Safe Patient Advocate

Helping injured patients.

12 Things to Ask When Your Doctor Wants Your Consent to Use a Medical Device

question 1Not every patient wants to be fully informed about his or her medical options. For the rest of us, the problem is sifting through the vast amounts of information available to focus on what’s truly significant. Worse, state laws often don’t require doctors to tell patients things that every patient would want to know. For this reason, patient safety advocates around the country are working to improve state laws to require better disclosures for patients. But in the meantime, one of the projects I’m working on (with the Patient Safety Action Network) is to come up with a list of questions patients can ask to help protect themselves, even when the law won’t protect them. You don’t need great laws if you ask the right questions. 

The list below is my own, not PSAN’s, and it’s developed from things I’ve learned in my legal practice representing patients injured by medical devices. In thinking about each of those cases, there are common issues that pop up: information that could have been delivered to my clients to give them a chance to avoid the devastating outcome that ultimately led them to my law office. So I’ve tried to put together a set of questions to ask any time a doctor proposes using a medical device on you or someone you love. These are the questions designed to force doctors to show you the red flags that could have saved my clients:

  1. Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
    •  Why? If a doctor knows their consent is being recorded, they will have more reason to more fully and fairly disclose the risks of the procedure. And you won’t have to rely on your memory or your notes when you try to learn more on your own.
  2. Has this device ever been subjected to human clinical trials? What information do you have about those trials? Were they sponsored by the manufacturer?
    • Why? The goal is to get the doctor to think about the true quality of the evidence the manufacturer’s sales reps have provided. Often, studies are simply sponsored by manufacturers, who cherry pick results. Or more often, there have never been human trials. Or there have been, but the quality is low because the trial was not prospective, randomized, double-blind, etc.
  3. Is the way you want to use the device “off-label”? Are there any warnings or contraindications on the device label?
    • Why? Doctors are not regulated by the FDA the way most of us think they are. Many believe they are free to ignore warnings and contraindications without even telling you.
  4. Do you have any written information about this device? What about materials that do not come from the manufacturer?
    • Why? One of the ways device manufacturers ease the burden on doctors is to provide the doctors with patient-facing materials. That way the doctors don’t have to go to the work of analyzing the product themselves. But this is obviously biased information.
  5. What has been your personal experience with the device?  Is there any sort of learning curve?  What is the worst outcome you know of that one of your patients has had with the device? What doctor, other than yourself, do you consider to be most experienced in using this device?
    • Why? The learning curve issue is real, particularly with devices used to perform surgeries. Doctors want to get over the learning curve, and they need willing patients to do that. But no law requires you to be the guinea pig. Find a doctor who has already made it through the learning curve, and let your doctor practice on someone else.
  6. Has the device ever been recalled?  Have you ever received a “Dear Doctor” letter related to the device? Have you checked with the hospital on these issues?
    • Why? Recalls are far more common than most patients know. Moreover, manufacturers often send out “Dear Doctor” letters to surgeons rather than doing recalls. The problem is, the surgeons don’t always get or pay attention to these letters. Your goal is to force the doctor to both ask and pay attention.
  7. What are the risks associated with this device, and do the benefits outweigh those risks? Why?
    • Why? Most doctors will do this in abbreviated form. The key is to ask follow up questions and have them give you specific information about each possible alternative. The doctor already knows what he or she wants to use. But if the choice is obvious, the doctor should be able to articulate why to you.
  8. What are the alternatives to using this device? How was this done before the device came on the market? Are there similar products from other manufacturers on the market? If so, why this specific device?
    • Why? New does not always mean better. Often, newer devices will offer benefits that, in the grand scheme of things, really don’t matter that much. Worse, they will sometimes also bring new risks that the more traditional procedures/older devices help you avoid.
  9. Do you expect to have any representatives from the manufacturer present during the procedure?  If so, why is that?
    • Why? This is another way to find out whether there is a learning curve. Often manufacturers have their sales reps present at surgeries when the doctor is new to the device. Or, they do it when the reps have a particularly strong relationship with the surgeon. That should also raise your eyebrows, because those relationships are often produced by small, repeated, favors, gifts, and sometimes even outright bribes. Sometimes the surgeon has a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. These relationships cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you.
  10. Have you ever received any gifts or financial benefits from the company that makes this device? What is the name of that company? 
    • Why? Same as last question. And be particularly thorough on this issue, because the ways companies pamper and pay doctors can be extraordinarily varied. Companies spend an enormous amount of money to make the doctors like them, and they do it for one reason: it works. Then, once you’ve gotten your answer from the doctor, check to see how candid he or she has been by searching for him or her on https://openpaymentsdata.cms.gov/
  11. Will you please record the procedure in which you use the device, and send the video to me?
    • Why? A doctor who knows he or she is being recorded will be more careful. Plain and simple. I think doctors should be required to offer recordings to patients. But until they do, we should all ask. A doctor who refuses this request needs to explain why.  (Imagine if your lawyer told you you were not allowed to watch opening statements or read deposition transcripts. Imagine if your contractor told you you could not be there while the work on your home was done.)
  12. What is the cost of this device and will insurance cover it?
    • Why? Most doctors do not think they are required to tell you this information if you don’t ask. But if you’ll end up paying thousands more, and there is little actual benefit, it pays to ask the question.

There is no doubt in my mind there are other questions to ask.  Probably better ones. But this is a good start, until the laws catch up. If you have ideas or concerns with this list, please feel free to contact me at: pmullenix@friedmanrubin.com

Who does juror bias favor in medical malpractice cases? Not the patient.

I stumbled today onto a great article from 2009 that tried to look empirically at the issue of whether jurors should be trusted to decide medical malpractice cases. The point of the article, published in Clinical Orthopaedics and Related Research, was to look at whether things like tort caps are really appropriate in medical malpractice.  The conclusion? The idea of runaway jurors punishing doctors because they don’t understand medical issues is a myth. Instead, jurors typically awarded the same as judges.  As the article puts it in the abstract:

Juries in medical malpractice trials are viewed as incompetent, antidoctor, irresponsible in awarding damages to patients, and casting a threatening shadow over the settlement process. Several decades of systematic empirical research yields little support for these claims. This article summarizes those findings. Doctors win about three cases of four that go to trial. Juries are skeptical about inflated claims. Jury verdicts on negligence are roughly similar to assessments made by medical experts and judges. Damage awards tend to correlate positively with the severity of injury. There are defensible reasons for large damage awards.

One of the most interesting parts to me concerned the issue of how juries decide cases that even doctors believe involve negligent care. One study discussed had independent doctors review closed insurance files.  Based on physician reviews of those files, patients should have won 67% of the cases. But they actually won only 21% of the cases that went to trial.  Juror Bias Graph

In other words, the idea that jurors are unfair to doctors in medical malpractice cases is wildly incorrect. Unfortunately, that’s also the idea that forms the central premise of our Congress’s current attempt to take away the right to a jury trial in medical malpractice cases.

Bravo to Tacoma for Joining Everett in Fight Against Opioid Makers

I think it’s the only way to make these companies pay attention: confront them with the *true* scope of the harm they caused.  The City of Everett, in my home-state of Washington, announced its intention to do so in January of this year.  Now Tacoma is also bringing suit. We should all be proud of the lawyers (David Ko for Tacoma, and the Kelley Goldfarb firm for Everett) and City decision-makers involved for having the courage to take these cases on.

My hope is that this is the wave of the future. Imagine how seriously drug companies will have to take these threats if these suits multiply. It’s always easy to blame the addict, but these Cities are trying to focus on the real problem: the drug dealer.

Hat tip to @ashleykgross of @KNKXfm for telling me (and her other twitter followers) about this great development.

