Understanding the Problems with Compounding Pharmacies

The job of a compounding pharmacy is pharmaceutical compounding, which essentially means creating a specific pharmaceutical product in order to meet the medical needs of a specific patient. The industry's initial role was to combine or to process appropriate ingredients in order to meet a medical need. For example, if a patient required a specific dose or combination of medications, if flavors needed to be added to a drug, or if medication needed to be changed from a solid to a liquid, a compounding pharmacy would do this job. 1034029_medicine_2.jpg

Compounding pharmacies, when they first began, operated on a relatively small scale. A doctor might prescribe a specific drug to a patient that did not already exist in the specific necessary form or dose. The compounding pharmacy met that need. This was especially common for parenteral medications or intravenous medications.

The industry, however, evolved over time into something much different than a small pharmacy meeting the needs of specific patients. Unfortunately, our Boston defective drug attorneys know that the regulatory system did not evolve with the industry. As a result, compounding pharmacies weren't properly regulated, pharmacies got negligent or careless, and people started dying.

Compounding Pharmacy Problems

As the number of medications grew and as drug shortages and rising costs started to become problems, compounding pharmacies morphed from small retail or boutique pharmacies to major manufacturing operations. Instead of just mixing drugs for specific patients or to meet a specific need, compounding pharmacies started to manufacture drugs on a massive scale and to sell those drugs across state lines. The compounding pharmacies weren't pharmacies at all but were drug manufacturers by another name.

Unfortunately, the regulations didn't change as compounding pharmacies did. The pharmacies were originally regulated by state boards responsible for overseeing pharmacies. The Food and Drug Administration (FDA), which regulates drug manufacturers, didn't have authority over the compounding pharmacies. State boards, however, also didn't really have any control over the major compounding manufacturers who were producing drugs on a massive scale. Further, state pharmacy boards weren't really qualified to handle regulating and overseeing these massive drug manufacturers.

The result of this was that no one was really watching what was going on in these compounding pharmacies. Some Democratic lawmakers tried to change that in 2007 but weren't successful and compounding pharmacies just continued to produce drugs with little oversight.

Then, however, the problems started. According to the American Society of Health-System Pharmacists:

  • Five patients developed an eye infection after being administered bevacizumab that Clinical Specialties Compounding Pharmacy had repackaged.
  • More than 50 people died and another 700 or so were injured when New England Compounding Center sent out drugs to more than 20 different states that had been contaminated with a fungus.
  • A compounding pharmacy called Med Prep Consulting sent out 50-mL bags of magnesium sulfate in a five percent dextrose injection that contained mold. Fortunately, an employee at the Connecticut hospital that received the drugs noticed the mold floating at the top.

These problems will be just the tip of the iceberg if someone doesn't step up and start overseeing what compounding pharmacies are doing. The Senate has introduced another bill to vest authority in the FDA, but it is not yet clear if this bill will actually pass or if compounding pharmacies will be free to continue wrecking havoc on unsuspecting patients.

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DePuy Hip Implants Causing Problems Across the Globe

DePuy is one of several manufacturers who produced and sold metal-on-metal hip implant products to patients who needed a hip joint replaced or resurfaced. Unfortunately, the DePuy metal-on-metal hip implant product did not live up to expectations. The metal-on-metal replacement joints have a high fail rate that necessitates surgical correction for many patients within five years or less from the original surgery, and the implants also are causing complications including metal toxicity and significant pain. 1036605_lap.jpg

Our Boston medical malpractice attorneys know that DePuy Manufacturing has been under fire in the United States for a long time with thousands of lawsuits filed against the company, many of which are moving forward in multi-district litigation in federal court. However, what people in the U.S. may not know is that they aren't alone. DePuy hip implant products were sold not just in the United States but throughout the world. As such, DePuy is facing litigation on many fronts.

DePuy Hip Implants Causing Global Problems

DePuy, a unit of Johnson & Johnson, has been waging legal battles in the United States and NJ.com recently reported that more than 10,750 lawsuits have been filed based on the DePuy ASR XL hip replacement product. The lawsuits have been filed in state courts throughout the U.S., and there are both individual lawsuits ongoing and federal lawsuits including consolidated multi-district litigation cases.

The news has been up-and-down for DePuy with the ongoing lawsuits, with the plaintiff winning the first bellwether trial and Johnson & Johnson winning the second. The bellwether trials are essentially test trials, the outcomes of which can determine whether DePuy settles other pending cases and for how much. The bellwether trials are important as they may be determinative of the outcome of U.S. cases pending against Johnson & Johnson as a result of the DePuy hip replacement products.

