Massive IVC Filter Study Underway

The Surgeon General estimates about one half million Americans are affected by blood clots annually and between 100,000 and 180,000 people die of pulmonary embolism (PE), a blood clot that travels to the lungs. To combat this problem, doctors implant hundreds of thousands of Inferior Vena Cava (IVC) filters inside patients each year to stop blood clots before they reach the lungs. Retrievable IVC filters have been reported to cause serious injuries if left in the body too long, however some physicians fail to remove the filters once the threat of pulmonary embolism has passed.

PRESERVE Study Investigating IVC Filter Safety

IVC filters have been linked to catastrophic injury and death.In August of 2010, the FDA issued a medical alert, warning that retrievable IVC filters can move or break, causing serious injuries, prompting researchers to begin investigating the devices. In 2014, the FDA issued an updated safety communication and in 2016, a study entitled, Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) began enrollment. The IVC Filter Study Group Foundation, sponsored jointly by the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR), oversees the project. Over the course of the five-year study, 2,100 patients are expected to participate through 60 different medical sites around the U.S. 

“Our foremost commitment is to patient safety, and this study will help determine how well filters prevent pulmonary embolism and how they function over the course of their implantation,” said Matthew S. Johnson, Fellow of the Society of Interventional Radiology and professor of radiology and surgery at Indiana University School of Medicine.

According to the PRESERVE website, the study is unusual because, “More typically, studies follow one or two devices. Studying filters produced by seven different manufacturers at once is an enormous undertaking. The trial will follow 300 patients per device.”

Participating Manufacturers:

  • ALN Vena Cava Filter – ALN Implants Chirurgicaux
  • Option™ Elite Retrievable Vena Cava Filter – Argon Medical Devices, Inc. (designed and manufactured by Rex Medical)
  • VenaTech® LP Vena Cava Filter – B. Braun Interventional Systems Inc.
  • Cook Günther Tulip Vena Cava Filter – Cook Incorporated
  • DENALI® Vena Cava Filter System – CR Bard Peripheral Vascular, Inc.
  • Cordis OptEase® Retrievable Vena Cava Filter – Cordis Corporation
  • Cordis TrapEase® Vena Cava Filter – Cordis Corporation
  • Crux® Vena Cava Filter System – Volcano Corporation

“The treatment of deep vein thrombosis in trauma patients has challenged physicians to know the best way to take care of those patients,” said co-principal investigator Dr. David Gillespie, chief of vascular and endovascular surgery at Southcoast Health System, Fall River, Mass. “There are a lot of devices from different manufacturers to choose from. Physicians have been using the retrievable filters with the idea they will retrieve them, but for many reasons they often don’t.

IVC filter lawsuits  

Patients from across the country who were harmed by IVC filters have begun to file lawsuits against device manufacturers, seeking compensation for their injuries. Sadly, some family members of IVC filter patients filed a wrongful death claim as a result of the dangerous device.

Avoid having surgery during the summer: What Ohio hospitals aren’t telling you

by R. Craig McLaughlin

It’s the championship football game and your favorite team is driving down the field to score a touchdown. Your star quarterback and seasoned offensive linemen are working together like a well-oiled machine. Everyone is in perfect sync and the entire team is seemingly moving as one. Your team can’t be stopped.

But wait! What’s this? A time out is called and in come a slew of substitutions. Your veteran quarterback and linemen are replaced by a rookie and four other practice squad players, who are being asked to play positions they have never played before.

For the rest of the game, lack of experience, unfamiliarity with each other and poor communication between the players lead to sacks, turnovers and a loss for your team.

Would the fans ever tolerate a change in personnel like this during the middle of an important game? No way!

But this is exactly the type of substitution that happens at Ohio’s teaching hospitals every summer and it puts patients at risk.

The most dangerous month for surgery

Every July, at teaching hospitals like The Cleveland Clinic, Ohio State University Hospital and Cincinnati Children’s Hospital Medical Center, there is a change of health care providers that threatens the safety of the patients at these facilities.