Why did doctors in California block the law requiring them to disclose misconduct to patients?

probation

An editorial in the LA Times last Thursday needs you to read it. It explains the demise of a recent bill that would have required “physicians disciplined for serious violations to notify patients that they are on probation, and why.” The bill failed because it was “strongly opposed by the California Medical Assn.”

It’s difficult to imagine *any* legitimate reason for resisting such a disclosure rule.  And it’s difficult to imagine any other profession successfully blocking such a disclosure rule.  But we are all less safe when our doctors do not have to tell us they are on probation.

Hat tip to Rex Johnson of Washington Advocates for Patient Safety for passing this along.

Financial disclosure rules for researchers are awesome, and not enough.

research money

Since I started representing people injured by medical devices, one of the most useful tools I’ve found is the Open Payments website. Open Payments is a feature of Obamacare added by a Republican, Chuck Grassley. It requires drug and device companies to report their financial transactions and gifts to doctors and hospitals.

It’s pretty surprising stuff. Surgeons — who consider themselves completely independent — routinely have received multiple $200+ meals from companies that make the devices they use. Why would the companies spend that money unless they thought it was getting something? Knowing the amounts paid at least gives the patient a chance to research cheaper or more effective alternative treatments.

A new article from The Chronicle of Higher Education looks at a different type of disclosure rule: the rules set by universities regarding disclosures by researchers of industry payments. The point of the article is that disclosure is not enoughbecause the doctors with the conflicts are *still* given the opportunity to publish their opinions. Those opinions, unquestionably biased, thus still influence other doctors’ treatment decisions. The article shows the example of a set of treatment guidelines related to treating depression with drugs published in the journal CNS Spectrums.  The article is written almost exclusively by authors with money ties to the companies that make the drugs that are recommended in the guidelines.  Many of the drugs recommended have never been shown to perform better or safer than cheaper alternatives.

The article then focuses different ways doctors have been able to game the system to avoid the universities’ financial disclosure requirements. It is extremely well written and highly recommended. As always, the reminder to patients is to always ask questions of the doctor when treatment is recommended. Are there any other treatments I could consider?  Have you ever received money from any of these companies?  Is this an on-label or off-label use?  What are the side effects?  What could go wrong?  Have you ever done this before?

My take on the House’s newest (slightly less horrible) version of Medical Malpractice “reform.”

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A friend of mine on twitter asked me today what I think of the House republicans’ latest version of “fixing” medical malpractice litigation. I’ve been wanting to talk about these things for a while: the proposed fixes will do far more harm to patients than good for doctors. It will remove incentives to keep things safe, and it will needlessly eliminate valid, meritorious medical malpractice cases, without getting rid of the (already extremely few) frivolous ones. Here is my (lengthy) response.

The Broken Bones of Tube-Fed Kids: The Problem of Neocate

Neocate

Some kids have very little luck, and I recently met the moms of three such kids.  All three kids have “trach” (tracheostomy) tubes, and all three kids were sensitive to cow’s milk.  For that reason, shortly after birth, all three kids went on Nutricia’s “Neocate” formula as their primary source of nutrition.

The results were disastrous. Broken bone after broken bone.  Eventually, each kid was diagnosed with hypophosphatemia: an absence of the phosphate needed for strong bones. Another name for this problem is Rickets. Either way, it means extremely weak bones.  And it meant years of misery for each of these families. One child, aged three, suffered 30 broken bones. The damage is permanent.

The Neocate, from all that’s known, was the problem. The company that makes it, Nutricia, knew about the problem by October 2015 at the latest. But families depending on Neocate to feed their sensitive kids did not find out about the problem until much later. Nutricia now admits the problem.

In 2017, the journal Bone published an article signed off by 21 authors from places like Yale and the Mayo Clinic and Walter Reed.  Their conclusion is simple: 51 kids had otherwise unexplained “hypophosphatemia.” Most had complex illnesses and had been fed *solely* with Neocate. 94% of these kids had rickets. That means, as shown below, their bones were too weak to avoid breaking. Taking kids *off* Neocate strengthened their bones, though often permanent damage had already been done. The picture below is a before-and-after: on the left is a kid being fed by Neocate, and on the right is the same kid after he was taken off the Neocate.  The results are striking: the bones on the right look so much stronger.  The 21 authors all decided to “strongly recommend” careful monitoring for kids on Neocate.

rickets

There’s an easy fix: if your kid uses Neocate as his or her primary source of nutrition, make your doctor reads the study linked above.  There is no reason for your family to go through what the families that called me went through.

What 5 things does Consumer Reports say patients should ask before EVERY test, treatment, or procedure?

CU

Last night I got to see a presentation at the Mercer Island Public Library in Washington state. The presentation was jointly put on by an energetic group of patient safety advocates from Consumer Union, which is the “policy and mobilization arm” of Consumer Reports, and the Washington Advocates for Patient Safety.  The attendees were just regular people who responded to an email invitation from Consumer Reports because they wanted to know more about protecting themselves from preventable mistakes in the hospital context.

The best takeaway was the list of five questions we should all ask our doctors every time they propose to do something.  Those questions are above.  But there was a lot more. For example, we got a tutorial in the Consumer Reports Hospital Ratings, and learned six things we should know about every drug we take.  (I’ll put those up in a later post.)  The presentation was fantastic, and I recommend anyone who gets the chance to go to one do so.

Peter Mullenix

Medtronic Issues Two Recalls Related to Its “HeartWare” Ventricular Assist Device

Medtronic Mechanical Circulatory Support is recalling its HeartWare Ventricular Assist Device (HVAD), a device that helps the heart deliver blood to the rest of the body. Patients with end-state left ventricular heart failure or those waiting for a heart transplant are affected by the recall. The company discovered a loose power connector could cause the rear portion of the pump’s driveline to separate from the front portion. This could allow moisture to cause corrosion and electrical issues, affecting the speaker volume on the device. If the speaker volume is not working, the patient might not be able to hear warning signals coming from the device.

Medtronic is also recalling its “Splice Kit” for the HVAD. Medtronic says it discovered that a design flaw with the repair cable in the Splice Kit made the HVAD vulnerable to shutting down from wear-and-tear forces. If the device shuts down during use, this could cause blood to stop circulating throughout the body.

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– Daniel Keum

FDA Issues Class I Recall for Newport HT70 and HT70 Plus Ventilators

The FDA recently issued a Class I recall, the highest level of a recall, on the Newport HT70 and HT70 Plus ventilators. These devices provide breathing support for those who can’t breathe on their own. The company which owns the ventilators, Medtronic, is recalling the ventilators after they discovered a software glitch could shut down the device without warning. For those who require continual ventilator support, this is bad news. The ventilators could turn off without the user knowing, leading to severe health consequences afterwards. A software update from Medtronic to fix the issue is expected soon. In the meantime, users and caregivers of the recalled ventilators should be vigilant when using these devices and, if possible, have a way to monitor the device’s activity when away from the patient. If you are affected by this recall, you can call Medtronic’s Technical Support Department at 800-255-6774.

– Daniel Keum

My Take on the Recent JAMA Study about Sales Reps and Docs’ Prescription Decisions

reps

One of the great myths of medicine is that our physicians are uniquely resistant to attempts by drug and device sales reps to influence the doctors’ judgments on what treatments should be ordered. Doctors are, we are told, independent, objective, and looking out only for us. They see through the sales pitches and focus on the science, for our benefit.

