past, Pacira has gone to great lengths to promote Exparel and silence critics.  In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. In 2020, Pacira agreed to pay $3.5 million to resolve allegations that it gave kickbacks to doctors to promote Exparel in research articles.

Legal Fight Brews Over Non-Opioid Pain Reliever

By Pat Anson, PNN Editor

Competition between drug companies can get so intense that some resort to bare knuckle tactics to preserve market share. Such is the case for Pacira BioSciences, which filed a lawsuit against the American Society of Anesthesiologists (ASA) last month for “false and misleading conclusions” about the effectiveness of Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain.

In February, the ASA published two research articles and an editorial in its journal Anesthesiology saying Exparel works no better than other bupivacaine products on the market. New Jersey-based Pacira considered that libelous, and filed a complaint in federal court seeking a retraction and damages for lost business.

Now comes word that Pacira’s attorneys withdrew their motion for a retraction after the ASA asked the court for a prompt hearing “to expose flaws in Pacira’s claims.”

“It is vitally important that we defend and stand behind these three works and the integrity and scholarship of those who contributed to them,” said Evan Kharasch, MD, editor-in-chief of Anesthesiology. “These authors are leading physicians and researchers in the fields of anesthesiology and clinical studies. Physicians and patients must have trusted information on which to base clinical decisions and care, and that information needs to be unaffected by commercial interests.”

It is not yet clear if Pacira will withdraw the rest of its libel case. “Our corporate policy is not to comment on pending litigation,” a spokesperson told PNN.

This is not the first time Pacira has used aggressive tactics to promote Exparel or fend off criticism. In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. The FDA said Pacira promoted Exparel for “surgical procedures other than those for which the drug has been shown safe and effective.”

Pacira won that case in an out-of-court settlement after the FDA backed down, withdrew its warning letter and changed Exparel’s label to say that it can be used for more types of post-operative pain.

In addition to doubts about Exparel’s effectiveness, some have questioned its cost. A 2015 STAT story pointed out that a vial of Exparel cost $285 and provided no better pain relief than a $3 vial of generic bupivacaine. 

In 2016, Pacira funded a report by an expert panel at the Jefferson College of Population Health that called for greater use of non-opioid medication for post-operative pain. One of the non-opioids recommended by the panel was Exparel. Pacira’s funding of the project was only noted at the end of the report.

In 2020, Pacira agreed to pay $3.5 million to resolve federal allegations that it gave kickbacks to doctors in the form of fake research grants that promoted Exparel.

Pacira has also been active politically, spending over $1.7 million on lobbying and campaign donations since 2018, according to OpenSecrets.org.

In 2019, Pacira hired former New Jersey Gov. Chris Christie as a consultant for $800,000 and lucrative stock options. The move was controversial, because Christie had just chaired President Trump’s opioid commission, which recommended that Medicare and Medicaid reimbursement policies be changed to encourage hospitals to use more non-opioid painkillers.

All this suggests that Pacira won’t back down easily from a fight. But it doesn’t sound like the ASA will either.

“Although Pacira started this lawsuit, ASA will not shy away from refuting Pacira’s claims and from exposing the important issues with Pacira’s controversial drug,” the ASA said in a news release.

Zynrelef Approved

Pacira is about to get more competition in the post-operative pain market. San Diego-based Heron Therapeutics says it has received FDA approval for Zynrelef, an extended-release analgesic for use by adults up to 72 hours after a bunionectomy, hernia repair and total knee replacement surgery.

Zynrelef combines bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. In clinical studies, the company says the synergy between the two drugs resulted in patients experiencing significantly less pain with less use of opioids compared to bupivacaine alone.

"The first three days after surgery are when patients experience the most severe postsurgical pain and are most likely to receive opioids to manage that pain. With the impressive reduction in pain and opioid use demonstrated by Zynrelef, we now have an important new option to help many patients achieve an opioid-free recovery," said Roy Soto, MD, an anesthesiologist at Beaumont Health System who consults with Heron. 

The company expects Zynrelef to be available by July. Patients are advised not to take the drug if they are allergic or have side effects from NSAIDs. The most common side effects of Zynrelef are constipation, vomiting and headache.

Hospira Recall

Pfizer’s Hospira division is voluntarily recalling a single lot of bupivacaine and a lot of lidocaine due to mislabeling that caused some of the vials to be incorrectly labeled as the other product. Both drugs are used to treat surgical pain. The mislabeling was identified after a customer complaint.

