Informed Consent & The Duty to Disclose Treatment Risks

On August 7, 2012, the Public Library of Science (PLOS) Medicine Journal released a study focused on medical malpractice lawsuits arising from doctor-patient disagreements regarding informed consent. With informed consent, doctors are expected to advise and empower patients by sharing information that may affect treatment decisions, including risks of adverse outcomes.

The study found, however, that "doctors, especially surgeons, are often unsure which clinical risks they should disclose and discuss with patients before treatment." The authors go on to assert that while most informed consent disputes involve disagreements about who said what and when (rather than arguments over whether a particular risk should have been disclosed), doctors may "routinely underestimate the importance of a small set of risks that vex patients."

Specific Study Findings

Of the nearly 10,000 malpractice claims and health care complaints sampled in the study, the researchers identified 481 disputes over informed consent, 45 of which were "disputed duty cases," defined by researchers as "disagreements between patients and doctors over whether a particular clinical risk should have been disclosed before treatment." Two-thirds of the disputed duty cases involved surgical procedures, and the majority (38 out of 45) involved five adverse outcomes:

• The need for further surgery
• Poor cosmetic result
• Impaired vision or hearing
• Chronic pain
• Infertility or sexual dysfunction

The authors reported that the most common justifications doctors gave for non-disclosure were that the risk was too rare to warrant discussion or the specific risk was covered by a more general risk that was discussed.

Nine in ten of the disputes studied centered on factual disagreements, or arguments over who said what and when. In these cases, the documentation of consent discussions leading up to medical treatment is especially important because written accounts may show whether and when an operative risk was discussed.

The study concludes, "Improved understanding of [informed consent disagreements] helps to spotlight gaps between what patients want to hear and what doctors perceive patients want - or should want - to hear. It may also be useful information for doctors eager to avoid medico-legal disputes."

Speak to an Experienced Colorado Medical Malpractice Attorney

If you feel that a medical provider did not properly explain or inform you of medical treatment options and risks, an experienced medical malpractice lawyer can help determine if you may be entitled to compensation for harms related to the oversight or mistake. In Colorado, contact the Denver law firm of Paulsen & Armitage, LLC for a free and informative attorney consultation regarding informed consent.

FDA Reviews Safety of Metal-on-Metal Hip Implants

For years, patients have reported debilitating pain and swelling caused by metal-on-metal hip implants, and in many cases, metal implants have been removed because of failures. On June 27 and 28, the Food and Drug Administration (FDA) convened the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek the latest expert scientific and clinical opinion on the risks and benefits of metal-on-metal hip systems, including:

• Failure rates and modes
• Metal ion testing
• Imaging methods
• Local and systematic complications
• Patient risk factors
• Considerations for follow-up after surgery

Most of the problems associated with metal-on-metal hip implants involve the release of metal ions into the body as the metal parts of the implant rub together. Reactions to the metal particles can cause soft tissue damage, inflammation, bone loss, and other complications that compromise the implant, eventually necessitating its early replacement or repair. Replacement surgeries can be very hard on patients, especially if a person's joint has been further deteriorated as a result of the failed implant.

Once the FDA announced its plan to scrutinize the safety of metal-on-metal hip implants, CBS News spoke with people who sustained implant-related complications. One woman, who had both hips replaced with Johnson & Johnson ASR all-metal implants in 2007 and 2008, had her implants removed in 2011 due to increasing pain and elevated metal levels in her blood. Because of early failures and research showing metal ions leaching into the bloodstream at a high rate, Johnson & Johnson had already recalled the ASR implants in 2010.

Many people are frustrated because most prosthetic devices, like hip implants, do not undergo rigorous safety testing before being put on the market. Rather, the FDA's fast-track clearing program waives clinical testing requirements for devices that appear similar to others already in use. Almost all metal-on-metal hip implants were approved without new safety testing because plastic and ceramic hip replacements have been available since the 1950s. As one man put it, "[They] used my wife as a lab rat, along with 500,000 [other] people."

Contact Concerned Medical Malpractice Lawyers in Denver, Colorado

If you live in the Denver area and you or a loved one has suffered complications after a metal-on-metal hip replacement surgery, or if your hip replacement has required early repair, please contact the experienced Colorado medical malpractice lawyers at Paulsen & Armitage, LLC. We can help you recover the compensation you deserve from the manufacturers and distributors of dangerous medical devices.

Nonprofit Organization Rates the Safety of Hospitals around the Country

On June 6, The Leapfrog Group, a nonprofit organization focused on hospital safety and transparency, released a hospital safety ratings list of United States hospitals, which is the first of its kind. As reported by ABC News and MSNBC, each surveyed hospital received a grade of A, B, C, D, or F based on data reporting medical errors, medication errors, patient injuries, and infections that occurred during patient hospital stays. Of the 2,652 hospitals issued a Hospital Safety Score, 729 received an "A" grade, 679 received a "B" grade, and 1,243 received a "C" grade or below. The names of the hospitals receiving "D" and "F" grades have not yet been released.
According to The Leapfrog Group press release that accompanied publication of the safety scores, hospital errors result in roughly 400 deaths each day. The statement goes on to explain that recent studies have also determined that one in four Medicare patients will leave a hospital with a potentially fatal issue they did not have prior to hospitalization. In similarly disturbing findings, one medication error occurs per day for each hospitalized patient, and more than 180,000 Americans die each year from hospital accidents, infections, and errors.

