Know the Risks and Benefits of Medical Devices

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Medical science continues to make great progress in diagnosing illnesses and treating them. Devices of many types allow doctors to see inside the body to diagnose a variety of conditions. Other types of medical devices that are used or implanted inside the body provide relief from many painful conditions. However, no matter how far medical science has progressed, there are still risks and benefits that people need to consider before undergoing even the most routine procedure involving a medical device.

Here are a few common devices and procedures, as well as some injuries and issues that have been associated with them.

Medical Scopes

Each year, millions of people in the U.S. have a procedure with a medical scope of some type. In these procedures, a doctor places an instrument called an endoscope inside the body to examine the esophagus, stomach, bile ducts, colon, lungs, bladder, or other organs. After each procedure these devices are cleaned and re-used on another patient. Duodenoscopes, which are used to diagnose and treat stomach and other GI tract conditions, have been of particular concern.

Since 2013, at least 35 people have died from after having a procedure that used a duodenoscope. The problem is that the design of the scope makes cleaning it extremely difficult, so even if the scope is cleaned according to the manufacturer’s instructions, bacteria can still be trapped inside the scope and transferred to another patient. A paper published in April 2018 showed that 71 percent of scopes tested at three major U.S. hospital were contaminated with bacteria.

In 2015 the FDA directed three duodenoscope manufacturers (Olympus, Fujifilm, and Pentax) to study this issue. Interim results of these studies released in December 2018 showed that up to three percent of samples were contaminated with “low-concern” organisms, and up to three percent were contaminated with organisms of high concern. Sampling is continuing.

One manufacturer, Olympus, pled guilty in December 2018 to charges of failing to file reports about infections stemming from its scopes.  The company agreed to pay $85 million to resolve the charges. Additionally, the company settled lawsuits with two women whose husbands died after undergoing a procedure with the scope and becoming infected with a “superbug” bacteria resistant to most antibiotics.

Other types of scopes are similarly difficult to clean. Bronchoscopes, which are used to look inside the lungs, have also been found to be contaminated, even after cleaning, and have likewise been linked to “superbug” infections.

Bone Cement

There are over a million joint replacements performed each year in the U.S. In many of these procedures, the surgeon uses bone cement. Bone cement doesn’t actually “glue” the joint into place; it fills the space between the artificial joint and the bone to keep the joint in place. The use of bone cement in joint replacements is not without complications, however. The bone cement can break loose, which can cause pain and affect movement. It can also leak into the body.

The most serious problem is bone cement implantation syndrome (BCIS). Fortunately, this complication is rare, but when it happens, it causes the cardiovascular system to collapse and can cause death, often during the procedure.  BCIS has been reported with knee, shoulder, and hip replacements. One study from the UK reported 41 deaths linked to the use of cement in hip replacement.

BCIS has also been reported in patients undergoing spinal surgery. As early as 2002, the FDA sent a warning about a bone cement that was being used to treat spinal fractures and had been linked to serious complications, including blood clots in the lungs, cardiac failure, and death.

In 2011 the government filed charges against a company called Synthes, a manufacturer of bone cement. The company had been testing a cement that had not been approved by the FDA for use in spinal surgeries. Five patients who received the cement had died during surgery after the company ignored reports that the cement could have fatal consequences. Because the company had not been conducting a clinical trial, patients weren’t advised of the risks and given a chance to decide if they wanted to receive the bone cement. Four Synthes executives were also charged, pled guilty and sentenced to time in jail.

Pelvic Mesh

Pelvic mesh is a relatively recent product that was initially marketed in the 1990s to treat stress urinary incontinence in women. After the success of that product, it started being used for pelvic organ prolapse. However, the use of the mesh for pelvic organ prolapse has been associated with complications including pain, infection, bleeding, mesh erosion, urinary problems, and perforation of organs, and has prompted tens of thousands of lawsuits.

