Understanding What Settlement Means in Boston Scientific Transvaginal Mesh Lawsuits

Boston Scientific is a medical device company that has produced a number of products including transvaginal mesh. Transvaginal mesh is a type of surgical mesh that was used to treat women suffering from conditions including stress urinary incontinence and pelvic organ prolapse. Boston Scientific was a pioneer in the creation and sale of transvaginal mesh products, releasing a product called Protegen in 1996. 952313_gavel.jpg

Our Boston transvaginal mesh lawyers know that transvaginal mesh products have turned out to be very dangerous and that these TVM products cause significant health issues for many women. Boston Scientific's Protegen was one of the first of the transvaginal mesh products to begin to cause complications. As a result of problems with the product, Boston Scientific settled Protegen lawsuits back in 2003.

Understanding What Settlement Means

In 2003, Boston Scientific settled a reported 738 lawsuits that had been brought by women who had Protegen implanted. When a company settles a case, the company agrees to provide some benefit or compensation to the plaintiffs. In exchange for this compensation, the plaintiffs who suffered injury or who were harmed give up any and all future rights to file a lawsuit that arises from the same harm.

In other words, when Boston Scientific settled the 738 lawsuits related to Protegen after the transvaginal mesh products turned out to be defective, the plaintiffs received compensation as determined by the settlement agreement and were not able to make any further claims for damages if they accepted that compensation.

After Boston Scientific settled these lawsuits, the company went on to produce and sell other transvaginal mesh products including the Lynx Suprapublic Mid-Urethral Sling system; the Obtryx Transobturator Mid-Urethral Sling; the Pinnacle Pelvic Floor Repair Kit; the Prefyx PPS Pelvic Sling System, and the Solynx SIS Vaginal Sling system. Unfortunately, these products didn't really turn out to be any safer than Protegen (nor did any of the other transvaginal mesh devices made by other manufacturers).

As a result of the fact that their new transvaginal mesh products are just as dangerous as their old ones, Boston Scientific is now being sued again. Boston Scientific will thus again have to make the choice about whether to try to settle the claims or risk going to court.

Boston Scientific may wish to settle the claims if bellwether trials, or test trials, show that the company is likely to be held legally responsible for all injuries arising from itsTVM devices. If the bellwether trials result in large verdicts for the plaintiffs, Boston Scientific may be even more likely to try to settle in order to keep control on the company's litigation costs and to get more certainty as far as what legal issues the company faces.

Whether Boston Scientific decides to be serious about settling transvaginal mesh cases this time around remains to be seen. However, any plaintiff who is offered any type of settlement should always consult with an experienced attorney for assistance in how best to protect his or her interests.

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Dialysis Infections Down But Patients Still Face Many Risks

When a person does not have functioning kidneys that can remove waste from the body, dialysis is generally the only viable treatment unless or until a kidney transplant takes place. Dialysis can keep a patient alive for a long time, even indefinitely, provided that the patient's medical care is provided by professionals in accordance with best practices. 477799_hands_washing_female.jpg

Efforts are continually being made to improve the health and safety of dialysis patients to ensure these patients remain as healthy as possible. UPI, for example, reports that the CDC has recently provided tools and guidelines to dialysis centers in order to help prevent bloodstream infections from occurring. As a result, a 32 percent decrease in bloodstream infections occurred in dialysis patients in facilities that used the federal prevention guidelines.

Our Boston dialysis injury attorneys know that tougher guidelines protecting patients can have a major impact on saving lives. However, dialysis patients still remain at risk of complications, including the potential of infection or the chance that a drug will later turn out to be dangerous, as so many have before.

Dialysis Infections Down

According to UPI, the CDC and participating dialysis centers first began working together in 2009 in order to create and implement interventions and guidelines that would prevent or reduce the number of bloodstream infections in dialysis patients.

There is a real need to fight bloodstream infections because these types of infections are far too common in patients who undergo dialysis. As many as 8 out of every 10 dialysis patients has a central line implanted. A central line is a tube that a doctor puts in a patient's chest or vein in order to administer medical treatment.

Unfortunately, central lines can become dirty or can be put in incorrectly. When and if this occurs, the central line can provide a way for germs to enter into the body, where the germs cause infections.