A great story co-published by Pro-Publica and NPR Shots on a new study takes that myth apart.  The study in question concerns the effects that drug reps have on the prescribing behavior. In short, the more access the reps have to the doctors at a hospital, the more the doctors prescribe those reps’ name-brand drugs as opposed to generic drugs. As NPR puts it: “When teaching hospitals put pharmaceutical sales representatives on a shorter leash, their doctors tended to order fewer promoted brand-name drugs and used more generic versions instead[.]”

pills

This really shouldn’t be a surprise.  Doctors are humans, subject to the same cognitive biases, incentives, and influences as the rest of us. The device and drug companies know this, which is why they send their reps out in droves to try to create relationships with the doctors. But even so, many of the doctors don’t believe they have the same weaknesses as the rest of us.

The article particularly reminds me of an exchange from one of our medical device trials against the maker of the “da Vinci” robot, Intuitive Surgical. Part of our case was that our deceased client’s surgery should not have gone forward given the inexperience of the surgeon, but that an Intuitive sales rep had encouraged the surgeon to think he was qualified to handle the surgery.  We showed that Intuitive actually had quotas for each of the surgeons at the hospital: i.e., the sales reps were expected to make sure the surgeons did a certain number of “da Vinci” surgeries each quarter, and the reps’ pay was directly dependent on meeting that quota. At the trial, Intuitive hired a doctor to testify that reps could not have such influence over doctors.  My partner Rick Friedman cross-examined him, pointing out that Intuitive actually had a quota for that doctor.  Here is the exchange:

Lilly 1

The doctor believed restrictions on company access were “silly” and “insulting,” because “I make the decisions that are best for my patients.”  But if that were true, the JAMA study would have come out a different way. And if that were true, it’s very unlikely that drug and device companies would spent $7.33 Billion on goodies for doctors in 2015 alone.  The companies spend the money because it works, and that means patients are not receiving truly independent advice from their doctors.

If you’re curious about what drug and device companies are whispering in your doctor’s ear, it’s a great idea to go on the Open Payments website.  I don’t let any doctor do anything to me or my family until I’ve looked them up on that website.

Peter Mullenix

Get the Word Out: Recall on Mislabeled Drug Used to Treat Seizures in Kids

PhenoPhenobarbital is a drug used to treat seizures in kids with epilepsy. One supplier of the drug is recalling one lot of the pills it sells. The recall follows a complaint where one consumer found 30 mg pills in a bottle labeled as containing 15 mg pills. This raises an overdose risk, and the danger from any overdose is serious: “cardiogenic shock, renal failure, coma or death.”

So get the word out: if you know someone with a kid who suffers from seizures or epilepsy, please pass this story along.

Peter Mullenix

 

Does a surgeon have to tell you if she’s never performed this surgery before?

tylerThis is a topic I’ve been wanting to write about for a while.  Then, the other day, I learned I don’t have to, because my friend Tyler Goldberg-Hoss (an attorney who focuses on medical malpractice cases) already described the issue perfectly.  Check it out here.

The gist? Not unless you ask.  That’s not a hard-and-fast rule, and there may be cases where the doctor’s inexperience is so important that the failure to tell you about it is deemed malpractice.  But the cases to date in Washington have not come out the right way.

So … ask!  If you tell a doctor it matters to you, and they don’t tell you, no judge or jury in the world would let them off.

Peter Mullenix

 

Declassified Documents Tell Story of Intuitive Surgical’s Recklessness with da Vinci Instruments

Intuitive

 

Our firm has brought several cases against the maker of the da Vinci robot: Intuitive Surgical, Inc. The cases I have been most intimately involved in over the past two years are cases involving Intuitive’s recall of its electrified scissors due to “microcracks.”  The microcracks matter because they are found in the electrical insulation of the scissors, meaning electricity can come out of  the wrong part of the instrument during surgery without the doctor’s knowledge.  The result is that people go home from surgery with internal injuries that their doctors don’t know about, those injuries fester, and people get deadly infections with lifelong consequences.

Through the process of discovery, I have had the chance to see all of the internal warning signs that Intuitive ignored from 2009-2013, before it ultimately decided to recall its defective scissors. But until now, due to Intuitive’s legal maneuvers, I haven’t been able to share what I know even with other attorneys representing injured patients, let alone the injured patients themselves or the general public.  But that changed recently, when the judge in our case officially declassified most of one court document that sets out the most crucial facts related to what Intuitive knew and when.  And so now you can see those documents as well:  2017-03-13 066 Redacted Pl MPSJ Memorandum

If you have questions about these issues, please feel free to email me at safepatientadvocate@friedmanrubin.com

Peter Mullenix

FDA Issues Urgent Recall for Lifesaving Defibrillators Kept in Homes and Workplaces

Physio-Control Inc. recently recalled its LIFEPAK 1000 Defibrillator after the company discovered an electrical problem could stop the device from working. The FDA defined this recall as a ‘Class 1’ recall, making it the most serious level of a recall where use of the device can result in “injury or death.” Defibrillators are kept inside hospitals, shopping malls, offices—basically anywhere with lots of people— in the case someone, likely older, suffers from cardiac arrest and needs revival. When used, defibrillators revive someone’s heart by delivering it electric shocks. According to an FDA report, oxidation formation in the wiring of Physio Control’s defibrillator can cause the battery to malfunction and disable the device. If the defibrillator stopped working during an emergency, it would delay or prevent someone from getting electric shocks to their heart. Throughout this delay, blood is not pumping, which means vital organs such as the brain continue to remain oxygen-starved. During cardiac arrest, seconds matter, and the longer someone goes without a beating heart, the greater one’s chances are of organ damage and ultimately death. If you keep this defibrillator in your home or workplace, or depend on one to maintain your heart rhythm, this recall may affect you.

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Very Bad MedMal Law Part 2: Shrinking the Statute of Limitations

As I wrote earlier, your congress is currently considering a very bad bill, which would drastically remove patients’ ability to be compensated for injuries caused by medical negligence. The last post focused on the proposal to cap non-economic damages. Today’s post focuses on another bad aspect of the law that will lead to valid claims being thrown out of court (or never brought): the statute of limitations.

bill

Section 3 of the law is called “Encouraging Speedy Resolution of Claims.”  That sounds good, of course.  But what the bill does is bar claims that are not brought within “three years of the procedure.”  Most states already have rules of this nature, but they also have three exceptions that keep claims from being thrown out when it would be unfair to do so. The new bill acts to counter those protections as follows:

  1. The “discovery rule,” which preserves a claim when the patient did not have reason to know that the injury was because of negligence, as opposed to just a natural result of the surgery, or when the patient did not know that the symptoms she complains of were caused by the surgery as opposed to just naturally occurring.  The new law prevents all 50 states from having this protection. In fact, patients would no longer get the full three years: they would get only one year from the time they “should have discovered” the injury, which is capped at three years. So if they know they are injured after a procedure, but they do not find out they were injured because of negligence until one year has expired, they do not get to bring a claim at all.  No matter how reasonably they have acted.
  2. The “continuous treatment rule,” which preserves a claim for a patient who continues to see the doctor that injured her, so that doctor can try to fix the problem caused by negligence.  In that situation, the statute does not begin to run until the allegedly negligent doctor stops treating the condition in question.  The new law prevents all 50 states from having this protection. 
  3. The “minor tolling rule,” which preserves the claim of a child until the time the child turns 18. This protects against situations where parents fail to assert the rights of the child. It is particularly important in cases where young children are harmed in ways that require a lifetime of care.  If the parent does not sue in time, the child can never bring a claim, even though the costs of the injury will continue the child’s entire life.  That often results in Medicaid picking up the costs, which means money that should come from a medical malpractice insurance company instead comes from the taxpayers.  The bill removes this protection for children over 6 years old but lets states choose to preserve claims until the child turns 18. 

The bill also recognizes that some states already have more draconian time limitations, and explicitly lets those states keep those limitations.