The FDA received over 10,000 reports of serious injuries from pelvic (transvaginal) mesh that occurred from January 2008 to October 2018, including 77 deaths. Previously, in 2011, the FDA had issued a warning, and in 2016 they classified it as a high-risk device.

Earlier this year, a woman was awarded $41 million in a verdict against one of the manufacturers of pelvic mesh, Johnson & Johnson. Altogether, more than 100,000 women are suing manufacturers of pelvic mesh due to the complications they have experienced. Some women describe continuous pain due to the plastic of the mesh perforating the vaginal wall.

This is another instance of the product being marketed and used without the benefit of long-term study, to the detriment of thousands of women. Transvaginal mesh and is banned in the UK, Australia and New Zealand. On February 12, 2019, an FDA panel met to discuss the future of transvaginal mesh in the U.S. The panel decided that rather than pulling the mesh off the market, they would like more long-term studies.

What to Do If You Need a Procedure or Medical Device

If you are faced with needing a medical procedure or device, how can you weigh the risks and benefits? You need to be fully aware of whether the device has been studied in clinical trials and has been approved by the FDA. Even if a device has been approved , such as a duodenoscope, you need to know if there are other issues, such as infection risk, associated with its use.

Doing an internet search on the device or procedure may help answer questions such as:

  • What is the history of the procedure/device?
  • Has the device been approved by the FDA?
  • What are the risks and benefits?
  • What complications have been reported?
  • Are there ongoing lawsuits associated with the device?
  • What are the alternatives?

You should also carefully read the consent document for the procedure, as it should list the potential risks and complications.

Speak with your healthcare providers also. What is their experience with the procedure/device? How many times have they done the procedure?  What are the most common complications? Before making a decision, you may also want to speak with other patients who have had the procedure.

The bottom line is that you should arm yourself with as much knowledge as you can before undergoing a procedure so you know the risks and benefits and can make an informed decision.  

Medical Errors Can Lead to Medical Malpractice

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A few months ago the AZ Daily Star reported that Banner University Medical Center’s conversion to a new computer system came with a cost to patient care and had resulted in numerous instances of medical errors. The Star cited an investigation by the Arizona Department of Health Services, the state licensing arm that licenses medical facilities and other medical providers, that found at least two substantiated allegations that included the delivery of medications and care for critically ill patients. Although the hospital denied the errors resulted in negative outcomes for patients, the unfortunate reality is that vulnerable patients are the ones at highest risk of medical malpractice in hospital settings.

Patients who have experienced an adverse outcome following a medical procedure or surgery often wonder if their experience rises to the level of medical malpractice, and if they have legal recourse against the doctor, nurse, or medical facility where the incident took place.

What is Medical Malpractice
According the Board of American Liability Attorneys, medical malpractice occurs when a hospital, doctor, or other health care professional, through a negligent act or omission, causes an injury to a patient. The negligence might be the result of errors in diagnosis, treatment, aftercare, or health management.

Medicare “Never Events”
Medicare also weighs in on medical malpractice by providing a list a “Never Events,” which are conditions that may happen in a hospital that are so severe that Medicare will not pay for the additional cost of treating for the event. The “Never Events” list includes:
 Pressure ulcer stages III and IV;
 Falls and trauma;
 Surgical site infection after bariatric surgery for obesity, certain orthopedic procedures, and bypass surgery (mediastinitis);
 Vascular-catheter associated infection;
 Administration of incompatible blood;
 Air embolism;
 Foreign object unintentionally retained after surgery.

Do I have a Medical Malpractice Claim?
When a medical malpractice attorney evaluates a medical malpractice claim, the initial screening will try to determine whether the medical harm was due to negligence, and assess the impact of the medical error to the patient. If there was negligence and the patient was inconvenienced for a period of time but was able to make a full recovery, it’s unlikely a medical malpractice attorney would accept such a case because the damages would not justify the cost of the claim.

However, if the attorney learns during the screening process that there was negligence on the part of the physician or other medical provider and the harm to the patient was catastrophic or resulted in death, the attorney may accept the case and begin the investigation process.