Colorado Hospital Safety Scores

In the Denver area, hospitals generally received good ratings with Denver Health Medical Center, Presbyterian-St. Luke's Medical Center, and Exempla St. Joseph Hospital all receiving "B" ratings, and Rose Medical Center and Centura Health-Porter Adventist Hospital receiving "A" ratings. In Boulder, however, the only hospital rated, the Boulder Community Hospital, received a "C" rating, and in Colorado Springs, both hospitals rated, the Memorial Health System and Centura Health-Penrose St. Francis Health Services, received "C" ratings.
The Leapfrog Group urges patients to consider hospital ratings before choosing a hospital, for while your hospital may boast the latest equipment and excellent specialists, failure to maintain basic safety practices, such as hand-washing, computerized medication control, and nursing staff levels, could present serious health risks to you and your loved ones.

Talk to Experienced Medical Malpractice Attorneys in Denver, Colorado

If you believe that you or a loved one has been harmed as the result of a medical error or oversight in a Colorado hospital, please contact the experienced malpractice attorneys at Paulsen & Armitage, LLC in Denver for a free and informative consultation. We can help you determine if you have a valid claim against a hospital, doctor, or other health care provider.

Prostate Cancer Screenings: A Health Risk for Patients; a Legal Risk for Doctors?

Between the ages of 40 and 50, many men in the United States begin receiving a routine prostate-specific antigen (PSA) screening for prostate cancer as part of their yearly health exam. The purpose of the test is to detect the disease as early as possible, and if cancer cells are found, to begin treatment to stop the cancer's progression. Of the 20 million men who get a PSA test each year, most likely believe they are taking a proactive step to protect their health.

However, a recently formalized recommendation from the U.S. Preventive Services Task Force (USPSTF) advises the elimination of routine PSA screenings in healthy men, regardless of age. The USPSTF's new guidelines wholly contradict the belief among both doctors and patients that all cancer screenings are always good for all people all the time.

Side Effects of PSA Tests

As reported by CBS News and ABC news, the primary reason that the USPSTF urges doctors to stop performing routine PSA screenings is that the tests lead to treatments that do more harm than good to patients. Specifically, "elevated PSA readings are not necessarily evidence of prostate cancer, and can lead to unnecessary prostate biopsy." The USPSTF said:

• PSA screenings are often unreliable, giving a falsely positive result 80% of the time.
• When biopsies reveal signs of prostate cancer cells, evidence shows that a large proportion of cells will never cause harm, even if left untreated.
• In older men, the disease typically progresses so slowly that they die of other causes.

According to the USPSTF, medical procedures arising from the tests can have serious side effects on patients, including heart attacks, strokes, and possibly death. Removal of the prostate, radiation, and other treatments for prostate cancer can also cause erectile dysfunction, complete impotence, urinary incontinence, and bowel damage.

Many doctors have issues with the USPSTF recommendation, from both health and legal perspectives. For example, most urologists maintain that PSA screenings do benefit patients and have prevented many men from developing advanced prostate cancer. And even doctors who agree with the new USPSTF recommendation may continue screenings for fear of medical malpractice liability. What if they stop screening a patient, and then he is diagnosed with cancer that could arguably have been detected sooner?

Contact an Experienced, Knowledgeable Medical Malpractice Attorney in Colorado

New research findings and government recommendations regularly affect patient treatment protocols, and may give rise to medical malpractice issues when doctors choose to follow or not follow such recommendations. If you believe a doctor's decision to perform or not perform a medical test negatively impacted your health, you should talk to an experienced malpractice lawyer about any claims for recovery you may have. In Colorado, contact Paulsen & Armitage, LLC for a free and informative attorney consultation.

Counterfeit Prescription Drugs in the United States

Risking harm to their patients, health care providers sometimes purchase and prescribe unapproved medications manufactured by foreign drug companies. This April, the U.S. Food and Drug Administration (FDA) issued a warning to medical practices in the United States regarding an unapproved cancer medication called Altuzan. Not only is the drug unapproved in the United States, but the fake product has no active ingredient, which means that patients treated with the counterfeit drug many not be receiving needed therapy.
This month's FDA warning is only the most recent regarding fake Altuzan. In February, the Administration issued its first warning, which explained that counterfeit Altuzan does not contain the medicine's active ingredient, bevacizumab. The medical practices that purchased the unapproved drug, and potentially counterfeit Avastin, did so from Quality Specialty Products, also known as Montana Health Care Solutions, a foreign supplier with medicines distributed by Volunteer Distribution in Tennessee. The counterfeit version is labeled as Avastin, the approved form of the drug in the United States.
In its warnings to health care providers, the FDA stresses that "medical practices that purchase and administer illegal and unapproved foreign medications are putting patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. Illegal drugs purchased from foreign sources may not be genuine or meet appropriate quality, safety, and efficacy standards, putting patients at risk and depriving them of proper treatment."
The FDA also notes that none of the unapproved cancer medications received by health care providers from Volunteer Distribution are in shortage in the United States, and that approved versions of the medicines are available in adequate supply to meet current demand. This means that medical practices purchasing the unapproved drugs were likely doing so only to save money.
If a medical provider knowingly treats a patient with an unapproved drug, he or she may be held liable for resulting damages to the patient. A physician or pharmacist may also be responsible for administering a counterfeit drug if he or she should have known it was fake or unapproved. If a wholesaler brought the drug into the United States, the wholesale company may also be liable to injured patients.

