Understanding Pelvic Organ Prolapse

Hundreds of women who received mesh to treat pelvic organ prolapse (POP) are suing manufacturers and physicians for injuries suffered as a result of the procedure.  As the focus on damage caused by improper treatment intensifies, the interest in what causes POP continues to grow.  What exactly is pelvic organ prolapse?

Symptoms of pelvic organ prolapse

For women, the relaxation of ligaments and muscles in the pelvic region sometimes allows for the intrusion of the bladder, colon, or uterus into the vagina. Upper vaginal tissue can also bulge into the lower vaginal area.  By one estimate, 40 to 70 percent of all women suffer some form of pelvic floor weakness during their lives.

Symptoms of POP are varied and include:

  • A sensation of pressure, or a protrusion, in the pelvic region
  • Bulging in the vaginal or perineal area
  • Urinary incontinence, or frequency or urgency of urination
  • Straining to defecate
  • Painful intercourse
  • Pelvic or lower back pain

Pelvic floor muscles weaken with age, leaving connective ligaments to support internal organs.  When ligaments weaken, tissue presses into the vaginal wall.  POP is more likely to occur following multiple vaginal births, after menopause, or as the result of obesity.

Treatment of POP

Mild cases of POP are treated with Kegel and other exercises designed to strengthen pelvic floor muscles. A pessary, estrogen supplements, or laparoscopic surgery can reduce or resolve symptoms.

Pelvic organ prolapse is relatively common and usually treatable. If you have suffered injury from implanted transvaginal mesh treatment for POP, be sure to seek experienced legal advice concerning your legal options.

Understanding the Black Box Label on Your Meds

Whether by need or by choice, many Americans look for health in a bottle.  According to the Centers for Disease Prevention and Control (CDC), in any given month during the three-year period from 2005 to 2008, almost 50 percent of the population took at least one prescription drug. With the steady increase in prescription drug use since that time, the percentage has risen alarmingly.

The U.S. Food and Drug Administration (FDA) is a federal agency charged with safeguarding public health through the regulation of food, drugs, medical devices and other products affecting the physical well-being of Americans.

As part of regulating pharmaceuticals, the FDA oversees the labels affixed to prescription drug containers.  A boxed warning or black box is the strongest alert or warning used by the FDA. It indicates that a drug meets one of the following criteria:

  • Given the possibility of a serious, potentially fatal adverse reaction, the benefit of the drug must be weighed against the risk
  • The risk of a serious drug reaction can be reduced or prevented by proper use
  • The FDA concluded that the drug is safe only in restricted use

In 2007, the FDA announced a boxed warning on the thiazolidinedione category of drugs, including Avandia, Actos, and Duetact. While the 2007 warning addressed the risk of heart failure, the FDA added additional warnings about bladder cancer from Actos in 2011.

Physicians and patients should discuss side effects of newly prescribed medications, although that does not always happen. If the best health outcome for you comes from a bottle, make sure you read the label and understand your risks. If you are seriously injured as a result of prescription drug side effects, you may wish to contact a personal injury attorney at our office for more information about your right to compensation.

Transvaginal Mesh: Never Tested?

Serious complications, loss of sexual pleasure, constant pain: a sad combination. Women who underwent vaginal placement of surgical mesh experience these losses daily, and wonder how this damaging procedure could have been recommended for them.

Our firm is at the forefront of Chicago attorneys aggressively pursuing compensation for victims of transvaginal mesh placement. Injuries from pelvic mesh result from failure of the medical device itself or medical error in implanting the device.

Sorting through accounts of the horrific damage done to women with implanted surgical mesh raises the pointed question of how this procedure was approved by the U.S. Food and Drug Administration (FDA).

In 2008, the FDA issued a public health notification that warned about these devices. In 2011, the FDA issued an update, noting that serious complications are not rare and that the benefits of the procedure are no greater than those of other less dangerous options available to treat pelvic organ prolapse (POP).

In May 2012, the non-profit organization Consumer Reports offered an in-depth article on dangerous medical devices. In discussing transvaginal mesh troubles, the authors detailed the entry of pelvic mesh kits onto the medical market by manufacturers claiming substantial equivalence to previously approved hernia repair kits.