Every case involving medical error is different, as is the level of harm. The attorneys at Hollingsworth Kelly encourage patients or patient advocates to contact our office for a free evaluation if they believe their unsatisfactory experience with a medical provider rises to the level of medical malpractice.

Hospitals Need to Report Infectious Outbreaks

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 “Sunlight is said to be the best of disinfectants…”

    – Louis Brandeis

The CDC estimates that there are approximately 1.7 million hospital-acquired infections each year, resulting in almost 100,000 wrongful deaths.

According to the Committee to Reduce Infection Deaths (RID), the most dangerous hospital-acquired infection is MRSA, a superbug that has become resistant to antibiotics. Hospital infections that are closely behind are vancomycin-resistant Enterococcus (VRE) and Clostridium Dificil (C-Diff).

In many states, health officials require hospitals to disclose information regarding infectious outbreaks. While some willingly comply, there is no incentive for hospitals to report because in most cases there are no regulatory or financial penalties for hospitals that don’t release such vital information.

There have been cases when records of infections have been released months or even years after known outbreaks, preventing patients from making informed decisions about which hospitals they choose to trust for their care.

Advocates for easily accessible infection information believe that when hospitals do not release outbreak information, they cannot truly improve the quality of care they provide to patients.

Often, lethal outbreaks have only been disclosed in public medical journals written by the doctors who treated infected patients. Concealing vital information which should be publicly disclosed places countless lives in danger.

As of October 2011, state legislation on healthcare-associated infections included 30 states that had laws requiring infectious diseases to be reported publicly. Five states, including Arizona, still give hospitals the option to voluntarily disclose infectious outbreaks or non-publicly report them to the Division of Health of the State Department of Health and Human Services. The remainder of the states have pending healthcare-associated infection legislations or no laws at all on reporting infectious outbreak information.

What is it going to take to end the silence?

States need to take immediate action to force hospitals to publicly disclose vital information about infection rates to patients. Reporting requirements should be amended to include strict regulatory and financial penalties for non-compliance.

The most vulnerable populations–the young, the elderly, and those with delicate immune systems–are the ones at most risk to contract an infection in a hospital. Through appropriate penalty-based reporting systems, hospitals can be held accountable and hopefully incentivized to take proactive steps to curtail hospital-acquired infection rates.

Medical Errors: Patients Deserve Safety

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Last summer, a Senate sub-committee on patient safety heard testimony that preventable medical errors in hospitals were the third leading cause of death in the U.S. The committee had called a hearing after a study appeared in the Journal of Patient Safety that found that more than 400,000 patients die each year from preventable injuries suffered in hospitals.

Tragically, patients are suffering medical malpractice not just in hospitals—medical injuries can often result from a delayed or wrong diagnosis at a doctor’s office, from receiving the wrong medication, from medical error or acquiring an infection during a procedure, or from inadequate care at a skilled nursing facility or nursing home.

With the goal of improving patient safety and increasing medical provider accountability, two organizations launched grass-roots efforts to collect patient stories and lobby for change and transparency.

Safe Patient Project

In 2003, Consumer’s Union, which publishes Consumer’s Reports, launched an initiative to reduce hospital infection rates, which eventually became the Safe Patient Project. Their efforts helped pass patient safety laws in 27 states that require public reporting of infection rates.

The Safe Patient Project has now expanded to much more than preventing medically transmitted infections. If a patient has been harmed by medical errors, the Safe Patient Project is ready to collect their story, which they will use to lobby for improved patient safety. Their website is easy to navigate and stories are collected in the following areas:

  • Healthcare-Acquired Infections
  • Medical Errors
  • Doctor Accountability
  • Hip and Knee Replacement

The Safe Patient Project website also has an active blog that offers patient safety information, such as, “3 Questions to Ask Your Doctors About Your Medications,” “6 Questions to Ask Before Getting a CT Scan or X-Ray,” and “A Surprising Way to Avoid Medical Errors in the Hospital.”