Hospira assessed the potential risk to patients if the mislabeled products were used to be “moderate to high severity.” If the mislabeled lidocaine was administered to a patient instead of bupivacaine, the patient may not get enough pain relief. If the bupivacaine was administered instead of lidocaine, the outcome could be even worse: an overdose of bupivacaine may occur, which could lead to seizures, respiratory problems, irregular heartbeat and cardiac arrest.

The recalled lots were distributed nationwide to wholesalers and hospitals in the United States, Puerto Rico and Guam from December 29, 2020 to April 15, 2021.

Hospira has not received reports of any adverse events associated with the mislabeling. The company did not respond to a request to explain how the mislabeling occurred or how it went undetected for nearly five months.

FTC Sues Drug Makers for Oxymorphone Monopoly

By Pat Anson, PNN Editor

It was in 2017 that Endo Pharmaceuticals – under pressure from the Food and Drug Administration -- stopped selling Opana ER, an extended-release version of the opioid painkiller oxymorphone. Opana had been reformulated by Endo to make it harder to abuse, but the FDA maintained the tablets were still being crushed, liquefied and then injected by illicit drug users.

Although Opana has been off the market for nearly four years, a legal battle still rages over sales of generic oxymorphone and whether Endo conspired with another drug maker to control the market for oxymorphone.

This week the Federal Trade Commission sued Endo, Impax Laboratories, and Impax’s owner, Amneal Pharmaceuticals, alleging that a 2017 agreement between Endo and Impax violated antitrust laws by eliminating competition for oxymorphone ER.

It’s the second time the FTC filed complaints against Endo, Impax and Amneal for allegedly creating an oxymorphone monopoly.

“The agreement between Endo and Impax has eliminated the incentive for competition, which drives affordable prices,” Gail Levine, Deputy Director of the FTC’s Bureau of Competition said in a statement. “By keeping competitors off the market, the agreement lets Impax continue to charge monopoly prices while Endo and Impax split the monopoly profits.”

According to the FTC complaint, Opana ER generated nearly $160 million in revenue for Endo in 2016 and was the company’s “highest-grossing branded pain management drug.” Endo explored bringing another oxymorphone drug on the market to replace its lost revenue, but ultimately decided to partner with Impax, which had the only extended-release oxymorphone drug on the market.. Their agreement allowed Endo to share in Impax’s oxymorphone profits, as long as Endo did not bring another generic tablet on the market.

“The purpose and effect of the 2017 Agreement is to ensure that Endo, the gatekeeper to competition in the oxymorphone ER market, has every incentive to preserve Impax’s monopoly. By doing so, it eliminates any potential for oxymorphone ER competition, allowing Endo and Impax to share in the monopoly profits. As a result, patients have been denied the benefits of competition, forcing them and other purchasers to pay millions of dollars a year more for this medication,” the FTC complaint alleges.

The 2017 agreement between Endo and Impax arose from a breach of contract case relating to a patent settlement between the companies over Impax’s generic version of Opana ER, in which Endo paid Impax more than $112 million not to compete. In 2019, the FTC ruled that settlement was an illegal "pay-to-delay" agreement.  

Both Endo and Amneal deny there was any effort to create a monopoly in their 2017 agreement.

“It is Endo’s position that the Agreement had no adverse impact on actual or potential competition.  At the time of the Agreement, the U.S. Food and Drug Administration had asked Endo to withdraw reformulated Opana ER from the market for safety reasons and Endo had publicly announced its intention to comply with the FDA’s request,” Matthew Maletta, Endo’s Executive Vice President and Chief Legal Officer, said in a statement to PNN.

“Significantly, as Endo has explained to the FTC, the Company has not launched or licensed any new opioid product(s) since that time, and the FTC’s theory that Endo would do so in the current litigation environment but for the Agreement is preposterous.”

“Far from being anticompetitive, the 2017 Amendment resolved a dispute between the parties that could have kept Impax's lower-priced generic product off the market entirely,” Amneal said in a statement. “We are confident there is no unlawful restraint in the 2017 Amendment, because nothing in the agreement prevents Endo from competing, and we intend to vigorously defend against the FTC’s claims.”

The FTC decision to sue Endo and Amneal a second time was approved on a split 3 to 2 vote by the agency’s commission. The complaint seeks monetary relief and a permanent injunction to prohibit the companies from engaging in similar conduct.