These trials, however, are not the only thing for DePuy to worry about. The company did not restrict its sales of hip replacement devices to the United States and there are people in multiple locations throughout the world who are experiencing problems as a result of trusting the DePuy products.

Recently, for example, ENCA revealed that there are thousands of South African residents who are coping with problems caused by defective DePuy hip replacement devices. Those in South Africa who have been affected by the defective medical device want their day in court too and now there is a good chance they will get it.

This is made possible because lawyers have been given the go-ahead to sue the British company that made the implants. Now, nearly 200 South Africans are already demanding damages from DePuy due to botched hip replacements that are causing complications including almost constant pain.

DePuy will have to respond to the lawsuits brought by the 200 South Africans who are suing, along with responding to the claims made in the United States and elsewhere in the world. Hopefully, DePuy will accept responsibility for its actions as people throughout the world suffer the consequences, and will step up, do the right thing and fairly compensate victims for their injuries.

Unfortunately, DePuy doesn't seem eager to right the wrongs caused by its dangerous products and injured victims will need to do everything possible to protect their rights and get their money from DePuy for their losses.

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Congress Finally Considering Action on Compounding Pharmacies

In 2007 Senator Pat Roberts and Senator Edward Kennedy attempted to pass legislation to expand the power of the Food and Drug Administration (FDA) to regulate compounding pharmacies. Compounding pharmacies where medications are mixed or altered fell into a regulatory gap where it wasn't really clear whether the FDA or state boards of pharmacies were in charge of oversight and safety compliance. The 2007 legislation would have changed that, but Congress failed to pass it. 1342025_medical_equipment.jpg

Unfortunately, the consequences of the lack of oversight and the consequences of the regulatory gap became far too clear in recent months when contaminated drugs from New England Compounding Center (NECC) caused more than 50 deaths and made more than 700 Americans sick. Our Boston injury attorneys know that the lack of oversight played a direct role in contributing to the deaths and injuries caused by deadly fungal infections in patients taking drugs from NECC. Something needs to be done to prevent this from happening in the future and the Senate is now trying again to take action.

Senate Considers Expanding FDA Regulatory Authority
According to the Boston Globe, the Senate recently introduced a bill intended to prevent future outbreaks like the one caused by the contamination at NECC. The legislation proposing rule changes is bipartisan and was drafted with support from Democrats and Republicans on the Senate Health, Education, labor and Pensions Committee.

The legislation would make clear that large compounding operations -- called compounding manufacturers -- are subject to direct federal oversight by the Food and Drug Administration. Traditional small compounding pharmacies would continue to be regulated by state pharmacy boards but would still be subject to new federal standards on the ingredients used. Traditional small compounding pharmacies that will remain under state control include pharmacies that mix or produce medication for a specific patient to match a specific prescription.

The bill identifies "compounding manufacturers" who are subject to federal oversight as pharmacies that produce injectable drugs without patient-specific prescriptions from physicians. To be considered a compounding manufacturer, the compounding operation would generally have to ship across state lanes.

This bill will make clear exactly what role the FDA plays in regulating and monitoring compounding manufacturers, which had previously been undefined. The issue is that these manufacturers became much bigger and took on a different role than anyone had originally anticipated. Thus, they need to be more tightly regulated because their new role means that serious and widespread injury can result when a mistake is made.

Now that the bill has been proposed, hopefully it will actually make it through both the Congress and will become law. Unfortunately, several Democrats in the House of Representatives who introduced similar laws have not been successful as Republicans in the House have shown little interest in moving the measures forward.

Hopefully, this Bill will not meet the same demise as the 2007 bill and lawmakers will actually be able to do something to prevent another tragedy occurring like the outbreak caused by the New England Compounding Center's negligence.

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Sharing the Road and Riding Safely -- A Group Effort in New England

According to a recent poll, about a third of Massachusetts residents feel that bicyclists, pedestrians and drivers interact with one another safely.

The Metro West Daily News reports that close to 50 percent of these people said that more bike lanes would be more effective in helping to keep these two-wheeled travelers safe out there. About 30 percent support efforts to improve enforcement of existing laws or pass stricter laws.
This survey was conducted just before a series of events focused on the way drivers, bicyclists and pedestrians share our roadways. It was all a part of the "Right of Way" series that kicked off on Sunday.

"As more commuters and hobbyists are leaving cars in the garage, drivers, bikers and pedestrians are forced to share more of our local roads," said Linda Polach, executive producer of WGBH.

Our Boston personal injury lawyers understand that everyone has a right to be there. And as we start seeing more and more bicyclists and pedestrians out there, we have to raise awareness in drivers about their presence and their vulnerability. The new series will be showing on WGBH and GateHouse Media's Wicked Local. it will be on air, in the papers and even on the radio. Don't forget the internet -- it'll be there, too!

