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.
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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.
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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.
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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.
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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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Report: Substandard Nursing Home Care Funded by Government

A recent report by the inspector general of the Department of Health and Human Services indicates that Medicare has been paying billions of dollars in taxpayer money to nursing homes in Massachusetts and across the country that aren't even meeting basic needs requirements.
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Our Boston nursing home negligence attorneys know that while many elder care facilities lament the fact that they often don't have the money to provide for the intense demand, this report reveals that in 2009, $5.1 billion worth of Medicare funds went to nursing homes that did not meet federal quality of care rules. In a number of these cases, those failures exhibited neglectful and dangerous conditions, sometimes resulting in serious injury and even death.

To give you an idea of how common this problem is, investigators were able to break it down like this: Every third patient who landed in a nursing home that year was placed in a facility where basic standards of care were not met.

We're not talking about luxuries here. We're talking about the bare minimum.

By law, facilities that are reimbursed by the government for the care they provide to patients are required to formulate - in writing - a specialized care plan for every single patient. The goal is for all the doctors, therapists, nurses, aides and other caregivers to be on the same page about what that patient needs so that the person can receive the best care possible.

In too many cases, these plans aren't being followed or sometimes not even properly developed.

For example, one-fifth of all care plans don't address the patient's specific health problems. In one example cited, an elderly patient was being given one medication for depression and two for psychosis. These are drugs that could have serious side effects, especially when used in combination and especially with an elderly person. And yet, the facility had made no plan to monitor the patient's use of these drugs.

In other situations noted, patients were receiving therapy and treatments they didn't actually need. These facilities apparently did not care that such action could in fact be harmful to patients or that it was a waste of money. It seems all they cared about were profits.

Ultimately, what this comes down to is that we as taxpayers are spending our hard-earned dollars to subsidize operations that are potentially putting our most vulnerable citizens at risk.

Still, this report should be just the beginning. While the inspector general did advise Medicare to improve regulations and oversight, it didn't name any individual homes or estimate the number of patients believed to have suffered mistreatment.

Medicare officials responded that legislators should consider aligning federal reimbursements to nursing homes, based on their record for good care.

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Report: Mass. Compounding Pharmacy Practices Warranted Sooner FDA Shutdown

On the heels of a report from the U.S. Food & Drug Administration regarding the increasing list of safety standard failures at a Massachusetts compounding pharmacy blamed for a deadly national meningitis outbreak, a scathing report from Congress slams the FDA for its inaction.
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Our Boston medical malpractice lawyers understand that the report, issued by House of Representative Republicans, claims the federal regulator should have acted years ago to shutter the New England Compounding Center. You may recall from earlier blog entries that contaminated pain injections produced by the company last year reportedly resulted in 53 deaths and more than 700 illnesses throughout the country. It was one of the worst outbreaks of medication-related illness in our national history.

The company was forced to close in October, and as of right now, faces more than 100 lawsuits.

Six months after the NECC was forced to close, an ongoing debate rages about whether this awful tragedy might have been preventable. The resounding answer appears to be: Yes.

A House subcommittee has been investigating the issue since last fall. What they have so far concluded is that the center should have been boarded up years ago. The House leaders pinned responsibility for the fact that it wasn't squarely on the FDA.

The first time the federal agency inspected the facility was 13 years ago. Four years later, in 2005, the regulator submitted a warning to the firm, noting the illegal practice of mass-producing replicas of drugs that were already being manufactured.

Compounding pharmacies are tapped as sources of customized drug mixes based on individual doctor prescriptions. Mass production of other types of standard drugs by these firms is illegal.

Over the course of the next five years, the FDA was flooded with complaints about the NECC. Some were from anonymous informants. Others were from state pharmacy regulators, doctors, hospitals, drug distributors and patients. This was all backed in documents the FDA handed over to the House Energy and Commerce Subcommittee on Oversight and Investigations for its research. The fact that the FDA essentially did nothing to halt this clearly troubled operation speaks volumes about what we can expect - or can't expect - when we receive medicine.

As Rep. Tim Murphy (R-PA) noted, the FDA had a decade of flashing red lights, warning signs and alarm bells. Yet, all of that was either blatantly ignored or resulted in a minor slap on the wrist - even though these violations could - and later did - result in serious injury or death.

The FDA's commissioner, Margaret Hamburg, testified before the subcommittee and appealed for a greater amount of oversight when it comes to the compounding industry, which in the last 25 years has been aggressive in court challenges of federal regulatory authority. She said her agency is trying to become more active on this front, but the laws and court decisions regarding the FDA's legal boundaries are spotty and conflicting.

