Pain Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

June 19, 2019

Is this any way to learn you’re dying — hearing MDs chat outside exam room?

Ron Naito already had been rebuffed by one specialist about the severity of his illness. He was awaiting in a doctor’s examining room for his lab test results and a consultation with a second expert about his already advanced cancer. What happened next stunned the Portland, Ore., resident. But now he’s doing something to help other patients in this way too common situation.

Naito overheard his doctor and a medical student talking about him and his lab results as they passed by the open room door, saying a tumor in his pancreas was “5 centimeters,” and was “very bad.”

That was the way Naito, who has practiced as an internist for 40 years, learned his condition was terminal. The cruel delivery of that crucial news convinced him that he needed to spend what time he has left working with his medical colleagues about their communication skills, especially in conveying the news to patients that they are dying.

June 16, 2019

For Insys, infamy in two opioid crisis firsts: convicted founder and bankruptcy

by Patrick A. Malone

Insys Therapeutics, a drug maker that peddled powerful and addictive painkillers in sordid ways, entered yet another phase of its penalties for its criminal conduct: The firm in quick fashion agreed first to pay $225 million to resolve federal bribery charges, then promptly sought bankruptcy protection.

Federal prosecutors, who earlier had won criminal racketeering convictions against the firm’s CEO and other Insys executives, emphasized that the Big Pharma firm hasn’t declared itself insolvent in its bankruptcy action and will pay up for damages caused by Susbsys, its chief product.

Subsys is a liquid containing the super potent painkiller fentanyl. It is administered as a drop under the tongue and was supposed to benefit cancer patients with grueling pain. Instead, Insys CEO John Kapoor “used speaker’s fees and lap dances to lure doctors into prescribing Subsys for far more patients than the drug was approved for and cheated insurers into covering prescriptions for the costly medication,” the Washington Post reported. Kapoor and other Insys execs await sentencing after their federal felony convictions.

May 28, 2019

Prescriptions for this painkiller abound. Evidence of its effectiveness doesn’t.

by Patrick A. Malone

Patients’ struggles with medical pain are a major problem. So, too, is the proclivity of Big Pharma, doctors, hospitals, insurers, and many others to respond to pain not only by pushing more prescription pills but also by overstating their benefits and downplaying their costs and potential harms.

As the nation grapples with an opioid painkiller crisis, New York Times columnist Jane E. Brody deserves credit for drilling down on gabapentin, “taken by millions of patients despite little or no evidence that it can relieve their pain.”

The drug won approval from the federal Food and Drug Administration a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” Brody wrote.

May 13, 2019

Wave of hip implant, opioid, talc suits tarnish a famed ‘family’ brand

by Patrick A. Malone

If consumers ever considered Johnson and Johnson just to be a family friendly health brand, the conglomerate’s legal challenges on three fronts—with problematic medical devices and drugs—may disabuse them of warm and fuzzy views.

As Bloomberg News Service reported, J&J will pay $1 billion to try to extricate itself from 95% of 6,000 lawsuits against it over defective metal-on-metal hip implants that not only caused patients great pain but also had to be surgically removed and replaced. The company still must resolve thousands of suits with patients who haven’t had replacement operations or whose implants were only partially metal.

J&J has battled over its Pinnacle implant from its DePuy unit for at least four years, losing sizable cases in Texas to patients who convinced judges and juries that the medical device maker had misled them about their artificial hips’ durability and risks, including assertions that it caused metal poisoning.

May 8, 2019

Big Pharma executives convicted of criminal racketeering with opioid sales

by Patrick A. Malone

Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular

Five top executives at a major drug maker have been convicted of criminal racketeering for their aggressive and deceptive marketing of a fentanyl spray in a case that prosecutors long have said may warn corporate leaders about their culpability in the nation’s opioid painkiller crisis.

Federal jurors deliberated for 15 days before finding guilty John Kapoor, founder and CEO of drug maker Insys (shown at right). Jurors also convicted Richard M. Simon, former Insys national director of sales; Sunrise Lee and Joseph A. Rowan, both former regional sales directors; and Michael J. Gurry, former vice president of managed markets. As the New York Times described the case against them:

April 30, 2019

Another front in war on opioids: Criminal charges for Big Pharma execs, MDs

by Patrick A. Malone

An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

April 22, 2019

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

by Patrick A. Malone

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.

The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.

The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.

April 11, 2019

FDA battles sketchy stem cell claims, while big hospitals jump into unproven treatments too

by Patrick A. Malone

When doctors and regulators crack down on the burgeoning and risky use of purported stem cell therapies, some well-known and respected big hospitals and health systems may have their own practices to explain, too.

As Liz Szabo reported for the nonpartisan Kaiser Health News Service:

Swedish Medical Center, the largest nonprofit health provider in the Seattle area … is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best …

March 5, 2019

For soaring drug costs and overdoses, officials offer blame and shame

by Patrick A. Malone

As tens of thousands of Americans die from overdoses and many millions struggle with skyrocketing prescription medication costs, lawmakers and regulators in the nation’s capital plodded along with procedural steps they claimed would help attack what voters insist are some of their top public policy priorities.

On Capitol Hill, seven of Big Pharma’s top executives danced and dodged with members of a U.S. Senate Committee about who is to blame for the relentless rise and unaffordable cost of American drugs. Media reports of the Senate Finance hearing called it “political theater,” and it offered lawmakers a chance to vent at execs from AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck, Pfizer, and Sanofi.

Sen. Ron Wyden, the senior Democrat on the committee from Oregon (shown above), blasted Big Pharma, telling the stone-faced corporate suits arrayed before him, “You’re willing to sit by and hose the American consumer while giving price breaks to consumers overseas,” the New York Times reported. He added that Big Pharma attempts to justify its prices, when so many patients cannot afford them, are “morally repugnant.” Sen. Bill Cassidy (R-La.) decried sky-high U.S. drug prices, especially compared with lower rates for patients elsewhere, saying, “It is almost as if the taxpayer has ‘stupid’ written on their face.”

February 26, 2019

Doctors, Big Pharma and FDA ripped for bungling control of potent painkillers

by Patrick A. Malone

A steady flow of news reports shows how our nation’s opioid crisis can be fairly blamed on just about every actor in the medical field that should have known better: Big Pharma, doctors, hospitals, and regulators. It’s been a toxic mix of incompetence, indifference and out-and-out deceptive conduct that produced the epidemic that now claims tens of thousands of American lives each year.

Take, for instance, the drug fentanyl, a lab-created painkiller 100 times more powerful than morphine. How did it escape the confines of legitimate prescription pain control to become a killer street drug? The Washington Post reports, based on research from Johns Hopkins experts, on how doctors, hospitals, and the federal Food and Drug Administration bungled a plan to safeguard the administration of this highly potent drug that had obvious abuse potential from the day it came onto the market.

Meantime, two other news organizations — the Pulitzer Prize-winning investigative website Pro Publica and the online health site Stat — have pried loose disturbing, sealed court testimony, showing how a wealthy, philanthropic family approved a lethal deceit about the potency of OxyContin, a billion-dollar opioid pushed relentlessly by Purdue, the Big Pharma firm they owned.