Boston Scientific Announces New Transvaginal Mesh Study

In January of 2012 the Food and Drug Administration (FDA) ordered 33 manufacturers to conduct post-marketing studies on the safety of transvaginal mesh products. The FDA imposed this requirement because it had become apparent that side effects and complications due to transvaginal mesh products were very common. 1088940_2_annual_reports__3.jpg

Now, Boston Scientific, one of the major manufacturers of transvaginal mesh products, will be conducting further studies. On July 3, 2013, Boston Scientific announced in a press release that a grant of more than $1 million would be given to the Pelvic Floor Disorders Network (PFDN) for a new clinical trial to evaluate the treatment outcomes of two different surgical options for women suffering from a specific form of pelvic organ prolapse.

Our Boston transvaginal mesh lawyers know that most studies have shown that transvaginal mesh provides minimal or no benefits over other treatment methods and creates significant complications. This further study will focus more in depth on the differing treatment outcomes in order to provide more information on whether vaginal mesh products are worth the risk.

New Study on Pelvic Mesh and Treatment Methods

According to the Boston Scientific press release, the new clinical trial is called SUPeR. The study will involve 180 women who are considering surgery for uterine prolapse and who do not intend to have any more children. The children will be randomly assigned to one of two different treatment methods: a uterine-preserving transvaginal mesh repair that makes use of the Boston Scientific Uphold® LITE Vaginal support system or a traditional surgery that does not use a mesh product and that instead includes a vaginal hysterectomy.

The study will involve a randomized trial to determine which of the patients has the better outcome in order to evaluate each of the differing treatment methods. The patients will be evaluated by researchers every six months for as long as five years in order to assess the success of the surgery; to determine how safe the patients are; to assess the cost-effectiveness of the surgery; and to get an idea of the quality of life that each patient is enjoying following the treatment.

The initial data from the clinical trial is expected to become available in 2017 and there will be a follow-up a year later. The study will be conducted by the Pelvic Floor Disorders Network (PFDN), which is funded by the National Institutes of health and which has eight different medical centers located throughout the United States.

Determining the Effectiveness of Vaginal Mesh Products

Different types of pelvic organ prolapse have differing treatment methods and not all women wish to undergo a hysterectomy as a method of treating their condition. Still, vaginal mesh is a dangerous product and many women have experienced serious complications because of the vaginal mesh that was used in treatment procedures.

Those who use vaginal mesh products face significant risks including a danger of mesh erosion, recurrent prolapse and significant pain during intercourse. Hopefully those women who are involved in this clinical trial will not experience unexpected and dangerous side effects due to the Boston Scientific transvaginal mesh.

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Long-Distance Festival Travel Wrought With Perils

On their way to the Bonnaroo music festival, two Indiana natives tragically lost their lives in a massive wreck in Tennessee, which authorities now say was caused by a semi-truck driver, who has since been cited with failure to exercise due care.
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Our Boston personal injury lawyers know that roadway hazards caused by fatigued or careless truckers is just one danger confronted by concert and festival-goers, many of whom travel long distances to see their favorite musicians and performers throughout the summer.

Bonnaroo, held in Tennessee, is one of the largest weekend-long festivals in the country. But there are a number of others that are still coming up and at which attendance is expected at least in the hundreds of thousands. Among those:


  • Warped Tour, June 15 - Aug. 4, National Tour;

  • Newport Folk Festival, July 27-28, Newport, RI;

  • Lollapalooza, Aug. 2-4, Chicago, IL;

  • Electric Zoo, Aug. 3 - Sept. 1, Randalls Island Park, NYC;

  • Outside Lands, Aug. 9 - 11, San Francisco, CA;

  • Rock the Bells, Aug. 17-19, Aug. 24-24 and Aug. 31-Sept. 1, San Bernadino, CA, Mountain View, CA and Holmdel, NJ;

  • Burning Man, Aug. 26 - Sept. 2, Black Rock Desert, NV;

  • Made in America, Aug. 31- Sept. 1, Philadelphia, PA;

  • Austin City Limits, Oct. 4-6 and Oct. 11-13, Austin, TX.