Extended-released oxymorphone is approved for the treatment of moderate to severe pain.  

Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

Lawyers May Not Expand Lawsuits Against Pharmacy Chains

By Pat Anson, Editor, PNN Editor

Lawyers involved in class action lawsuits that allege pain patients were discriminated against by three major pharmacy chains are being tight-lipped about whether the lawsuits may be expanded to include additional plaintiffs and pharmacies.

The lawsuits were filed earlier this month in California and Rhode Island against CVS, Walgreens and Costco on behalf of two women who say the pharmacies refused to fill their prescriptions for opioid pain medication.

At least six different law firms around the country are handling the cases. They’ve set up a website called Seeking Justice for Pain Patients, which invites other patients to participate in the lawsuits by sharing their personal information and experiences at pharmacies. It’s not yet clear how the information will be used or if the cases will be expanded.

“Pain patients have been contacting us in response to the lawsuits. The overall response has been very positive and happy that some action is being taken,” Robert Redfearn, a Louisiana attorney, said in an email to PNN. “Though there are no plans to do so at this time, additional individual named plaintiffs could possibly be added, but if a national class is certified, it should not be necessary.” 

Other lawyers involved in the lawsuits did not respond to requests for comment.

Redfearn represents Susan Smith, a 43-year old mother from Castro Valley, California who lives with severe chronic migraines. The only medications that give her relief from head pain are opioids. Smith says pharmacists at Walgreens and Costco refused to fill her opioid prescriptions and publicly shamed her.

“After being harassed by pharmacists [and] pharmacy staff for a number of years — being laughed at, being called names in front of my child — I really couldn’t take it anymore,” Smith told the San Francisco Examiner. “It has been really stressful, demoralizing, not to mention discriminating. On top of that, they were making it really hard for me to live a pain-free life.”

‘Find a New Pharmacy’

“There has to be a change,” says Edith Fuog, a 48-year old Tampa, Florida mother who filed the lawsuit against CVS. Fuog has lived for many years with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions.

“People need to understand what is happening. Everybody in their life is going to be a pain patient at one point or another, whether it’s an accident, becoming elderly, a disease or cancer. If this is happening to people who have chronic pain, the people who are just coming in with acute pain are never going to be treated.”

Fuog told PNN she had no trouble getting her opioid prescriptions filled at a CVS pharmacy until the CDC’s controversial opioid prescribing guideline was released in 2016.

“As soon as those guidelines came out, my life changed. The manager pulled me aside and said, ‘Look, I’m not going to be able to fill these anymore. I suggest you find a new pharmacy.’” said Fuog, who then went to other CVS pharmacies in the Tampa area and was repeatedly turned down.

“They all said, ‘We’ll be happy to fill all your other meds, but we will not fill the opioids.’ And I said, ‘I take 13 other medications. Why would I come here then?’”

EDITH FUOG

Fuog eventually found a small neighborhood pharmacy that was willing to fill all of her prescriptions. She also found a lawyer to file the class action lawsuit against CVS. If her case is successful, Fuog anticipates making only a few thousand dollars in damages.

“It’s not like I’m going to make a bunch of money. The decision could come down for a hundred million dollars, but that’s for the class and the attorneys. I’ll get a ‘rep fee” being the class rep. That’s it. I don’t get anything for my damages or the stress I go through, and the fact I have severe anxiety because of this,” she said.

Fuog says she will only settle out-of-court if CVS adopts a written public policy that makes clear to its pharmacists that they should fill all legitimate prescriptions for opioids.

“My goal in this is to make change that affects the most amount of people with chronic pain. If I can get them a lot of money, I’m going to do it. Why wouldn’t I? To me, these companies deserve to pay all these people money for what they’ve been through,” she said.

Costco, CVS and Walgreens did not respond to requests for comment.  CVS, Walgreens and other large pharmacy chains have been named in lawsuits alleging they helped fuel the opioid epidemic by selling millions of pills in small communities. They’ve also been fined hundreds of millions of dollars for violating federal rules for dispensing controlled substances.

Pharmacies Sued for Discrimination Against Pain Patients

By Pat Anson, PNN Editor

National class action lawsuits have been filed against three of the nation’s largest pharmacy chains for discriminating against pain patients trying to fill legitimate prescriptions for opioid medication. 

Class action complaints against Walgreens, Costco and CVS Pharmacy were filed in California and Rhode Island on behalf of two women seeking legal relief that will allow them to get their opioid prescriptions filled without delays or restrictions, and without the fear that their prescriptions will be denied. 

