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The Truth About Medical Malpractice

Thursday, February 17th, 2011

Healthcare has become a hot topic on Capitol Hill, and reform policy an issue of much debate. Central to the debate, certainly, are the ways in which healthcare costs may be cut without sacrificing quality. Lobbyists, specifically those on behalf of the medical insurance industry, have long argued that the price of healthcare is largely driven by payouts from medical malpractice suits, and that settlement caps therefore provide an easy solution to rising costs. Studies have shown that these claims are false, however.  Though the proposed caps save money for the insurance industry, they fail to significantly reduce the cost of healthcare, and thus to redress the problem at hand.

In February 2003, NJ doctors went on strike to protest the state’s skyrocketing malpractice insurance rates. Insurance companies claimed that rates had climbed due to the staggering number of medical malpractice suits that year. The incident attracted the attention of Americans for Insurance Reform (AIR), who launched a comprehensive study of New Jersey medical malpractice insurance. The results were conclusive: The average NJ medical malpractice attorney, “already demonized by President Bush in his demand for tight tort reform,”[1] was not at all the thief that insurance industry lobbyists made him out to be, and neither was his client.

AIR’s conclusions were twofold: First, that payouts for New Jersey medical malpractice suits had remained fairly constant over the previous sixteen years; and second, that premiums charged to doctors had little or no correlation to payouts rendered. This incongruity underscored the falsity of  insurance industry claims that premiums had risen as a result of payouts rendered. The discovery sparked further investigation, which revealed to the real instigator of insurance rate change: The economy.

In times of economic instability or uncertainty, the Fed cuts interests rates, thereby reducing the amount of investment income seen by insurance companies. Because insurance companies derive the majority of their profits from this investment income, they are forced to hike insurance premiums to compensate for losses. AIR’s study concluded that NJ premium hikes, occurring at intervals of roughly every ten years (in the early 70s, 80s, 90s, etc.), directly corresponded to such Fed interest rate cuts.[2]

This revelation led to the investigation of several other myths concerning medical malpractice litigation. A 2006 study conducted by researchers at Harvard University, for instance, concluded, “Portraits of a malpractice system that is stricken with frivolous litigation are overblown.”[3] The truth is in the numbers: Compared to the estimated 238 thousand deaths that occur each year as a result of preventable medical errors (including birth injury) the justice system awards only 38 thousand payouts—if anything, the issue here is the abundance of medical errors, not the number of victims compensated. Moreover, according to the Congressional Budget Office,[4] these payouts amount to less than two percent of the overall cost of healthcare—not exactly the driver of healthcare costs that lobbyists made them out to be.

But healthcare cost is not the only argument insurance industry lobbyists use to push for settlement caps—there are a variety of other reasons, they say. Amongst them, that doctors flee or retire early in states where settlement caps have yet to be instituted; and also, that doctors who choose not to flee or retire early practice “defensive medicine,” or order superfluous tests and procedures to avoid negligence suits, and thus unnecessarily inflate the cost of healthcare. It’s no surprise that these claims, too, are false.

Doctors are not fleeing the profession, nor are they avoiding states without settlement caps.  Recent studies have shown that the number of doctors nationwide is increasing faster than the population, and what’s more, that “the ratio of doctors to population is higher in states without caps.”[5]

Though investigations into the practice of defensive medicine have yet to reveal its prevalence in the field, the reasons for its implementation (if and when it occurs) are clear: Doctors who practice defensive medicine do so either out of genuine concern for patients or as a means of bolstering income. Private practices in Florida came under close scrutiny, for instance, when “health authorities determined diagnostic-imaging centers and clinical labs were ordering additional tests because the majority were physician-owned and the tests provided a lucrative stream of income.”[6] In fact, an article published in the Cornell Law Review found that fear of medical malpractice insurance was the reason for the implementation of defensive medicine less than one percent of the time.