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The first question is: why a federal law?  Each state currently has the right to balance these considerations carefully, in the ways their doctors, patients, and voters see fit. A uniform law is not needed.

The second question is: why do we want to do away with meritorious cases in these situations?  Why, when the patient did not know there was a claim, do we want to punish the patient?  Why, when the patient and the doctor are working together to minimize the damages and avoid a lawsuit, do we want to punish the patient?  Why do we want to punish kids who need a lifetime of treatment just because their parents did not realize there was a reason to sue?  Why shift that burden to the taxpayers rather than the doctors’ insurance companies, where it belongs?

And will this really work to limit claims?  Or will it just make patients bring lawsuits before they have had the chance to fully investigate the claims.

Regardless, you should tell your Congressperson how stupid you think this idea is.

Peter Mullenix

Your Congress is considering a very bad law.

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Your congress is currently considering House Bill 1215, which is a really terrible proposal related to medical malpractice cases. The most important things the law would do are these:

  • $250,000 cap on damages for lost enjoyment of life and physical pain;
  • Bar any claims that are not brought within 3 years of the procedure (including those for which the mechanism of injury was not discovered in the first three years);
  • Cap attorney fees at 15% of any amount recovered over $600,000;
  • Prevent doctors from being liable for negligently prescribing incorrect drugs and devices that have been allowed on the market by the FDA;
  • End laws that make all negligent defendants jointly liable for the total harm caused when the plaintiff is an innocent victim.

My first thoughts whenever I see proposals like this is: why doctors?  Why do doctors get special treatment by our laws in addition to exorbitant salaries? Why do for-profit doctors get to say they work at non-profit hospitals? If these laws make so much sense, why don’t we see them for accountants? Architects? Insurance brokers? Estate planners?  Financial advisers? Pilots? Truck Drivers? Engineers? Why would we want to remove incentives to act carefully from the people whose negligence can harm us most?

But those initial thoughts aside, each of these individual ideas is terrible. The problem is, none terrible idea in the abstract.  You have to look at how each would affect actual people to understand why it’s such a bad idea. To do that, I’m going to look at each of these issues one at a time over the next few weeks.  Today we’ll start with the first terrible idea: damages caps on “noneconomic damages”.

noneconom

Noneconomic damages include things like lost enjoyment of life from an injury: for a man who loved to fly fish but can no longer leave his home, there is compensation.  They also include physical pain: for a woman who deals with constant pain during urination because of damage to her urinary tract, there is compensation.  Discomfort is addressed by noneconomic damages: for those who can no longer sleep for more than an hour at a time because they cannot get comfortable, there is compensation.  And there is compensation for damaged relationships: when a husband and wife can no longer have sex because one is disabled, noneconomic damages address that.  When a spouse is no longer there for comfort or companionship, there is compensation.

Noneconomic damages are the realest form of damages, because they concern the things people actually experience.  They are the opposite of “economic” damages — things like lost wages and incurred treatment costs — which are simply counted up with invoices and lost pay checks.

The most important thing to remember about noneconomic damages are that they are what keeps us all equally valuable in the eyes of the law.  When only economic damages are considered, a blue collar worker’s life is simply not worth as much as a wealthy person’s life. A blue collar worker will not have the same wage loss as a wealthy person.  A blue collar worker won’t be able to afford the same high quality follow-up treatments as a wealthy person.  So their economic damages will never be as high.

But we all suffer in the same ways.  We all experience pain.  We all find joys in our lives, and we know the importance of those joys when they are taken away from us.  We know how it would feel if our husband or wife were suddenly taken away from us for no good reason.  Through non-economic damages we can tell our doctors (and bus drivers, and airplane pilots, and manufacturers) that each life is valuable. So they need to be careful even when no wealthy person’s life is at stake.

The proposed law would remove that incentive.

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Imagine a stay-at-home mother of three with an easily diagnosable, highly treatable form of cancer. Imagine the cancer is missed because a for-profit hospital constantly overworked its doctors.  Instead of an easy surgery to remove the cancer, she spends the next ten years getting slowly worse.  Though she used to exercise frequently, she can’t anymore.  She rarely sleeps through the night, which puts pressure on her relationships with her family.  She can’t do what she used to do at the home.  Her children become her caretakers, which humiliates her and makes her feel worthless. The pain slowly grows until it is constant.  She realizes her body won’t sustain her for long.  She looks for a lawyer to take her case. She wants to stop this from happening to others.  She wants to provide for her family.  She wants compensation for what she, and her husband, and her children, have lost.

With the new law in effect, the lawyer now has to look at a case like this differently. The cancer causation expert will run at least $50,000. Another expert will be needed to show the hospital screwed up with its policies. Another $50,000. A third expert to show the cancer should have been caught. Another $50,000.  Court reporters, deposition trips, paying to depose the hospital’s experts will all add to the total.  The lawyer estimates the cost will be at least $300,000 if the case goes to trial.  That doesn’t factor in his normal overhead: leased office space, legal research, staff.  The woman’s total medical bills are $500,000 to date, with little more to come. But the insurance company had a deal with the hospital so it only paid 250,000, even though the woman was billed all $500,000.  She has no provable lost wages, so that means her “economic” damages are just $250,000.

In other words, she’s got a case worth $500,000 total: $250,000 economic and $250,000 noneconomic.  Let’s say the lawyer takes the case on a 40% fee. Even assuming it’s a guaranteed win, it’ll take an incredible amount of his time and effort.  And his best case scenario is the $500,000 win, which will let him repay the $300,000 in costs advanced and take the $200,000 as the 40% fee. But the woman and her family will not see a dime in that situation. And regardless, the lawyer knows he could make more on other non-medical cases, with much less risk.  So the case does not go forward.

So let’s say the lawyer cuts his fee and takes only 20% ($100,000).  That would mean sinking $300,000 into a case that he can only hope to make $100,000 in profit on. That won’t keep the lights on. Even if he wins half of the cases like this, it’s a losing proposition.  And the $100,000 the woman actually takes home is nowhere near what would be just compensation for the pain, suffering, discomfort, and fear.  It’s nowhere near just compensation for her children losing a mom, her husband losing a wife.

In other words, capping the noneconomic damages means good cases won’t be brought.  And that means bad behaviors won’t get caught.

So tell your congress person how stupid you think this idea is.

Peter Mullenix

Under 50 colon cancer rates are increasing while over 50 are decreasing, and we don’t know why.

chartThere is a fantastic story from our local public radio station (KNKX.org) about a confounding trend in the rates of colon cancer for young people vs. those over 50. As the story explains: “Cancer incidence is creeping up by 1 or 2 cases per 100,000 people under 50. By way of comparison, the disease rate among older Americans has plummeted by more than 100 cases per 100,000 people.”

According to the story, which analyzes a very recent study out of the Journal of the National Cancer Institute, the epidemiologists looking at the issue don’t have a satisfactory answer for why the rate is dropping in the over 50 but increasing in the under 50.

The real fear is that the failure to see the rate decrease in those currently under 50 may mean we see significantly increased rates of cancer in that age group once they reach the age of 50.  As the story puts it: “the under-50s will eventually grow older. What will happen to their risk then?”

The recommendation is the thing none of us want to do: get screened via colonoscopy once we reach 50 (the recommended age).

