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

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Malpractice Killed Mom

What was supposed to be a routine procedure for a Texas mom instead became a tragic example of medical malpractice, according to reporting in Texas Monthly.

Kimberly Ray had been getting injections in the lower lumbar region for pain from an old injury. But the injections stopped working, so her provider recommended getting a rhizotomy. Ray never woke up from the procedure. Her family ordered an autopsy, which found she “died as a result of complications following an injection procedure for pain.”

The family then hired a lawyer whose investigation found red flag after red flag associated with Integrity Wellness, the clinic where Ray sought treatment, and the medical staff associated with it.

For one, the CRNA who administered anesthesia and performed the procedure wore a white coat and scrubs 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 her heart had stopped because the CRNA who gave her 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 tasked with monitoring Ray and failed to notice she had no pulse and wasn’t breathing, has his own questionable history, the investigation found — as did many of the other medical staff hired at the clinic.

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

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

Opioid Titan Avoided Major Payout

Despite having a robust multi-billion dollar case against it, an opioid maker only had to pay a fraction to the people harmed by its products, according to ProPublica.

Back in 2013, a whistleblower filed a lawsuit against the drug manufacturer Endo Health Solutions alerting the government to the company’s shady business practices. The lawsuit charged that the company’s marketing was “purposely designed to fraudulently manipulate prescribing physicians.”

For instance, in earlier years at the company, salespeople were incentivized to sell as much Percocet as possible with those making the most sales winning BMW corporate cars. The sales team had flashy tactics to demonstrate “unique” features of their flagship opioid, Opana ER, despite that these claims contradicted what the FDA had said about the drug. Endo also continued to supply opioids to doctors whom other businesses had blackballed for being reckless.

For a decade, the DOJ had a winning case with a wealth of evidence against Endo — yet it delayed in taking action. In that time, Endo manipulated its business structure and rearranged its debts to avoid accountability.

While Endo owed up to $7 billion, in the end it only had to shell out $200 million. Just $40 million was split between opioid victims, which is about $1,000 each (for reference, Purdue Pharma victims are set to receive anywhere between $3,500 to $48,000 each). Meanwhile, executives split $95 million in bonuses and lawyers raked in $350 million.

Landmark Trial Questioned

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

Ticagrelor is the only P2Y12 inhibitor still under patent and makes an outsized profit, despite relatively small market share. But the pivotal trial underpinning its use has been questioned for years. The PLATO clinical trial involved 18,624 patients in 43 countries and found that ticagrelor led to better outcomes than its competitor, the older drug clopidogrel (Plavix).

However, a subgroup analysis of only U.S. participants found that it actually did worse and had a 27% higher risk of death from vascular causes, myocardial infarction, or stroke — the primary endpoint. AstraZeneca explained this away citing “an unusually high aspirin dose seen almost exclusively in the U.S.,” which didn’t convince the FDA, who initially denied ticagrelor.

In most of the 43 countries, the sites were monitored by the sponsor itself. However, “In the four countries exclusively monitored by non-sponsor personnel — Georgia, Israel, Russia, and the U.S. — ticagrelor fared worse,” the article stated.

The trial was probed 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 raise the alarm about data integrity and other trials failed to replicate the results.