House Democrats on the committee, while also critical of the FDA's response, did concede that the agency needs clearer authority to be able to act more decisively in the future.

The late Ted Kennedy, D-Massachusetts, introduced such a bill but it was not passed by fellow members of Congress.

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Massachusetts Injuries from Robotic Surgery Mount

The Massachusetts Board of Registration in Medicine has been alerted to an increasing number of injuries tied to robotic surgery, prompting health officials to demand more training, a higher level of oversight and clear disclosure to patients about the risks they may face when undergoing such a procedure.
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Our Boston medical malpractice attorneys know that while state officials haven't listed the exact number of robot-assisted surgery injuries in the state, they did cite three examples with devastating consequences.

One of those involved a patient whose rectal tissue was mistakenly left inside the abdomen following a surgery to correct ulcerative colitis.

Another patient who had undergone robotic surgery for ovary removal and hysterectomy suffered major damage to one of her ureters and the bowel, which mandated she undergo a number of painful corrective surgeries to fix.

The state board issued an advisory to the public, warning that surgery with the assistance of robots, like any other surgery, can have serious complications and outcomes that are poor. The state cautioned too that surgeons should be rated by patients not on the basis of how many surgeries they have completed, but rather the surgeon's proven proficiency and competency.

State officials never specifically called out any one company in their warning. However, Intuitive Surgical Inc., which is based out of California, is the only firm with a robot system that has been approved by the U.S. Food & Drug Administration for soft tissue surgeries in America.

Those familiar with robotic surgery know that it essentially works like this: A surgeon will sit at a console in front of a high-definition screen. Similar to a video game, the surgeon will be able to manipulate hand and food controls to position the mechanical arms of the device, which are affixed with various surgical tools. On the screen, the doctor views a 3-D image of the work as it is being done.

The idea is to improve precision. In theory, it's great. However, the actual outcomes have in some cases been less-than-stellar. That's not to say that surgeons don't make mistakes when they are performing such operations by hand. However, a strong argument has been made that these machines aren't any better or more effective than regular surgery and that the rate of error fails to justify the enormous cost associated with these machines.

Patients are often not informed of this, however, because hospitals tend to exaggerate the effectiveness of these devices. Researchers with Johns Hopkins University School of Medicine conducted a study in 2011 that found nearly 9 out of 10 hospital websites that made mention of robotic surgery asserted that such procedures were superior to regular surgery, though none of those websites detailed any of the risks.

In the last year, nearly a dozen lawsuits have been filed alleging major injuries from robotic surgery, and nearly all of those make mention of the fact that surgeons aren't being adequately trained on the devices.

Federal regulators right now are working to compile information regarding this recent increase in adverse reports, which include at least 70 deaths in the last four years.

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Boston Dialysis Patients Potentially Exposed to Virus

Our Boston injury attorneys know that dialysis patients are dependent upon receiving regular medical care multiple times per week. Because the kidneys of a dialysis patient no longer work properly, the patient must regularly visit a designated dialysis clinic for hours at a time multiple times weekly in order for a dialysis machine to clean the blood. 1295739_virus.jpg

At a dialysis clinic, the idea is that the patient will sit in a chair while the dialysis machine works to clean the blood. The patient will be given appropriate medication and supplements to help improve health and to ensure that the dialysis process doesn't do any damage to the body. Unfortunately, things don't always work that way and dialysis patients can experience many complications. Five patients in Boston recently found that out when they were informed that they had been exposed to a virus.

Dialysis Patients Exposed to Hepatitis B
According to the Nephrology News and Issues, five patients who had undergone dialysis at the Boston Medical Center (BMC) received a telephone call after they underwent their dialysis procedure.

According to one of the patients who received the phone call, the contact came only a few hours after the dialysis treatment had finished for the day. The caller was an administrator from BMC who had bad news.

The BMC administrator indicated that the medical center had become aware that some of the dialysis machines had not been properly cleaned. As a result of the dirty and contaminated machines, some of the patients undergoing dialysis at the treatment center ended up being exposed to the Hepatitis B virus. In total, there were five patients who were potentially at risk of becoming ill as a result of the exposure to the virus from the dirty machines.

Because of the exposure, the patients who were affected and potentially at risk were informed that they would need an injection of gamma globulin. Gamma globulin is a substance that is made up of antibodies that help the body to fight the Hepatitis B virus. Boston Medical Center sent someone to the home of at least one of the affected patients to administer the shot.