In New England, regional festivals are popular draws through the summer and autumn months. While some patrons may spend the extra cash to fly in to their location, many are expected to make these trips by vehicle.

We understand that for many, the road trip is half the experience. We sincerely hope it is a memorable one - for all the right reasons.

Gearing up for long-distance travel means making safety a priority. Yes, the event may be all throwing caution to the wind, lowering your inhibitions and freely expressing yourself. But you have to make sure you and your friends get there and back safely. That takes some planning.

Consider the following before you head out:


  • Have your vehicle checked out. You need to make sure your vehicle is in good shape. The National Highway Traffic Safety Administration recommends that you take your car in for a full check-up. Have the mechanic check the belts, the hoses, the cooling system, the battery and the tires. Make sure to check your tire pressure regularly throughout the trip and keep an eye on your gas levels.

  • Know where you're going. If you're traveling far from home, you want to avoid getting lost or stranded. GPS is fine in areas with an strong signal, but you have to consider that this may not be the case, particularly if you are traveling in more isolated terrains. Take paper maps too just in case.

  • Figure out the best time to travel. If you can, avoid heavy traffic times and plan for inclement weather.

  • Have supplies in your vehicle in case you do get stranded. Have your car charger, extra food, water, blankets, tire repair kit, first-aid kit, flashlight and road flares.

  • Make sure you get enough sleep. We know you're excited and you want to get there. But the NHTSA warns that some 100,000 crashes annually are the result of drivers who are really too tired to be behind the wheel. If you take the risk of driving while fatigued, not only could you miss the show, you could suffer serious, life-long consequences as well.

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Boston Mayoral Candidates Talk Bicycle-Safety Plans

Our Boston bike accident lawyers know that preventing cycling injuries is a top-concern in our city. In fact, bicycle safety is such an important issue that many of the candidates running for mayor have answered some questions for Boston.com on their plans to improve cycling safety in the city. 1379253_directions_sign.jpg

The candidates face off in a primary election on September 24th, but in the meantime, their answers on bicycle safety are worth considering as many of the potential future mayors have some good ideas for preventing serious injuries or fatalities when traveling on bikes in Boston.

Bicycle Safety Plans Proposed by Potential Boston Mayors

According to Boston.com, the safety plans suggested by the different mayoral candidates include the following:


  • Candidate John Barrows suggests improving safety by providing targeted safety training for groups that have high crash rates. This would include cyclists; MBTA and taxi drivers and university students. The candidate would encourage workplace and on-campus training. Finally, the potential mayor would also redesign and install bike facilities in areas with high crash rates; encourage helmet use; make low-cost helmets and illumination products available; and enhance data collection to learn more about bike accident risks.

  • Candidate Bill Walczak believes in the importance of helmet use and of biker and driver education. His plan for improving bike safety includes giving bike riders more clearly designated and more heavily protected bike lanes in all neighborhoods, and putting up signs to remind drivers and cyclists about driving safely.

  • Candidate Don Conley suggests that a public education campaign on sharing the streets safely would be a good step towards making cycling safer. Continuing with his educational approach, he also suggests micro-campaigns addressed at certain groups to address common mistakes. Helmet vending machines and kiosks around the city are also part of his plan, as are improved enforcement of traffic laws and the potential adoption of a mandatory bicycle helmet law.

  • Candidate Charles Clemons suggests a citywide PSA campaign as well as better enforcement of traffic laws.

  • Candidate Felix Arroyo believes that new infrastructure such as cycle tracks could be helpful in making biking safer. His plan also includes collecting more data about dangerous areas; raising awareness of bicycle dangers; and combining data from different government departments to better understand bike accident risks.

  • Candidate Ron Consalvo would create a "Share the Road" public education campaign, and would support the Boston Bikes program that is already in existence. Infrastructure improvements, updated crash reporting practices, and innovative engineering solutions are also part of his bicycle safety plan.

  • Candidate John Connolly wants to increase both cycle tracks and protected bicycle lanes. He believes in a "complete streets," plan that incorporates cycling into all aspects of road design. He was a prior sponsor of the Hubway bike share initiative when serving on City Council and he wants to expand Hubway into more neighborhoods.