In 2010, there were close to 11 pedestrian fatalities in the state of Massachusetts, according to the National Highway Traffic Safety Administration (NHTSA).

There were also close to 10 bicyclists killed in Massachusetts in 2011. These accidents accounted for close to 2 percent of all the traffic accident fatalities. Unfortunately, that's a number that's one the rise.

With that being said, you might think that bicyclists have it easy out there since they didn't see nearly as many fatal accidents as pedestrians. But you'd be wrong. The reason these statistics look as they do is because typically we see more pedestrians than bicyclists. But as the warm season rolls in, that could soon change. More residents and visitors are hopping on two wheels, without worrying about the headaches of maneuvering a motor vehicle on our busy city roadways.

We're just not doing our part to pay attention. Many times, we rely on others to see us and to always yield to us. The truth of the matter is that we need to be one move ahead of everyone else -- ready to elude danger when it strikes.

Officials with Boston University are always working to keep bicyclists and pedestrians safe in the area. Check these posters and promotional publications are now in use at Boston University that are now in use on the campus.

Lastly, we'd like to remind you of Bay State Bike Week: May 11-19.

No matter how you're traveling out there, whether it's on foot, with two wheels or in the driver's seat of a motor vehicle, you've got to remember that we're all out there together. As friends, coworkers, students and Massachusetts family, we've got to make sure we're keeping an eye on each other -- especially on our roadways.

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Bicycling: No Joy Ride in Boston

A photojournalist with Boston University was riding his bicycle along Comm Avenue when a tractor-trailer swung wide. The bicyclist collided with the trailer and was killed. This is the University's second student to die in a bicycle accident in a month, according to Wicked Local.
A local columnist is no stranger to these kinds of accidents either. During Labor Day, he was riding his bicycle in Buxford when a vehicle t-boned him. In the accident, all of his ribs on the left side were crushed, his collar bone was broken and his left lung was punctured. After roughly $300,000 in medical bills, he's still spending much of his time in rehab.

Our Boston bicycle accident lawyers understand that there were nearly 10 bicyclists who were killed in the state in 2011. These accidents accounted for close to 2 percent of all traffic accidents reported in the state, according to the National Highway Traffic Safety Administration (NHTSA). It's surely no joy ride out there, but there are things you can do to help better ensure a safe journey.

In the state of Massachusetts, the law of the road concerning movement of vehicles says that bicycles are vehicles. This means that for the most part you should operate your bicycle like a driver of a vehicle. The rules are the same. You are a part of traffic and you have a right to expect to be treated as other drivers are.

To help to keep you save out there, consider the basics of traffic cycling:

-Go with the flow. You want to make sure that you're riding with the flow. You never want to ride against oncoming traffic.

-Be on the lookout for traffic on bigger streets. You may have the right of way as a cyclist, but it's important that you remember that drivers can't always be relied on. You've got to fend for yourself, ride defensively and stay one step ahead of the vehicles around you.

-Always drive in a straight line. If you have to move out of the line, make sure you yield.

-Always cross the road at intersections. Use traffic lights and stop signs to your advantage. This is where traffic is most likely to see you.

-Avoid riding at night. This is when your risks for an accident are the highest. If you have to, make sure there are working lights on the front and rear of your bicycle. Wear bright colored clothing and make sure there are reflectors on your bike. Stay seen out there.

You can't always avoid the dangers that come along with the dangerous driving habits of others. But you can best prepare yourself to react and to avoid these dangers. Stay alert out there and stay safe on two wheels. You have a right to that roadway, too!

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Boston Bicycling Accidents - Reducing Injury Risks When a Crash in Unavoidable

We've been talking a lot about bicycle safety, after all it is National Bike Safety Month. But we do understand that accidents happen. Do you know what to do when an accident is unavoidable?

Our Boston bicycle accident attorneys are here with tips from Bicycling.com to help to better your risks against injury in the event of a fall.
The first thing you've got to remember is to look where you're going. Naturally, our body shift into the direction we're looking. If you're looking at a rock you want to avoid, the more likely you are to run into it. Your best bet is to keep looking into the clear path in the area you wish to ride. Your eyes will guide your bike.

Secondly you want to make sure that your pedals are ready for anything. Your best bet is to ride with clipless pedals. You don't want to strap yourself onto a falling bike. Make sure you can remove your feet easily whenever needed.

Next you want to make sure that you're staying loose and that you're moving with the road. If you happen to jump a hump in the road or shoot over a pot hole, you want your body to be ready to absorb the movement. Staying stiff is only going to work against you and increase your risks of a fall.