Edith Fuog, a 48-year old Florida woman and breast cancer survivor, lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions. Fuog’s lawsuit alleges that since 2017, CVS pharmacies have refused to fill her prescriptions for opioid medication in violation of the American with Disabilities Act (ADA), the Rehabilitation Act of 1973 and the anti-discrimination provisions of the Affordable Care Act.  Her complaint was filed in Rhode Island, where CVS has its corporate headquarters.

43-year old Susan Smith of Castro Valley, California, filed a similar class action against Walgreens and Costco in the Northern District of California. Smith suffers from Mesial Temporal Lobe Sclerosis, which resulted in scar tissue in her brain that causes severe chronic migraines. The only medication that gives Smith relief from headache pain are opioids.  She alleges that Walgreens and Costco pharmacies refused to fill her opioid prescriptions in violation of federal law.

"Many Americans are unaware of the difficulties chronic pain patients have getting pharmacies to fill their lawfully-obtained opioid prescriptions. It is not only a crisis for Edith and Susan, but for millions of Americans due to the backlash caused in part by the national publicity concerning opioid abuse,” said Scott Hirsch, a Florida lawyer who is one of several lead attorneys handling the cases.

“These lawsuits seek to allow the millions of chronic pain patients to obtain their legitimate opioid prescriptions without being discriminated against, harassed, denied, or embarrassed.  It will hopefully improve their quality of life and save many lives in the process."

Pain patients in the U.S. have complained for years about pharmacists refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and excuses, such as a pharmacy claiming it was out of stock of a particular medication. The California and Rhode Island cases are believed to be the first class action lawsuits to address the problem.

“I have always thought that this is one of the better potential legal avenues for an ADA action regarding prescription opioids.  It is a violation for any person with a disability to be denied service by a place of public accommodation, and pharmacies are clearly covered as places of public accommodation under the ADA,” said Kate Nicholson, a patient advocate and civil rights lawyer who handled discrimination cases at the Department of Justice for over 20 years.

“Whether this will succeed will depend on a lot of intangibles such as the quality of the complaints, what is learned during discovery about any nationwide policies the pharmacy chains had in place, or, alternatively, repeated instances of fills for legitimate prescriptions being denied. Also, whether the court which hears it considers the refusal to fill prescriptions tantamount to a denial of service. I think it’s promising.”

Corporate Policies Profile Patients

While pharmacies have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, the lawsuits allege that CVS, Walgreens and Costco adopted corporate policies that encourage their pharmacists to profile patients as drug abusers and impose limits on opioid medication. The companies did not respond to a request for comment.

Walgreens adopted a “secret checklist” in 2013 that required its pharmacies to watch for red flags such as patients paying for opioid prescriptions in cash, seeking an early refill or taking an “excessive” number of pills. If anything was suspicious, pharmacists were instructed to “inform the patient that it may take additional time to process the prescription.”  The policy was implemented after Walgreens was fined $80 million by the DEA for violating rules for dispensing controlled substances.

CVS adopted a policy in 2017 to limit the dose and supply of opioids for short-term, acute pain to seven days. For both acute and chronic pain, opioid prescriptions were not filled if they exceeded a 90mg MME daily dose. Customers enrolled in CVS’ pharmacy benefit plan were also required to try immediate release formulations, before using extended release opioids. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act.

In a recent letter to the CDC, the American Medical Association called the CVS and Walgreens policies "inappropriate" because they misapplied the CDC opioid guideline in ways that were harmful to patients. The AMA said it has received numerous complaints about Walgreens pharmacists refusing to fill prescriptions because of corporate policy.

Other big pharmacy chains have similar policies. Walmart has been accused of “blacklisting” doctors for writing high dose prescriptions. And a tearful video posted online by a California woman with stage 4 breast cancer went viral after a Rite Aid pharmacist refused to fill her prescription for Norco.

The law firms that filed the cases against Walgreens, Costco and CVS are seeking additional information from patients interested in joining the legal action at this website.

Can Pain Patients Sue the CDC?

By Carol Levy, PNN Columnist

Almost every report on the CDC opioid guideline that I’ve seen online gets this response from pain patients: “Class action lawsuit! Sue the CDC!” 

