Articles Posted in medical malpractice

In the first out of some 2,000 pending lawsuits against Johnson & Johnson and its division Ethicon, a woman was awarded approximately $11 million for the pain she had suffered due to the now-recalled Prolift vaginal mesh.

Our Boston personal injury lawyers were encouraged at the precedent this case sets, though not surprised at all that the companies are vowing to vigorously appeal. They don’t want a verdict like this to stand because that might force their hand in terms of providing a greater incentive to settle future claims, so they won’t incur the enormous cost of a trial on each.

This verdict could have a significant impact not only these manufacturers but others who produced similar defective medical products.

The plaintiff in this case, a 47-year-old nurse from South Dakota, filed suit back in November of 2008 in Atlantic City, NJ.

As you are likely familiar, the mesh was used to treat pelvic organ prolapse. It’s characterized by a portion of the vaginal canal protruding (or prolapsing) from the opening of the vagina. Most often, this conditions happens when the pelvic floor collapses due to childbirth.

It’s a condition suffered by about 316 million women worldwide as of 2010, or more than 9 percent of all women. In the U.S., it’s estimated to be about 34 million women.

In severe cases, surgery, with the implantation of the mesh, was supposed to fix the problem. But the real problem is that these devices in fact weren’t safe. These manufacturers had a duty to know they weren’t safe, and they failed to warn patients and doctors about the issues that were being reported.

In this woman’s case, she suffered almost immediate and near constant levels of pain after having the transvaginal mesh implanted. As a result, she had to undergo another 18 operations in order to repair the abdominal injuries she suffered as a result.

The product was taken off the market completely last year, but it was too late for tens of thousands of woman who had already had the procedures. By that time, the FDA had received some 1,000 reports of adverse events, including pain, infections, erosion, incontinence and even a recurrence of the prolapse.

Ultimately, this woman was awarded $3.3 million in economic damages and $7.8 million in punitive damages.

This sounds like a lot, but consider that J&J has assets totaling $122 billion and a net worth of $65 billion, as of Dec. 31, 2012. This is a drop in the bucket for the company. That’s why they are seeking to aggressively fight this verdict.

No doubt, other manufacturers will as well. (It’s estimated that Endo Health Solutions, another top manufacturer of the mesh, is currently preparing to face some 3,000 lawsuits making similar claims.)
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When it comes to drug addiction, there is little room for doubt in our modern understanding that it is a disease.

As such, those who perpetuate the disease – i.e., the illicit dealers – are sanctioned by society, typically in the criminal justice system. To often, the exception to this are those who are causing the most harm: The doctors.

Our Boston medical malpractice attorneys know that in 2009, some 15,500 people died in this country as a result of narcotic painkiller overdoses. That is a 300 percent increase in a period of two decades. For every death attributable to this cause, there are another 10 treatment admissions, more than 30 trips to the emergency rooms and roughly 830 non-medical users of these substances.

Prescription narcotics cause more deaths today than cocaine and heroin – combined.

The U.S. Food and Drug Administration this month released an open letter to doctors, calling the abuse and inappropriate use of opiod painkillers “epidemic” and a “major public health challenge.”

Some 320,000 doctors across this country wrote prescriptions for at least one opiod last year – most wrote many more. These physicians may not be able to control whether the drug is stolen from the patient or whether the patient turns around and sells it on the street. However, doctors do have a responsibility to be informed about illicit uses. They need to use their best judgment in terms of figuring out who is actually a legitimate patient and who may be an addict or a street dealer. They also have a responsibility to educate their patients about the appropriate use of the drugs, as well as the potential risks and the right way to dispose of them.

We want to believe that most doctors are being cautious and doing the best they can. Unfortunately, there is a lot of anecedotal evidence out there to suggest that is simply not the case. And sadly, many doctors are putting profits ahead of the welfare of both their patients and society at-large.