  • Candidate Marty Walsh indicates that he plans to initiate a comprehensive traffic flow review if elected mayor in order to improve bicycle safety and make the city move more smoothly. His plan also includes developing cyclist amenities including more bike lanes and share road markings, as well as bike stoplights and bike boxes at intersections. Finally, public awareness and public education on issues such as helmet use are important and he wishes to incorporate training in schools, driver's education courses and community fitness programs.

It is good news that each of these different candidates takes bike safety so seriously, and it is also good news that this issue is important enough that Boston.com believes this is an important concern for voters who will select the city's next mayor. While each of the candidates has different ideas, hopefully whoever is elected will be able to make a significant difference in making the roads safer for riders.

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Boston Bicycle Riders are a Diverse Group - Summer Bike Accident Prevention Important

Recently, the Boston Globe addressed the so-called "image problem," of Boston's bicycling community.

According to the Globe article, many people incorrectly assume that Boston bicycle riders are all either hipsters and/or white, wealthy and middle aged. This image problem and the stereotype of bicycle riders has, according to the Globe, made it more difficult to make improving bicycle safety into an important political issue. 1347817_biker_in_the_curve.jpg

Our Boston bike accident lawyers know that improving bicycle safety is good for everyone throughout the city. By recognizing that bike riders are a diverse group and that improved safety measures can benefit everyone, hopefully lawmakers and local politicians will be able to make safety initiatives more of a priority. This is especially important as prime bicycling season is underway during the summer and everyone - drivers and cyclists alike- need to make a serious effort to be safe when sharing the roads.

Boston Bicycling Community is a Diverse Group

The perception of bicycle riders as hipsters or as wealthy white people has become so entrenched that there is even an acronym: MAMILS, which stands for middle-aged men in Lycra. The cyclist stereotyping has caused many, including some local politicians, to view bicycle safety issues as affecting only a small minority of local area residents. This problem is exacerbated by the fact that those individuals most vocal on bike lanes and bike safety programs tend to fit the stereotype of the rich middle-aged rider.

In reality, however, the Boston Globe indicates that bicycle riders are very diverse and that many people ride bikes as a matter of necessity. In fact, studies have shown that cycling is a growing method of transportation among both racial and ethnic minorities. Lower income individuals who are unable to afford the costs associated with a car also use bicycle riding as their means of getting to work and running essential errands.

This trend towards an increasingly diverse group of bikers isn't isolated to Boston either. In 2011, for example, a Rutgers University study revealed that minorities are making up an ever-increasing share of bicycle riders throughout North America. In 2001, African American, Hispanic and Asian people made only 16 percent of cycling trips but in 2009, individuals within these ethnic groups accounted for 23 percent of rides. Yet, many of the minorities who are increasingly riding bikes do not tend to attend events organized by pro-cycling advocates.

Some Boston lawmakers believe that an important opportunity is missed by failing to engage all bicycle riders, including minority riders who may not traditionally speak out in favor of improved bike safety measures. By raising more awareness of safety issues and of the diversity of bicycle riders, bike safety can become a more popular cause and more politicians may be willing to take real action to improve conditions for cyclists in Boston. This would be good for all riders, especially as adults and kids take to the roads on their bikes for fun or pleasure this summer and beyond.

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Johnson & Johnson Tries to Block Experts in DePuy Hip Implant Cases

DePuy hip implant devices are one of several brands of metal-on-metal hip implants that have proved to be dangerous to patients. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, is currently defending itself against a number of lawsuits from patients harmed by their defective hip replacement and hip implant products. Recently, Harris Martin reported that the company asked the court in one of those cases to prevent two experts from testifying. 1207444_courtroom_1.jpg

Our Boston DePuy injury attorneys know that DePuy lost a past case when an injured plaintiff was awarded $8.3 million in damages. The company is likely trying to prevent future large verdicts. The motion to the court to keep these two experts from testifying in the case is just another attempt to escape liability for the defective metal-on-metal devices.

DePuy Orthopaedics Seeks to Block Expert Testimony

The case against DePuy Orthopaedics is a product liability case and the plaintiffs have the burden of showing that the metal-on-metal hip implant products were dangerous and failed to live up to the promises made by the manufacturer. The plaintiffs do not need to demonstrate that DePuy Orthopaedics was negligent in not producing a safer product since strict liability rules apply. Experts have testified in past cases that the problems with DePuy's products were well-known before the medical devices even came onto the market.