Many doctors cite the CDC’s opioid guideline when they stop writing prescriptions for opioids or reduce the amount they prescribe. Many of their patients say the tapering left them bedridden and unable to work because the pain returned to unbearable levels. Some even attempted or completed suicide as a result of no longer having the relief that opioids gave them.  

Is that enough grounds for a class action lawsuit against the CDC?  I am not an attorney, but I wondered if there is a basis for such a lawsuit.

Based on my research, the pain community does not meet the necessary legal criteria to do this.  

Aside from the difficulties of suing a federal agency, one of the many rule requirements in federal court to certify a class action lawsuit is this: “the class must show that the defendant acted in a way generally applicable to class members.” 

Few of us can point to the CDC guideline as the specific reason their doctor is no longer prescribing opioids at the same dose. It would need to be proven that all members of the class were treated in essentially the same way by the defendant CDC.

And it is doctors who changed their prescribing routines, not the CDC. Therefore, it appears we cannot form the requisite “class.” 

In addition, the CDC’s clarification of the guideline in June passed the buck by blaming individual practitioners for the guideline’s misuse:

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

So are there no actions we can take?

A recent decision by the New Hampshire Board of Medicine is one example of what happens when we do act. A patient reported his doctor to the board for refusing to continue prescribing opioids that had greatly helped his pain. As a result of the tapering, the patient’s pain became so unbearable he threatened suicide. At that point, the doctor refused to prescribe anymore opioids to the patient and dropped him. 

The board found that the doctor violated the ethical standards of professional conduct. He was fined, reprimanded, and ordered to take classes in pain management and record keeping.  

Another action is simply writing a letter, emailing or calling your federal and state representatives. Some of these people are working, intentionally or not, to hurt us.

The latest is a bill from Senator Joe Manchin of West Virginia and Sen. Mike Braun of Indiana. Neither have medical degrees, yet they have introduced a bill that instructs the FDA to tell doctors that opioids are "not intended for the treatment of chronic pain" except for cancer pain, end-of-life care or when no other pain treatment is effective.  

By telling our stories, by getting the authorities and legislators to understand what chronic pain is, and how it affects not only us but our families, community and the country, we can keep up the pressure. By submitting our complaints or filing lawsuits against individual doctors, we can be the voice of change. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

This column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Prominent Pain Doctor Faces Hundreds of Lawsuits

By Pat Anson, Editor

Imagine spending your retirement defending yourself against hundreds of lawsuits in courthouses around the country – all of them alleging that you played a key role in starting the opioid crisis and that you were indirectly responsible for thousands of overdose deaths.

“It is mind boggling to me and its frightening, actually. I don’t know how I’m going to defend myself,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Right now, we’re just trying to keep our head above the water.”

Webster has been named as a defendent in so many class action lawsuits – along with Purdue Pharma, Johnson & Johnson, Endo, Janssen and other opioid manufacturers – that he’s lost track. He knows of at least 80 lawsuits but believes there are many more.

“I think it could be several hundred,” he says.

The latest one was filed this week by Salt Lake County, Utah -- where Webster lives -- alleging that drug makers employed him in deceptive marketing practices that downplayed the risks of addiction and overdose. Like the other lawsuits by states, counties and cities, Salt Lake County seeks to recover taxpayer money spent on treating addiction, combating opioid abuse and policing opioid related crimes.    

DR. LYNN WEBSTER

“Utah’s opioid crisis stems directly from a callously deceptive marketing scheme that was spearheaded by certain opioid manufacturers and perpetuated by prominent doctors they bankrolled,” the lawsuit alleges.

“Dr. Webster’s advocacy of opioids was designed to create a veneer of impartiality. But Dr. Webster was a forceful proponent of the concept of ‘pseudoaddiction,’ the notion that addictive behaviors should be seen not as a warning, but as indicators of undertreated pain. The only way to differentiate between the two, Dr. Webster claims, was to increase a patient’s dose of opioids.”

Until he retired from clinical practice in 2010, Webster operated the Lifetree Pain Clinic in Salt Lake City. The lawsuit makes a point of mentioning that at least 20 of Webster’s patients died from overdoses and that he was investigated – but never charged with a crime -- by the DEA and the U.S. Senate Finance Committee.

“Most of what they have in there, at least about me, is false. And I think I can prove that,” Webster told PNN.

A footnote in the lawsuit contains the curious but important disclaimer that “Salt Lake County asserts no claim against Dr. Webster arising from his medical practice. The claims against Dr. Webster relate solely to his participation, as a KOL and otherwise, in Manufacturing Defendants deceptive marketing campaign.”