A recent extensive investigation by The Los Angeles Times found in a review of coroners’ reports that a small number of physicians were responsible for writing a disproportionate number of the prescriptions of people who were ending up dead of an overdose.

In reviewing some 3,735 prescription-related deaths, nearly 50 percent were directly and solely attributable to prescription painkillers. Of those, 0.01 percent of doctors in the area were responsible for 17 percent of the deaths. Four of those doctors had 10 or more patients who had overdosed, with the most being 16 in a four-year time frame.

Some are calling for a review of a doctor every single time a doctor’s patient dies of an overdose. Our Boston personal injury lawyers would certainly support such a move.

What the FDA is asking for is:

• Assurance that doctors have adequate training in opiod therapy;
• Proof that doctors have knowledge of the content of most of the current opiod drug labels;
• That doctors take the time to inform patients about the appropriate use of these drugs and the risks.

All this, in our view, would be just a start.
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As news spread of the dangerous GranuFlo and NaturaLyte products being used in kidney dialysis facilities across the country, our Boston dialysis lawyers wanted to know how our local dialysis centers are rated when it comes to things like cleanliness, mortality, hospitalizations and infections.

Turns out, there is a troubling amount of room for improvement.

News organization ProPublica conducted extensive research into the issue of kidney dialysis safety, publishing a series of articles detailing widespread problems among the nation’s dialysis providers. Reporters also created a database of facilities nationwide, posting periodic updates with the latest inspection reports on each facility, which is searchable by city or zip code.

Here are the basics:

Every year, taxpayers shell out approximately $20 billion to help pay for patients who are on dialysis. That’s about $80,000 a year per patient, mostly through Medicaid. That is more than any other developed country in the world. And yet, the U.S. has one of the highest mortality rates for those in dialysis care.

It’s true that some 400,000 people a year depend on this treatment to keep them alive, as many patients are gravely ill to start. But it’s precisely this latter fact that causes people not to bat an eye when it’s revealed that someone receiving the treatment has died. It’s sometimes chalked up to the pre-existing condition.

But all too often, that’s not the case, and had the treatments been administered appropriately and according to the minimum standards of care, these deaths would have been prevented.

Among some of the common findings by ProPublica’s year-long research, facilities were notoriously lacking in cleanliness. In some cases, there were instances of pests running rampant and blood splattered on walls, floors and seats.

Many of these facilities may be “overseen” by a doctor, but they are run either by nurses or even LPNs or aides, some without any extensive medical training. As a result, needles are routinely improperly injected. When this happens or when the needle comes out during the procedure, the patient is at risk of severe illness and death.

Several facilities have been cited in recent years when patients were exposed to a host of dangerous infections while receiving treatment there. Among those infections: HIV, tuberculosis, staph and hepatitis. One center out of New York was closed when cross contamination resulted in three patients being infected with hepatitis C within just six months. Considering these individuals are already coping with a weak immune system, this kind of thing is truly unacceptable.

But perhaps more disturbing is the fact that so many of these facilities with ongoing problems remain open. One of those, located in Tennessee, had been cited on numerous occasions for things like: inadequate care, dangerous conditions, improper dispensing of certain medications, subpar clinical results and higher-than-expected mortality rates. But it stayed open. Just nine days after an inspection noting those problems, a 66-year-old who came in for treatment was mistakenly given a dose of medication meant to dissolve clots. He died several hours after leaving the center – of a massive brain hemorrhage.

It should not have happened, though the government oversight agency defended its lack of action against the facility by saying that it’s not in the business of shutting these firms down.

In Boston, there are 10 major dialysis centers noted in the ProPublica database. A number of those appear to meet state standards. However, a few have mortality rates that are more than twice as high as both the state and national averages (47 percent compared to 22 and 20 percent, respectively).

Hospitalization rates were an average of 15 percent higher than the national rate, and there were a number of major deficiencies, which are those characterized by widespread or serious problems with care. One facility was noted to have 33 standard deficiencies and four major deficiencies.