Settlement caps on malpractice suits fail to address the problems insurance industry lobbyists say they do. Why would they push for them? Because the insurance companies are the ones responsible for paying the settlements. These companies have gone through great pains to concoct and spread myths regarding not just New Jersey medical malpractice litigation, but medical malpractice litigation nationwide. One thing remains clear, however: Medical negligence infringes on the American citizen’s right to life liberty, and the pursuit of happiness and must therefore be stopped. When malpractice results in a birth injury like cerebral palsy, it’s not just the child who suffers, it’s the child’s entire family. In such cases, the damage is limitless—so too should be the punishment.

[1] “The Doctor is out in NJ.” The New York Times 02 Feb 2005 Web.27 Jun 2009. http://www.nytimes.com/2003/02/05/opinion/the-doctor-is-out-in-new-jersey.html.

[2] “Medical Malpractice Insurance: Stable Losses/Unstable Rates in New Jersey.” Jan 2003 Web.27 Jun 2009. <http://www.centerjd.org/air/issues/StableLossesNJ.pdf>.

[3] David M. Studdert, Michelle M. Mello, Atul A. Gawande, Tejal K. Ghandi, Allen Kachalia, Catherine Yoon, Ann Louise Puopolo, Troyen A. Brennan, Claims, Errors and Compensation Payments in Medical Malpractice Litigation, New England Journal of Medicine, 354;19, May 11, 2006.

[4] Limiting Tort Liability for Medical Malpractice, Congressional Budget Office, January 8, 2004.

[5] “AMA Data: Doctors Not Fleeing The Profession.” American Association for Justice Web.27 Jun 2009. <http://www.justice.org/cps/rde/xchg/justice/hs.xsl/8691.htm>.

[6] “AMA Data: Doctors Not Fleeing The Profession.” American Association for Justice Web.27 Jun 2009. http://www.justice.org/cps/rde/xchg/justice/hs.xsl/8691.htm.

Written by Nick Bakshi

Surgical Mesh, used to treat Pelvic Organ Prolapse and Stress Urinary Incontinence, can cause Serious Complications

Wednesday, February 16th, 2011

Between 2003 and 2006, over 35,000 women were treated for female stress urinary incontinence with the implantation of an ObTape vaginal sling, manufactured and designed by Mentor Corporation. The sling was designed to support weakened pelvic muscles at the bladder and urethra to prevent involuntary leakage. Due to a defective design, slings were manufactured with a non-woven surgical mesh that blocked nutrients and oxygen from passing through, potentially causing serious complications that will surface months or even years after the procedure. A study, published in the “Journal of Urology” in October, 2006, reported that more than 13% of women who received the Mentor Sling for incontinence suffered vaginal extrusions.  There were also a number of cases involving chronic vaginal discharge and abscess. Following the release of this study, some medical institutions stopped using the device.

In a letter to healthcare practitioners issued in October, 2008, the FDA reported that in the last three years they have received over 1000 adverse reports from surgical mesh manufacturers on complications associated with mesh devices implanted transvaginally to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The most frequently reported complications include:

  • Erosion through vaginal epithelium
  • Infection
  • Urinary problems
  • Recurrence of prolapsed and/or incontinence
  • Perforation of bowel, bladder or blood vessel during insertion
  • Vaginal scarring
  • Mesh erosion
  • Severe pain and discomfort

Treatments for various complications include IV therapy, blood transfusions, drainage of abscesses and additional surgeries to remove the mesh. Specific characteristics of patients who may be more at risk for complications are still unknown but several factors may contribute to the erosion and extrusion of the sling which include the size and placement of the sling, bacterial infection, incompatibility, attachment of sling to mobile structures, and the material of the sling. Solid or excessively woven materials were associated with higher instances of complications than meshed slings, most likely because they are not porous enough to allow tissue and capillaries to grow though and be fully incorporated into the body.  

