Malpractice Killed Mom; Opioid Giant Avoided Payout; Landmark Trial Questioned

This is a story from MedPage Today.

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting in health care each week.

Malpractice killed mom

What was supposed to be a routine procedure for a Texas mother became a tragic example of medical malpractice, according to an article in Texas Monthly.

Kimberly Ray had received injections in her lower lumbar region to relieve pain from an old injury. But the injections stopped working, so her provider recommended she have a rhizotomy. Ray never woke up from the procedure. Her family ordered an autopsy, which found that she “died from complications following a pain injection procedure.”

The family then hired an attorney whose investigation revealed red flags after red flags associated with Integrity Wellness, the clinic where Ray sought treatment, and the medical staff associated with it.

For one thing, the CRNA who administered the anesthesia and performed the procedure wore a white coat and lab coat and the family didn’t realize he wasn’t a doctor. A medical expert reviewed Ray’s case and said there was a “distinct possibility” that his heart stopped because the CRNA who gave him the anesthesia administered it in a way that caused “muscle paralysis that would prevent the recipient from breathing.”

The other CRNA in the room during the procedure, who was assigned to monitor Ray and failed to notice that she had no pulse and was not breathing, has a questionable history of his own, the investigation found — as do many other medical staffers hired at the clinic.

Not to mention the insane billing practices. At another clinic, Ray’s insurance was billed $2,000 per injection. But Integrity Wellness charged a whopping $139,000 for the same service.

Since this tragic case in 2021, Integrity Wellness has since been renamed Cedarwood Surgical Center.

Opioid Titan avoided major payout

Despite a strong multibillion-dollar case against him, an opioid maker had to pay only a fraction to people harmed by its products, according to ProPublica.

In 2013, a whistleblower filed a lawsuit against drugmaker Endo Health Solutions, alerting the government to the company’s questionable business practices. The lawsuit accused the company’s marketing of “being deliberately designed to fraudulently manipulate prescribing physicians.”

For example, in the company’s early years, salespeople were incentivized to sell as much Percocet as possible to those who had the most sales of BMW company cars. The sales team had flashy tactics to demonstrate the “unique” characteristics of their flagship opioid, Opana ER, despite the fact that these claims contradicted what the FDA had said about the drug. Endo also continued to supply opioids to doctors that other companies had excluded for their recklessness.

For a decade, the DOJ prevailed with a wealth of evidence against Endo – but it was slow to act. At that time, Endo manipulated its business structure and reorganized its debts to avoid accountability.

While Endo owed up to $7 billion, it ultimately only had to pay $200 million. Only $40 million was distributed among the opioid victims, or about $1,000 each (for reference, the Purdue Pharma victims are expected to receive between $3,500 and $48,000 each). Meanwhile, executives shared $95 million in bonuses and lawyers raked in $350 million.

A historic trial called into question

Fifteen years after a landmark trial of the antiplatelet drug ticagrelor (Brilinta), data integrity questions remain, according to an article in the BMJ.

Ticagrelor is the only P2Y12 inhibitor still under patent and it is making considerable profits, despite a relatively low market share. But the pivotal trial that underpins its use has been in question for years. The PLATO clinical trial involved 18,624 patients in 43 countries and found that ticagrelor produced better results than its competitor, the older drug clopidogrel (Plavix).

However, a subgroup analysis of only US participants found that outcomes were actually worse and the risk of death from vascular causes, myocardial infarction or stroke was 27% higher – the primary endpoint. AstraZeneca explained this by citing “an unusually high aspirin dose seen almost exclusively in the United States,” which did not convince the FDA, which initially denied ticagrelor.

In most of the 43 countries, the sites were monitored by the sponsor itself. However, “in the four countries monitored exclusively by unsponsored personnel—Georgia, Israel, Russia, and the United States—ticagrelor fares less well,” the article states.

The lawsuit was opened by the U.S. Department of Justice in 2013, but the investigation was dropped a year later. Researchers reviewed the trial data and continued to sound the alarm about the integrity of the data, while other trials failed to replicate the results.