Tag: lawsuit

Landmark Decision Holds Drug Maker Responsible In Opioid Crisis

An estimated 130+ people die every day from opioid-related drug overdoses, and now a landmark decision in Oklahoma is holding one drug maker responsible.

An Oklahoma judge has ruled that pharmaceutical company Johnson & Johnson deceptively marketed opioids, which helped fuel the state’s opioid crisis, a crisis that claimed the lives of more than 6,000 people, and must pay $572 million to the state.

The landmark decision, which was handed down by Judge Thad Balkman on Monday, is the first of its kind, in which a pharmaceutical company is being held directly responsible for one of the worst drug epidemics in American history.

“Defendants caused an opioid crisis that is evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome in Oklahoma,” Judge Balkman said in the ruling.

Johnson & Johnson immediately released a statement in which it was said that the company “plans to appeal the opioid judgment in Oklahoma.”

The case and the subsequent ruling have undoubtedly been closely watched by plaintiffs in other opioid lawsuits, of which there are currently more than 2,000 pending.

It is estimated that more than 130 people die every day in the United States from opioid-related drug overdoses.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

AMA Lawsuit Puts Doctors In the Middle of Abortion Debate

The American Medical Association is suing over two abortion-related laws, because they force physicians to lie to patients, “to commit an ethical violation.”

Julie Rovner, Kaiser Health News

The American Medical Association is suing North Dakota to block two abortion-related laws, the latest signal the doctors’ group is shifting to a more aggressive stance as the Trump administration and state conservatives ratchet up efforts to eliminate legal abortion.

The group, which represents all types of physicians, has tended to stay on the sidelines of many controversial political issues, and until recently has done so concerning abortion and contraception. Instead, it has focused on legislation that affects the practice and finances of large swaths of its membership.

But, said AMA President Patrice Harris in an interview, the organization felt it had to take a stand because new laws forced the small number of doctors who perform abortions to lie to patients, putting “physicians in a place where we are required by law to commit an ethical violation.”

One of the laws, set to take effect Aug. 1, requires physicians to tell patients that medication abortions — a procedure involving two drugs taken at different times — can be reversed. The AMA said that is “a patently false and unproven claim unsupported by scientific evidence.” North Dakota is one of several states to pass such a measure.

The AMA, along with the last remaining abortion clinic in the state, is also challenging an existing North Dakota law that requires doctors to tell pregnant women that an abortion terminates “the life of a whole, separate, unique, living human being.” The AMA said that law “unconstitutionally forces physicians to act as the mouthpiece of the state.”

It’s the second time this year the AMA has taken legal action on an abortion-related issue. In March, the group filed a lawsuit in Oregon in response to the Trump administration’s new rules for the federal family planning program. Those rules would, among other things, ban doctors and other health professionals from referring pregnant patients for abortions.

“The Administration is putting physicians in an untenable situation, prohibiting us from having open, frank conversations with our patients about all their health care options — a violation of patients’ rights under the [AMA] Code of Medical Ethics,” wrote then-AMA President Barbara McAneny.

It’s an unusually assertive stance for a group that has taken multiple positions on abortion-related issues over the years.

Mary Ziegler, a law professor at Florida State University who has written several books about abortion, said that the AMA’s history on abortion is complicated. In general, she said, the AMA “didn’t want to get into the [abortion] issue because of the political fallout and because historically there have been doctors in the AMA on both sides of the issue.”

In recent years, the AMA has taken mostly a back seat on abortion issues, even ones that directly addressed physician autonomy, leaving the policy lead to specialty groups like the American College of Obstetricians and Gynecologists, which has consistently defended doctors’ rights to practice medicine as they see fit when it comes to abortion issues.

Ziegler said it is not entirely clear why the AMA has suddenly become more outspoken on women’s reproductive issues. One reason could be that the organization’s membership is skewing younger and less conservative. Also, this year, for the first time, the AMA’s top elected officials are all women.

In its earliest days, the AMA led the fight to outlaw abortion in the late 1800s, as doctors wanted to assert their professionalism and clear the field of “untrained” practitioners like midwives.

Abortion was not an issue for the group in the first half of the 20th century. The AMA became best known for successful fights to fend off a national health insurance system.

Leading up to Roe v. Wade, the 1973 Supreme Court decision that legalized abortion nationwide, the AMA softened its opposition. In 1970, the AMA board called for abortion decisions to be between “a woman and her doctor.” But the organization declined to submit a friend-of-the-court brief to the high court during its consideration of Roe.

In 1997, the AMA, in a surprise move, endorsed a GOP-backed measure to ban what opponents called “partial-birth abortions,” a little-used procedure that anti-abortion forces likened to infanticide. A year later, however, an audit of the AMA’s leadership found its trustees had “blundered” in endorsing the bill and had contradicted long-standing AMA policy.

One reason the organization may be moving on the issue now could be the shifting parameters of the abortion debate itself. In 1997, the abortion procedure ban that the AMA endorsed “polled well and allowed abortion opponents to paint the other side as extremist,” Ziegler said.

Exactly the opposite is true today, she said, as states pass abortion bans more sweeping than those seen at any time since Roe v. Wade. Yet most public opinion polls show a majority of Americans want abortion to remain legal in many or most cases.

“As abortion opponents take more extreme positions, the AMA is probably a little more comfortable intervening” Ziegler added.

Molly Duane, a lawyer from the Center for Reproductive Rights who is arguing the case for the AMA and North Dakota’s sole remaining abortion clinic, said the laws being challenged are “something all doctors should be alarmed by. … This is an unprecedented act of invading the physician-patient relationship and forcing words into the mouths of physicians.”

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Oklahoma’s ‘Precedent-Setting’ Suit Puts Opioid Drugmakers On Trial

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Jackie Fortier, StateImpact Oklahoma

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical Industries of Jerusalem, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

Precedent-Setting Case

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

‘There’s Nothing Wrong with Producing Opioids”

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Federal Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths. “Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Looking For Treatment

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. The state is trying to win money from the drug companies to pay for treatment for people like Greg, who is afraid he’ll lose his job if we use his last name.

Greg and his wife, Judy, said they haven’t been able to find the integrated treatment that Greg needs for both his opioid addiction and his bipolar disorder. It’s either one or the other.

“They don’t give you … a treatment plan for both,” Judy said. “They just say ‘Here, you can talk to this person.’ They don’t recognize that it’s like self-medicating.”

The couple live in Guthrie, Okla., about an hour north of the courthouse where the opioid trial will take place. Greg said he has been addicted to opioids for 11 years. People with prescriptions sell him their pills — sometimes Greg binges and takes 400 milligrams of morphine at once, a huge dose.

Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis. Judy said she hopes the treatment center will eventually help Greg.

“I wish he would stop using [opioids], but I love him. I’ll always be here,” she said.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.