The FDA recommended physicians to be vigilant of potential adverse events and to inform patients about the serious effects of complications that may alter the patient’s quality of life. Symptoms of complications from sling surgery include:

  • High fever
  • Vaginal pain
  • Pelvic pain
  • Pain during intercourse
  • Chronic infections
  • Perineal cellulitis
  • Severe pain in the back, hips and legs

Any individual who is experiencing symptoms of complications from sling surgery should contact a healthcare professional immediately.

Pregnant with H1N1

Wednesday, February 16th, 2011

Studies have shown that women who are pregnant may be more vulnerable to H1N1 due to body changes that occur during pregnancy.

Results from three new studies, published in the Journal of the American Medical Association, on critically ill patients who contracted H1N1 showed that for some people H1N1 was only a mild case of the flu, while for others it was a life threatening condition that required aggressive treatments in intensive care units. The condition of the patients observed in the JAMA studies deteriorated rapidly soon after they were hospitalized.  Their symptoms progressed to respiratory failure, and shock, which led to organ dysfunction and failure. Although only a small number of people who contract H1N1 become severely ill, health authorities are nevertheless concern about an outbreak that can overwhelm the country’s intensive-care facilities. Dr. Anne Schuchat, the Center of Disease Control’s Director of Immunization and Respiratory Diseases, said there was “significant flu activity in virtually all sates,” which she added was “quite unusual at this time of year.”

Dr. Schuchat expressed particular worry regarding pregnant women. A disturbingly disproportionate number of pregnant women were affected by H1N1. As of late August, over 100 pregnant women were hospitalized in intensive care units and 28 had died since the beginning of the outbreak in April. According to federal studies released late September 2009, pregnant women infected with H1N1 were four times more likely to be hospitalized and perhaps are more likely to die from H1N1. Of the 45 deaths reported between April 15 and June 16, 2009, 13% were among pregnant women. All of them had been healthy prior to contracting H1N1 and subsequently developed viral pneumonia, leading to acute respiratory distress that required them to be placed on ventilators.

It is unclear why pregnant women are more susceptible to the more severe effects of H1N1.  However, it is hypothesized that it is due to the immunological shift that occurs during pregnancy, which affects the body’s ability to fight off viruses. Symptoms of H1N1 include:

  • Fever
  • Cough
  • Sore throat
  • Runny or stuffy nose
  • Body aches
  • Headache
  • Chills
  • Fatigue
  • Sometimes diarrhea and vomiting

Maternal fevers during the first trimester increases the risk of birth defects to the child and maternal fevers during labor has been shown to be a risk factor for the development of birth defects such as seizures and cerebral palsy. 

If a woman who is pregnant suspects that she has symptoms of the flu, it is recommended for her to go to the emergency room or contact her healthcare provider immediately.

Post-Claim Underwriting: A Dangerous New Trend

Tuesday, February 15th, 2011

When 59-year-old Robin Beaton was diagnosed with Invasive HER-2 Genetic Breast Cancer, doctors told her she would need to undergo immediate surgery. At the time, Beaton, who had taken out an individual policy with Blue Cross and Blue Shield in December 2007, believed herself fully covered. You can imagine her surprise then, when the Friday before surgery she received a call from her insurer—her claim had been red flagged.

Several months earlier, Beaton had visited a dermatologist to help treat acne. A word had been written on her chart that did not mean, but could have been interpreted as meaning, pre-cancerous. Due to the size of the claim, Blue Cross launched a retroactive investigation into Beaton’s medical history and, upon discovering the chart, canceled her coverage.[1] (more…)

Zimmer NexGen Knee Implant

Monday, February 14th, 2011

Zimmer NexGen Knee Implant Device Loose After 2 Years.
Should Last 15 Years.

Several Zimmer Artificial Knee Implants Recalled

In December 2010, the FDA announced a recall by joint implant manufacturer Zimmer Inc. of the NexGen Complete Knee Solution LPS Femoral Components. The devices were shown to exhibit a nonconforming internal CAM radius, although not every device was believed to be defective.

In September 2010, a recall was issued for the NexGen Complete Knee Solution MIS Tibial Components. This device was recalled after receiving complaints of loosening that often resulted in patients undergoing painful and expensive revision surgeries.