Experienced Colorado Medical Malpractice Lawyers

If you have a prescription drug concern in Colorado, contact the medical malpractice attorneys at Paulsen & Armitage, LLC in Denver. During a free initial consultation, we can help you determine if a medical provider has made an actionable oversight or error in your treatment.

Medical Malpractice Liability for Referrals: It Cuts Both Ways

When most people think of medical malpractice, they likely imagine a botched surgery, a missed diagnosis, or a prescription error directly caused by the treating medical provider's oversight or mistake. In some cases, however, doctors, physicians, and/or hospitals may be liable for patient injuries related to a decision to suggest, or not suggest, another form of treatment or another health care specialist. As we'll explain, this presents somewhat of a catch-22 for medical professionals and patients.

To Refer or Not to Refer, That Is the Question

In the modern medical age, the forms of treatment available to patients are often numerous and varying. Both conventional and alternative therapies may exist to treat the same condition, but patients may not always benefit from all treatments available to them. In some situations, physicians may be concerned about their own exposure to liability if they refer patients for alternative treatments, such as chiropractic therapy or massage therapy. Likewise, a doctor may not suggest a novel medical treatment for fear of liability if the treatment presents unknown risks or side effects to the patient.

At the same time, health care providers are often correct to be cautious, for they could indirectly harm a patient by unknowingly referring him or her to an incompetent health provider, or by failing to accurately evaluate the safety and/or efficacy of a procedure or treatment. If a physician does not fully explain the suggested therapy, he or she could also be liable for not providing adequate informed consent. In some situations, the doctor may not fully understand the proposed treatment him or herself.

Patients deserve to receive the best care possible from health care providers and treatment facilities, and medical professionals should not be more concerned with avoiding a medical malpractice lawsuit than providing the highest level of care to their patients. If health care professionals stay abreast of advancements in their industry and the work of their colleagues, patients are less likely to be the victims of inferior or shortsighted treatment.

Experienced Colorado Medical Malpractice Attorneys

Claims based on the failure to make a referral or negligence in making a referral are complex, and require the advice and counsel of an experienced medical malpractice attorney. If you believe that a Colorado health care provider's negligence or oversight compromised the medical treatment received by you or a loved one, please contact the medical malpractice attorneys at Paulsen & Armitage, LLC in Denver. During a free initial consultation, we can discuss your rights and legal options.

Colorado's Medical Transparency Act

When people find themselves in the difficult and stressful situation of choosing a doctor, surgeon, or other health care provider to perform a major procedure or treatment, they likely conduct some research to ensure they are making the right choice, but much comes down to basic trust in the medical profession. While a high level of trust is necessary to feel at ease in another's care, a lot can be discovered about a health care provider's experience and credentials because of laws requiring medical professionals to publicly disclose background information.

In 2007, Colorado passed one of the first and most patient-oriented transparency acts in the country, requiring doctors to make public a broad range of information, including information that had been considered confidential like hospital privilege restrictions and medical malpractice settlements. The legislation arose from the tragic case of Michael Skolnik, who died after undergoing brain surgery. The surgeon had recently relocated to Colorado from Georgia after losing a medical malpractice suit based on the same surgery. The Georgia incident was not reported on his record in Colorado.

Under the "Michael Skolnik Medical Transparency Act," when Colorado health care providers apply for or renew a license, they must provide the following information:

• Any public disciplinary action taken against the applicant by any other state or country


• Any agreement whereby the applicant temporarily ceased or restricted practice


• Any involuntary limitation on the applicant's privilege to practice at a hospital or clinic


• Any involuntary surrender of the applicant's registration with the Drug Enforcement Administration


• Any final criminal conviction or plea arrangement connected to a felony or crime of moral turpitude in any state or country


• Any final judgment, settlement, or arbitration award for medical malpractice

The scope of the Skolnik Act was expanded in 2010 (legislation that went into effect in the second half of 2011) to include not only medical doctors, but also most licensed or registered health care providers, including podiatrists, chiropractors, dentists, midwives, nurses, physical therapists, psychologists, social workers, and family therapists, among others.

With health care providers under significant pressure to serve numerous patients as quickly and economically as possible, medical malpractice can result from oversights, mistakes, or incompetence. It is important to know if your doctor has a clean, or questionable, track record.

Colorado Medical Malpractice Attorneys

If you believe that you or a loved one has been the victim of medical malpractice in Colorado, please contact the attorneys at Paulsen & Armitage, LLC in Denver for a free and informative consultation.