March 23, 2013

Transvaginal Mesh Defect Results in Multi-Million Dollar Verdict

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.)

Continue reading "Transvaginal Mesh Defect Results in Multi-Million Dollar Verdict" »

March 21, 2013

First DePuy Hip Trial Results in $8.3M Verdict For Plaintiff

There are more than 10,000 lawsuits that have been filed regarding the premature failure and other complications of the DePuy ASR hip replacement system.
Our Boston DePuy ASR hip replacement plaintiff lawyers understand the first of those has set a promising precedent: An $8.3 million verdict in favor of the plaintiff. This verdict is likely to open the door to future settlements in the case with parent manufacturer Johnson & Johnson.

With so many cases pending, the company is likely to want to speed up and resolve the pending litigation. Seeing that plaintiffs are having success in court means it's less costly for them in terms of time and lawyers fees to simply settle a claim before it ever gets to court.

Court documents in this case revealed that Johnson & Johnson, as well as DePuy, were aware of critical design flaws in the product that would result in early failure - years before they initiated a recall on the ASR model. In fact, DePuy knew that the product had failed internal testing as far back as 2007. And yet, according to The New York Times, the company continued to sell the product without disclosing to doctors the results of those tests.

Those internal tests showed that the ASR model was probably going to fail within five years on about 40 percent of the patients who received it. Compared to the failure rates of most other orthopedic implants, the DePuy ASR was eight times higher.

These devices are metal-on-metal, with a metal ball inside a metal pocket. The inherent problem is that the cup had only a small surface area in which the ball could move. In turn, that increased the risk for the ball to grind against the cup, which generates metallic debris and further erosion. The production of debris, additionally, resulted in shards of chromium and cobalt being released into the nearby tissue, which resulted in swelling, inflammation and even poisoning.

In this case, the plaintiff's hip implant was installed sometime in 2007. Immediately after the surgery, he knew something wasn't right. He suffered severe complications, which included extreme pain, difficulty with walking and metallic poisoning. In order to have the device removed and replaced, he had to undergo a risky revision surgery.

It wasn't until August of 2010 - some three years after DePuy and Johnson & Johnson knew about the defects that would lead to situations like this, that the devices were actually recalled, some 93,000 units.

The trial stretched several days, after which the Los Angeles jury awarded the plaintiff nearly $400,000 in economic damages and $8 million in non-economic, or punitive, damages.

Of course, DePuy has announced its intention to appeal. It would, since it's never accepted responsibility. Our Boston hip replacement plaintiff attorneys believe they have little chance at success.

A second trial is underway involving a 54-year-old nurse from Illinois who had the device implanted back in 2008.

Andrew Ekdahl, president of DePuy's orthopedic products unit, testified before a Chicago jury in that case that the reason for the recall was that the revision rate, or the number of patients who had to return for corrective surgery, was "not acceptable."

Continue reading "First DePuy Hip Trial Results in $8.3M Verdict For Plaintiff" »

March 18, 2013

Food Poisoning: Undeclared Nuts Can Prove Deadly

Most people with a severe nut allergy know from a very young age that they must be extremely cautious about any and all foods they consume and products they use, as even miniscule contact could be fatal.
However, our Boston personal injury lawyers know that all too often, problems arise when companies fail to properly note every ingredient in their products. Alternatively, sometimes food manufacturers or restaurants aren't careful in their food preparation, causing cross-contamination to occur.

Even in cases where an individual may not have died from the incident, taking the company to court may help prevent such a situation from ever occurring there again.

Sadly, these kinds of errors happen all the time.

For evidence of this, just peruse the U.S. Food & Drug Administration's recent list of recalled food products. On March 1, the agency recalled some 20 lots of cereal produced by the California-based Food for Life because there were almonds in the cereal that weren't listed as an ingredient on the box. Specifically, the Original, Golden Flax and Cinnamon Raisin varieties were all affected. There haven't been any illnesses reported to date, but affected individuals may not have realized what made them sick - as they wouldn't have suspected cereal that didn't have nuts listed as an ingredient. The boxes were distributed between late last November and early February.

And then just last month, the FDA recalled numerous lots of snack mixes produced in Florida for undeclared peanuts.