'Key Opinion Leader'

KOL is an acronym for “key opinion leader” – a euphemism for doctors alleged to be so influential that they helped convince other physicians to prescribe more opioids. Webster and three other pain doctors -- Russell Portenoy, Perry Fine and Scott Fishman -- are portrayed in the lawsuits as KOLs who greedily accepted millions of dollars in payments from drug makers in return for their promotion of opioids.

“It's mind boggling to think how four individuals can be accountable for essentially brainwashing all of the doctors in the country to do something intentionally to make pharmaceutical countries rich. How can anyone think that is plausible? It’s crazy,” says Webster. “Most of the pharmaceutical companies that they’ve listed I never received a dime from.”

According to the Salt Lake County lawsuit, Webster was “handsomely rewarded for his efforts,” receiving nearly $2 million from opioid manufacturers from 2009 to 2013. Webster says that dollar amount is unfair and misleading because most of it stems from his work as a researcher. He is currently Vice President of Scientific Affairs at PRA Health Sciences, a clinical research company.

“If you’re a principal investigator in a research program that has contracted with a pharmaceutical company, that money goes under your name. But its money to conduct a trial. Not a penny of it goes to me,” says Webster. “I have received compensation for consultant work and advisory boards. My consultant work is because of my area of expertise. That’s not unusual. And I do not speak for a company’s product. I do not benefit at all because I personally have no shares in any pharmaceutical company.”

Since retiring from clinical practice, Webster has become an outspoken critic of efforts by the government and insurance industry to limit opioid prescribing -- which he believes have gone too far and unfairly punish pain patients, while ignoring the larger issue of illicit fentanyl, heroin and other black market drugs.

He's written a book, called "The Painful Truth" and self-financed a PBS documentary by the same name.  Webster also comments frequently on PNN about opioid related issues.

With so many lawsuits hanging over him, Webster’s financial future is uncertain.  He says he and his fellow KOLs could be bankrupted by legal fees before any of the lawsuits come to trial.

“We don’t have any big pocket that’s going to pay for anything,” he said. “If a jury decided to award money from us, they wouldn’t get any money, because there is no money. We would be all bankrupt by the time we got to court.”

Drug makers, on the other hand, do have big pockets. And during the 1990’s many of the same law firms now involved in opioid litigation helped win big settlements with the tobacco industry worth upwards of $200 billion.  That includes the law firm of Hagens Berman, which is handling the Salt Lake County lawsuit. The firm also represents the city of Seattle in a nearly identical lawsuit against opioid makers, in which Webster is named as a KOL.

Webster is also named in a string of lawsuits filed by the law firm of Simmons Hanly Conroy, which represents dozens of states, counties and cities. Simmons will pocket one-third of the proceeds from any opioid settlement,  which could run into hundreds of billions of dollars.

Simmons is well connected politically, having donated $219,000 to the re-election campaign of Missouri Sen. Claire McCaskill (D), who coincidentally released a report in February that's highly critical of patient advocacy groups and medical associations for accepting money from opioid manufacturers.

It is against these political, financial and legal forces that Webster must find a way to defend himself.

“The body of the allegations are inaccurate, misleading and irresponsibly paint a picture which ignores the realities of Dr. Webster’s compassionate commitment to alleviating suffering in his chronic pain patients,” Peter Striba, Webster’s attorney, wrote in a letter to the Salt Lake Tribune. “It is estimated that there are approximately one-hundred million chronic pain patients in our Country, and it is very telling that their suffering and their medical condition is entirely absent in the narrative of the Complaint.” 

How the CDC Opioid Guidelines Affected Me

By Sarah Irvine, Guest Columnist

I'm 42 years old and have been suffering from chronic pain for the past several years. I was injured at work almost 8 years ago and, like many others, I have been affected by the CDC opioid guidelines.

I have herniated and bulging discs in my lower back, scoliosis and I ambulate with a cane. I have Protein C deficiency, a blood clotting disorder, and I am not a surgical candidate.

I live with excruciating pain and my pain medication, morphine sulfate, has been decreased from 150 mg daily to 45 mg daily. I also was recently prescribed Lyrica and baclofen, a muscle relaxer.

This does nothing to alleviate my pain. I'm becoming shorter, my spine is shaped like a serpent and my muscles are becoming more atrophied. Workers compensation refuses to pay for any more physical therapy and Medicare won't cover it either.