-Peter Mullenix

Over 3,600 Shoulder Replacement Devices Recalled

Zimmer Biomet is recalling its “Comprehensive Reverse Shoulder” hardware, which is used in shoulder replacements.  According to the FDA, the shoulder pieces are “cracking” at an abnormally high rate.  The hardware looks like this and applies to units made between August 25, 2008 to September 27, 2011.  This means many of these units are currently helping to move human arms, and that many of those people are now looking at an extra surgery.  The units look like this:

Zimmer

One of my pet peeves, since I’ve started tracking recalls, is that manufacturing firms — even though they act as though they are trying to limit harm — make no mention of the recall on the front of their web pages.  For instance, Zimmer’s webpage has a section called “The latest news @ZimmerBiomet.”  But that section does not mention this news, even the FDA has determined that continued use of this shoulder equipment “may cause serious injuries or death.”  See below. (No mention on Zimmer’s twitter feed either.)

zimmer 3

Peter Mullenix

 

What is “QI Privilege,” and why does it make people injured in hospitals want to tear their hair out?

qualityImagine your lawyer failed to get you a necessary expert, and your case got thrown out of court.  You’re horribly injured, but now you have no way to recover.  This same lawyer had told you your case had a multimillion dollar settlement value.  That lawyer is quickly fired by his law firm — but none of that matters anymore, because you’re out of luck.

In talking to other lawyers, you realize your lawyer’s error was inexcusable, and you sue him for legal malpractice.  But the law firm denies responsibility.  It says your lawyer acted reasonably in not getting the expert.  And it says your case was terrible anyway.  So your new lawyer asks for discovery — all the documents related to the firing and the internal investigation by the law firm that led to the firing.  You know there will be evidence in those files contradicting their new defenses.  Why else would they have disciplined him?

In a legal malpractice case — you get that information no problem, and you win your case.  Same with accounting malpractice.  Malpractice by an engineer.  Or an architect.  A financial planner.

But you’ll never see it in a medical malpractice case in Washington, because of the “QI” (quality improvement) privilege. You can read the statute yourself, but the important part is this: you don’t even get to find out what’s in the hospital’s internal investigation files.

Here’s how it works.  Hospitals are required to “maintain a coordinated quality improvement program” for the “prevention of medical malpractice.”  To do so, they have to set up “quality improvement committees.”  The committee must collect “information concerning the hospital’s experience with negative health care outcomes and incidents injurious to patients[.]”  But the information and documents created during the investigation aren’t even discoverable in civil litigation. As the law says: “Information and documents…collected and maintained by, a quality improvement committee are not subject to … discovery or introduction into evidence in any civil action[.]”  So if the doctor admits to a screw up during the investigation? You don’t get to know. If the doctor admits to believing you would have done well, absent the screw up?  You don’t get to know.  If the nursing staff tells the committee they think the doctor screwed up? You don’t get to know.

In other words, the system they’ve set up for “prevention of medical malpractice” is also designed to prevent you from learning what caused your injury in a way that lets you bring a malpractice claim. But there’s no such system in place for other professionals who have to hold themselves to a professional standard of care.

So why the special treatment for doctors? Isn’t it desirable to “improve quality” that prevents other forms of malpractice?

Washington Supreme Court orders new trial in our wrongful death suit against Intuitive Surgical, maker of the da Vinci robot.

taylor appealIn 2013, our firm teamed up with Otorowski Johnston to hold Intuitive Surgical accountable for the death of Fred Taylor.  Our lawsuit chronicled abuses by Intuitive Surgical, the maker of the “da Vinci” surgical robot.  Intuitive sold its robot to Harrison Medical Center in Kitsap County, Washington, just like it does to rural hospitals around the country.  But Intuitive did not explain to Harrison that the learning curve for using the robot is extremely steep, requiring at least 20 surgeries for “basic competence.” Instead, Intuitive pushed Harrison to allow its surgeons to operate without supervision after only two supervised surgeries.  Harrison did so, and our client was his surgeon’s first unsupervised surgery.  He died as a result.  The original trial was covered by the NY Times.

So why does Fred’s widow get another trial? In 2013, the jury found for Intuitive because it believed Fred’s surgeon had been adequately warned about the learning curve.  But the jury was not allowed to decide whether Intuitive should have warned the hospital about the learning curve too.  Warning the hospital is important, because only the hospital can make sure that adequately trained doctors are allowed to perform robotic surgeries. Doctors need to be given “credentials” from hospitals before they are allowed to perform robotic surgeries.  If hospitals are not given adequate information about the learning curve, they can’t set their credentialing process in a way that protects patients.  Today, the Supreme Court ordered a new trial to allow us to present that argument to the jury for the first time. The Supreme Court’s opinion can be found here.

Peter Mullenix

Tip #3 for preventing medical device injury: “Who all will be in the operating room?”

empty orHere is Tip #3 protecting yourself from harm caused by medical devices in operating rooms. (See video below for context on what you’re protecting yourself from.) Today’s tip: find out who all will be in your operating room.

When you ask this question, there are two things you want to listen for: “device rep” and “proctor.”  You care about device reps because devices sometimes have steep learning curves.  For that reason, device companies will send their reps to participate in the surgeries, giving advice to the surgeons.  If that’s the case, you want to know about it: why doesn’t your surgeon feel comfortable enough with the device to use it without the aid of a rep?

The presence of a “proctor” is an even bigger red flag.  Surgeons have proctors when they are brand new on a given procedure.  The proctor’s job is to supervise the surgeon and then certify to the hospital that the surgeon knows what s/he is doing.  Depending on the hospital, the proctor may have authority to scrub in and take over if the surgeon gets into trouble.  Regardless, you don’t want that surgeon. Let someone else be the guinea pig.

These conversations are uncomfortable, but I’ve met several men and women who wish they’d had them.

Stay tuned for Tip #4, and click here for Tip #1 and Tip #2. And if you missed our video on the Five Things patients ought to know about medical devices, here it is:

Peter Mullenix

Why do we force our newest doctors to work in intolerable conditions and then lament about medical errors?

surgical resident life We lament about medical errors in hospitals, but we force our newest doctors to work in intolerable conditions: sleep deprived and hungry.  Why do we do that?

That’s the question not explicitly asked in this excellent essay by unasked question in this excellent essay by Jennifer Bernstein on Catapult. The essay goes into the nitty gritty of “The Surgical Resident Life,” showing how the incredible stress and unreasonable hours we expect these people to work lead to alcoholism.

Of course, it doesn’t have to be this way.  Hospitals could bring in more support for these new doctors.  They could pay more of them to reduce the workloads.  Doing so would cost money but would unquestionably reduce the medical errors.

Regardless, the next time one of these residents slips and hurts somebody, we should all remember that the system put that doctor in an impossible position.  Our efforts to prevent harm (and our anger) should be directed at that system.

Drug and device companies fear Trump, but none of the changes they fear will make patients more safe.

WSU

Whenever I see medical device and drug companies oppose something, my default setting is to support that thing. That’s because, as I’ve noted before, the device industry does $148 billion in business each year, and those incentives lead to shortcuts that lead to injured patients.

But when Donald Trump is involved, all default settings should be checked and re-checked. So why do these companies fear him? The Wall Street Journal says it’s because the repeal of the Affordable Care Act will reduce the number of insureds, meaning less profit.  Moreover, the ACA imposes excises taxes on drugs and device companies that likely will not be repealed. And finally, the companies fear that Trump will let Medicare negotiate drug prices, which will drive prices down.

In other words, none of this is about patient safety or delivering better devices and drugs. It’s all about the profitability to the companies. No one worries that Trump is going to increase safety standards or federal investigation of the safety of new drugs and devices. Quite the opposite, industry apparently sees Trump as an opportunity to roll back federal anti-kickback laws – which means more patients will be getting drugs based on doctors’ financial incentives than their medical needs.

Peter Mullenix

Surgical instrument “caked with old blood and brown ooze” delivered as “sterile” for pediatric surgery

Picture2Kudos to the Detroit News, which has continued to expose the use of dirty surgical instruments at Detroit Medical Center.  For context, the News ran several articles about a “decade of complaints” about dirty instruments at the hospital.  That led to a three month investigation by the State of Michigan.  A day after the State announced the hospital was in compliance with its health codes, “a laparoscopic grasper caked with old blood and brown ooze was marked as sterile and delivered to a Children’s Hospital of Michigan operating room[.]” (Click the link above to see the picture.)