To fight infection, the CDC made several recommendations including using an antiseptic for the skin called chlorhexidine. The CDC also issued guidelines related to catheter exit-site care; training for staff; and testing methods to determine if staff uses proper aseptic techniques and cares for the catheter properly. Finally, vascular access care audits, hand hygiene protocols and feedback systems are also part of the CDC guidelines.

Dialysis centers that implement the CDC guidelines can do a lot to protect patients, thus reducing some of the potential dangers. With a 32 percent decrease in bloodstream infections, every dialysis center should try to implement the CDC guidelines in order to reduce the risk to patients. If a patient does develop an infection and these best practices are not followed, then it could be argued that the dialysis center was negligent and is responsible for the injuries that the patient suffered due to the infection.

Of course, even when a dialysis center is able to reduce infections, this doesn't mean patients are guaranteed smooth sailing. From the risks of dangerous drugs such as the GranuFlo and NaturaLyte disasters, which caused thousands of deaths, to the risks of blood clots or uncontrolled bleeding, dialysis patients face many potential dangers. Doctors and care providers need to do everything possible to reduce the dangers from these complications and to keep patients safe.

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New Lawsuit Filed Against Boston Scientific Corporation

Throughout the United States, women have been taking action against medical device manufacturers that showed a callous disregard for their health and safety. These women had transvaginal mesh implants using surgical mesh that was approved by the FDA through a special shortcut process called 501(k) clearance. 1373700_blue_eyes.jpg

Recently, yet another transvaginal mesh lawsuit has been filed. This time, the claim was filed by a Wisconsin woman against Boston Scientific Corporation. The lawsuit was filed on April 30 in the U.S. District Court for the Southern District of West Virginia, Charleston Division. Our Boston transvaginal mesh lawyers know that this lawsuit is not the first against Boston Scientific and it won't be the last. The outcome of all of these lawsuits could help to shape the rights of women in the future.

Lawsuits Against Boston Scientific Corporation

According to the most recent April lawsuit filed against Boston Scientific, the plaintiff had the company's Pinnacle Pelvic Floor Repair Kit and the Aris Trans-Obturator Tape implanted in her in 2010. The plaintiff, like many women, had the transvaginal mesh device implanted because manufacturers had promised that these products would revolutionize the way certain medical conditions were treated.

The two medical conditions designed to be treated by transvaginal mesh products were Stress Urinary Incontinence (involuntary urination) and Pelvic Organ Prolapse (pelvic organs shifting out of place and protruding into the vaginal wall). Previously, these conditions had been treated by tightening the muscles but the transvaginal mesh products provided an easier alternative. The mesh products were essentially used to hold organs in place.

Unfortunately, the mesh began to create many problems once implanted in female patients. These problems included the mesh eroding through the vagina; the mesh causing infections, bleeding or significant pain; discomfort during sex; perforation of organs and urinary issues.

The plaintiff in this new lawsuit alleges that she suffered serious injuries and complications, including several of the side effects listed above that have been linked to transvaginal mesh devices. Her lawsuit indicates that the Boston Scientific products were defective and that they led to a number of serious injuries.

The plaintiff alleges that the harm she and other women are suffering occurred as a result of the negligence of Boston Scientific and other companies that make transvaginal mesh. Because these cases are product liability cases, strict liability rules apply to make manufacturers liable if there is some problem with their products that causes injury. The plaintiff is actually suing based on three counts of strict liability including design defects; defects in the manufacturing of the Boston Scientific Mesh products; and a failure to warn patients of the product defects. The plaintiff's new lawsuit against Boston Scientific also alleges breach of express warranty and breach of implied warranty and fraudulent concealment since Boston Scientific may have known about the dangers and kept quiet.

The plaintiff's newly filed lawsuit becomes part of a pending multi-district litigation action with many other patients who were also harmed by transvaginal mesh. The outcomes of these cases could encourage the company to settle and pay damages to all of the victims or the cases could be decided by judges and/or juries and each plaintiff would be awarded an appropriate amount of damage given her unique injuries.