This is when the most experienced residents graduate and leave the hospital. These graduating residents have spent the past three to six years training under the guidance of more experienced doctors and the patients at these teaching hospitals served as their case studies.

However, these experienced residents are replaced by brand new doctors who just graduated from medical school. To compound the problem, the remaining residents who have been at the hospital for a year or two are now being asked to assume new and unfamiliar roles. Consequently, this can be a very dangerous time for patients at these teaching hospitals.

A medical team performing an operation
Do you know which month is most dangerous for surgery?

This is such a dangerous time of year for patients that studies show the rate of patient deaths and complications from medical procedures increases between 8% and 34% during the month of July.

Dr. John Young of the University of California, San Francisco, reported these findings in a study he published in the Annals of Internal Medicine. Every year this “July effect” – as the hospitals sometimes refer to it – affects about 100,000 doctors in teaching hospitals around the country. According to Dr. Young, no other industry undergoes such a dramatic change in personnel on such a regular basis.

Steps for a safer medical operation

So what can you do to protect yourself and your family members? Here are three tips from an experienced Ohio medical malpractice attorney:

1. Ask your doctor if he or she will be performing your surgery at a teaching hospital where doctors in training may be involved in your care. Some hospitals are not teaching hospitals or your procedure might be performed at a surgery center that does not use residents. If that is the case, then you likely won’t be affected by this problem.

2. If your surgery is elective and it is safe for you to put it off, request that your surgery be scheduled during the first six months of the year. At that time, the doctors being trained at a teaching hospital will be more experienced and familiar with the hospital’s policies, procedures and nursing staff, and there will be less of a chance for a mistake to be made.

3. If you have to have your surgery during the summer months because it can’t wait, let it be known that you want the most experienced doctor to perform your surgery and to be very involved in your care. Ohio’s teaching hospitals are important to train the doctors of the future, but your health and well-being should not suffer because you are being used as the guinea pig for a brand new doctor.

 

Craig McLaughlin represents people who have been seriously injured or killed as a result of nursing home neglect, motor vehicle crashes, defective products, workplace accidents and medical negligence. He has been recognized by Super Lawyers, Martindale-Hubbell, AVVO and is a life member of the Multi-Million Dollar Advocates Forum and Million Dollar Advocates Forum.

Is your hospital safe?

Not all hospitals are the same. In fact, one recent study showed patients who undergo common surgeries are safer at busy hospitals that perform the procedures regularly.

Hospital surgical volume matters

A medical team performing an operationAn article published in U.S. News and World report has shed the light on a little-known surgical risk: inexperience. Extrapolating data from Medicare statistics, the study revealed that hospitals performing only a small number of common surgical procedures place patients at a far greater risk than high-volume hospitals.

How big of a problem is it? “You can save your life by picking the right place,” says Leah Binder, director of the Leapfrog Group, a nonprofit organization that measures hospital safety and performance.

Dr. John Birkmeyer, Professor of Surgery at Dartmouth–Hitchcock Medical Center has estimated that as many as 11,000 deaths could have been prevented nationally if patients who went low-volume hospitals opted to for the highest volume hospitals instead. For example, at one low-volume Colorado hospital, patients were three times more likely to die during hip replacement surgery and 24 times more likely to die during a knee replacement.

Increased risks with low-volume hospitals

According to the study, hip replacement patients who had their surgery in in the lowest-volume hospitals were about 50 percent more likely to die than patients treated at surgical centers in the top 20 percent. Knee replacement patients took a larger gamble using low-volume hospitals, with a nearly 70 percent higher risk of death. Patients with congestive heart failure and chronic obstructive pulmonary disease fared somewhat better; however, they still had a 20 percent increased risk of dying.

While these numbers are dramatic, it’s important to remember that volume is only one indicator patients should consider when selecting a healthcare facility. In fact, some low-volume hospitals provide excellent care. Conversely, some high-volume centers may perform unnecessary surgeries.