Lastly, you want to make sure you're stable. Whenever you're pedaling at a slow speed or you're heading up a hill, you're going to want to make sure there's space between you and the bike. Get up and use your body to pedal. It's a good workout and it's safer.

So you followed all of those safety precautions, but you still get into an accident. What now? The best thing you can do is prepare yourself for the fall and know what you're doing.

The first thing you want to do is go with the flow. You want to fall along with the bike. Don't put your arms out to stop yourself. That's only going to increase your risks for a fracture or a broken bone (if not more than one). Instead, your best bet is to tuck your chin into your check, make your body into a ball and roll with the fall.

If you happen to fall backwards, you want to do something a little different. This is where you want to stop the energy. You still want to tuck your chin, to avoid whiplash or a head injury. Instead of rolling with the fall though, you're going to want to extend your arms to the side to stop the momentum from rolling you further. Remember not to put your arms behind you to stop the fall, because you run the risk of a break or a fracture, but put your arms aside to stop.

To keep safe no matter what kind of fall you endure, your best bet is to lower your center of gravity. The lower you are, the easier it is for you to tuck and roll and the shorter distance it is to get to the ground.

With these tips, we're not telling you it's okay to get into an accident because you have a better chance of surviving. We're just offering up these safety tips IN CASE something unavoidable happens. Best of luck out there!

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Bay State Bike Week Shines Light on Biking Safety in MA

The entire month of May has been dubbed National Bike Safety Month, according to MassBike. Massachusetts takes it one step further though and celebrates its own Bay State Bike Week.
Bay State Bike Week is an annual celebration of human-powered, two-wheeled transportation. It is fitting that Massachusetts would be the only state in the nation with a statewide bike week, given our long history of biking. From Worcester's bicycle racing champion Major Taylor to the world-famous Springfield Bicycle Club Tournament, the love of biking has deep roots in our state.

Our Boston bicycle accident lawyers understand that bicycling is a popular way to get around town, especially with the warming weather. We're urging residents to get out there and to get involved to help spread the word about safe biking. You can check the bicycling event calendar on MassBike and find events near you.

Throughout the month, and during our Bay State Bike Week, officials will be pushing the "Same Roads, Same Rules" campaign. "Same Roads, Same Rules" is a program that is aimed at both bicyclists and motorists. It's a program that is about coexisting in a shared space, respecting each other as human beings, using common sense and keeping yourself and others safe by following a common set of rules. The number of bicyclists has skyrocketed in the area and the need for more information has become urgent, with many on the road, bicyclists and motorists alike are too often unsure how to safely interact.

We're here to help the bicyclists out and to get riders to refresh their bicycling safety knowledge before bike seasons gets into full swing. Read the following safety tips and share them with your biking loved ones to help ensure everyone a safe ride:

-Make sure you have plenty of space. You've got a legal right to the road, so use it - take the full lane when needed, stay away from car doors, and don't squeeze between lanes. Two bicyclists can ride side-by-side, but get into single file if cars can't pass safely.

-Ride with the flow. You want to make sure you're riding in the same direction as traffic. That means ride on the right-hand side of the road. Never ride against oncoming traffic. It's too dangerous.

-Give yourself a break. When you come to red lights and stop signs, you've got to obey them too. Use this as a time to catch your breath and take a break.

-Shine in the night. Make sure you have a light in your bicycle, not only to help you to see where you're going, but to help others see you as well.

- Always wear a helmet. There's no substitute and no better way to protect your head, skull and brain. Make sure your helmet fits properly and that you're always wearing it.

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Medical Device Company's Profits Plunge Due to Transvaginal Mesh Legal Fees

Thousands of transvaginal mesh lawsuits have been filed by women across the country who are suffering from complications as a result of transvaginal mesh products.

With the first transvaginal mesh trial resulting in a verdict of $11 million awarded to a transvaginal mesh plaintiff, many manufacturers are nervous about the potential compensation they will have to pay out to all those who were hurt. 1388612_market_movements_2.jpg

One such company, C.R. Bard, recently released financial information that showed just how serious a problem these lawsuits are for the makers of transvaginal mesh products. However, the same data also showed that the drug company still remains very profitable and well-equipped to pay out compensation to injured victims.

Our Boston injury attorneys know that these manufacturers will likely end up paying out millions in damages via settlements or lawsuits and we urge plaintiffs to take action to hold these hugely profitable medical device manufacturers accountable for the harm that they caused.

C.R. Bard's Q1 Profits Plunge

According to Mass Device, profits plunged during the first quarter for the medical device company C.R. Bard. Mass Device indicates that profits declined as a direct result of $26 million in legal fees paid out as a result of transvaginal mesh lawsuits.