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Drug Reps Rarely Share Side Effects with Doctors

When a patient is prescribed a drug, that patient has the right to know about any potential side effects the drug may cause. Doctors need to be aware of the potential side effects and risks so that patients can be kept informed, and it is essential that no important details be left out when a prescription is written. 1421532_pills_drugs.jpg

This is why it is so disturbing that a recent study shows drug reps are rarely forthcoming about harmful side effects of the drugs they are promoting to physicians. Our Boston drug injury attorneys know that doctors are more likely to prescribe drugs that are promoted to them by sales reps. Unfortunately, this means that many patients may be dosed with drugs without full and complete information about the risks.

Drug Reps Silent on Dangerous Side Effects

According to Futurity.org, a new large scale study on drug reps was conducted by surveying doctors in Canada, France and the United States. The study, which was published in the Journal of General Internal Medicine, showed that sales reps routinely failed to be forthcoming with doctors.

In fact, in 59 percent of all sales visits to doctors' offices, drug reps did not volunteer details on:

  • Common side effects.
  • Serious side effects.
  • Patients who should not use their drugs.

Failing to provide this information is egregious. In fact, a U.C. Davis professor of medicine and one of the study's co-authors indicated that the interactions between the sales reps and the doctors "failed to meet even a minimum standard for the information needed for safe prescribing."

Patients are Put at Risk
This failure on the part of drug sales reps to keep doctors informed is a serious and large scale problem. The study involved more than 255 physicians who were asked to complete a questionnaire every time a drug sales rep visited their office. During the course of the study, these doctors were subject to more than 1,692 promotional visits from drug sales reps.

The reps were promoting medications for a variety of different conditions including Type 2 diabetes; hypertension; osteoporosis and depression. In some cases, these drugs had "black box" label warnings, which indicated that there were potentially serious or life-threatening risks associated with the medications.

Yet, despite the dangers of the drugs, drug reps mentioned serious side effects in only six percent of promotions. In 57 percent of the promotions that had a black box or governmental warning, no risk of harm was mentioned to physicians at all. These drug reps were keeping silent despite the fact that the laws require sales representatives to explain both the harms and the benefits of the drugs they are encouraging doctors to prescribe.

Tragically, this means that the drugs most prescribed by doctors may be offered to patients without essential information being shared. Patients who experience side effects may have a cause of action against doctors or drug companies for their failure to disclose side effects, but this is small comfort after a serious injury or death has resulted from an adverse drug reaction.

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Boston Youth Risk Survey Causes Concern Among Parents

Protecting kids is the top priority of every parent and parents need to know what types of risks their children face. Every year since 1998, a survey of Massachusetts students has been conducted in order to provide more information to educators and parents about some of the dangers that children in the area are facing. The survey is administered both to sixth grade students as well as to high school kids in eighth through twelfth grade. 1386665_lets_all_drink_lemonade.jpg

This year, the youth risk survey gave parents plenty of reason to be concerned. In addition to showing that as many as four percent of high school males and five percent of high school females had attempted suicide over the past year, the survey also showed that many kids were drinking alcohol despite being under the legal age to drink. The survey also showed that a lot of kids are using drugs. Our Boston injury attorneys know that when kids drink, they are at serious risk of sexual assault, alcohol poisoning and drunk driving accidents.

Teen Drinking And Drug-Use is a Dangerous Epidemic

The Harvard Press reported on the results of the Massachusetts Youth Risk Survey, indicating that:

  • Sixty-three percent of seniors at one local area high school had consumed alcohol over the past spring.
  • Thirty-five percent of all responding students in grades 9-12 indicated that they had consumed alcohol during the past spring.
  • For grades 9-12 combined, 32 percent of female students and 39 percent of male students admitted to using alcohol in the month prior to the survey.
  • Forty-percent of students in grade 12 indicated that they had recently used marijuana.
  • Among all students in grades 9-12, 22 percent admitted that they had used marijuana in the prior month.

Students who take drugs or who use alcohol are likely not just to stay at home while drunk or on drugs but instead to attend school dances or events, to go to parties or to go places with their friends. The Harvard Press, for example, indicating that schools expressed concern about students who had recently come to school dances while intoxicated in the prior year.

When these students drank or do drugs and they go places, they get behind the wheel of a car. They put themselves in danger when they do this, but they also put every other driver who is on the road with them at risk as well. A drunk or high teen may be even more dangerous behind the wheel than an intoxicated adult since teens are already more likely to get into car wrecks because of their inexperience.