Choosing a hospital

One of the best ways to make a decision is to ask questions. Here are a few examples:

  1. What procedures do you recommend for my case, and why?
  2. Do I need this surgery? What other options are there?
  3. How many times have you performed this procedure in the past year?
  4. What is your complication rate?
  5. How do you follow a patient post-surgery?
  6. What will my follow-up care look like?
  7. Tell me about your medical team – nurses, physical therapists, and others who can help guide me pre and post-surgery.

There are also rating systems available online, including U.S. News Best Hospitals and Hospital Safety Score. So how do you know which hospital or surgeon is right for you? There is no magic formula, but most experts agree patients should take the time to educate themselves about the doctors and medical facilities they choose.

 

Sources:

“Risks Are High at Low-Volume Hospitals” by Steve Sternberg and Geoff Dougherty, U.S. News & World Report, May 18, 2015.

“Hospitals Move to Limit Low-Volume Surgeries” by Steve Sternberg, U.S. News & World Report, May 19, 2015.

Benzodiazepines Linked to Alzheimer’s Disease

Most of us take medications knowing there is a risk of side effects, but that risk is small, right? Surely the FDA ensures the health benefits outweigh these minor inconveniences, right? But what if I told you that if your grandmother took a sleeping pill, she’d be 50% more likely to develop Alzheimer’s disease? Do I have your attention now?

Benzodiazepines linked to Alzheimer's Disease.A study published in the British Journal of Medicine has yielded some startling results. Researchers found that for older adults who took benzodiazepines for at least 90 days, the risk of developing Alzheimer’s disease was increased by 43% to 51% during a five year period.

The study also revealed that people who were on a long-acting benzodiazepine like diazepam (Valium) and flurazepam (Dalmane) were at greater risk than those on a short-acting one like triazolam (Halcion), lorazepam (Ativan), alprazolam (Xanax), and temazepam (Restoril).

What are Benzodiazepines?

Benzodiazepines are a class drugs used to treat anxiety, insomnia, and a range of other conditions. Commonly known as tranquilizers, these medications act directly on the brain and central nervous system, affecting a person’s mood. They are one of the most widely prescribed medications in the U.S., particularly among elderly patients. Benzos are commonly divided in groups:

Short-acting anti-anxiety benzodiazepines

  • alprazolam (Xanax)
  • lorazepam (Ativan)
  • oxazepam (Seresta)
  • diazepam (Valium)

Longer-acting anti-seizure and “hypnotic” drugs frequently used to treat insomnia:

  • clonazepam (Klonopin)
  • flurazepam (Dalmane)midazolam (Versed)
  • nitrazepam (Mogadon)
  • temazepam (Restoril)
  • triazolam (Halcion)

The authors of the study warn that doctors should “carefully balance the benefits and risks when initiating or renewing a treatment with benzodiazepines and related products in older patients.” Although the study only included elderly patients, it is important for people of all ages to discuss the use of benzodiazepines with their health care provider.

Other Risks

It is important to note that benzodiazepines may pose other serious risks for seniors. In 2012, the American Geriatrics Society added benzodiazepines to their list of Potentially Inappropriate Medication Use in Older Adults. The group warned that an increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents could pose serious dangers, stating, “In general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults.”

Source:

de Gage, S.B., Moride, Y., Ducruet, T., et al. Benzodiazepine use and risk of Alzheimer’s disease: case-control study. BMJ 2014; 349:g5205. Published September 9, 2014. Accessed October 29, 2014.

Using Technology to Prevent Bedsores

For millions of Americans, staying in a long-term healthcare facility means an increased risk of developing bedsores. Also known as pressure ulcers, these skin lesions can cause serious and painful infections of the skin, bones and joints. Complications can include tissue and nerve damage, organ failure and even cancer.

Bedsores can be prevented.The best way to prevent pressure sores from occurring is to reposition patients frequently – doctors recommend changing positions every two hours. Unfortunately, with many nursing homes and other long-term healthcare facilities woefully understaffed, many patients are neglected. As a result, more than 2.5 million people in the United States develop pressure ulcers every ear.