Unlike many of the problems we write about here, there is not much a patient can do to protect herself from a problem like this. Though this young woman was lucky enough to avoid the horrible infections she could have faced if the instrument was used, many more will not be so lucky because the remaining contaminants are not so obvious.

At some point, we are at the mercy of the hospitals we go to.  But getting the word out about the problem and looking for root causes — are hospitals skimping on sterilization/quality assurance costs? — is one way to at least focus attention on the problem.

Peter Mullenix

When a City Takes on a Drug Manufacturer

Picture1I call this great news.  The City of Everett, Washington (not far from Seattle) is considering filing its own lawsuit against Purdue Pharma, which makes OxyContin. And why not? According to the City: “the drug manufacturer was negligent when it aggressively marketed OxyContin as a supposedly less-addictive alternative to other pain medication while simultaneously ignoring evidence that substantial quantities were diverted through ‘pill mills’ to illegal drug traffickers.” In other words, the company knew its drug was more dangerous than doctors and patients were aware, even as addictive as morphine. The result has been a spike in homelessness and drug overdoses for Everett. The company that got all of those people addicted ought to bear its share of the burdens imposed on the City.

It is exciting to think that Cities might be willing to take these matters in their own hands, rather than waiting for the federal government to prosecute.  That thought has to be terrifying to Pharma companies trying to decide whether they should fully disclose, or obscure, the dangers of a product.

 

 

 

 

One firm’s solution to the PTFE guidewire crisis

solution to ptfeWe’ve been watching the recalls on the PTFE guidewires closely, as set out previously.  The problem, in broad summary, is that the PTFE coating on the guidewires can flake off, which presents an extreme stroke/embolism danger.

Here is one firm’s potential solution. The firm, Surface Solutions Group, argues that the problem isn’t necessarily the material (PTFE) so much as the manufacturing process.  According to SSG: “by using new stringent surface preparation techniques and adjusting how the coating is applied makes the problem go away and the new coatings adhere as well as the old ones did.”

I hope this proposed solution works, and I hope it’s widely adopted.

Peter Mullenix

 

Why don’t doctors think should tell us that when they aren’t very good?

not-adeptI subscribe to several medical ethics feeds on twitter. Since doing so, I’ve often been surprised at how easy some of the purportedly “tricky” ethical questions doctors face really are. This medscape article featuring @arthurcaplan is a perfect example.

The question Caplan, an ethics professor, is answering is: “Should you tell a patient you’re not adept at a procedure?”  It’s hard to think of a much easier “ethical” question to answer.  Yes.  Of course.  Always. The patient has a right to know.  The patient might not want to be a guinea pig.  The patient might want to seek out a more qualified doctor.  The doctor’s desire to improve his or her skills does not outweigh the patient’s right to be informed. 

But not only does Caplan treat the question as though it’s difficult, he argues that most of the time doctors don’t need to tell us they’re not “adept.”  He cites the example of a teaching hospital: “Unless people are brought into the emergency room, they know that they are in teaching hospitals and can make a choice as to whether or not they want to go to that kind of a setting.”  Yikes.

As a lawyer, the idea of taking on something I’m not “adept” at without telling my client is horrifying.  I wouldn’t handle a divorce, an adoption, a will, a criminal case, or anything outside my wheelhouse, without making that extraordinarily clear to the client.  The fact doctors see the parallel issue as a nuanced or complicated one is frankly disturbing.

The solution, as is often the case in these posts: Ask! (1) When was the last time you’ve done this procedure?  (2) How many have you done this year?  (3) What are the potential complications?  (4) What complications have you personally experienced?  (5) If you had to have this procedure done, who would you go to?

Peter Mullenix

For the second time in its history, FDA bans a medical device (powdered gloves)

bannedOnce, in 1983, the FDA banned a medical device: prosthetic hair fibers.  Since then despite all of the recalls, lawsuits, deaths, and adverse event reports, it has banned no device.  But today, that changes, as the FDA again used its ban power.  This time, it applied the ban to various kinds of powdered gloves used by doctors and surgeons.  Click the picture to see the updated rule, or click here to learn more about the FDA’s ban power.

Peter Mullenix

Class 1 Recall for Catheters Used to Sample Blood

centurion-recall-picFDA announced a Class 1 Recall (the most serious kind) today for for “single lumen” catheters made by Centurion Medical Products.  Over 1,000 of these products are subject to the recall. The product is a tiny tube used to sample blood or administer medications. These recalled catheters were made improperly, so that pieces of the end of the catheter can break off and actually enter the blood stream.  The danger is that the material will cause “blood clots, embolism of the excess material to vital organs, or death.”

If you’re having blood sampled in or drugs administered, ask your doctor or nurse to double check whether they are using a Centurion catheter, and inform them of this recall.

 

(Image Taken from FDA Recall Page)

Peter Mullenix

Great Freakonomics Series on Myths in Medicine

freak-1

It’s always nice when you can get your patient safety information with your entertainment.  The folks at Freakonomics have given us a great opportunity to do that with their latest podcast series: Bad Medicine.  It’s a three-part series.  Only the first two are out.  The first talks about how we all came to (incorrectly) believe that the “normal” temperature is 98.6.

Peter Mullenix

What Has Changed Since We Learned That We Suffer Enough Medical Error Deaths Each Week to Fill Four Jumbo Jets

In 2012, Johns Hopkins surgeon Marty Makary wrote an essay in the Wall Street Journal about “the disturbing closed-door culture of American medicine.”  According Makary, one of the primary reasons so many people die from medical errors is simply the refusal of doctors to criticize the mistakes of their colleagues.  Makary describes one particularly doctor, who had been nicknamed HODAD (“Hands of Death and Destruction”).  According to Makary: “His operating skills were hasty and slipshod, and his patients frequently suffered complications. This was a man who simply should not have been allowed to touch patients. But his bedside manner was impeccable[.]”  So his patients repeatedly suffered complications and extended hospital stays. As a result, there are enough unnecessary medical deaths each week to fill four jumbo jets. This is a terrifying thought.

picture1

Makary’s first solution is simply tracking information.  “Every hospital should have an online informational “dashboard” that includes its rates for infection, readmission (what we call “bounce back”), surgical complications and “never event” errors (mistakes that should never occur, like leaving a surgical sponge inside a patient).” Second, he says doctors should be scored on their “safety culture,” to encourage nurses and doctors to speak up when they fear a colleague is making (or has made) a mistake. Third, he says more parts of doctors’ practices should be videotaped, to provide better accountability. Fourth, he says patients should be able to review the surgeon’s notes easily, to catch communication errors. Fifth, he says hospitals should stop trying to silence criticism with contractual gag orders?

So, how far have we come?  Do you see any of this information on your hospital’s website?

Makary is dear to our heart at Friedman Rubin because he is also a longtime critic of the da Vinci robot, which has been responsible for massive, unnecessary injuries to several of our clients. Makary argues that da Vinci injuries are significantly underreported.  This comports with our experience: none of our burn cases were reported by the company (Intuitive Surgical) to the FDA until lawsuits were filed. The next trial of those cases will take place in King County, Washington in February.