Other products the agency has recently recalled for undeclared nuts include:

  • Brownie mix;

  • Coffee;

  • Fruit cereal;

  • Cookies;

  • Candy;

  • Granola bars;

  • Fruit bars;

  • Ice cream bars;

  • Pasta;

  • Pies;

  • Spreads;

  • Chocolate protein drinks;

  • Popcorn.

Severe nut allergies are basically the body's overactive immune response triggered by the allergen. People suffering an episode may have trouble breathing, plummeting blood pressure or an increased pulse rate due to shock.

It's estimated that approximately 200 people in the U.S. die every year due to nut allergies, with about 60 percent of those caused by peanuts. Tree nuts, meanwhile, are another common allergy, meaning those individuals must steer clear of things like almonds, cashews, chestnuts, hazelnuts, macadamia nuts, pecans, pine nuts, walnuts and pistachios.

The problem is that these foods, and their derivatives, are found in so many different products. Those with allergies know they have to carefully screen labels and grill their restaurant servers. But these entities have a responsibility to know what is in the product and to inform consumers.

Undeclared nuts are a top concern to the FDA, due to the fact that they can potentially be life-threatening. Other kinds of undeclared ingredients that are on the agency's top list of inspection priorities for the same reason are: milk and milk by products, eggs, fish and shell fish, soy and wheat.

The most common offenders, according to the FDA, are bakeries, candy manufacturers and ice cream manufacturers.

Other food items in which you might not readily expect to find nuts include: chilis and soups, breads, honey, vegetarian burgers, pasta sauces, marinades and salad dressings.

Continue reading "Food Poisoning: Undeclared Nuts Can Prove Deadly" »

March 16, 2013

Boston Malpractice Cases Could Stem from Painkiller Overdoses

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.

Continue reading "Boston Malpractice Cases Could Stem from Painkiller Overdoses " »

March 13, 2013

Boston Injury Lawyers: Z-Pak Heart Risk Warning From FDA

Given that it's cold and flu season, patients will no doubt be headed in droves to doctors' offices and pharmacies in search of antibiotics - particularly a powerful one called Zithromax, also sometimes called a Z-Pak.
These prescriptions are most commonly used for bronchitis, sinus infections, pneumonia and other respiratory infections. It tends to be more popular than other similar drugs because its potency allows it to be taken for a shorter period of time.

However, our Boston personal injury lawyers have learned that the drugs are also now tied to a sudden deadly heart problem. That's according to a recently-concluded 14-year study conducted by Vanderbilt University researchers in Tennessee.

The risk was reportedly relatively rare, but surprising, and not one that has been advertised by distributors or warned about by doctors or pharmacists.

Researchers looked at outcomes for nearly 550,000 patients who were given Zithromax between 1992 and 2006. Of those who took the five-day treatment, there were approximately 30 heart-related deaths. That was more than double the rate of what patients who had taken other antibiotics - or no antibiotics - had suffered.

So per 1 million Z-Pak patients, researchers estimated about 85 would be at risk for a sudden heart death, compared to 32 among patients who took amoxicillin and 30 among those who took no antibiotics at all. To put it another way, there would be 47 more heart-related deaths among those patients given Z-Paks versus those given amoxicillin.

Researchers said they controlled for heart risks, meaning that those in each category were no more at risk for a heart complication or problem than those in any of the other groups.

Although the risk at first glance may appear to be relatively low, consider that some 40 million people in this country are prescribed the drug annually. That means that on average, we're talking about 3,400 deaths a year from sudden heart problems caused by this drug. That is a significant number.

Those with existing heart complications undoubtedly should be steered away from the drug, as should those with lower-than-normal levels of magnesium or potassium in their blood.

Doctors worry what the longer-term effects might be of this news, and whether there are other potential risks involving the drug that we don't yet know about. Z-Paks, which are marketed by Pfizer Inc., have only been around for about 20 years, which means we may yet have a lot to learn. Sales last year alone for the drug topped nearly $465 million.

There has been past research that has shown that Z-Pak's might benefit people who have severe lung disease, but in light of this new information, it's not clear whether those individuals should continue to take it.