Without recalling the product, the FDA ordered safety studies earlier this year. Since then, Johnson & Johnson subsidiary Ethicon has taken four mesh kits off the market.

In 2010 alone, about 100,000 women received surgical mesh to treat pelvic organ prolapse. The slipshod approval process that led to the unnecessary daily suffering of so many women must be changed — if not by regulation, then by litigation.  If you have suffered serious injury as a result of transvaginal mesh implantation, contact a personal injury attorney in our office to determine if you are eligible for compensation.

Approving Too Quickly? Drug Safety and the FDA

In October, 2010, the U.S. Food and Drug Administration (FDA) approved the drug dabigatran to reduce the risk of blood clots and stroke in patients with atrial fibrillation. Marketed as the twice-daily miracle drug Pradaxa, dabigatran is now suspected in more than 540 patient deaths and thousands of drug injuries.

Side effects of Pradaxa are serious, disabling and potentially fatal. Patients prescribed Pradaxa may suffer internal bleeding, hemorrhage, kidney failure and other disorders. In September of this year, the Journal of the American Medical Association (JAMA) questioned whether the FDA compromised drug safety by approving Pradaxa without more rigorous safety testing.

Quoted in Forbes Magazine, the authors of the JAMA report cited approval of three drugs — one of which was Pradaxa — despite significant, unanswered safety questions.

In a field dominated by warfarin (Coumadin) for decades, Pradaxa is a dangerous option. While warfarin bleeds are treated with infusions of Vitamin K, hemorrhaging caused by Pradaxa has no known antidote.

What about access to improved treatment?  And what about a cursory review of potentially deadly drugs?  In the search for safe treatment of atrial fibrillation, patients injured by Pradaxa might say the FDA moved too fast.

But awareness of the danger of Pradaxa is ever-increasing. The FDA surprised the medical and financial communities in June by delaying the approval of the next new anticoagulant drug, Eliquis. Setting a new approval date of March, 2013, the FDA continues to review drug studies provided by manufacturers Pfizer and Bristol Myers Squibb.

If you have suffered uncontrolled bleeding as a side effect of using Pradaxa, please contact our office to discuss your injuries and your legal options.

Pradaxa Product Liability Update

When introduced by German pharmaceutical manufacturer Boehringer Ingelheim, it was hoped the prescription drug Pradaxa would replace Coumadin, a popular blood-thinning product with a troubled history of serious side effects. Both drugs are prescribed to reduce the risk of stroke in patients with irregular heart rhythms. Unfortunately, however, hopes for Pradaxa as a replacement for Coumadin did not come to fruition.

According to the Food and Drug Administration (FDA), over 1.1 million prescriptions for Pradaxa (dabigatran), were filled between October 2010 and October 2011. However, in 2011 alone, the FDA received reports of around 3,700 adverse drug reactions to Pradaxa. More than 500 deaths were reportedly linked to it.

Approved for sale by the FDA in October 2010 and still on the market, Pradaxa is now the focus of large scale litigation.

As experienced personal injury attorneys in Chicago, our firm helps clients pursue their rights after injury caused by Pradaxa. In recent legal news, the Joint Panel on Multidistrict Litigation (JPML) entered an order consolidating current and future federally-filed Pradaxa cases in the Southern District of Illinois. In reviewing 21 federal cases, the JPML held that:

  • The actions concern common questions of fact
  • Centralization in Illinois serves both parties and witnesses
  • The actions share common allegations of severe bleeding caused by irreversible effects of the anticoagulant Pradaxa
  • Consolidation avoids duplicate discovery, and preserves the resources of  both the parties and the judiciary

Our Chicago personal injury attorneys represent individuals and families injured by Pradaxa.  If you have questions, contact our office about your injury.

The Heart of the Matter — Side Effects of AF Medications

Arrhythmia is a condition in which the heart beats too quickly and irregularly. Atrial fibrillation (AF) is a type of arrhythmia that occurs when disorganized electrical signals cause the upper and lower chambers of the heart to contract or beat too quickly, or fibrillate.

According to the National Center for Biotechnology Information (NCBI), atrial fibrillation is the most common arrhythmia. It increases with age, and differs widely in presentation and severity.  If you have AF, what do you need to know?