Peter Mullenix

*Another* Class 1 Recall: What’s going on with PTFE coating?

alertFor the second time in as many weeks, a manufacturer is issuing a Class 1 recall  — the most serious kind — for a guidewire product coated in a substance called PTFE. On November 22, the maker of the FindrWIRZ Guidewire system (SentreHeart) recalled its product because the wire’s PTFE coating could flake off during procedures, causing a danger of deadly clots.  Now, another manufacturer — Medtronic — is recalling its aneurysm treatment system for the same reason.  According to Medtronic’s press release, the recall affects 84,278 units worldwide made between July 2014 to September 2016. The list of affected lots is here.

How to protect yourself? If you are having any surgical procedure, ask your doctor if any sort of guidewire is going to be used. If it is, ask the doctor to call the manufacturer to confirm the guidewire does not have PTFE coating.  To see the recall notice, click here or the picture below:

recall-ptfe

And if you’ve been injured in surgery involving a PTFE coated product, click here to talk to an advocate.

Peter Mullenix

Tip #2 for protecting yourself from harm from a medical device: Know the Learning Curve

Here is Tip #2 in for protecting yourself from the Five Dangers most people don’t know about medical devices. Today’s danger is the learning curve. 

learning-curve

Some medical devices come with substantial learning curves.  For instance, achieving “basic competence” in using a surgical robot to perform prostatectomy takes at least 20-25 procedures (see the preview to Ch. 16). We have a client whose deceased husband unwittingly became the surgeon’s third procedure, when a simple ferry ride would have put him in the hands of a doctor who had performed thousands.  That client, tragically, didn’t know what questions to ask.  What’s more disturbing: many doctors (and some courts) believe the doctor doesn’t have to tell you where he or she is in the learning curve of a device.  That means you have to ask and follow up with questions to get specific information.

  • How many times have you used this device?
  • What complications were experienced?
  • What training and certification was received?
  • How long has the doctor held credentials at this hospital to do this procedure?

Then ask another doctor whether this is enough experience for this type of procedure.  Always ask every doctor who they would choose if they or a loved one were in your place. “Who would you have do it on you?”

Peter Mullenix

FindrWIRZ Guidewire system recalled: “may cause serious injuries or death”

Today the FDA announced a Class 1 recall — the most serious kind of recall — for a catheter guidance tool called FindrWIRZ Guidewire.  Surgeons use the wires to go into blood vessels when placing catheters.  But they are defective because a coating on the wires can slough/peel off.  According to the Recall notice: “Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death.” Find out more about the recall here.  The manufacturer is SentreHeart, a Redwoods, CA firm started in 2005, which recently closed a $35M round of funding to fund a clinical trial on another product.

ucm530343

If you are having a surgery that involves putting guidewires blood vessels, be sure your surgeon knows about this recall before you undergo the procedure.  If you have been harmed, click the button above to talk to an advocate.

Picture above taken from recall notice.

What will Trump and the Republican Congress mean for the FDA?

This article by Stat News takes on the question I’ve been wondering about since 11/8: are the already-thin protections offered by the FDA about to get even thinner?  According to the regulatory experts I work with in device litigation, the FDA is incredibly underfunded.  That means it ends up relying on industry to regulate itself far more than ordinary people expect when they learn about a new drug or device.  Stat News says this will get worse under Trump, citing comments by his supporter Newt Gingrich, who argued the FDA should be abolished altogether.

Could the FDA be dismantled under Trump?

Tip #1 for protecting yourself from harm from a medical device: Ask MAUDE

(This is the first tip for protecting yourselves from the medical device dangers described in our recent animated “Five Dangers” video. The second tip is here.)

The best, most important strategy for protecting yourself from surgical harm is also the most obvious one: Ask the doctor if there are any medical devices that will be used in treatmentmaude Get the brand name and the product (model) number for any devices the doctor plans to use.  Ask what they do and why the doctor has chosen that kind of device. Then get online. Whenever something bad happens with a device, the company is required to report it to the FDA.  The FDA keeps that information online in a free searchable database called “MAUDE.” (Just google “FDA MAUDE” and you’ll find it.) But beware: only a small percentage of malfunctions that happen are actually reported to the FDA.  So if you see any alarming trend in the reports, make sure your doctor is aware of it and ask how he or she will protect you from this problem.  If the doctor is dismissive, find another doctor.  Be sure to come back for the 2nd strategy for protecting yourself from harm from a medical device.

Peter Mullenix

Off Label: Should device makers be allowed to sell doctors on untested uses?

unapproved-uses

When the FDA allows a drug or device on the market, it is only for certain kinds uses that have been (to some degree) tested for safety.  The manufacturers are not allowed to send sales reps to push doctors to try devices out in untested ways.  Based on some recent lower court rulings touching on the freedom of speech, this prohibition on “off label promotion” has been under fire.  This week, the FDA held a hearing on whether to loosen these restrictions.

The Minnesota Star Tribune has a great writeup of the issue.

17,000 Heart Patients Warned: Bacteria Possibly Sprayed into Open Chest Cavity

symptoms

 

 

 

According to Consumer Reports, the Mayo Clinic has warned 17,000 of its patients about potentially serious bacteria they may have had sprayed into their open chest cavities during heart surgeries using a “heater cooler” device. ucm492579 During heart surgery, the chest-cavity can be open.  The “heater-cooler” is used to regulate their body temperature during this vulnerable time. The device uses water, and certain bacteria can grow in that water.  According to Consumer Reports, several outbreaks of a certain bacteria have been traced to a European company called LivaNova, which makes 60% of the heater-coolers in use.  The thought is that the design of the device allows the “spraying” of the bacteria into the air, and the bacteria then goes into the chest cavity.  This bacteria is particularly dangerous to those with weakened immune systems, which applies to many heart patients.

So, what to do? The letter sent by the Mayo Clinic tells patients to “contact their primary care doctor if they have questions or experience any symptoms linked to the infection, including night sweats, substantial weight loss over several months, and a persistent, unexplained fever.” Hospitals have also been advised to test their LivaNova machines for the bacteria.  So if someone you love has recently had a surgery involving a heater-cooler, keep an eye out for these symptoms and call your doctor as soon as possible.

(Graphic Above Taken from FDA web advisory)

Chilling Account of a Doctor Watching His Mother Die Due to Substandard Care

wapopng

Jonathan Welch was a 33 year old ER doctor in Boston when he got the call from an ER doctor in Wisconsin that his mother had a dangerous form of sepsis.  He caught the next flight but, on reaching the hospital, saw that several of the necessary steps to prevent the infection from becoming deadly had not been taken. There was no cardiac monitor.  Her vital signs had been recorded infrequently, and showed serious problems.  And the sepsis protocol had not been started because her doctor had left for the day.  He demanded that she be moved to the ICU.  But that didn’t end the nightmare, and she ultimately died because her doctors had acted too slowly.

The story, published in 2012, details Welch’s frustrations, and then his ethical dilemma as he decided whether to sue the care providers whose missteps had cost him his mother. It is a fascinating look into the mind of a doctor who had to face the conflicting emotions we hear from grieving families all too often: how do we balance the need for accountability and change with our own need for closure and affection for our longtime doctors?

(Graphic above a screenshot from Washington Post website.)

Your doctor’s politics matter to your treatment.

According to a new study out of Yale and published in The Proceedings of the National Academy of Sciences, the advice you get from your doctor can depend on whether the doctor likes donkeys or elephants more.  You can view the whole study (for pay) here or the abstract (for free) here. politicsThe study asked 20,000 doctors from 29 states to analyze nine different “vignettes,” only three of which involved “especially politicized” issues (marijuana use, abortion, and firearm storage in the home).  The political leanings of the doctors predicted their rating of the seriousness of the issue and their proposed course of treatment.  The political differences were not associated with differences in the non-politicized vignettes.

So, if you have a politically charged health question, you may want to figure out your doctor’s politics.

(Image above a screenshot from The Sacramento Bee)

What if we recorded our informed consent conversations so we’d have them later?