One of the two expert witnesses, a professor of biomedical engineering and surgery at McGill University, testified at a previous DePuy trial that the rate of adverse events associated with the metal-on-metal hip implants produced by DePuy should have caused alarm and raised "red flags" as far back as 2003. This was before the DePuy hip implants were even released on the market. The other expert criticized DePuy's effect analysis and the company's failure mode.

DePuy is likely seeking to prevent these two expert witnesses from testifying because it believes that the evidence presented significantly damages the defense case. DePuy is trying to prevent the testimony from being presented during a multi-district litigation and submitted supporting briefs barring the testimony on June 14, 2013.

The judge will now need to make a decision on whether these experts should be permitted to testify in the upcoming bellwether trial in September. If the judge permits the experts to testify, then it is likely that the information presented will once again be damaging to DePuy Orthopaedic's case. Both DePuy Orthopaedics and the plaintiffs who wish to present testimony from the experts will have a chance to make arguments to the judge about whether the testimony should be allowed.

Determining what evidence is or is not admissible in a case against a drug manufacturer can be a complex and technical process. Responding to actions such as this one is just one of the many tasks that attorneys will do to help victims of defective metal-on-metal hip implants to get the justice they deserve.

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Transvaginal Mesh Supplier May Have Used Plastic Not Suitable For Human Implantation

For women suffering from pelvic organ prolapse or stress urinary incontinence, transvaginal mesh manufacturers promised surgical solutions that would help to correct their health issues. Unfortunately, transvaginal mesh or TVM turned out to be a very dangerous product that caused a number of complications including significant pain; recurrent prolapse and breakdown of the mesh in the body. 1420892_plastic_model_parts_in_frame.jpg

Since transvaginal mesh not only failed to perform as promised but also caused harm, many patients have taken action against TVM manufacturers. In one lawsuit against a TVM manufacturer, plaintiffs are alleging that the manufacturer knowingly used a plastic that was not safe for use in people. Our Boston transvaginal mesh lawyers know that TVM from all manufacturers has generally proved to be dangerous. However, this new evidence indicates that at least one manufacturer may have gone beyond simply failing to disclose risks and instead intentionally acted in a way likely to cause harm.

Emails Show Transvaginal Mesh Manufacturers Intentionally Put Patients at Risk

According to a June 26 Bloomberg news article, CR Bard may have knowingly sold vaginal mesh devices that were made of a plastic material manufacturers had warned was not suitable for implantation in humans.

The plastic was made by a Chevron Phillips Chemical Co. unit and was resin-based. Chevron Phillips Chemical Co. had registered a warning that the mesh should not be permanently implanted in people and after this warning was issued, managers at Bard's Davol unit knowingly used the plastic in mesh units intended for the treatment of hernias. Now, plaintiffs in a transvaginal mesh claim contend that this same unsafe mesh was also used not just in hernia products but in transvaginal mesh products as well.

Evidence indicates that CR Bard Inc. acted intentionally to use this unsafe plastic, rather than just simply using it by mistake. For example, two emails were sent in 2004 and in 2007 by Davol executives warning colleagues not to tell Chevron Phillips or other manufacturers of the resin-plastic that the plastics were being used in medical devices that were placed in people.

One of the e-mails sent by a top Bard executive, who is now a vice president at the company, expressly cautioned that Chevron Phillips would probably "not be interested in a medical application due to product liability concerns." The same email indicated that Davol shouldn't be mentioned to any of the manufacturers because the manufacturers likely were unaware of C.R. Bard's implant applications.

These emails are extremely incriminating because they can be used to demonstrate that top executives in the company knowingly made the decision to use a plastic that was proven unsafe, despite an awareness that people could get hurt.

It is not unreasonable to believe that the same plastic was used not just in mesh used to treat hernia injuries but also in patients undergoing surgical procedures with transvaginal mesh. Plaintiffs in TVM cases may thus be able to use the emails to strengthen their claim against the medical device company, by presenting the emails as proof that Bard intentionally took dangerous risks with patient health.