Preventing Bedsores with Patient Monitors

An exciting new medical device may hold the answer to this pervasive medical mistake. A company called Leaf Healthcare, Inc. has developed a wearable patient sensor, which can help medical professionals reduce bedsores. Created for healthcare facilities, the Leaf System is comprised of patient sensors and a wireless central monitoring system. The system electronically monitors patients’ position and movements, recording each time a patient is moved and alerting caregivers when patients need to be repositioned.

Leaf Healthcare recently conducted a multiphase clinical trial, which yielded encouraging results. According to a news release, “The study showed that use of the device increased compliance with hospital turn protocols – a standard of care method to prevent pressure ulcers – from a baseline of 64 percent at the start of the trial to 98 percent after the monitoring system was deployed.”

Nursing Home Residents’ Rights

Section 3721.13 of the Ohio Revised Code provides residents of nursing homes with certain rights. Among these is the right to an “adequate and appropriate” level of care, which includes taking steps to prevent bedsores. If you have questions about nursing home neglect or abuse, including whether standards of care are being met, contact our experienced attorneys for a free, confidential case review.

 

*Links to other sites are for informational purposes only. The inclusion of links to other web sites does not imply any endorsement of the material on the web sites or any association with their operators. 

 

Sources:

Tarver, Chris; Schutt, Suann; Pezzani, Michelle. “We’re Sensing You! A Multiphase Clinical Trial Examining Innovative Technology to Improve Patient-Turning Compliance.” [Presentation]. ANCC National Magnet Conference® Dallas, TX. 08 October 2014 to 10 October 2014.

 Leaf Healthcare, Inc., (16 Oct. 2014). “Study Shows Leaf Healthcare Wearable Sensor Dramatically Improves Compliance with Pressure-Ulcer Prevention Efforts.” [Press Release]. [Accessed 28 Oct. 2014].

Is Your Doctor Giving You Fake Drugs?

It seems that even doctors can fall prey to the same counterfeit drug scams that have plagued consumers. We received an email today, which announced the FDA has launched a new website, warning health care professionals about a growing trend: Fake drug distributors.

“There is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market,” read the email. The new website,“Know Your Source,” advises healthcare professionals to only purchase  prescription drugs from licensed wholesale distributors.

Too little, too late?

FDA: Know your sourceWhile we applaud the efforts of the FDA to combat this problem – fake drugs undoubtedly pose a serious risk to patients – the problem is anything but new. In a letter dated December 19, 2012, the FDA notified medical practices they may have received unapproved medications. According to the FDA, “These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.”

In fact, consumers have been warned about counterfeit drugs for years, with “Canadian” distributors at the forefront of the problem. So, how is it that doctors are unaware of these scams—many of which appear to be rather obvious. For example, one flyer on the website warns doctors to “Beware of Offers Too Good to be True” and that, “Aggressive marketing tactics and deep discounts on prescription drugs may indicate that the products are stolen, counterfeit, substandard, or unapproved.”

The FDA also shared these rather common-sense signs that a drug may be fake:

  • The label is not in English.
  • The packaging looks slightly different from the FDA-approved product
  • The product names differs from the name of the FDA-approved drug
  • The dosing recommendations are unfamiliar
  • Safety information or warnings are missing
  • The dosage form or administration is different

How can we, as consumers, protect ourselves?

When a doctor administers medication in the office, you probably won’t see the packaging. A nurse may hand you a pill or give you a shot. So how can you be sure they received the medicine from a reliable distributor? ASK.

Don’t be shy about asking your doctor questions regarding your medication

  • Ask where the medication came from. While it is not a guarantee, medicines are generally safe if your doctor purchased them directly from the manufacturer or a state-licensed wholesale drug distributor.
  • Ask for a copy of the package insert, detailing the possible side effects and other important safety information.
  • Tell your doctor if you experience unusual side effects or if the medication doesn’t seem to be working. These may be signs of counterfeit medication. 

Remember, while most prescription drugs in the United States are safe, it is important to be a vocal advocate for yourself and your loved ones.