In response to the study, which was recently published in the New England Journal of Medicine, federal authorities with the U.S. Food and Drug Administration have issued a formal notice to doctors. Additionally, the agency announced that new labels warning of the risk would be added to the prescription bottles, so they could be easily read by patients.

Continue reading "Boston Injury Lawyers: Z-Pak Heart Risk Warning From FDA" »

March 11, 2013

Dorchester Pedestrian Accident Injures Two Children

An unfortunate accident in Dorchester left two children seriously injured. According to the Boston Globe, the man is being charged for driving under the influence.

The at-fault driver reportedly struck the children as they attempted to use the crosswalk at the intersection of Dorchester and Talbot avenues at about 6:00 p.m. Accident reports indicate that the 28-year-old drive appeared to be intoxicated and he failed a number of sobriety tests. He has been charged with negligent operation of a motor vehicle, operating under the influence of drugs and operation after license suspension. The child pedestrians were transported to Boston Medical Center.
Our Boston personal injury attorneys understand that our child pedestrians are most at risk. Whether drivers are intoxicated or not, many of them overlook children. To make it even worse, these young pedestrians don't always understand the workings of traffic and unknowingly put themselves at risk. Sit down and talk with the child in your family and make sure they know how to act near vehicular traffic -- their safety relies on it.

According to SafeKidsUSA, there were close to 400 children under the age of 14 who were killed each year since 2000 in pedestrian accidents. In 2009, there were about 244 child pedestrian fatalities recorded in the U.S. In addition, there were close to 15,000 child pedestrians injured in these same scenarios. Although this number is on the decline, we're still losing way too many of our youngsters.

With spring break approaching, our children are going to be spending more time outside and spending more time in dangerous situations. The maturity level of children under the age of 10 makes them less able to correctly gauge road dangers and renders them at greater risk for injury and death.

Talk to your child about always using a crosswalk or a street corner to cross the road. Make sure they know to look in all directions before stepping out. They need to know to never assume that a driver sees them. Always make sure that children make eye contact with drivers before attempting to cross.

When you're walking with your child, make sure to hold their hand. This goes for sidewalks, when crossing the street and even when walking in parking lots.

You should always beware when sending children to the bus stop. Make sure they know to wait at the bus at least 5 giant steps from the roadway. Make sure they're in bright clothing so that motorists can see them more easily. If they've got to walk along a road that has no available sidewalks, make sure that they know to walk facing oncoming traffic as far from cars as possible. You also want to teach them that this is no time for horseplay. Always stay aware of your surroundings.

Continue reading "Dorchester Pedestrian Accident Injures Two Children" »

March 9, 2013

Boston Child Injury: CPSC Releases Tougher Play Yard Standards

If there's a young child in your household -- Listen up! Officials with the Consumer Product Safety Commission (CPSC) recently released new standards to help to keep children safe in play yards.

Play yards are those framed enclosures that have a solid floor and fabric or mesh for side panels. They can be folded for storage or for travel. They can also be dangerous for your child.
Last month, CPSC officials announced new standards as a part of the Danny Keysar Child Product Safety Notification Act. It's also called "Danny's Law" and it was named after a young child who was killed back in 1998 in Chicago while he was napping. He was napping in one of these play yards when it collapsed and he was suffocated. The Act is working to make sure that this doesn't happen to another family.

Our Boston child injury lawyers understand that these devices are designed to offer our children a safe place to play and nap. Unfortunately, many of the designs are faulty and can serve up some serious dangers to children. With the new standards, the design should be safer and should provide parents with more peace of mind.

New Standards for Play Yards from the CPSC:

-Play yards must have safe rails. They can't have rails that have sharp edges that can cut children.

-They're required to have stronger brackets. These brackets are to help to prevent any kind of sharp edges or cracks to prevent a collapse.

-The mattresses are to be sturdier. The attachments that keep the mattresses to the floor are also required to be sturdier. This is to help children from getting trapped, suffocated or sustaining other injuries.

There are other things that parents can do to help to ensure their child's safety while in play yards and in cribs. These safety precautions start with the items you place in with the children. You want to be careful of the pillow and blankets you offer your child. We want them to be comfortable, but we want them to be safe.