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New England Fireworks Injuries a Risk Through Fourth of July Holiday

State Fire Marshal Stephen D. Coan asks residents and visitors of Massachusetts to set a good example for your children and leave the fireworks to the professionals.

Our Boston personal injury attorneys are urging you to enjoy the many displays of fireworks supervised by local fire departments and conducted by licensed professionals instead of attempting to put on your own shows.
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If you chose to have some fun at home, it's important to make sure that the fireworks you've got are legal in the state.

"While fireworks may be purchased legally in other states, it is illegal to bring them into or through Massachusetts," said State Fire Stephen D. Coan.

In the state of Massachusetts, firecrackers, torpedoes, skyrockets, flares, candles, bombs, wheels, colored fire, fountains, mines, and serpents are all illegal.

Sparklers are still legal though. But remember that they can still be dangerous.

Sparklers light up your Fourth of July with their crackling glow and glowing trail of light. Kids of all ages are in awe of the sparks that fly around Fourth of July celebrations, but these devices are merely wire sticks that are dipped in a mixture of metals and chemicals and set on fire.

Doesn't sound too safe, does it?

Remember that these pretty little devices can also heat up to nearly 2,000 degrees.

It's easy for parents to believe that sparklers are safer that ordinary fireworks, but the truth of the matter is that they're just as dangerous and it's time to stop overlooking the dangers.

According to the Consumer Product Safety Commission (CPSC), close to 20 percent of all firework-related injuries are actually the result of sparklers. Young children account for a majority of these incidents, too.

Before handing a sparkler to a child or someone else in your family, read over these safety tips and be on your best behavior:

-You never want to hand over a lighted sparkler to another person. Make sure that you give then one that's not been lit let. If you're letting a child hold one, make sure that an adult light it.

-Only use one sparkler at a time. You don't want to intensify the dangers by adding more in the mix.

-Remember that fireworks are still hot long after they've gone out. When they go out, confiscate them from children and place them directly into a bucket of water or under a running hose.

-Never allow children to play with any kind of fireworks without the proper supervision of a competent adult.

-Only purchase sparklers from a reputable vendor.

Each year, there are about 200 people who wind up in an emergency room every day during the month around the Fourth of July. Don't let it happen to you. Be safe and have fun out there. Happy Fourth of July!

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Transvaginal Mesh Company Pays $55.4 Million to Settle Some TVM Cases

According to Reuters, a unit of Endo Pharmaceuticals has recently agreed to pay out $54.5 million to settle just some of the thousands of lawsuits the company is facing over its transvaginal mesh surgical products. 1221952_to_sign_a_contract_3.jpg

Transvaginal mesh, or TVM as it is called, was used by patients worldwide as a method of treating pelvic organ prolapse and stress urinary incontinence. Our Boston transvaginal mesh lawyers know that the Endo Pharmaceuticals unit is just one of many manufacturers facing lawsuits and that this settlement is only just the beginning of the compensation that will need to be paid to the women whose health was adversely affected by dangerous mesh products.

Company Settles Without Admitting Fault
Reuters reported that the unit of Endo Pharmaceuticals paying out the $54.5 million settlement is called American Medical Systems. American Medical Systems disclosed this settlement payout in a regulatory filing with the United States Securities and Exchange Commission on Thursday June 20th. The company did not indicate exactly how many cases it was resolving with the $54.5 million settlement agreement.

In settling the claims, American Medical Systems did not admit that the company was at fault or liable for the health problems that the women were facing. Transvaginal mesh has been linked to numerous medical issues including erosion of the mesh; significant pain; recurrent organ prolapse and other problems that normally necessitate at least one repeat surgery to correct. However, the company did not admit fault or liability for these symptoms or problems.

American Medical Systems has estimated in the past that it expects to spend at least $160 million to settle the vaginal mesh claims against the company. Other manufacturers that also made transvaginal mesh devices have their own lawsuits to resolve as well, so manufacturers throughout the United States will likely be paying many millions of dollars to compensate people whose lives they damaged through releasing an unsafe medical device.