According to the Safe Patient Project, if you are planning a hospital stay, ask a friend or relative to monitor your care, insist that nurses and doctors wash their hands, and ask about medications that are unfamiliar. Also make sure hospital staff checks your wristband when delivering medication and make sure that any surgical site is marked.

Patient Voice Institute

Like the Safe Patient Project, the Patient Voice Institute is a non-profit patient advocacy organization that collects patient stories and lobbies for positive change in patient safety and dignity.

The Patient Voice Institute also has a blog on their website with patient stories about their experiences and how patients and their families were motivated to effect change. One story talks about the late architect Michael Graves, who was paralyzed by a rare virus and had a dehumanizing hospital experience. Another story is written by a mother who tragically lost her 22-year-old son due to medical error during brain surgery. She later helped pass a patient protection law in Colorado.

The more informed you are as a patient, the less likely you are to become a medical error statistic. The more patient groups shine a light on the vast numbers of such errors, the more likely medical institutions are to effectuate positive changes for patient safety.

Do the Elderly Need to be Protected From Their Doctors?

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Patients often make the mistake of believing they can place their full confidence and trust in the skill and knowledge of their medical providers, many times not realizing that neglect or medical malpractice can be fairly common, especially among the elderly.

A study published online last May in the medical journal Injury Prevention found that one in five Medicare patients suffered an injury from medical treatment not related to their underlying condition. The study drew attention to outpatient care, citing that most of the malpractice happened in doctors’ offices, clinics, surgery centers and nursing homes, with one-third occurring in hospitals.

Researchers noted that the more delicate the health of the patient, the more likely it was that he or she would experience a medical injury during treatment. They found that elderly patients were often more vulnerable to being given the wrong medications or receiving treatments that could induce allergic reactions or additional complications, adding to their previously existing underlying illnesses or problems.

The study also drew attention to complications that go hand-in-hand with medical malpractice–death rates are estimated to double when additional injuries occur with the elderly, along with increased health care costs due to extended and comprehensive follow-up treatment.

The focus of this study is to recognize the cause of unnecessary medical injuries that elderly patients are experiencing. It is also a wake-up call for members of the health care profession on the need to be educated in geriatric medicine, and understand that the elderly, because they are more vulnerable than healthy young adults, need a greater degree of care and protection when receiving medical treatment.

Selecting a Personal Injury or Medical Malpractice Attorney

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Why is it important to know how well an attorney performs in trial?
Because the insurance companies certainly do. The reality is that the only personal injury and medical malpractice cases pursued are those where there is insurance coverage, absent an individual having substantial personal assets.

Insurance companies are aware of the fact that of the over 2,000 attorneys in a community like Tucson, less than five percent have actual, significant courtroom experience. And of that five percent, even less have consistent, successful jury trial outcomes. When a lawyer doesn’t have a proven track record, insurance companies know they can get away with undervaluing an injured person’s claim.

When insurance companies know that a personal injury lawyer or a medical malpractice attorney is willing to take a case to trial, and has proven time and time again that he or she can obtain excellent results, they are far more likely to pay full value for injuries. This is a basic economic principal involving a risk/exposure analysis.

How do you find out about a lawyer’s track record?
It’s simple. Ask the attorney to show you. There are two ways jury trial results are recorded. The first is a Minute Entry, a document generated by a judge at the conclusion of a trial. A lawyer should have a compilation of minute entries to prove his or her record.

Perhaps a more valuable method of documenting trial results is through the Trial Reporter, a publication that summarizes the history of each trial, along with strategies employed, witness testimony, closing arguments and trial results. Pre-trial negotiations are also included.

By requesting and reviewing these historical accounts, you should easily be able to form an opinion about the skill level of an attorney, which will assist you in making a wise choice when hiring an attorney to represent you in a serious personal injury case due to an auto accident or medical malpractice in the Tucson area.