In 2012,  national news outlets broke a story about a malicious scam concerning counterfeit, implant hardware being used for spinal fusion surgeries in California hospitals. Pacific Hospital and Tri-City Hospital, both in the Long Beach area, were at the center of the allegations.

As of October 2014, lawsuits have reportedly been filed by over 30 former patients. Attorneys say thousands more patients may have been affected.

The allegations include an elaborate scheme involving bribes to doctors in exchange for referrals to these hospitals, and the manufacturing and use of non-FDA approved, counterfeit implant screws in the subsequent surgeries. Michael Drobot, the former owner of Pacific Hospital, is accused of personal involvement in the scheme.

The lawsuits maintain that the hospitals charged full price for the counterfeit screws, which were made at a fraction of the cost of FDA-approved hardware. The use of the allegedly inferior materials may have put the well-being of thousands of patients, in these southern California hospitals and elsewhere, at risk.

According to the state discharge data, there were 550 spinal fusions at Pacific and Tri-City alone in the last decade.

Click below to read more.

Wall Street Journal article:
http://online.wsj.com/articles/SB10001424052970204319004577088712149447348

Outpatient Surgery article:
http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/california-hospitals-docs-accused-of-lucrative-spine-surgery-scam–10-21-14?utm_source=news&utm_medium=email&utm_campaign=tji

This firm strongly supports the Pack Patient Safety Act, which will be on the November 2014 General Election Ballot.

The Act adjusts, for the first time in 39 years, the cap on damages in medical negligence cases. That cap, placed at the time of the initial legislation in 1975, was $250,000.00. It has stayed the same, without any adjustment for inflation, for nearly four decades. The cap is worth only $58,000.00 in today’s dollars.

The lack of any inflationary adjustment has had the impact of preventing people with very valid claims from pursuing justice.

The Act also requires, among other things, that doctors prescribing narcotics to a patient for the first time check a database to ensure that the patient is not doctor shopping.

You can read more about the Act here: https://www.facebook.com/38IsTooLate/timeline

Please join us in supporting patient safety and this very worthy legislation.

Patients considering robotic surgery are not getting the full picture of its risks, according to a new investigative report from Bloomberg (“Unreported Robot Surgery Injuries Open Questions for FDA“).  Many “adverse events” — when something goes wrong — are never reported to the FDA, due to a deeply flawed reporting system.

“While a U.S. database lists reports of deaths and injuries sent to the Food and Drug Administration, the agency has no authority to force doctors to contribute. And while hospitals are supposed to report, they often don’t, critics say.”

“Every link in the chain has a reason not to report,” according to a source.

But surely, the FDA requires robots made to perform surgery to pass some test of safety and efficacy at some time, right?  Wrong.  Many medical devices, including many surgical robots, are not required to pass FDA “pre-market approval” testing prior to being used on patients.  Instead, they are “grandfathered” into the market through a loophole in the pre-market approval process.  A loophole which purportedly exists because the FDA lacks the resources to conduct testing or review data on every new product.

When clinical data on safety and efficacy is not required before the marketing of a new device, and adverse events are under-reported afterward, how can the FDA, hospitals or doctors make an informed decision on whether to use them — much less patients?

Bloomberg cites a plan announced by the FDA in September 2012 to improve its monitoring of medical devices, including working toward automated reporting of adverse events.  But the reforms are not coming quick enough for many critics.

“[The ultimate goal] is years away and still won’t address the training and marketing issues that have been spotlighted by the Intuitive [da Vinci surgical robot]. The FDA doesn’t regulate doctor training on devices or most hospital device marketing.”

We’ve blogged about the importance of doctor training on surgical robots before (“CUTTING EDGE MEDICINE AT ITS FINEST – THE 2012 UCSD PATIENT SAFETY CONFERENCE“). Experienced surgeons continue to put down their scalpels for joysticks.  Thankfully, some hospitals recognize the need for thorough training. But don’t think that the FDA requires it, approves it, or monitors it.

The robotic revolution is a sea change in surgical medicine that holds a lot of promise, a lot of risk, and deserves our full attention.  Unfortunately, we are looking at an incomplete picture, painted by those with an incentive to keep it rosy.

The New York Times recently reported on a link between an increase in liver injuries over the past decade and the largely unregulated world of over-the-counter dietary supplements. According to this article, a shocking 70 percent of dietary supplement companies are not following basic quality control standards, in addition to other serious concerns.

Use caution when selecting and taking supplements. Herbal supplements in particular may appear more “natural” but can contain a highly concentrated amount of their active ingredient, at a level not found in nature. “[L]iver injuries attributed to herbal supplements are more likely to be severe and to result in liver transplants,” according to new research from the National Institutes of Health.

Seek guidance from your doctor on whether and what to take, and know your legal rights and limitations if something goes wrong.

Signature gathering has begun for a new ballot measure to adjust the California medical malpractice cap for inflation, provide drug testing for doctors, and require checking the CURES database, about a patient’s prescription history, before prescribing narcotics.

Raise the cap on medical malpractice damages