FDA data shows that in 2010 alone, there were an estimated 300,000 women diagnosed with pelvic organ prolapse and around one out of every three of these women had a surgical procedure using transvaginal mesh. Another 260,000 women during the same year had surgery for stress urinary incontinence, around 80 percent of whom used transvaginal mesh.

The $54.5 million settlement from AMS is thus only the tip of the iceberg. Although the company has not admitted fault, its settling of the claims mean that the victims of its dangerous mesh devices will at least have their bills, costs and other losses covered. That the company is estimating paying out more in settlement money is a strong indicator that they believe a judge or jury would see a link between their products and the symptoms experienced by patients.

The company is likely to continue to be willing and eager to settle cases when possible in order to avoid claims going to court and juries rendering verdicts for plaintiffs who were harmed. Settlements allow injured victims to avoid having to go through the process of a trial in order to obtain monetary damages, but plaintiffs should speak to an attorney before accepting a settlement to ensure they are getting the full amount of compensation they deserve.

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Judge Upholds DePuy Verdict for Patient Injured by Metal-on-Metal Hip Implant

Thousands of patients throughout the United States are currently involved in litigation to hold DePuy Orthopaedics responsible for damages caused by the metal-on-metal hip implant devices manufactured by this Johnson & Johnson subsidiary. While some of these cases against DePuy Orthopaedics are just getting started, others have already been tried and decisions rendered. 1409595_gavel_5.jpg

Our Boston defective hip implant lawyers know that many of the cases have been successful for injured patients. In March of 2013, for example, a California man was awarded $8.34 million in damages due to injuries sustained after he had a DePuy ASR hip replacement device implanted. DePuy Orthopaedics appealed the decision that was made by the jury in that case, but a judge recently made the decision that the verdict would be upheld.

Judge Upholds Jury Verdict
Juries make decisions about whether a defendant is legally liable (legally responsible) for causing injuries and about the extent of the damages that the plaintiff endured. The damages can include medical expenses; lost income/missed work time; pain and suffering; emotional distress and other economic and non-economic losses. The damage award is a monetary award that is supposed to "make the plaintiff whole."

In the recent DePuy case, the jury determined that the California plaintiff was entitled to $8.34 million in damages to fully compensate him for his losses. The injured plaintiff had underwent hip surgery in 2007 and subsequently experienced serious complications including metal toxicity, pain and walking problems.

After the jury awarded the plaintiff the multi-million dollar verdict, DePuy Orthopaedics asked the judge to grant a new trial or for a judgment notwithstanding the verdict (JNOV). A JNOV would mean that the judge would say that the jury was wrong, that they made a decision that wasn't supported by the law, and that a different ruling should be entered.

The judge, however, declined to either allow for a new trial or to grant a JNOV. Instead, the judge said that there was sufficient evidence that the jury could reasonably have concluded that the DePuy ASR product had a defect and that the medical device manufacturer failed to provide adequate information to patients about the risks of using the metal-on-metal hip replacement product.

The judge's decision means that the verdict still stands, at least for now, against DePuy Orthopaedics. When the judge announced his decision, he also scheduled a hearing for later in the month to address the plaintiff's request that the medical device company be responsible for paying $1.2 million in court costs and litigation expenses.

This is bad news for DePuy Orthopaedics not only because of the large damage award that the company is supposed to pay to the plaintiff, which could get larger if the judge determines that the company has to pay the plaintiff's costs. It is also bad news because there are thousands of other lawsuits out there.

Since one jury has already found that DePuy was responsible for millions in injuries, there is a good chance that at least some of the other juries hearing DePuy cases will also find for the plaintiff and award compensation to those patients injured by the defective hip replacement devices.

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Update on New England Steroid Injection Bacteria Outbreak

Consumers, especially patients with medical conditions, are often in the position of blindly trusting their doctors, pharmacists, and the manufacturing companies that develop and distribute drugs. While most of the drugs on the market have been tested, there are always potential dangers. Since the outbreak of meningitis associated with steroid shots last year, the Food and Drug Administration has been scrutinizing the manufacturing plants of similar products.

The FDA is the federal agency responsible for ensuring that specific products, including over the counter drugs, prescriptions, and other food products, are safe for consumption. When reporting dangerous drugs or other contaminants, the FDA can recall those products temporarily or ban the products completely. Currently, the agency is investigating reports of bacteria found in the same steroid shots that caused a deadly outbreak of meningitis last year.