Parents Need to Take Teen Drinking Seriously

As this data shows, teen drinking is not a small problem but is something that many teenagers choose to do. Parents need to be aware of the high numbers of kids who use alcohol or drugs and every parent should be sure to stress the dangers of driving drunk or high.

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NTSB Recommends Changing the Definition of Drunk Driving

Everyone today knows that it is illegal to drive with a blood alcohol content (BAC) above .08. The laws impose this limit to ensure that people do not drive when they are too impaired to react quickly, to pay attention and to make safe choices behind the wheel. Unfortunately, the laws may not be doing enough, as it is possible that those with a BAC below .08 may still be affected by alcohol and thus unable to drive safely. 1231362_sign_no_alcohol.jpg

Our Boston car accident attorneys knows that drunk driving accidents can be devastating and that it is important to do everything possible to prevent intoxicated people from getting behind the wheel. This is why new NTSB proposals on lowering the alcohol level constituting drunk driving could be a good thing that helps to reduce the risk of drunk driving crashes.

NTSB Considers Changing Permitted BAC Levels
According to NBC News, the National Transportation Safety Board (NTSB) recently voted to recommend that states lower the permitted blood alcohol content levels and change their definitions of drunk driving.

The NTSB recommends that states drop the permitted BAC level down from .08 to .05. Currently, all 50 states in the United States define drunk driving using the .08 BAC rule, so this would be a widespread shift in drunk driving policy in the United States. However, changing the BAC level from .08 to .05 would put the United States more in line with other countries.

Currently, only Canada, Iraq, the United States and a few other locations have their drunk driving BAC set at .08. The majority of locations throughout Europe, including Russia, define intoxicated driving as having a BAC of .05 or higher. Most of South America and Australia also have a lower permitted BAC than in the United States and when Australia changed their laws from allowing a .08 BAC to .05 BAC, provinces in the country reported between a five and 18 percent decline in the number of traffic deaths.

Arguments for Change
Of course, adjusting our laws to match the rest of the world's is not the only argument, nor the strongest argument, for reducing the allowable BAC level. The fact is that reducing the permitted BAC level could save lives.

According to the NTSB, some drivers begin to experience problems with depth perception and other visual functions once they have a BAC of .05 or higher. The chances of an accident at this level increase by 39 percent. By the time a person's BAC level reaches .07, his or her cognitive abilities are likely to be impaired, and by the time the BAC rises to .08 percent, then the chances of an accident are increased by a full 100 percent.

Since a person begins to suffer impairment at .05 and the accident risk increases so dramatically, there is little reason to allow people to drive after they are at this stage of intoxication. Changing the law could reduce crashes and save lives, and lawmakers should seriously consider embracing the NTSB's recommendation.

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Massachusetts Malpractice Watch: Hospital Infections Devastate Patients

When you go to a hospital, you expect that you will get treatment and hopefully get better. Unfortunately, many patients pick up something that they don't expect while they are in the hospital: a severe infection. A wave of dangerous "superbugs" has found its way into hospitals in Boston and throughout the U.S. and while hospitals are supposedly trying to battle the bugs, their efforts may not be enough. 1342025_medical_equipment.jpg

Our Boston medical malpractice attorneys know that hospitals fall short in many ways when it comes to ensuring the clean, sterile environment that a patient has the right to expect when getting medical care. When a hospital is negligent in its policies or in protecting patients, the hospital can become responsible for any losses incurred by the patient as a result of its failures.

Hospitals Allegedly Fight Superbugs, But it May Not be Enough

According to USA Today, the problem of patients becoming infected in hospitals is a growing concern. It is estimated that one patient out of every 20 develops an infection in a hospital. While these infections can sometimes be relatively minor, they can also be major health issues that are very hard to treat.

