Boston Personal Injury Attorney Blog

April 30, 2013

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.

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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April 29, 2013

Massachusetts Hip Replacement Litigation: Mixed Results in DePuy Cases

by Jeffrey S. Glassman

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.

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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April 28, 2013

Are There Arguments Against Banning Transvaginal Mesh?

by Jeffrey S. Glassman

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.

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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April 27, 2013

Boston Nursing Home Neglect Lawyers Warn of Dangerous Drugs

by Jeffrey S. Glassman

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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April 25, 2013

US Airways v. McCutchen – Third Party Injury Compensation

by Jeffrey S. Glassman

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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April 24, 2013

Boston Injury Lawyers Report Class 1 Recall of Knee Surgery Device

by Jeffrey S. Glassman

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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April 22, 2013

Airbag Defects Force Recalls of Nearly 3.5 Million Vehicles

by Jeffrey S. Glassman

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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April 21, 2013

Report: Substandard Nursing Home Care Funded by Government

by Jeffrey S. Glassman

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.

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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April 19, 2013

Report: Mass. Compounding Pharmacy Practices Warranted Sooner FDA Shutdown

by Jeffrey S. Glassman

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.

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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April 18, 2013

Massachusetts Injuries from Robotic Surgery Mount

by Jeffrey S. Glassman

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.

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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