 

 

Resources:

FDA warns doctors to beware fake drug distributorsModern Healthcare /Associated Press, September 23, 2104

The Possible Dangers of Buying Medicines over the Internet” FDA.gov, January 26, 2011.

Hospital Cyber-Attack puts Ohioans at Risk for Identity Theft

Hospital cyber-attack puts 4.5M patients at risk for identity theft.Anyone who went to a hospital within the Community Health Systems network may be at risk for identity theft. In a regulatory filing with the U.S. Securities and Exchange Commission, the Community Health Systems said it was attacked during April and June of this year by an “Advanced Persistent Threat” group believed to be operating out of China.

Community Health officials have said the only information taken was “non-medical patient identification data related to the Company’s physician practice operations and affected approximately 4.5 million individuals who, in the last five years, were referred for or received services from physicians affiliated with the Company.”

So, what does that entail? Although CHS maintains your medical records and credit card information have not been compromised, important personal information is now in the hands of hackers, who can use it to steal your identity. The cyber-attack successfully liberated “patients’ names, addresses, birthdates, social security numbers, and, in some cases, telephone numbers, and the names of employers or guarantors.

Community Health Systems owns, leases or operates 206 hospitals in 29 states.” In Ohio, the company operates four medical facilities:

In a press release, CMH stated they would contact individuals whose records were compromised and offer free identity theft protection as well as credit monitoring services.

 

Source: DuBois, Shelley, “Community Health Systems data breach affects 4.5M.” The Tennessean, August 18, 2014.

Acne Treatments Can Cause Dangerous Side Effects

The U.S. Food and Drug Administration (FDA) issued a warning that some products used to treat acne may cause potentially life-threatening side effects. According to an agency press release, over-the-counter acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause severe irritation or even fatal allergic reactions.

FDA warns acne products may cause severe allergic reactions.
Acne treatments such as Proactive may cause severe irritation or fatal allergic reactions.
(Photo credit: Yuki Matsukura – Flickr)

The FDA warning names popular topical acne medications such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. Available without a prescription, these treatments are available as gels, lotions, facial washes, solutions, cleansing pads, toners and face scrubs.

Serious allergic reactions differ from the less harmful irritations included in acne treatment warnings, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says FDA medical officer Dr. Mona Khurana. “It’s important that consumers know about them, and that they know what to do if they occur.”

Use Acne Products Safely

While severe reactions are rare, there are important steps you can take to protect yourself. For example, if you have never used a topical acne treatment before, the FDA recommends applying a small amount of the product to a small affected area for three days. If no discomfort occurs, then follow label directions for normal use. Other safety measures include the following:

  • Avoid using the product if you’ve had previous allergic or hypersensitivity reactions
  • Stop using the product if you develop hives or itching of the face or body
  • Discontinue use and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing

Although no deaths have been reported, nearly half of the 131 known cases of allergic and hypersensitivity required hospitalization, with the majority since 2012. Approximately 86 percent of the patients were female, and the average patient age was 32 years. Based on the information reported, the FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both.

“FDA will continue to monitor closely and evaluate this safety issue,” Khurana says. The FDA encourages consumers to report any negative reactions or side effects from use of these products to the FDA’s MedWatch program.

 

Source:FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products.” U.S. Food and Drug Administration, Safety Announcement, June 25, 2014.

Google Glass in the Operating Room: Help or Hindrance?

The first time I saw the Google Glass, I was positively captivated. The possibilities for this wearable computer with an optical display and camera seemed endless.

As technology has become exceedingly pervasive, it’s no surprise that the health care industry has been keen to adopt new innovations. From beeping pulse oximeters to robots performing surgery, it seems computers are everywhere – even worn by surgeons in the operating room.

At first blush, wearing computerized glasses with a heads up display and recording capabilities seems like a great idea. The device can provide surgeons with instantaneous, hands-free access to a patient’s medical records, vital signs, and other important information while in the operating room. The doctor can also transmit a live-stream video of the surgical procedure to remote locations, allowing for real-time consultations with specialists or providing valuable educational experience for medical students.