I'm certainly not able to pay out of pocket and at this point I'm in too much pain to function. Due to the Protein C deficiency, I should not take NSAIDs or steroids because they increase my risk of bleeding. I am also on a high dose of Coumadin for my blood disorder.

SARAH IRVINE

Things have gotten so bad because of the guidelines that my doctors are now telling me to take NSAIDs and are prescribing steroids; whereas before I was warned to avoid those medications and doctors refused to prescribe them for me.

I have never abused, misused, shared or sold my medications! It truly seems as though the CDC and DEA want to decrease the population of those who suffer from chronic pain by refusing patients adequate medical treatment and appropriate pain management.

I also believe that they hope those of us who are suffering will take our own lives, rather than try to endure the horrific chronic pain.

I'm on disability and no longer able to work because of my injury and the pain I endure. My quality of life has deteriorated to nothing. Some days all I can do is lay in bed. I can't even enjoy reading a book or watching a TV program without my pain interfering.

I do not understand why I and thousands of others in the same situation are being forced to suffer unnecessarily! We aren't criminals, drug dealers or addicts! We are victims of our pain!

Every aspect of my life is affected by my pain on a daily basis. I know I'm not alone. I only want to enjoy whatever is left of my life.

There are medications that would allow me and others to do so. Why are they being withheld from us? If we were animals, we would be treated more humanely than this.

I just want to know what I can do, who I can call, email or write to in order to get these abusive, inhumane laws changed. Also, is it possible to file a class action lawsuit against the DEA, CDC or both? Is there a class action lawsuit in place right now? If so, what can I do to get involved?

It's not about financial gain. This is about quality of life! What is happening right now is downright cruel, inhumane and criminal. I would be very appreciative if someone could lead me in the right direction so that I can do whatever is within my power, to get my life back and help others, before it's too late. I'm tired of being abused and victimized. I want my life back.

Sarah Irvine is from New York state.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Kratom Vendors File Lawsuit Against Feds

By Pat Anson, Editor

Four kava bar owners in South Florida – one of them a retired police officer – have filed a federal lawsuit against the U.S. Department of Justice over its threated ban on kratom.

Named as co-defendants are Attorney General Loretta Lynch and Chuck Rosenberg, the acting administrator of the Drug Enforcement Administration.

The lawsuit, first reported by New Times Broward Palm Beach , was filed by Michael Dombrowksi, who owns the Tenaga Kava bar in Palm Beach Gardens.  Dombrowski says his business relies on kratom tea sales and he risked losing a million dollars in revenue if the DEA carried out plans to list two of the active ingredients in kratom  as Schedule I controlled substances.

“Plaintiff business relies primarily on kratom tea sales, as do 9 other kava and tea lounges where consumers purchase and rely upon kratom tea for a variety of claims from medicinal value to relaxation,” the lawsuit states. 

“Defendant will lose all of his investment in the creation of his business in 2015 including the bulk of his law enforcement retirement and the loss of his livelihood which he planned for his happy retirement.”

Listed as co-plaintiffs in the lawsuit are James Scianno of the Purple Lotus Kava Bar in Boynton Beach and Keith Engelhardt and Thomas Harrison of Kavasutra in West Palm Beach. 

The lawsuit, filed in U.S. District Court in West Palm Beach, seeks an emergency injunction to prevent the scheduling of kratom, along with punitive damages of $14 million.

The lawsuit was filed on September 30, the same day the DEA could have made the sale and possession of kratom a felony by putting it in the same class of controlled substances as heroin, LSD and marijuana.. The agency delayed the scheduling after a backlash from kratom consumers and some members of Congress, who urged the DEA to seek public comment on its ruling.

The DEA claims kratom, which comes from the leaves of a tree in Southeast Asia, has a high potential for abuse because of its “psychoactive effects” and that imported kratom products are “routinely misdeclared and falsely labelled.”

Kratom is usually sold as dried or crushed leaves, powder, capsules, and tablets. Some kava bars, like the ones in Florida, brew kratom leaves with kava root to make a strong tea. In 2013, a lawsuit was filed against the owners of the Purple Lotus bar for not disclosing that the tea contained kratom. The plaintiff in that suit – a recovering alcoholic -- claimed she became addicted to kratom tea.

Kratom supporters say the herb is no more addictive than caffeine and helps treat symptoms of chronic pain, anxiety, depression and addiction.