Despite the decline in profits, however, C.R. Bard still exceeded Wall Street expectations and posted profits of $90.7 million on sales of $740.3 million. These millions of dollars in profits are made from a variety of different medical devices sold by the company.

Holding Transvaginal Mesh Manufacturers Responsible
While the legal fees were a major expense for C.R. Bard, the fact is that the company is still immensely profitable, just as many medical device manufacturers are. These companies make huge profits from selling medical products to people who need care.

Unfortunately, sometimes these companies put profits over people. This was the case when manufacturers sold dangerous transvaginal mesh products without proper testing and without ensuring that the products were safe for users. The products were rushed to the market under special 501(k) clearances that allowed for minimal testing and, even in light of ever-increasing problems, they have not been universally pulled from the shelves by all manufacturers.

Transvaginal mesh products, therefore, were implanted in thousands of women throughout the country and put these women at risk. Drug companies made millions off of these untested and dangerous products and drug companies continue to make profits that far exceed their legal costs.

These drug companies and medical device manufacturers need to pay for the harm they caused. Those who have experienced complications should consult with an experienced transvaginal mesh attorney in order to explore options for collecting compensation including joining a multi-district litigation. Such cases may be resolved in trial or may be resolved in out-of-court settlements, but in any case, C.R. Bard and the other manufacturers have huge profits available to help them pay for the costs of the plaintiff's losses.

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Could More Transplant Options Become Available for Dialysis Patients?

For patients with kidneys that do not function properly, dialysis is a way of life. Dialysis is a process used to clean the blood in cases where the kidneys are not able to filter out waste. While dialysis can allow a person to live with failing kidneys for a long time, it is not without complications, including the potential that a dialysis patient will be injured by a defective drug during treatment. 1416030_chemistry.jpg

For those patients undergoing dialysis routinely, progress is being made by scientists to find a solution that could allow for an escape from the dialysis cycle. As Reuters recently reported, scientists have now successfully made a rat kidney that does everything a natural kidney can do. Our Boston dialysis injury attorneys know that this is a promising development for patients that may provide hope for the future.

Dialysis Patients Hope for Solutions
Dialysis is a remarkably effective treatment for most patients and can allow patients to live for many, many years even once their kidneys have failed. However, like with any medical procedures, things can go wrong when a patient has to undergo any type of medical treatment. With dialysis, which often occurs multiple times per week, patients are thus naturally at greater risk of complications or problems since they are submitting so often to medical treatment.

Numerous issues in recent years have shown just some of the risks that dialysis patients face. For example, we recently wrote about dialysis patients who were exposed to viruses during their dialysis treatment. We are also representing many patients or surviving family members of patients who were injured by defective dialysis products made by Fresenius.

These products, GranuFlo and NaturaLyte, caused the body to have too many bicarbonates, which created many complications including an increased risk of heart attack. Thousands of patients suffered cardiac events because of GranuFlo and NaturaLyte, and some of those patients died as a result of the harm that they endured.

Tragically, these dialysis complications are far too common among those who need to routinely undergo this type of treatment. While many patients will be able to undergo dialysis successfully, there is always a risk of these complications and it would be a better alternative if a long-term solution was found that eliminated the need for dialysis entirely.

The hope is that the development of the artificial rat kidney will soon open the door for the creation of a human kidney that can do what the body's kidneys can do. Reuters reports that several labs are competing with each other to develop the most efficient ways of producing full functioning artificial kidneys and other organs, making use of 3D printing technologies.

Hopefully, these labs will be able to find a solution and come up with a kidney that works in people. While this will come too late for the thousands who died as a result of GranuFlo and NaturaLyte, allowing patients an alternative to dialysis could save lives and prevent further complications due to bad drugs or unsafe medical practices in the future.

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Massachusetts Hip Replacement Litigation: Mixed Results in DePuy Cases

Our Boston hip replacement injury attorneys know that there are thousands of lawsuits pending by patients who had metal-on-metal hip replacement devices implanted. These lawsuits are against many different manufacturers, but DePuy Orthopaedics is one of the major companies that is being sued for their hip replacement systems. DePuy Orthopaedics is a division of Johnson & Johnson that released a product called an ASR Hip Replacement System, which had a very high failure rate. 1409592_gavel_2.jpg

In the first DePuy hip replacement trial, a jury in Los Angeles awarded $8.3 million in damages to the plaintiff, who had experienced complications. The damages were later reduced to $8.26 million to account for amounts that were paid by a collateral source. The outcome of this lawsuit gave hope to many other plaintiffs who had pending litigation against DePuy. However, a subsequent lawsuit resulted in DePuy not being held responsible for losses.