I’ve been thinking lately about ideas to give patients to help themselves avoid becoming some lawyer’s client someday.  Better information is always the best answer. idea I’ve heard several clients say, after suffering a bad outcome, that if the doctor had been up front about risks, they would have chosen a different treatment method.  I’ve also heard several say that the things the doctor says s/he told the patient were never actually said.  This is what I call the He Said/MD Said. And anyone who has ever had a surgery knows that some doctors blaze through the consenting process and brush risks off as virtually nonexistent.  I distinctly remember one doctor (who I chose not to use) telling me the risks of a proposed elective surgery in less than a minute and then saying: “But that never happens.”  I wonder if he’d have remembered telling me that if I ended up with a bad outcome?

So what can patients do to incentivize doctors to give all of the information necessary to make a decision?  How can patients have an accurate record of what they’ve been told — so they can talk to their family members and do their own research?  How can they avoid the He Said/MD Said?

What if we just recorded the informed consent process?  We all have phones with video capability.  What if, once the doctor started to outline the risks and benefits of the various options, we just said: “Hold on a second, I’d like to record this so I can talk to my family about what to do and do my own research later.”  Would this make the doctor be more objective and thorough in discussing the risks?  Would it prevent the doctor from exaggerating his or her warnings later, after a bad outcome?

There may be a few downsides.  Most importantly, some states have two-party consent laws.  (Washington’s is here.)  So you’ll want to make sure you get consent of the doctor to record on the recording.  Something like: “Ok, Doctor, like we just talked about, I’m going to record this so I can talk with my family about what to do. Is that okay?”  And of course, it may make the doctor uncomfortable, or the doctor may refuse.  But maybe that is valuable information in itself.  What does it say about the doctors that they don’t want a real record of what they told you? And finally, you still have to ask the right questions during the consenting process.  That’s a topic I’ll discuss in later posts.

What am I missing?  Email me at safepatientadvocate@friedmanrubin.com if you have thoughts or criticisms, and I’ll post the best ones.

Willy Rusch Tracheostomy Tube Recalled

As if the parents of kids who need tracheostomy tubes don’t have enough to worry about. According to the FDA, device maker Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient. trach-tubeThe purposes of these tubes is to provide oxygen-rich air to patients who cannot breathe unassisted on their own.  According to the FDA: “If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube.” The ultimate result may be “oxygen deprivation, brain damage and death.”

If you know someone who uses, or whose child uses, a “trach tube,” please be sure to pass this information on.

(Picture taken from link above.)

What is your surgeon’s complication rate?

Information about complication rates of surgeons is only really useful to you before you have the surgery.  One way to find that information is to head to Pro Publica, a nonprofit investigative journalism outfit that consistently finds great information related to patient safety.  One of its latest projects is the Surgeon Scorecard, where Pro Publica has taken Medicare data to calculate complication rates for surgeons performing common elective procedures.  The project assesses over 17,000 surgeons.

surgeon-scorecard

It is also worth checking out their companion article about why the surgeon you select is more important than many realize. One of the more startling facts from that article?  “A small share of doctors, 11 percent, accounted for about 25 percent of the complications.” So take a look at your surgeon’s record: an ounce of prevention is worth a pound of cure.

(Graphic from https://projects.propublica.org/surgeons/)

 

 

 

 

Robotic Surgical Instruments ‘Virtually Impossible to Clean’

studyOur firm has four filed cases against Intuitive Surgical, the maker of the da Vinci surgical robot.  But the revelation in this study is new even to us: the robots are “virtually impossible to clean.”  This from a new study conducted in Japan in which robotic and ordinary instruments were tested according to manufacturer instructions, and protein levels then compared.  “The overall level of residual protein in each instrument was much higher for robotic instruments than for ordinary instruments.”  The reason is that the structure of robotic instruments “is so complex that updating their cleaning methods is a challenge for healthcare professionals.”  The study calls for new cleaning standards, which it says could prevent dangerous infections in patients.The study is available here.

This is another in a disappointing series of revelations about Intuitive Surgical, the Sunnyvale, California company that has come to dominate robotic surgery worldwide through hyper-aggressive, direct-to-consumer marketing.  The company also achieved its success by pressuring hospitals and doctors to adopt the technology despite the absence of documented benefit, increased expense, and a daunting learning curve.  You can learn more about these practices in this article about a Friedman | Rubin case currently before the Washington Supreme Court, Josette Taylor v. Intuitive Surgical, Inc.  Our firm also represents two women and one man injured by defective insulation in the robotic electrified scissors sold by the company.  The defect in question is described here.

Minnesota Newspaper uncovers Adverse Event dumping practice by medical device makers

Kudos to the Minnesota Star Tribune.  The paper has uncovered a hidden practice that allows device companies to distort true number of injuries associated with devices.  And the FDA allows this practice.  The practice?  Accepting late reports from device companies that cover “hundreds of thousands of incidents, sometimes years after the fact.”

Link: http://www.startribune.com/fda-protocols-allow-medical-device-makers-to-keep-adverse-events-out-of-view/397256291/

Introducing Safe Patient Advocate

Despite technological advances and increased efforts and coordination by government and patient advocacy groups, in some ways it is scarier to go to the hospital than ever.  This isn’t necessarily because there is more danger; it’s rather that we just know more about the danger now.  More than ever before, ordinary patients can learn about the dangers of medical errors and device malfunctions they might face when they walk through hospital doors.  The FDA provides free updates related to recalls.  Bad medical device outcomes for each manufacturer are maintained on a free, searchable database.  Even the payments doctors receive from private companies are now, more than ever, publicly available.  Patients can even search the complication rates of their surgeons.  And this is just the tip of the iceberg in terms of information available for protecting ourselves.

But money still drives medicine, and that means safety is often knowingly compromised by those who stand to gain.  According to the International Trade Administration (SelectUSA.gov), the US medical device market is $148 billion per year, and there are more than 6,500 medical device companies.  There are over 3,500 new drug compounds currently in the “biopharmaceutical pipeline.”  The tiniest market advantage can lead to massive profits, which is why shortcuts are taken in terms of patient safety.  This leads to massive settlements and punitive damages, as our legal system tries to clean up the mess made by drug and device companies.  That’s why Boston Scientific was ordered to pay $100 million to one woman for its vaginal mesh, why Johnson and Johnson lost three verdicts over $50 million each for the ovarian cancer caused by its talcum powder, and why Stryker had to pay $1.4 Billion to settle claims related to its hip implants.  It’s why Intuitive Surgical, the maker of the da Vinci surgical robot, is being sued by its own insurance company for hiding more than 700 product defect claims. Greed breeds danger.

The purpose of this resource is to identify and rebroadcast major stories related to patient safety so that those interested in protecting themselves have the best chance to do so.  It is also designed to help those who were not fortunate enough to prevent errors to help solve the “mystery” of what happened to them.  Finally, because we are legal advocates for patients, we will also share victories patients have scored in courtrooms against rulebreakers in the medical field, be they doctors, hospitals, pharmaceutical companies, or medical device maker.

This resource is run primarily by Peter Mullenix, a Seattle, Washington attorney who represents patients who have been victims of medical errors and medical device malfunctions.  If you are having trouble figuring out what happened to you or a loved one, or if you know what happened and want to know what to do next, click on the “Talk to an Advocate” button to help find answers.  Doing so will help you submit your inquiry for review by a team of lawyers trained in using the tools of the legal system to help injured patients and their families put their lives back together and prevent further tragedies.

Please be aware that we can only take on a very small portion of the cases submitted.  But we are always willing, even for cases we do not take on, to help injured patients find other lawyers or answer legal questions that will help patients better understand their claims.