Individuals who have suffered from negligent dialysis center care – or those who have watched helplessly as a loved one endured it – should contact our Boston personal injury lawyers today.
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Everyone who has ever known a doctor or who has watched doctor shows on television knows about the medical residency process. The medical residency process is essentially an apprenticeship (and a test of endurance) wherein a medical school student or med school graduate observes and provides care under proper supervision. The purpose is to learn medical techniques and get real-world hands-on practice treating patients. Residents typically work very long hours, often for minimal pay, and may be on call with few vacations or days off for lengthy periods of time.

While long nights and days may seem a rite of passage for new doctors, on February 22, however, the Wall Street Journal addressed the potential dangers created by a system where those providing care are continuously overtired. Our Boston injury attorneys believe that the points made in the Journal are extremely important ones that should give any patient cause to be concerned.

Medical Residents May be Dangerously Fatigued
According to the Wall Street Journal, there was no limit on the number of hours that a medical resident could work prior to 2003. This meant that residents could work multiple 36-hour shifts in could end up getting little or no sleep for days.

To try to address this problem, the Accreditation Council for Graduate Medical Education established a new rule in 2003. The Accreditation Council is the Council that approves and accredits training programs in U.S. hospitals so hospitals must comply in order to remain eligible to train resident physicians. The Accreditation Council’s new rule limited residents to working only 80 hours per week. In 2011, the Accreditation Council then went even further and banned first year residents from working 24-hour overnight shifts.

Some, however, suggest that hours could be cut even further. In Europe, for example, residents are limited to working only 48 hours per week. One argument in favor of imposing a tougher limit more closely resembling the European standard is that cognitive performance is reduced because of fatigue. A person who gets insufficient sleep, in other words, can be just as impaired and have functioning just as interrupted as a drunk driver and probably shouldn’t be making life and death decisions.

Counter-arguments also exist, of course, and were published in the Wall Street Journal as well. The author of the article, for instance, indicates that the cost of further restricting residents hours could be crippling for cash-strapped hospitals. Further, the author suggests that this extra cost might not be worth it since there is no evidence that limits on residents hours actually help people to stay safe. In fact, shorter shifts means more frequent hand-offs of patients from on doctor to another, which creates a continuity problem that can be dangerous.

How to Keep Patients Safe
The top priority in every situation should be keeping patients safe. Unfortunately, it is unclear whether it is best to restrict residents from working too long, thus avoiding the risks of fatigue but increasing the risk of information being lost as a patient transitions from one care giver to another.

It does, however, seem clear that there is some need to limit the amount of hours that a resident works. Whether the limit should stay at 80 or be reduced to a lower number is an area of controversy, but almost all agree that there does need to be some guidelines to prevent residents from providing medical help when they are too overtired to be safe and effective.
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On February 2, 2013, the New York Times published an article indicating that drugmakers were not placing as much emphasis on television advertising as in the past. Our Boston injury attorneys were glad to hear this news, as television ads can encourage patients to push doctors for unnecessary and untested pills that may later turn out to be dangerous.

When a drug is advertised on television, its side effects and serious potential risks are often glossed over or downplayed, although they must be mentioned. Drugs may also be heavily advertised that later turn out to be seriously dangerous to patients. Drug advertising is risky because it encourages those watching the ads to jump into taking a medication without a full understanding. As such, any cuts in advertising on TV could help to keep people safer.

Drug Ads Declining
The New York Times provides some specifics on the decline in the popularity of drug ads on television. According to the Times:

• Spending on advertising name-brand prescriptions on TV has dropped more than 20 percent over the past five-year period. This is a marked contrast in a market that was a fast-growing venue just a few short years ago.
• Drug companies spent an estimated $3.1 billion advertising their products in 2007 according to Nielsen. However, spending fell considerably in 2010 and 2011 in sharp contrast to the advertising push that began when the FDA lifted its regulations in 1997 to allow drug makers to advertise directly to consumers.