In fact, the problem has been exacerbated in recent years as "superbugs" have developed in hospital settings. Superbugs are antibiotic resistant and can be almost impossible to treat. They can also be both costly and deadly. For example, as USA Today points out:

  • Around 100,000 patients each year die as a result of hospital infections.
  • Hospital infections cost an estimated $30 billion to treat each year.
  • There are multiple different superbugs causing this devastation including methicillin-resistant staph (MRSA) and Clostridium difficile (C-diff), which is linked to an estimated 14,000 U.S. deaths each year.
  • New superbugs develop all the time, including a "nightmare" bacteria that showed up recently in at least 200 hospitals and that is resistant to antibiotics.
  • Infections can spread not just on surgical knives and in operating rooms, but also on bed rails, television remote controls and other nooks and crannies in hospitals.

Unfortunately, many hospitals simply are not doing enough to combat what has become a major public health problem. In fact, hospitals may actually have a perverse financial incentive not do to as much as possible in the way of prevention, since Hospital Infection.org indicates that a hospital can make an extra $15,275 on average when a patient contracts an infection and needs treatment as a result. With an estimated 2 million infections developing each year, this would make treating hospital infections a $30.5 billion dollar industry.

Taking Action Against Hospitals

Hospitals need to do more to fight infection. While USA today indicates new technologies are being tested, including germ-resistant copper bedrails and machines emitting ultraviolet light and hydrogen peroxide vapors, playing around with technology is simply not sufficient to ensure patients don't get sick from superbugs.

Hospitals need to take sterility very seriously and make fighting infection a top priority. It is important that hospitals have a financial incentive to take these steps, which means those who develop hospital infections should take legal action and ensure hospitals have to pay for the losses caused. Only by making sure that hospitals don't profit and that hospitals instead have to pay through a malpractice claim will these facilities really be forced to take infection fighting seriously.

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Dog Bites Top Cause of Homeowner Insurance Claims in New England

You could potentially have your home insurance rates hiked because of your lovable pup. What's even worse is that you may even be refused coverage.
According to KLS, many states have insurance companies that won't cover certain breeds of dog. Agents say that some breeds have a risk that is just too high to be included in home insurance coverage.

Our Boston dog bite lawyers understand that one insurance company's ad claimed that dog bite incidents accounted for about a third of all liability claims filed. The Insurance Information Institute reports that the insurance industry saw close to $500 million in dog bite-related liability claims in 2011. When you average them all out -- each claim costs about $30,000. That's a number that's up more than 50 percent in the last decade.

Commonly uncovered breeds:



-Mastiff Breeds

-Preso Canarios

-Pit Bulls

-German Shepherds

-Alaskan Malamutes

And these companies can deny you coverage, even if your own dog has no viscous history. Thank the science behind the statistics.

"Those are the breeds that are more aggressive," said Craig Densley of Bear River Mutual Insurance.

What people on both sides of the debate agree on is that any breed of dog has the potential to bite.

It's difficult to determine just how much a dog's genetics influence behavior, just like it's hard to know how much of a person's personality is inherited. It's true that some breeds simply have more ability to injure people. Though it's no more likely to bite than a smaller dog, if it does bite, a Great Dane can do much more damage than a Maltese, for example.

Each and every year, there are close to 5 million people who are bitten by a dog in the U.S. According to the American Veterinary Medical Association (AVMA), one out of every five of these victims requires medical attention. Overall, close to 1 million Americans seek medical attention for a dog bite each year. About half of these victims are children.

Dog bite losses exceed $1 billion per year. In the past several years, there have been 30 to 35 fatal dog attacks in the USA annually.

Among children and adults, having a dog in the household is associated with a higher incidence of dog bites. As the number of dogs in the home increases, so does the incidence of dog bites. Adults with two or more dogs in the household are five times more likely to be bitten than those living without dogs at home.

Before bringing a pup into your home, make sure you talk with your home insurance provider. Make sure there are no limitations. It's also a good idea to talk with a professional, to see what kind of dog is best for your household. Dogs with histories of aggression are inappropriate in households with children.

National Dog Bite Prevention Week takes place during the third full week of May each year, and focuses on educating people about preventing dog bites.

