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

On July 31, 2012, the Missouri Supreme Court struck down a $350,000 cap on noneconomic damages (pain and suffering) in medical malpractice lawsuits.  The court held that the cap on damages violated a person’s constitutional right to trial by jury under the state constitution.  The complete text of the opinion can be found here.

Missouri now joins six other states that have held damage caps in medical malpractice actions unconstitutionally take a victim’s compensation of the hands of the jury.  Other states include Alabama, Georgia, Illinois, New Hampshire, Oregon and Washington.  California and six other states have challenges pending.  See an updated list here.

For more information, or if you or a loved one have been injured in California, please contact the experienced lawyers at Mulligan Law.  Our telephone number is 619-238-8700.

Tomorrow, the U.S. House of Representatives will vote on H.R. 5, the deceptively-named “Protecting Access to Healthcare Act” (The PATH Act).  Unfortunately, it will pass.

Should this bill become law, it would “protect” at-fault healthcare providers, drug companies and their insurers from responsibility, by drastically limiting the rights of patients injured by medical malpractice, unsafe drugs, medical devices and nursing home care.  Among other broad “reforms,” H.R. 5 would establish a permanent $250,000 cap on non-economic damages (e.g., pain and suffering) on all medical negligence cases.

As we know too well in California, such damage caps can do the most harm to patients who have been injured the worst – those that have been permanently and catastrophically injured by the culpable conduct of their healthcare provider.  These patients can be compensated for their suffering no more than significantly less injured patients.  And when the risk of a large judgment is removed, so is a strong motive for the provider to use due care.

The Center for Justice and Democracy has written a compelling letter to the House against the bill, outlining the damages cap issue and other flaws; it is available Here.

This article in the Huffington Post describes the bill’s discriminatory impact on women.

The full text of H.R. 5 can be found Here.

The bill’s many flaws were no doubt exacerbated by its rush to the floor without thorough vetting.  But given the political mechanics of the House, it appears that there are simply not enough votes to defeat H.R. 5.  Still, it must pass the Senate in some form, and a strong opposition in the House could deprive the bill of momentum, and convince lawmakers to think take a second look at the bill before casting an “Aye.”

The Obama Administration’s official Statement of Administration Policy on H.R. 5 – released earlier today –  indicates that the President’s “senior advisors” would recommend a veto, should the bill pass both houses of the legislature.  The Administration takes particular issue with the bill’s egregious damages caps.  From the Administration’s Statement:

[T]he Administration has serious concerns with key aspects of medical malpractice provisions included in H.R. 5. The goals of medical malpractice reform should be to provide fair and prompt compensation to patients who have been harmed by medical negligence, reduce preventable injuries, improve the quality of care, reduce defensive medicine, and lower medical liability premiums. However, H.R. 5 would establish inappropriate and harmful restrictions on health care lawsuits without effectively meeting these goals. Specifically, the Administration opposes placing artificial caps on malpractice awards which will prevent patients and other claimants who have been wrongfully harmed from receiving just compensation.

Hopefully, the fight over H.R. 5 will not come so close as to require a presidential veto.  While the above statement is promising, the President himself has not yet taken a position.  Call your legislator.  Let them know that the way to reform healthcare is not to harm those wrongfully and significantly injured by those to whom they entrusted their health.  The phone number for the Capitol Switchboard is 202-224-3121.

Update:  H.R. 5 did pass the House 223 to 181.

For more information, or if you or a loved one have been injured in California, please contact the experienced lawyers at Mulligan Law. Our telephone number is 619-238-8700.

“Never Do Harm” means doing nothing.  Strict adherence to this tenet of the Hippocratic Oath, taken by healthcare professionals upon their admission to practice, would hamper progress and stifle innovation that could save lives and ease the suffering of countless persons in need.  Medical tools and theory must be allowed to evolve.  But how can emerging, cutting-edge technology be safely introduced into practice?  This issue was the subject of the 2012 Patient Safety Conference held Thursday, February 16, 2012 at the University of California, San Diego School of Medicine.

Maximizing Benefits and Minimizing Risks

The title and focus of the conference was “Introducing New Technologies to Patient Care: The Promise and the Peril.”  Speaker Thomas Krummel, MD, of Stanford University, set the tone for the event by emphasizing that the modern, responsible approach to “Never Do Harm” is maximizing benefits while minimizing risks to the patient.  To this end, the seminar was flush with revolutionary medical technologies and methods, carrying the promise of maximal patient benefits… and the peril of catastrophic harms, if utilized incorrectly.

Robotic Surgery Continues to Progress

Frederic Moll, MD, co-founder of seminal robotic device innovator Intuitive Surgical, Inc. and now Hansen Medical, Inc. explained the accuracy and efficiency of new robotic surgery techniques.  A technique that continues to gain ground is the use of 3D preoperative imaging to allow surgical robots to “learn” the patient’s body before a procedure.  This allows the surgeon, who formerly had the benefit of physically touching the tissue he was working with, to sit at a remote video station and control a precise robotic surgical tool, without completely losing his sense of touch, or “haptic feedback” from the patient.