Officials with the CPSC estimate that there were about 700 children under 12-months who were killed from 1998 to 2010 because of the pillow and blankets that were in their cribs and sleep environment. The safest way to allow your child in a crib is with no pillows, no heavy quilts, no thick blankets, no pillow-like stuffed toys or other large stuffed toys and no child carrying devices, recliners or sleep positioners.

Be cautious of what you offer your child in their crib or play yard. Sometimes, the soft and comforting items can quickly turn deadly.

Continue reading "Boston Child Injury: CPSC Releases Tougher Play Yard Standards" »

March 7, 2013

Boston Injury Lawyers Note FDA Injunction Against Ohio Cancer Drug Maker

The federal government has issued a permanent injunction against an Ohio drugmaker for numerous violations related to cleanliness, appropriate practices and investigations.lab.jpg

Our Boston personal injury lawyers know that the U.S. Food and Drug Administration has really given Ben Venue Laboratories Inc. more chances than it ever deserved to get its act together. That the FDA has taken such a strong stance in actually shutting down operations speaks volumes not only of the severity of violations here, but also of a repeated and blatant unwillingness or inability to address these problems.

The FDA has a list of minimum requirements that drugmakers have to meet in order for operations to be considered abiding by good manufacturing practices. The end goal is that the companies will ensure both the purity and quality that the company advertises is actually what patients are getting.

These minimum requirements include things like sterile work environments, efforts to minimize contamination and proper training and protocol for staffers. Drugmakers really should be going above and beyond these standards, as they are a minimum.

But Ben Venue, a primary manufacturer of certain cancer drugs, including Doxil, apparently couldn't even do that, according to the government, and this move was a long time in coming.

Since February 2002, the firm has had no fewer than 40 recalls of its products and drugs. Ten of those have occurred just in the last handful of years, and France and Germany have actually forbidden Ben Venue's drugs to be sold. About a quarter of those recalls were prompted by reports of serious negative health effects and the risk of death.

Back in 2010, the FDA conducted an inspection of the company and found that a leaking roof caused metal contamination in two different medications. That inspection also reportedly found mold in areas where the drugs were made, equipment that was rusted, glass contamination and a huge bucket in the manufacturing area that contained urine. A number of the medications were found to have been contaminated with bacteria.

This was followed by another inspection in the spring of 2011. Following that, FDA inspectors reported some 48 violations that included untimely and insufficient investigations, failure to prevent contamination of products, inadequate quality control and employee practices that were sorely lacking.

Another month-long inspection at the end of 2011 prompted company officials to voluntarily shut down operations, where some 1,300 people were employed. A number of drugs were also recalled, including those used to treat patients with ovarian cancer, AIDS, viral eye infections and those with myelodysplastic syndromes (bone marrow diseases).

But the halting of operations at the lab created a huge problem: exacerbation of the serious shortage of Doxil, which already had a waiting list of cancer patients hoping to gain access to the drug.

So as part of the injunction, FDA is allowing the firm to continue making Doxil and a few other in-demand drugs, but under an extremely intense microscope and only after adopting a number of corrective actions. Before the firm can fully resume operations, it must:

  • Hire an outside expert to regularly inspect the facility and to conduct batch-by-batch quality control tests;

  • Develop and implement a remediation plan;

  • Undergo an in-depth FDA inspection to make sure that operations are in full compliance with the law.

Unless and until these criteria are met, Ben Venue will not be able to resume full operations.

That it took such severe and repeated violations for the firm to be ordered into compliance is beyond disappointing. Those who have been harmed by Ben Venue's products should contact an attorney to discuss the potential for compensation.

Continue reading "Boston Injury Lawyers Note FDA Injunction Against Ohio Cancer Drug Maker" »

March 5, 2013

Boston Kidney Dialysis Facilities Don't Always Meet the Standards

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. injection.jpg

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.

Continue reading "Boston Kidney Dialysis Facilities Don't Always Meet the Standards" »

March 2, 2013

Medical Residents May Be Dangerously Fatigued

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.

Continue reading "Medical Residents May Be Dangerously Fatigued" »

March 1, 2013

Drugmakers Cutting Down on TV Advertising

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. 1115701_black_and_white_crime_2.jpg

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.