DePuy Case Outcomes
According to Healio.com, the second lawsuit took place in a Cook County Illinois Circuit Court and the ruling came down from the jury on April 16. The jury indicated that DePuy was not liable for the harm the plaintiff had suffered. In response to the outcome, a press released was issued by DePuy indicating that the company had acted in a responsible way in regards to its hip replacement products.

Unfortunately, the reality is that this is not true. DePuy released its metal-on-metal hip implant products with minimal testing under special FDA approval rules called 501(K) clearance rules. This allowed for the hip replacement product to come to market quickly because it was substantially similar to other devices already being sold. Once the product came to market, problems began to develop and the high failure rate of the DePuy hip replacement systems rapidly became apparent. Yet, the product continued to be sold.

It was not until August of 2010 that DePuy finally made the choice to recall the hip replacement products. This did not occur until after the National Joint Registry for England and Wales had already reported that between 12 and 13 percent of all patients with DePuy implants would require a revision surgery within a five year period.

That DePuy released a product with minimal testing and then failed to act quickly makes clear that the company made mistakes. However, in product liability cases, this is not even a key issue since manufacturers can be held strictly liable for defective medical devices. If the DePuy hip replacement products cause health problems for patients, as all medical data and evidence suggests that the products cause, then DePuy Orthopaedics should be found liable and should be made to pay the plaintiff's damages.

The outcome of the Los Angeles Case, in which the jury ruled that the design of the ASR system was defective, was the right outcome that makes the most sense in light of the facts. More trials are pending and plaintiffs are hopeful that the cases will be resolved in the same way as the Los Angeles case, with injured patients being fully and fairly compensated for all of the losses caused by the defective hip replacement devices.

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Are There Arguments Against Banning Transvaginal Mesh?

As our Boston transvaginal mesh attorneys know, many hospitals and health professionals throughout the country have taken action to ban transvaginal mesh (TVM) products in light of the serious dangers presented by these medical devices. The FDA has also mandated that manufacturers conduct further studies to determine the danger of TVM, and some manufacturers including Johnson & Johnson have voluntarily pulled their products from the shelves as more and more patient complications arise. 1157469_you_are_ill_2.jpg

Yet, even with mounting concerns and with thousands of patient lawsuits throughout the country, some officials are actually making an argument that transvaginal mesh should not be banned. This argument comes from officials at the American Urogynecological Society (AUGs).

The Banning of Transvaginal Mesh Products
According to Ob.Gyn. News.com, the American Urogynecological Society believes that decisions on the use of transvaginal mesh should be made in consultation with a physician and should be made on a case-by-case basis. The Society recognizes that transvaginal mesh does present some very significant dangers but has issued a strong opposition to a blanket ban on the use of the products.

The Society released their statement after a medical malpractice company, state medical organization and health care system all either considered a ban on the use of transvaginal mesh or adopted a ban.

It is important to note that these bans are issued with very good reason. Transvaginal mesh products, which are used in the treatment of stress urinary incontinence and pelvic organ prolapse, have proven to be very dangerous.

Many women who have had these transvaginal mesh products implanted have experienced serious complications including pain, infection, erosion of the mesh and a repeat prolapse that necessitates further surgery. Further, when complications do develop, multiple revision surgeries are normally required because the mesh becomes part of the tissues of the body and is hard to remove.

Taking a risk of experiencing these side effects is often not worthwhile, especially with the high failure rate of transvaginal mesh products and when most evidence indicates that using transvaginal mesh is generally not any more effective than other methods of treating pelvic organ prolapse or stress urinary incontinence.

The bans, therefore, exist in order to try to protect women from a dangerous product.

AUGS Guidelines
AUGS suggests that hospitals and healthcare providers follow specific guidelines that have been issued in order to determine on a case-by-case basis when transvaginal mesh products should be used. These guidelines address auditing surgeons who perform procedures, using special credentialing procedures before a physician performs surgery, and creating special hospital review boards to review cases and complications.

AUGS also stresses the importance of obtaining informed consent from patients before transvaginal mesh products are used. While these are good principles to employ in practice and while no surgery should ever be performed with uninformed patients, it seems there are very few situations where the added risk of a transvaginal mesh product would be justified in light of the serious potential issues that may arise.

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Boston Nursing Home Neglect Lawyers Warn of Dangerous Drugs

A new report published in The Journal of General Internal Medicine indicates that doctors in the U.S. are far too frequently prescribing drug that are potentially harmful to geriatric patients.
Our Boston nursing home negligence attorneys understand that the problem may be especially pronounced in nursing home facilities.