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Boston Scientific Transvaginal Mesh Lawsuits

Boston Scientific was the pioneer in the creation of transvaginal mesh products, releasing its first product called Protegen in 1996. Protegen was released with minimal clinical testing, including as part of its main evidence a three-month study on the safety and effectiveness of the mesh product in rats. Protegen cleared the way for other transvaginal mesh devices, which were released by both Boston Scientific and other manufacturers with minimal FDA oversight or requirements under special 501(K) rules. 117629_surgery.jpg

Unfortunately, the Boston Scientific transvaginal mesh products, including Protegen as well as subsequent mesh offerings, started causing problems for patients. Our Boston transvaginal mesh attorneys know that hundreds of women experiencing complications sued Boston Scientific back in 2003 and that more women today are attempting to take legal action against the company. Boston Scientific has settled such lawsuits in the past and may be forced to pay again, this time to new victims of transvaginal mesh products that the medical device company has continued to push on an unsuspecting public.

Boston Scientific Transvaginal Mesh Lawsuits

In 2003, Boston Scientific settled 738 lawsuits arising from Protegen. Boston Scientific continued to sell various transvaginal mesh products, however, including the Advantage Fit Transvaginal Mid-Urethral Sling system; the Lynx Suprapublic Mid-Urethral Sling system; the Obtryx Transobturator Mid-Urethral Sling; the Pinnacle Pelvic Floor Repair Kit; the Prefyx PPS Pelvic Sling System, and the Solynx SIS Vaginal Sling system.

Many of these new transvaginal mesh products began causing complications and problems as well including:

  • Infection
  • Severe pelvic pain
  • Discomfort or pain during sexual intercourse.
  • Repeated organ prolapse
  • Organ perforation
  • Urinary issues
  • Vaginal bleeding
  • Vaginal scarring
  • Shrinkage
  • Neuro-muscular issues

These side effects of transvaginal mesh were not exclusive to Boston Scientific mesh products but began to occur among many patients who used transvaginal mesh from many different manufacturers. By 2010, for example, more than 4,000 reports of adverse events had been made to the Food and Drug Administration.

With more than 300,000 women estimated to have received transvaginal mesh implants, these complaints may only be the tip of the iceberg. Women have begun to take legal action against the manufacturers of the mesh products, including Boston Scientific.

Currently, there are multiple consolidated lawsuits underway related to vaginal mesh products. Boston Scientific has also faced individual lawsuits from injured plaintiffs. Boston Scientific has tried many tactics to fight these lawsuits, including claiming in one recent Ohio case that the statute of limitations rendered the claim time-barred. This claim was rejected, however, because the plaintiff did not yet know in 2008 that her occasional stress urinary incontinence was related to problems with the Boston Scientific transvaginal mesh device.

As the lawsuits continue, plaintiffs will need to prove that the transvaginal mesh had a problem or defect that directly resulted in complications occurring. The extensive evidence about transvaginal mesh product dangers and the many injuries caused by mesh released by Boston Scientific should be helpful in assisting plaintiffs in making a case that they deserve compensation. Boston Scientific may again choose to settle and resolve cases out of court or a jury may hear the cases and award damages to injured plaintiffs harmed by Boston Scientific's bad mesh products.

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Understanding the Impact of Mixed DePuy Trial Results

DePuy metal-on-metal hip replacement products have proved to have a very high failure rate and are causing significant complications for patients. Unfortunately, thousands of patients are suffering from problems due to DePuy's hip replacement devices and are now suing its parent company, Johnson and Johnson, in order to try to recover compensation. 1002813_x-ray_image_of_the_leg.jpg

Our Boston defective hip attorneys know that DePuy may end up settling many cases with plaintiffs in order to resolve multiple claims at once. However, DePuy will settle cases only if the company accepts responsibility for the defective hip replacement products and if some determination can be made about how much each case should be worth. As such, the outcome of "bellwether" trials will play a major role in how cases against DePuy proceed.

Bellwether Trials Produce Mixed Results

Bellwether trials are the first legal actions that are being heard in court related to defective DePuy hip replacement products. The cases go before the court and a jury renders a verdict as to whether DePuy is responsible for causing harm and how much DePuy has to pay for the harm.

The outcome of these trials can shape how the company handles future litigation. If it becomes clear that DePuy is being held responsible in multiple trials, then this is an indicator that legal liability is clear and that DePuy will be blamed in most pending cases against it. As a result, DePuy may be more likely to negotiate a reasonable settlement with plaintiffs whose cases are outstanding. The compensation awarded to the victims in the bellwether trial can serve as a guide to help make clear how much cases should be worth.