Unfortunately, when anyone is exposed to any type of virus, there can be devastating consequences to that person's health. For patients undergoing kidney dialysis who are already struggling with medical issues and whose bodies cannot effectively remove waste products, the effects of this type of exposure could be even worse. A virus could undermine the health of the dialysis patient, making the patient sicker. This can be a major problem, especially if the patient is undergoing dialysis while awaiting a kidney transplant, since a patient can no longer have such a transplant once he or she becomes too sick.

Tragically, exposure to a dirty machine is not the only time dialysis patients have been put at risk. A number of other medical malpractice issues and dangerous drug issues can also endanger dialysis patients. For example, many dialysis patients are given the wrong antibiotic medication according to studies published in Nephrology News. In other cases dialysis patients may be given a medication intended for their care such as GranuFlo or NaturaLyte but the drugs themselves will turn out to be dangerous and to increase the chances of a heart attack.

These mistakes and the harm that come to dialysis patients are simply inexcusable. Drug manufacturers, clinic operators and healthcare providers all need to do better to ensure that the dialysis experience is one that promotes and maintains health rather than an experience that compromises health and makes things worse.

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Injuries and Deaths Mount after Boston Marathon Explosions -- Investigation Continues

On April 15, Patriots Day, two bombs exploded at the finish line of the Boston Marathon. According to the most recent updates on CNN, there were three fatalities and more than 150 injuries as a result of the explosions. Numerous amputation patients were reported among the injured. 1342516_flag.jpg

Our Boston injury attorneys understand that there is no current information on who was responsible for setting the bombs. Additional news is still forthcoming and full details on the number of victims and the extent of injuries has not yet been released. No matter who was to blame, the event was a tragic and terrible act of terror.

Boston Marathon Bombing Information

As CNN reported, the two explosions occurred at approximately 2:50 p.m. This was more than two hours after the first of the runners in the race had crossed the finished line. At 7:49 p.m. it was reported that ball bearings were being removed from victims in the emergency room, which indicate that the bombs were potentially designed in order to propel shrapnel. Additional unexploded devices were found at locations throughout Boston, with some indications that the bombs were crudely made. However, a representative from the House Homeland Security Committee indicated that the incidents suggest a sophisticated, coordinated planned attack.

In total, there were an estimated 27,000 runners from all over the world at the marathon today. According to the most recent news reports, the two deaths included one eight-year-old boy. The identities of the victims killed in the bombing have not yet been released. Boston area hospitals are also reporting that many of those who were injured were missing limbs after the explosion. The final count of the number injured is not currently known but some of the injuries have been described as critical.

Following the explosions, rumors began circulating that a suspect was in custody and that cellular telephone service has been shut down. However, there is no confirmation regarding these rumors. In fact, CNN reports that the cellular phone service was simply overloaded and Verizon had indicated that they had not been asked to turn down its wireless service by any government agency. As news unfolds on this tragedy, more information will become available.

President Obama spoke at a press conference at shortly after 6:00 P.M. Monday in response to the tragic events. The President indicated that any responsible groups or individuals will feel the full weight of justice. The House also observed a moment of silence.

As the events of the day unfold, our thoughts and prayers are with the victims of this tragedy. The news reported shortly after the event that the American flag was still flying high over the area of the debris and that runners who had completed the race had run immediately to the hospital in order to give blood in support of the victims. Within hours of the race, so many had given blood that the Red Cross indicated that there was no more need for blood donations.

Those who provided help to the victims and the response from people in Boston and throughout the United States show the strength of the American spirit that no bombing or terrorism can vanquish.

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Transvaginal Mesh Products -- PBS Explores the Risks

Transvaginal mesh (TVM) products are currently the subject of thousands of lawsuits brought by patients who had the surgical mesh implanted to treat pelvic organ prolapse or stress urinary incontinence.

The thousands of victims suffering from the dangerous side effects of TVM have to live with their story every day and have to cope with the ongoing pain and problems. Many people, however, may be unaware of TVM, of its dangers to patients or of the broader risk illustrated by this defective medical device. 167744_black_5.jpg

Recently, PBS aimed to draw more attention to the issue of transvaginal mesh products in the documentary entitled Need to Know. The documentary aired for the first time on March 22, 2013. Our Boston transvaginal mesh attorneys know that every patient who experienced transvaginal mesh complications deserves some type of compensation but that many people aren't aware of their rights. Programs such as the Need to Know segment of PBS can help to educate patients and the public about what went wrong with TVM products.