The study, conducted by medical doctors at Brown University's Alpert Medical School in Rhode Island, found that one out of every five senior citizens receiving Medicare received prescriptions for drug that had been singled out by doctors as important for older folks to avoid, precisely because of the high risk of severe adverse side affects.

Factors such as socioeconomic status, access to quality care and education seemed to play a role in whether a person might be vulnerable to this type of negligence.

Researchers referenced the National Committee for Quality Assurance's list of drugs for the elderly to avoid. It's a sizable compilation, but some of the more common drugs included are:

  • Antianxiety medications like Equanil and Equagesic;

  • Antihistamines, such as Ephedrine, Diphenhydramine and Hydroxyzine;

  • Amphetamines, like Adderall, Dexedrine and Dosoxyn;

  • Barbituates, such as Amytal, Mephobarbital and Phenobarbital;

  • Benzodiazepines, such as Valium, Libriumand Limbitrol;

  • Skeletal muscle relaxants, such as Soma, Paraflex and Norflex;

  • Oral estrogen;

  • Narcotics like Meperidine, Pentazocine and Propoxyphene;

  • Vasodilators, such as Ergot mesyloid and Isoxsuprine.

A lot of these drugs are widely prescribed to the general population, and usually without any major issues. The problem is that specifically for these substances, negative side effects are known to be amplified for older patients.

For example, Valium is a common anti-anxiety drug, and many people take it and have no major issues. But in older folks, there are elements of it that can be tough for the body to metabolize. That means it will stay longer in their system. That long-lasting sedation has the potential to increase their risk for falls. It also has a high risk of addiction. Even in a controlled environment, that kind of physical stress is harder on the body of an elderly person.

Researchers looked at data from some 6 million Medicare patients across the country to reach the conclusion that these drugs are being over-prescribed to older people. Of those 6 million, about 1.3 million had been prescribed at least one of these risky drugs. A smaller amount, about 5 percent, had been prescribed more than one of these substances simultaneously.

The author of the study says it's not quite clear why this is being done at such high volumes. There may be exceptions for appropriate use in certain cases, but the increasing numbers in recent years - even when adjusted for a national demographic that is rapidly getting older - is a troubling indication that a lot of our elderly loved ones may be at serious risk of illness, injury or worse.

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US Airways v. McCutchen - Third Party Injury Compensation

The U.S. Supreme Court recently issued a decision in the case of US. Airways, Inc. v. McCutchen in a ruling that underscored common sense must be applied when third-party compensation litigation is involved.
In the end, the court found that an insurance company can't force a person to reimburse the full cost of third-party compensation if doing so would actually make them worse off than had they not pursued third-party action in the first place.

This kind of scenario actually crops up fairly frequently, so our Boston injury lawyers were pleased to hear it being addressed.

This important case started in a rather ordinary way: With a car accident.

The plaintiff was an injured airline mechanic. He was injured in an off-the-job motor vehicle crash in which he was not at-fault, though he was badly injured. This individual had medical insurance through his employer, US Airways.

His total medical expenses ended up being nearly $67,000, which the company insurer covered without issue.

But here's where it got tricky: The injured man then sued the other driver and his insurer. He won. As a result, he received total compensation in the amount of $110,000.

However, about 40 percent of that went to his attorneys, who helped him to win the case. What that meant was that he was then left with $66,000. This is a little less than what US Airways had paid.

The firm's health plan had a clause that required injured parties to reimburse the company for any money it had paid out of what had been recovered by the third party.

What the justices were asked to decide was whether that policy meant that this injured man would have to fork over every single penny of that $66,000 he was awarded - plus another approximately $1,000 - or whether he was only required to reimburse a portion.

In the end, the court decided in favor of the injured man. The reasoning went this way:

There wasn't actually any language at all in the health plan that mentioned the issue of attorneys' fees. As Justice Elena Kagan wrote, that could be interpreted one of a couple of different ways. The first would be that the injured party would be required to pay back every single penny of the total he received from that third party. The second would be that the reimbursement would only be deducted after the "true" cost of recovery.

In other words, while the judgement was for $110,000, the true recovery in this case for the plaintiff was $66,000.

The justices reasoned that fairness would require the court to interpret the plan in the second way. She rightly pointed out that when it comes to third-party recoveries, they aren't free. This man could not have expected to receive any compensation without the help of an attorney, whom he would rightly be expected to pay. But should the injured party be worse off for the fact that he pursued legal damages from the wrongful party?

The justices decided that unless there was some amount of cost sharing, the injured party's health insurer would basically be getting a "free ride" - receiving all the compensation without having to put it any of the effort or investment it would take to receive reimbursement.