The Times also provides some specific potential reasons why drug makers may be slowing down on the advertising. The reasons include:

• Controversy over the ads.
• Complaints from health insurers about the fact that customers were driven to request expensive new drugs.
• Complaints from doctors who also complain that patients pressure them into prescribing new and potentially unnecessary drugs that are heavily advertised.
• The risk that dangerous drugs can more quickly become widespread due to heavy ad campaigns, even if the products are new and untested.

In 2004, the last point was illustrated clearly when Vioxx had to be withdrawn from the market. Vioxx had been very heavily advertised before studies revealed an increase risk of strokes and heart attacks for those on the popular medication. Merck had to pull the drug from the market, but the damage was done and many people were hurt solely because they requested a drug that had been so widely advertised on TV.

Why Drug Ads Are Dangerous
Drug ads are very risky because they are most likely to be for new and potentially untested drugs. The longer a drug is on the market, the more problems come to light and the more confident patients can be that the side effects are well-known (but the less interest in ads there will be, especially if a generic version is available and the drug is no longer a big money-maker).

When a brand new drug is released and suddenly everyone is taking it or asking for it because it is so heavily advertised, then it may start to replace older and safer products. A larger group of people may take the new – and dangerous- drug before any side effects become known and more people could be hurt if it later turns out that the drug was harmful.
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Our Boston medical malpractice attorneys are seeing a shift in the kinds of clients who seek legal help for mistakes caused by their cosmetic surgery/procedure providers.

It’s in line with the trend recently reported by the American Society of Plastic Surgeons. Last year – for the first time in half a dozen years – the number of breast and buttocks augmentations are actually down, while facial surgeries, injections and laser procedures are on the upswing.

Primarily, this is being attributed to the fact that cosmetic surgery patients are skewing older these days. A big part of this is the aging of the baby boom generation. People in their 50s and 60s are less likely to be interested in breast augmentations and more likely to be concerned with smoothing their facial wrinkles and fine lines.

There is, of course, nothing wrong with this, and it’s a major confidence booster to many who undergo these procedures successfully. What’s troubling to us is that these “less invasive” procedures – namely injections and laser treatments – are being colored by providers as somehow being without significant risk. This is not true, and that kind of message is dangerous on two fronts. First of all, patients should be informed of all potential risks anytime they submit to a procedure, whether it’s elective or not. Secondly, regardless of whether a doctor has adequately informed you of the risks, you have a right to expect that he or she has the education, skills and appropriate tools to conduct the procedure without harm.

Too frequently, that’s not what we’re seeing.

Breast augmentations, which remain the most popular cosmetic surgery with about 285,000 women undergoing it last year, has actually dipped by about 7 percent. Buttocks augmentations, dropped by about 35 percent in the last year.

But overall cosmetic procedures saw a 5 percent rise, with about 14.5 million people seeking out either surgery or injections or laser treatments last year.

The latter of these are increasingly the norm, as a growing number of baby boomers are seeking out these kinds of services.

Of course, we all know surgery has its risks – infections, hematoma, numbness, anesthesia complications, even death (though thankfully, that last one is fairly rare). One of the best ways to reduce that risk is to choose a surgeon who is board certified by the American Board of Plastic Surgery.

With facial surgery in particular, there have been problems with things like:

• Visible scars;
• Facial paralysis or palsy;
• Speech problems;
• Breathing problems;
• Damage to muscles;
• Eye drainage problems;
• Infections.

But there are problems with those injection and laser treatments too.

Sometimes referred to as “skin resurfacing,” laser treatments have been known to result in blistering that can cause permanent scarring. They have additionally been associated with infections and even permanent skin discolorations.

Botox injections, meanwhile, have been known to result in paralysis in some cases. There is also the possibility of an allergic reaction or botulinum poisoning. Either of these can result in severe complications, from respiratory and breathing trouble to paralysis.
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