Rights of Victims

The failure of certain Zimmer artificial joint devices can cause symptoms such as pain, looseness, instability and swelling at the site of the implant, and can ultimately lead to revision surgery. Revision surgery is costly and painful. Recovery takes at least as long as the original surgery, and for many people, this means a detrimental loss of income, on top of extensive hospital bills. Patients who have suffered early device failure, especially that which leads to revision surgery, deserve compensation for the associated physical, financial and emotional losses. Compensation can be obtained by filing a claim against Zimmer with the help of one of the experienced and aggressive personal injury attorneys of Oshman & Mirisola.

Research Discovers Additional Zimmer Implant Failure

As part of the mounting public scrutiny over under-regulated medical devices, prominent medical experts have expressed grave concern over the serious risks associated with another popular Zimmer knee implant device: NexGen CR-Flex. The NexGen CR-Flex Knee Implant is intended for total knee replacement.

Some doctors have found that the porous non-cement femoral component of the device (the part that covers the head of the femur or thigh bone) is prone to high failure rates. Two renowned Chicago orthopedic surgeons—Richard Berger and Craig Della Valle from Rush University Medical Center—argue that Zimmer’s NexGen CR-Flex Knee Replacement devices should not be used on any patient, given their high risk of failure and serious side effects.

It was increasing concern over the NexGen CR-Flex that prompted Berger, a former Zimmer consultant, and Della Valle to conduct research on the implant. The study found that within two years of Zimmer NexGen CR-Flex knee implantation, 36 percent of the implants of study participants were loose and more than 8 percent required revision surgery due to looseness and serious pain. Dr. Berger describes this failure rate as “horrific.”

MDL Consolidation Strengthens Lawsuits Against Zimmer

Those involved with suits against Zimmer regarding certain NexGen knee replacement products have won the right to have their actions consolidated into an MDL (multidistrict litigation). This was an important step for those who have filed claims and those who are considering filing. Now the MDL plaintiff steering committee can help these clients and their cases by working together and sharing information to build a stronger attack against Zimmer.

Have You Been Injured by an Artificial Joint Made by Zimmer?

If you or a loved one has received a failing Zimmer NexGen knee replacement device, you may have a legal case against Zimmer. Please contact the qualified and skilled medical device attorneys of Oshman & Mirisola who will listen to your story and determine the best way to help you receive compensation for medical expenses and lost income, as well as your physical and emotional suffering.

Lack of Safety Testing on Medical Devices in US

According to a New York Times report, US orthopedic medical device makers are not required to submit safety data prior to FDA approval if a similar device has already been approved, making it difficult to determine the true safety of each medical device on the market today. This questionable process, known as 510(k) approval, is considered outdated and unsafe by many experts in the medical device field. As the news report attests, “those with the most to lose [from this lack of safety testing and reporting] are the hundreds of thousands of people who receive an orthopedic device each year.”

 

Tylenol/Acetaminophen

Monday, February 7th, 2011

FDA LOWERS THE ACETAMINOPHEN DOSAGE LIMIT
& PROPOSES BLACK BOX WARNING

On January 13, 2011 the Food and Drug Administration (FDA) lowered the limit of acetaminophen allowed to be included in prescription drugs to only 325 milligrams per dose. The FDA also mandated an update to labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. There is a wide array of both prescription and over the counter drugs that include acetaminophen (see list of drugs at the bottom of this page) and prior to this new limit, many of the prescription medications had up to 750 milligrams of acetaminophen per dose. The FDA also now proposes inclusion of their most severe “Black Box” warning on all prescription products that contain acetaminophen.

Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER) said, “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

TAKING MORE ACETAMINOPHEN THAN YOU KNOW. WHAT IS APAP?