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While the FDA and the Centers for Disease Control and Prevention work to determine the newest species of fungus and bacteria, the victims have continued to suffer from adverse effects, including skin and soft tissue abscesses. Our Boston dangerous drug attorneys understand the gravity of injuries and are dedicated to helping victims protect their rights against large drug manufacturers and pharmaceutical companies.

The agency initiated the investigation after reports that the products were linked to infections. According to the FDA, the contaminants were found in sealed vials of steroids, which were produced and packaged by Main Street Pharmacy. The company has since recalled its products nationwide after 24 people developed abscesses at the site of their injections in Tennessee. Though meningitis has also been linked to the same injections, the FDA claims that there are no cases associated with the new site.

The injuries and consequences caused of the meningitis injections have been severe and widespread. According to the CDC, 58 people died and 745 other victims developed infections after receiving contaminated injections from the New England Compounding Center in Massachusetts. Overall, there have been over 300 cases involving abscesses or bacteria related infections caused by the drug.

The newest outbreak involves products that were distributed to 13 states. The federal agencies are continuing their investigation to determine if more patients are at risk. The agencies are particularly concerned about the injections since meningitis outbreak and have found that many of the manufacturing plants were in violation of regulations and operating under unsterile conditions.

To prevent additional injury and health risks, the FDA is requesting that health care providers and consumers report adverse consequences of drug use or any additional problems that could be associated to the Main Street products. If you or someone you love was injured or suffered because of a defective drug, you should report that injury to FDA's MedWatch Adverse Event Reporting program.

The consequences of a dangerous or infected drug can cause significant and permanent health conditions and in some cases, death. Victims and their families in New England or nationwide may be entitled to significant compensation for those losses and should contact an experienced advocate who can initiate an immediate investigation.

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What You Need to Know About Swimming Pool Safety This Summer

Early this June, CBS Local reported that an 18-year-old girl was seriously injured in a swimming pool accident. The teen suffered a spinal injury, a fractured skull and a broken wrist. The teen also faces trespassing charges because she and a friend were allegedly "pool-hopping" at the time of the accident. Essentially, this means that the teens broke into someone's back yard to go swimming. Unfortunately, they chose the backyard of someone whose pool had been emptied for repairs, which was how the 18-year-old was injured when she jumped in. 1341083_neglected_pool.jpg

Our Boston accident attorneys know that swimming pool accidents are far-too-common over the summer months. While pool-hopping teens may not be a common occurrence, trespassers coming onto properties to use swimming pools occurs frequently through the hot summer months, and many of these trespassers are young children who could drown within minutes. Young kids are even at risk of drowning in swimming pools with parents in arm's reach, since most people don't really recognize the signs of drowning.

Keeping kids (and teens) safe from summer swimming pool accidents thus needs to be a joint-effort. Parents and caregivers should do their part by supervising their kids carefully, teaching their kids to swim and learning the signs of drowning. Pool owners need to carefully secure their swimming pools to ensure that kids don't wander into the pool and lose their lives.

Protecting Kids from Swimming Pool Accidents

The homeowner of the pool where the 18-year-old kid was injured had done everything right to try to prevent accidents and trespassers. The homeowner was actually a building inspector for the town of Westford whose job it is to make sure pools are up-to-code. He had a six-foot privacy fence to block the view of the pool and a four-foot-tall chain link fence around the rest of the area.

While his fence did not keep the teens out because they were intent on trespassing, it would have kept out an average child wandering around the neighborhood.

Having a fence is so important that the U.S. Consumer Product Safety Commission recently issued a call-to-action encouraging homeowners to put a fence around all pools. The CPSC's news release on the fence issue was sent out because the majority of kids who drown -390 each year on average- do so in backyard pools.

Having the pool fence can protect these young children and it also protects homeowners from being held legally liable for injuries that kids sustain.

Of course, while a fence can keep trespassing kids out, kids are also at risk when swimming with permission unless they are carefully supervised. Supervised mean not just keeping an eye on them, but also knowing how to recognize the signs of drowning.