The Promises and Perils of Telemedicine

Attorney Janice Mulligan of Mulligan & Banham discussed the promises and perils of “telemedicine” with Lawrence Friedman, MD and Brett Meyer, MD of UCSD.  Telemedicine, or “therapy at a distance,” allows a physician or specialist in one area of the world to examine, or even perform procedures (via robot control) upon a patient in another.

The benefits of telemedicine are stunning – the best physicians become instantly available to the patients most in need, wherever they may be.  But proper physician adaptation to this new paradigm of care is essential. Legal concerns are also paramount. Mulligan cautioned that under existing law, a doctor from one state operating on a patient in another state without proper licensing can lead to criminal charges as well as unlimited civil liability and medical licensure censure. Change in states laws to facilitate telemedicine law across state and federal borders is necessary,but it is hampered by laws designed to preserve business for doctors in the states where patients are located.

Evolving EMR Standards

Joshua Lee, MD, of UCSD lectured about the rise in prevalence of Electronic Medical Records (EMR) and the need for vigilance in EMR standards to safely and ethically realize the possibilities of this exponentially expanding data cache.  Todd Pawlicki, PhD, also of UCSD, expressed pointed criticisms of the current state of electronic data platforms in medicine, urging hospitals to demand the same information-rich but user-friendly standard from their vendors that consumers demand of tech giant Apple, Inc.

Veteran Physicians: The New Novices

The common theme throughout the presentations on Thursday was that emerging technology and treatment techniques, with all of their hopes of “maximizing benefits” for patients, threaten to run afoul of the essential second half of the modern “Never Do Harm” tenet:  “minimizing patient risks.”  As cautioned by Dr. Moll, when you change the tools, you change the risk profile of a procedure. A poignant example was the personal experience of Santiago Horgan, MD (UCSD) with the treatment of achalasia.  Dr. Horgan has had to learn and re-learn how to perform surgical treatment for this disorder four times, in four different ways, over just two decades, due to evolving methodological standards.

The disconnect between the way physicians were taught to practice in medical school, and the procedures that are now demanded of them, is more pronounced now than ever before.  Experienced, “hands-on” surgeons are being told they should sit at a computer and control their scalpels with joysticks. Patients, the consumers of medicine, demand progressive laparoscopic and robotic techniques from their doctors, which are marketed to them as safer, cheaper, and with less cosmetic consequence.  But this change of tools has the practical effect of transforming veteran surgeons into novice students.  No matter how promising a new technology may be, in the hands of the inexperienced, it can be treacherous.

Lack of Opportunities to Train

Experience is everything.  The seminar’s consensus of the solution to realizing the maximal patient benefits promised by new technology, while minimizing the peril for patients, is a simple one:  PRACTICE.  And this practice is simply not available, nor ethically appropriate, “in the field” – i.e., by operating on patients.

Christopher Kane, MD, of UCSD, explained that in the case of robotic radical prostatectomies, for example, data shows that a surgeon does not reach proficiency until around his 300th procedure.  But the average urologist performs only about twelve of these procedures a year, and is “certified” after his second proctored procedure.  Given that lack of exposure, how can a surgeon become competent, much less proficient, even over an entire career?  And what is the use of emerging technology, if through lack of experience it causes more harm than existing techniques?

Prescription: Precise Simulation

Thankfully, the conference presented more than a diagnosis of the problem; but also a prescription for it.  UCSD, already the largest and most well-equipped teaching hospital in the region, has been busy building the solution.  The new, state of the art Simulation Training Center at the UCSD School of Medicine contains multiple mock-up patient rooms, operating rooms and training mannequins, and precisely the same equipment that trainees will use in the “real world” – from the latest multi-million dollar surgical robots down to fully functioning autoclaves (for sterilization of tools used on… dummies!  That’s thorough.)

Dr. Horgan, a world class physician and pioneer in laparoscopic procedures, robotic surgery, and emerging NOTES techniques (“scarless” surgery through natural orifices), has taken on an integral, hands-on role in the development of the Center and the execution of its goals.

The richness and authenticity of this training experience promises to take a novice to near proficiency before he or she need ever attempt the procedure on a living patient.  The Center is already in use and in high demand, not just by medical students, but by physicians and health care workers from UCSD and other area hospitals.

Don’t Be Your Doctor’s Dummy

For those of us in Southern California and surrounding areas, we are extremely fortunate that UCSD’s Simulation Training Center exists.  Patients take note: this training is available.  The better physicians, surgeons and nurses are taking advantage of it.  Demand the experience and demonstrated skill that simulated training provides from your health care provider – particularly if you are considering progressive surgical technologies or techniques.

For more information, or if you or a loved one have been injured in California, please contact the experienced lawyers at Mulligan Law.  Our telephone number is 619-238-8700.