“APAP” is an abbreviation for acetaminophen that many drug-makers use as shorthand in the list of ingredients on their drug packaging. Even if the prior dosage of acetaminophen had been an appropriate amount, it is not uncommon for users to accidentally exceed recommended dosage limits by taking more than one medication that includes acetaminophen at a time without realizing it because they do not recognize that “APAP” is, in fact, also acetaminophen! Some of the most popular drugs that use the abbreviation “APAP” are Percocet, Vicodin, and Tylenol with Codeine, among others. (more…)

Transvaginal Mesh Patch

Monday, December 6th, 2010

In July 2011, the Food and Drug Administration (FDA) issued a safety alert warning of serious complications linked to transvaginal mesh patches. Transvaginal mesh patches (also called surgical mesh) may be used to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). In some cases, complications of the surgical mesh require correctional surgery or symptoms may persist for the remainder of a woman’s life. The FDA announced that thousands of reports of transvaginal mesh complications have been filed.

According to the FDA, implantation of the transvaginal mesh patch may have significant adverse health effects. The most common transvaginal mesh injuries that have been reported to the FDA are:

  • Mesh erosion through the vaginal tissue
  • Pain
  • Infection
  • Bleeding
  • Urinary problems
  • Pain during sexual intercourse
  • Organ perforation
  • Recurrence of prolapse, incontinence or both
  • Neuro-muscular issues
  • Vaginal scarring
  • Vaginal wall shrinkage

The FDA found that the most commonly reported issue was mesh erosion through the vagina. Mesh erosion can be a devastating side effect requiring multiple surgeries to repair. In some cases, the problem may not be reparable by surgery.

Surgical Mesh Equally Effective, But More Risky

After analyzing data from the last 15 years regarding the use of surgical mesh to repair POP, the FDA found that transvaginal mesh is not any more effective than traditional non-mesh methods. Additionally, the FDA announced that the use of surgical mesh presents more risks than the traditional method.

Problems During Implantation

In addition to these post-surgical complications, women may also suffer injuries during the surgical procedure itself. Such transvaginal mesh surgery complications can include puncturing of the bowel, bladder and blood vessels.

According to a 2008 FDA warning, many women experience discomfort and pain after receiving a transvaginal mesh patch to the extent of diminishing her quality of life. In light of these serious risks, the FDA urges all doctors to speak with their patients about these potential risks.

Have You Been Injured by a Transvaginal Mesh Patch?

If you have suffered injuries in association with transvaginal mesh patch, you might be able to seek compensation for your financial expenses, as well as physical and emotional losses and suffering.  To learn more about your legal rights and options after transvaginal mesh complications, please contact our qualified and experienced attorneys.  We can evaluate your case to determine the very best way to help you get the support you deserve.

Overview of the Transvaginal Mesh Patch

During the course of childbirth, or following surgery or a traumatic injury, a woman’s vaginal walls can become damaged.  The transvaginal mesh patch was designed to provide strength and support to the vaginal walls.  This medical device is often recommended for women with any of the following conditions:                  

Stress Urinary Incontinence (SUI): characterized by uncontrolled urination with increased abdominal pressure, which can occur when laughing, sneezing or coughing.

Pelvic Organ Prolapse (POP): characterized by a weakening of the pelvic floor tissues, leading to displacement of the bladder, uterus, vagina, urethra, bowels or rectum.

When these conditions affect a woman, a doctor may recommend a transvaginal mesh patch.  Such mesh patches are surgically implanted into the vaginal wall (also referred to as the pelvic floor by some medical professionals). The procedure is considered minimally invasive; however, women are increasingly reporting problems associated with the surgical mesh itself.

Transvaginal Mesh Injury Solutions

When women experience serious adverse consequences after receiving a transvaginal mesh patch, the medical solutions are often costly and invasive.  Such transvaginal mesh injury solutions include:

  • Surgical repair, often to remove the defective mesh device
  • IV therapy
  • Blood transfusions
  • Drainage of hematomas or abscesses

The solutions to transvaginal mesh patch issues may be pursued alone or in conjunction with one another.  This process is often lengthy, expensive and requires significant recovery time. Some women will never fully heal from transvaginal mesh patch complications.