Google Glass use in the operating room raises concerns.
Google Glass use in the operating room raises concerns. (Photo courtesy of Antonio Zugaldia.)

Distracted Doctoring

While Google Glass may offer an abundance of opportunities for health care providers, since it is connected to the internet, there are serious concerns over potential abuses.

“Being able to see your laparoscopic images when you’re operating face to face instead of looking across the room at a projection screen is just mind-bogglingly fantastic,” said Dr. Peter J Papadakos, anesthesiologist and Director of Critical Care at the University of Rochester Medical Center. “But the downside is you don’t want that same surgeon interacting with social media while he’s operating.”

We all know that texting while driving is dangerous because our attention is diverted from the task at hand. Now imagine your surgeon, anesthesiologist, or a nurse distracted by their smart phone or tablet during a surgical procedure. Think it doesn’t happen? Think again. A 2011 article published in the New York Times stated that examples of distracted doctoring “include a neurosurgeon making personal calls during an operation, a nurse checking airfares during surgery and a poll showing that half of technicians running bypass machines had admitted texting during a procedure.”

To combat this problem, many hospitals and other care facilities have established (or are in the process of creating) rules regarding the use of personal electronic devices by health care providers. Deviation from these regulations during critical care, which results in harm to a patient, may be considered medical malpractice.

Evidence

Although some critics advocate banning such devices from the operating room, there may be an upside. In the unfortunate event of a medical mistake, the video capabilities of Google Glass may provide critical evidence at trial. Much like the dash cam of a police officer, the visual evidence collected by the device during surgery, combined with expert testimony, can help make a compelling case.

If you have questions about injuries in a medical setting due to a distracted health care professional, contact an experience medical malpractice attorney.

Sources

Google Glass Enters the Operating Room” by Anahad O’Connor, New York Times, June 1, 2014.

As Doctors Use More Devices, Potential for Distraction Grows” by Matt Richtell, New York Times, December 14, 2011.

Common Anesthesia Errors that Lead to Medical Malpractice

anesthesiologist in ORFor most patients, a procedure requiring anesthesia goes according to plan.  Unfortunately,when emergency rooms, operating tables or surgical centers get busy, mistakes can happen.  As a result, anesthesia errors happen more often than most people think they do.  If you believe that a loved one has suffered injury or death due to an anesthesia error, it’s best to contact a medical malpractice attorney immediately to see if you have a viable claim for a lawsuit.

Anesthesia errors often happen because anesthesiologists and other medical professionals are forced to multitask during surgery. There are many different things happening at once, which can lead to distracted doctors and nurses. In turn, this can lead to mistakes, such as:

  • Administering too much or too little anesthetic medication
  • Waiting too long before administering anesthesia
  • Giving the wrong anesthesia drug
  • Interactions with prescription drugs
  • Bad reactions for patients with allergies
  • Forgetting to warn a patient that he should eat or drink prior to surgery
  • Failure to administer oxygen during surgery or properly monitor the patient
  • Defective medical devices and equipment used to administer anesthesia

Too small of a dose may cause the patient to remain partially or fully conscious during the procedure, meaning that he or she could experience extreme pain as surgeons are operating. Improper administration can cause other serious side effects, including:

  • Asphyxiation (loss of oxygen)
  • Aspiration of gastric contents (entry of stomach contents into the respiratory system)
  • Anaphylaxis (serious allergic reaction)
  • Tracheal (windpipe) damage
  • Birth defects
  • Hypertension (high blood pressure)
  • Cardiac dysrhythmia (irregular heartbeat)
  • Myocardial infarction (minor heart attack)
  • Major heart attack
  • Stroke
  • Coma
  • Severe brain damage
  • Death

A medical malpractice attorney can help you determine if a loved one’s death or injury while on the operating table was caused by an error in the dosage or nitroglycerin concentration of the anesthesia that was administered prior to the procedure. If this is the case, your medical malpractice attorney can help you attempt to recover monetary compensation for the injuries or death caused by the anesthesiologist’s negligence.