Further, by leaving the injured party even worse off, Kagen remarked, this man was in effect paying for the "privilege" of serving as a collection agent for the insurer.

Such an injustice could not stand.

The court did not decide exactly how much the injured man should have to pay. That question was remanded back to the lower court.

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Boston Injury Lawyers Report Class 1 Recall of Knee Surgery Device

The highest possible level of recall - Class 1 - has been issued for a surgical device used in knee replacement operations.
Our Boston defective medical product attorneys want to make sure we get the word out. Just because while the device hasn't been available on the market since last fall, doesn't mean there isn't ongoing potential for patients to experience problems with the implanted devices. There is a high probability that a lot of people who have had knee surgery over the last couple of years may be suffering the negative affects of their surgeon using this device during the procedure.

The ShapeMatch Cutting Guide is produced by a company called Stryker Corp., which manufactures a host of medical device and equipment. The product in question is a single use cutting guide that surgeons purchase in order to help position the components of a knee replacement operation, formally known as an arthoplasty. It would allow the doctor to guide in the marking of the bone before anything is actually cut.

Sometime last fall, the company became aware of a digital defect in the computer software used to make the devices. The firm now says that defect resulted in the displayed depth parameters of cut, angle and resection to be unmatched to the cutting guides that were provided.

What that basically means is that a surgeon's cut would not be as precise as he or she believed. In the end, that has the potential to result in a number of very serious complications. Those would include fractures, joint instability, limitations in mobility, chronic pain, the possible need for revision surgery or all of the above.

So in November, the company issued a warning letter to field locations, surgeons who were registered and also imaging centers, advising them to immediately stop using this device in the course of surgery.

Then in January, the company issued another letter to these same entities, as well as hospitals, warning them of the problem and ways to potentially mitigate the risks for current patients.

However, it wasn't until April 10 that the company finally issued an Urgent Medical Device Recall. The FDA terms this a Class 1. This designation is reserved for products that are either defective or dangerous that could predictably cause serious health problems or death. It is the highest level of recall. Class 2 and Class 3 recalls are considered less serious.

As of this month, the U.S. Food & Drug Administration reports that it has received nearly 45 reports of adverse events, which include at least three injuries and 41 malfunctions.

Patients may not even know whether the device was used during the course of their knee surgery, so we would recommend asking your physician. If so, consider contacting our Boston law offices to learn more about your potential rights of recovery.

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Airbag Defects Force Recalls of Nearly 3.5 Million Vehicles

A massive recall by some of the largest name brand auto manufacturers in the world is due to faulty airbag inflators.
Our Boston defective product attorneys understand that the issue is specifically with the front passenger airbags, where the bag has the potential to deploy with too much pressure. If that happens, the inflator casing could burst, which could result in debris being spewed at the passenger and subsequently result in a serious injury.

Among the vehicle makers affected:

  • Toyota: 1.7 million vehicles (including the Tundra, Matrix and Corolla models);

  • Honda: 1.1 million vehicles;

  • Nissan: 480,000 vehicles;

  • Mazda: 45,000 vehicles.

Additionally, both BMW and General Motors are planning to issue similar recalls in the near future.

The majority of the vehicles being recalled are from model years 2001 through 2003.

Although none of the automakers have reported any serious injuries or deaths resulting from this defect, that doesn't mean they didn't happen - or won't in the future. The fact is, accidents happen at lightning speed. If a person is injured in a wreck, their first thought may not be to question the high pressure deployment of the airbag.

Honda did report that it was aware of one incident in which the casing of an airbag exploded after it had been activated under high pressure. However, that incident did not result in a serious injury.

This very same problem was responsible for a series of previous Honda recalls that started back in 2008, though those involved problems with the driver's side airbags.

Meanwhile, Toyota - king of recalls in recent years, with 5.3 million vehicles recalled last year in the U.S. alone - said it has noted five reports of malfunctioning airbags in recent years. However, there have been no major injuries reported as a result, at least according to the company.

Earlier this year, Toyota had issued another airbag recall due to inadvertent deployment, which could cause serious injury in the event of a crash.

Although this latest recall is sizable, it's not the biggest in the auto industry. Just last October, Toyota recalled nearly 7.5 million vehicle worldwide because of a power window issue that had the potential to result in a fire.

And in 2009-2010, the company recalled some 8 million vehicles across the globe due to a problem with accelerator pedals that stuck.

For this recall, the automakers say they will be contacting owners if their vehicle is affected. However, you can't always rely on it. If you want to check whether your vehicle is on the recall list, you can visit Safecar.gov.

The airbag manufacturer believed to be responsible for the defect is a Japanese supplier called Takata Corp.

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