Continue reading "Drugmakers Cutting Down on TV Advertising" »

February 28, 2013

Lawsuits Filed for Dialysis Injury

GranuFlo and NaturaLyte were two products made by a drug manufacturer called Fresenius Medical Care. The products were used in dialysis centers operated by Fresenius as well as at other centers throughout the United States.

Unfortunately, the Fresenius dialysis solutions turned out to be very dangerous products that significantly increased the possibility that a dialysis patient would suffer from cardiac arrest. Our Boston injury attorneys believe that Fresenius was responsible for the deaths that occurred due to its defective and dangerous products and we believe that the company will be held liable in the numerous lawsuits that have already been filed. 778761_heart.jpg

Lawsuits Filed Against Fresenius
Fresenius products were used by thousands of dialysis patients throughout the United States, all of whom were put at risk. The problem arose because doctors were not warned that GranuFlo contains a substance that converts into bicarbonates when it is in the body. The solution, therefore, was not mixed correctly by physicians to account for the extra bicarbonates. Too many bicarbonates can result in cardiac problems developing, including catastrophic heart injuries and even cardiovascular death.

As a result of the improper use of the dangerous GranuFlo and NaturaLyte products, many patients did suffer heart attacks or experience strokes. Because these adverse medical events can be traced directly back to the bad dialysis solutions, Fresenius should be responsible for compensating victims who suffered.

Lawsuits have already been filed across at least eight different states in order to hold Fresenius accountable for what the company did. The lawsuits were filed in states including Ohio, Texas, Florida and California and all allege dosing errors that resulted from the negligence of Fresenius Medical Center.

The patients who suffered the deaths due to Fresenius who have already filed suit range in their ages from 23 to age 89. All have something in common though: they suffered as a result of the use of Fresenius' products and some even died from cardiac arrests or strokes.

These initial lawsuits may be only the tip of the iceberg, as many others who suffered from complications due to GranuFlo and NaturaLyte will likely also take legal action or have already begun the process of doing so. When a product is used as widely as GranuFlo and NaturaLyte, it doesn't just injure a few people but instead injures thousands throughout the country.

All of these plaintiffs normally join together in class actions and/or in multi-district litigations in order to hold the manufacturer of the defective medical product accountable. In fact, on December 12 we discussed a motion that had been filed to establish a multi-district litigation.

Holding Fresenius Accountable
When there are multiple different lawsuits against a single manufacturer based on a single product defect, then the first lawsuit to go to trial is normally very important. This case will be the first to test in court in whether it can be proved that Fresenius is accountable to its patients for injuries. If the trial ends in favor of the plaintiff and a large verdict is awarded, then Fresenius may be much more eager to settle the case quickly and for a fair amount of money for all plaintiffs.

While this can be a desirable outcome for those who have been injured by Fresenius, you should not wait to see how the lawsuits unfold before you take action if you have been hurt. You have only a limited amount of time to file your claim within the statute of limitations and you want to be sure you have a chance to stand up for yourself and to fight to obtain compensation for your own injury or for the loss of a loved one due to the dangerous Fresenius products.

Continue reading "Lawsuits Filed for Dialysis Injury" »

February 27, 2013

Transvaginal Mesh: Manufacturers Ignored Reports of Complications

Transvaginal mesh is a type of surgical mesh product that became a popular choice for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Both SUI and POP are conditions that are caused by muscle weakening and doctors traditionally had to perform surgery to strengthen the muscles. Transvaginal mesh presented an easier alternative by permitting doctors to use the surgical mesh to fashion a sling to hold the pelvic organs in place where they belonged.

Unfortunately, Transvaginal mesh turned out to be far from the easy solution that was promised to patients. The mesh began to cause very serious complications including significant pain for women as well as infections and recurrent POP. Often, revision surgeries were required and the entire process of treating the complications became a painful and expensive one. 1385735_sterilisation.jpg

In light of the many problems, thousands of transvaginal mesh lawsuits were filed, including around 1,800 claims against Ethicon, a manufacturer of Transvaginal mesh and a subsidiary of Johnson & Johnson. The first of these cases went to trial in February and our Boston transvaginal mesh lawyers have been closely monitoring the case as the outcome can affect transvaginal mesh compensation for all injured plaintiffs.