Unfortunately, the two DePuy bellwether trials that have occurred so far have not produced any clear guides for how things should proceed going forward. This is because the results have been mixed.

In a Los Angeles trial, DePuy was held legally liable by the jury for an estimated $8.3 million in damages to a former prison guard who experienced pain and suffering due to design flaws in the DePuy ASR hip replacement system. No punitive damages were awarded, but the case still resulted in the plaintiff receiving a substantial monetary award. This boded well for others who had DePuy products implanted and who were experiencing complications.

In a second bellwether trial, however, a jury in Chicago rejected the claim of a plaintiff who said she had experienced complications as a result of a DePuy hip replacement system. The jury found that DePuy had not acted improperly in marketing the device and that the plaintiff was not entitled to damages.

The varied outcomes mean that DePuy is unlikely to definitively act in offering reasonably generous settlements to injured plaintiffs, at least not until there is a clear trend showing that DePuy trials will generally end in favor of injured patients damaged by the DePuy hip replacement systems.

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Boston Scientific Transvaginal Mesh Products Endanger Patients

When transvaginal mesh products came on the market, manufacturers sold the products as a cure or treatment for pelvic organ prolapse and stress urinary incontinence. The hope was that the mesh products would make correcting these medical problems easier. Unfortunately, the products haven't lived up to the promises made by manufacturers. In fact, transvaginal mesh products turned out to be very dangerous and to create many unpleasant side affects. 565751_a_babys_coming.jpg

Our Boston transvaginal mesh lawyers know that many different manufacturers produced transvaginal mesh products that have been causing harm to patients. One such manufacturer is Boston Scientific. Boston Scientific had its first transvaginal mesh product approved in 1996 and has numerous products on the market, many of which are causing problems and leading to lawsuits.

The Boston Scientific Transvaginal Mesh Products

While a lot of attention is given to transvaginal mesh products by big name manufacturers such as Johnson & Johnson, Boston Scientific too is being sued by many patients and played an important role in bringing the dangerous mesh products to widespread use within the U.S. market. In fact, it was a Boston Scientific product that paved the way for other transvaginal mesh devices to be sold.

Boston Scientific's first transvaginal mesh product approved in 1996 was called Protegen. Protegen was intended as a treatment for stress urinary incontinence, which is a condition wherein the weakening of the bladder muscles make it difficult for a woman to control her urination.

Prior to the release of Boston Scientific's transvaginal mesh product, stress urinary incontinence was treated by using sutures to lift sagging organs. No implants or mesh products were used. Protegen changed that and doctors began to adopt the use of the Protegen product because of a belief that it would provide additional support and allow for better outcomes for patients.

Boston Scientific subsequently followed up its original release of Protegen with other bladder sling and pelvic mesh products including the:

  • Prefyx PPS Pelvic Sling System.

  • Soloynx SIS Vaginal Sling System.

  • Lynx Suprapublic Mid-Urethra Sling

  • Advantage Fit Transvaginal Mid-Urethral Sling System.

  • Pinacle Pelvic Floor Repair Kit.

Unfortunately, problems soon began to develop. In 2003, Boston Scientific was sued based on complications and side effects developing as a result of Protegen. Boston Scientific decided to settle 738 of the lawsuits arising from Protegen problems.

Even after settling, however, Boston Scientific did not pull all of is transvaginal mesh products nor was much additional investigation done into whether TVM products were safe for use. Instead, not only did Boston Scientific keep right on enticing patients to use Transvaginal Mesh but also other manufacturers jumped on the bandwagon and started selling mesh products of their own.

Many of the manufacturers who came out with transvaginal mesh products did so with minimal testing of their own medical devices. The manufacturers got away with this because the FDA has an expedited approval process called 501(k) clearance that allows a product to be released without the normal rigorous clinical testing that is usually required.

Products can be released using 501(k) clearances provided that there is an existing product that is substantially similar. The Boston Scientific product, Protegen, was the product that was used by the manufacturers seeking 501(K) clearance. It was the basis, therefore, of the approval of a class of TVM products that have caused untold harm to patients worldwide.

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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.

Continue reading "Sharing the Road and Riding Safely -- A Group Effort in New England " »