The Problem with Transvaginal Mesh Products

Transvaginal mesh products can cause a number of serious health problems once implanted. Some of the potential complications include:


  • Erosion of the mesh.

  • Pain, especially during sexual intercourse.

  • A relapse of the pelvic organ prolapse.

  • Puncture/perforation of the bowels, intestines, bladder or blood vessels near to where the mesh was in the vaginal wall.

  • Urinary/incontinence problems.

  • Vaginal bleeding, chronic discharge or drainage.

  • Vaginal infection.

  • Scarring of the vagina.

  • Shortening of the vagina

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These side effects occur far too often and leave many patients struggling to get medical treatment to try to resolve the complications. Often, multiple complex and expensive surgeries are required, putting patients through a terrible ordeal.

All of these serious side effects raise the question: how did this product ever get on the market? PBS largely focuses on this issue in its Need to Know Documentary because it is an issue that led not just to dangerous TVM products but also to many other dangerous medical devices as well.

The problem is that the medical device came to market under special 510(K) rules. These rules allow for a device to be fast-tracked as long as there is already a substantially similar product on the market that has never been subject to a formal recall.

TVM was thus pushed through because it was substantially similar to a previous existing product. There was little testing or oversight of the new TVM products nor was their verification that the device they were based on was still considered safe. Instead, the medical device came to the market and caused thousands of patients to get hurt because of the lack of proper testing and oversight.

The PBS segment raised attention to this very important issue and it is one every American should be very concerned about as more dangerous devices like TVM could find their way into doctor's offices and hospitals nationwide.

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FDA Finds More Problems at Compounding Pharmacies

The New England Compounding Center is allegedly responsible for one of the greatest drug disasters in modern history, causing 53 deaths and making at least 680 other people sick after sending out drugs tainted with fungus, which caused hundreds of cases of meningitis.

The conditions found at the New England Compounding Center were in clear violation of safety standards and the tragic outcome that resulted was enough to send fear through the hearts of every patient depending upon a drug produced at a compounding pharmacy. 635810_softgel_capsule.jpg

Unfortunately, the news for patients is not good. According to a recent Washington Post article, the bad conditions and breached safety standards don't just exist at the New England Compounding Center. In fact, the article indicated that there were "widespread" safety issues including "dozens of potentially dangerous safety problems." Our Boston drug injury attorneys know that even one bad compounding pharmacy can cause hundreds of illnesses and deaths. With a widespread problem throughout the industry, the potential implications could be terrible for public health, not to mention patients who are victimized.

FDA Finds Widespread Safety Problems

Although New England Compounding Center was reportedly the compounding pharmacy responsible for making everyone sick, this pharmacy is far from the only one to put patients in danger as a result of failure to fulfill safety obligations. In fact, the FDA's recent inspections conducted between February and April revealed that there were serious problems at an estimated 30 specialized compounding pharmacies.

The FDA's investigation of Compounding Pharmacies was prompted by the disaster at the New England Compounding Center and it was the first time that the Food and Drug Administration specifically targeted these special compounding pharmacies. The inspections were considered to be "priority inspections" and the FDA specifically focused on compounding pharmacies that create high-risk sterile products (like those produced at the New England Compounding Center).

These specialty pharmacies are a key part of the multi-billion dollar compounding industry, which has not been very well regulated by the FDA prior to this terrible outbreak. The compounding facilities are not subject to the same standards as drug manufacturers although many of these compounders are masss-producing drugs.

Unfortunately, the lack of regulations and overweight led to deplorable conditions. The FDA investigation, for example, found:


  • Mold in "clean" rooms (rooms that were supposedly sterile).

  • Rust in clean rooms.

  • Tears in gloves that technicians were wearing as they worked in the compounding process.

  • Black particles of mysterious or unknown origin inside of seven different vials of an injectable medicine.

These were just some of the many safety problems found at the 30 specialized pharmacies investigated. There may be more problems but unfortunately the FDA is going to have an uphill battle to find these issues before they lead to another terrible outbreak.

The FDA has only limited authority to handle investigations of compounding agencies, with five of the pharmacies initially denying the FDA investigators access to records and facilities during the priority investigations. The FDA did prevail after getting a court ordered inspection warrant. But the agency wants Congress to give it more authority to investigate compounders of high-risk sterile products. Hopefully Congress will act and the FDA will be able to step up enforcement to prevent another disaster like the one caused by the New England Compounding Center.

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