Accusations of Intentional Complications

On February 16, the Herald Online reported an update in the transvaginal mesh case. According to the Herald Online, the attorneys for the plaintiff in the case against Ethicon showed emails and video tapes revealing that Ethicon had ignored reports of complications caused by Transvaginal mesh.

According to the evidence presented, at least one doctor expressed grave concerns about whether the transvaginal mesh products were safe. Ethicon executives, however, apparently ignored these concerns because they were so eager to get their product onto the market and start selling it.

In one of the emails that an Ethicon executive wrote, the doctor expressing concerns was told that his opinion was respected and that Ethicon would be following up. Of course, Ethicon never did follow up and the product was released on the market in order to compete with AMS mesh, a product that was being offered by a competitor.

The Responsibility to the Consumer
The information on the video and in the emails about Ethicon ignoring possible problems with their product is strong information that shows the company should be held responsible for the damages that their product caused.

All manufacturers of products are expected to release only reasonably safe items to the public. In fact, a tough standard called strict liability is used to impose responsibility on manufacturers whenever their products cause harm when used as they should be, regardless of whether a manufacturer was negligent or intentionally did anything wrong.

In this case, Ethicon did more than just fail to identify a potential problem. The evidence indicates that the company had at least one warning that their product caused complications and that they ignored that warning. This is egregious behavior and the company should be responsible for all of the harm they caused to thousands of women.

Continue reading "Transvaginal Mesh: Manufacturers Ignored Reports of Complications" »

February 26, 2013

Facial Surgeries Increasingly Common, as is Error Propensity

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. syringesandvial.jpg

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.

Continue reading "Facial Surgeries Increasingly Common, as is Error Propensity" »

February 25, 2013

Harvard Bus Accident Injures 35 Passengers

There were 35 people who were injured in a recent bus accident in Massachusetts. According to the Boston Globe, the bus was leaving Harvard when is slammed right into an overpass. The bus was heading back to Philadelphia as the bus' driver was trying to navigate his way through some of our busiest roadways.

Reports indicate that the man looked down at his GPS, looked back up and slammed into the overpass.
According to Massachusetts State Police, one person is still in the hospital in critical condition from this accident. Four were hospitalized in stable conditions, one was listen under serious condition and one was scheduled to be discharged over the weekend. Some of the passengers were trapped inside the bus for over an hour.

Our Boston bus accident attorneys understand that the bus did not belong on the road it was traveling on -- Soldier's Field Road. As you may know, this is a major crosstown street where there are signs posted regarding the 10-foot height limit. Over-sized, heavy vehicles are prohibited from traveling along this street, but this didn't stop the Calvary Coach.

Officers are saying that the drivers will likely receive an over-height violation. Massachusetts State Police officers are also looking into how long he was driving that day to see if he was driving longer than allowed under federal law. That might just determine if there will be more serious charges in the case.

The Calvary Coach driver also drives a school bus in Pennsylvania.

Transit officials sent backup buses to the scene of the accident to rescue the passengers and to get them out of the wickedly cold weather.In the collision, there was cosmetic damage done to the bridge and to the road, according to state police. The bus sustained significant damage in the wreck.

You might remember the accident that happened in Syracuse back in 2010. This accident was alarmingly similar as that driver also looked down at the GPS and slammed his bus into an overpass. Four people were killed. The driver was acquitted of homicide charges. He was also accused of being overly sleepy behind the wheel when that accident happened.

The truth of the matter is that there are no excuses for these kinds of accidents.

It's important that travelers who turn to busing companies do their research before choosing a company. You can do this easily by checking out the Federal Motor Carrier Safety Administration's (FMCSA) SaferBus app. Don't risk your life or the lives of others by making an uninformed decision. Through this app, you can get immediate information on a busing company's safety ratings complaint records and performance records. It's available all day every day so there's no excuse not to use it. Safety should be your number one priority when choosing a company. And remember, the cheapest bus ticket might not always be your safest choice -- and you can't put a price on your life.

Continue reading "Harvard Bus Accident Injures 35 Passengers" »