The faulty electrical signals underlying AF are caused by both transient and chronic factors, including:

  • Coronary heart disease
  • High blood pressure
  • Drug interactions
  • Stimulants like caffeine
  • Sleep apnea
  • Chronic illnesses such as lung disease
  • Viral infections

With AF, blood pooling in the upper chambers of the heart can clot and lead to stroke. In many cases, a blood-thinning agent is prescribed to reduce that risk.

While the prevention of blood clots is important, established drug Coumadin (warfarin) and new drugs like Pradaxa (dabigatran) have high-risk side effects. With no medical antidote, Pradaxa can facilitate internal bleeding and massive fatal hemorrhaging. Recent disclosure of the dangers of blood thinning drugs has increased the medical and legal focus on patients injured or killed by these pharmaceutical compounds.

Atrial fibrillation poses risks, but so does its treatment. If you suffer from serious drug side effects from blood thinners, get to the heart of the matter with your doctor — and speak with a knowledgeable personal injury attorney.

Actos: Blowing the Whistle

The drug pioglitazone, marketed as Actos®, is prescribed to treat type 2 diabetes. Chemically related to the diabetes drug Avandia, Actos has come under fire in recent years for serious, sometimes fatal side effects.

Representing clients injured by Actos, our attorneys in Chicago provide skilled legal service pursuing compensation for drug-related injury like bladder cancer, macular edema, and heart or liver failure. While money brings some justice, it does not restore health. Many of our clients injured by Actos wonder how much Takeda Pharmaceutical Company knew about the dangers of the drug it marketed to an unsuspecting public.

A 2010 safety announcement from the U.S. Food and Drug Administration (FDA) mentions that one Takeda study found an increased risk of bladder cancer among patients with the longest exposure to Actos. But in a whistleblower lawsuit unsealed this past spring, a former consultant for Takeda claims she was instructed not to accurately report adverse drug events associated with Actos.

In her lawsuit, whistleblower Dr. Helen Gee claims:

  • Takeda purposely failed to report all heart failure cases to the FDA
  • Underreporting the adverse drug effects of Actos aided Takeda after the GlaxoSmithKline drug Avandia was linked to damaging cardiac events
  • Upon revealing her findings to Takeda, Dr. Gee was fired

Actos lawsuits are presently filed in Cook County where the manufacture Takeda is located. We have filed a number of cases against Takeda and expect to file more as people who are affected by Actos seek legal representation. While the question remains about what Takeda knew in 2008, there is no doubt now of the dangers of the prescription medication Actos.  If injured by Actos, be sure to seek experienced legal advice.

How to Know If You Have a Case for Medical Malpractice

Of all types of personal injury cases, medical malpractice can be one of the most difficult to prove. The burden of proof is entirely on the patient to show that the doctor had a duty to treat him or her and failed in that duty. Medical malpractice is also subject to the professional liability standard, which means that the actions of the treating doctor are measured against someone who has similar training and experience. If that doctor would have behaved in the same manner, you may not have a case. You should also keep in mind that a poor outcome for a medical treatment or procedure doesn’t automatically mean that medical malpractice was committed.

Although medical malpractice takes many forms, the following are the most common:

  • Failure to diagnose a condition that another doctor would have diagnosed
  • Surgical errors, such as operating on the wrong body part
  • Improper diagnosis
  • Birth injuries and defects caused by incompetence
  • Pharmaceutical errors
  • Dental malpractice
  • Lab and test result errors

While these mistakes can happen in seconds, they have the ability to impact you for the rest of your life. Mistakes by doctors, nurses, anesthesiologists and other medical professionals end up killing nearly 100,000 people every year.

Phillips Law Offices in Chicago has more than 65 years of experience assisting victims of medical malpractice get the compensation they deserve. Our lawyers interview expert witnesses and do whatever else is necessary to prove that your injuries happened the way you said they did. Attorney Stephen Phillips is the head of the Medical Negligence Committee of the Illinois Trial Lawyers Association and is eager to put his experience to work for you. We invite you to contact our office to schedule a free case evaluation as soon as possible.