Unfortunately, many believe that drowning involves flailing and splashing like they see in the movies. The reality, however, is very different. As a Slate article recently indicated, drowning doesn't usually look like drowning because a drowning person cannot cry out for help or flail. A drowning person cannot cry out because he cannot breathe, and he cannot flail because his drowning mechanism will cause him to extend his arms laterally and press down on the water's surface.

Actual signs of drowning thus include a mouth that sinks and reappears regularly; movements that look as if the drowning person is climbing a ladder; and having glassy, closed or unfocused eyes.

If homeowners put up fences and parents and caregivers learn the signs of drowning this summer, hopefully there will be fewer deadly or dangerous drowning accidents and kids will make it through the summer season OK.

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Boston Doctors Seeks to New Solutions To Traumatic Brain Injury Treatment

It is a long-standing and well-accepted rule that doctors need to obtain informed consent before providing treatment to patients. When a patient is unable to give his consent, family members or those with medical power of attorney need to be consulted. These rules exist to ensure that people understand the risks of receiving medical care and can make choices about how they want to handle their own health issues. 666037_x-ray_head.jpg

Unfortunately, our Boston brain injury attorneys know that patients who suffer some of the most severe injuries are not able to give informed consent when they need treatment. Those who are brought to the hospital after suffering head trauma from a car accident, slip and fall, work accident or other incident are often unconscious as a result of head injuries.

Because brain injuries often occur in trauma situations, patients may not have their family with them either. These brain injury victims need treatment right away to have the best chance of avoiding brain damage, but there is that issue of informed consent to think about.

Boston Doctors Seek New Solution for Brain Injury Patients

A group of Boston doctors is currently seeking permission to try out a new solution in treating brain injury patients. According to the Boston Globe, the doctors are hoping to join a national trial that is intended to assess the impact of administering the hormone progesterone to a brain injury patient in the hours immediately following the injury. Doctors want to be able to provide the hormone treatment to patients through injections that are given right away, entering them in the trial without waiting for informed consent.

This is a departure from the traditional rules associated both with providing medical care and with putting patients into clinical trials. Usually, patients need to be told of the risks of participating in trials or studies and need to be given the chance to refuse enrollment. However, because doctors in this clinical trial would be giving the hormone injections right away to unconscious patients, there generally would be no chance to say no.

If the Boston doctors are given permission to enter into the study, this would be the first time that an exemption was made at a Boston hospital on the issue of informed consent since the FDA created rules in 1996 allowing such exemptions. The law permits exemptions in situations where emergency care is necessary.

When a brain injury occurs, every second counts when it comes to treatment because a "secondary cascade" of harm occurs to the brain after the initial trauma. The secondary cascade refers to the fact that swelling, metabolic changes and fluid build-up can result in cells continuing to die until the brain is stabilized. The more cell death that occurs, the more cognitive and neurological impairments a patient experiences. The cell death is permanent and cannot be cured or reversed, so the only hope for staving off serious brain damage in head trauma cases is prompt treatment.

The hope is that the progesterone will be effective at stopping the secondary cascade of injuries if administered promptly after the trauma because the progesterone can stop cell death. If the doctors at Boston-area hospitals are allowed to go forward and enter the trial to study the effects of progesterone on brain injury patients right after a trauma, patients will have a reason to hope that brain injury treatment will be more effective at preventing permanent harm.

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Preventing Injury Caused by Dangerous Drug Interactions

Patients who take regular medications or multiple medications are at risk of injury caused by dangerous drugs. According to some health and medical experts, there are some ways you can help to avoid the consequences of dangerous drugs or dangerous drug interactions. Our Boston injury attorneys are experienced in these medical-legal cases and are dedicated to helping patients protect themselves and their loved ones from medical negligence.

According to statistics, the average American fills approximately 12 prescriptions per year. This creates significant opportunities for prescription errors including wrong medication, overdose, or dangerous mixing of drugs. While doctors, pharmacists, manufacturers and other medical professionals should be held accountable for dangerous drugs and injuries, there are some steps a consumer can take to avoid injures.

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The Agency for Healthcare Research and Quality has reported that more than 77,000 injuries and death occur every year as a result of drug related events. Consumers and patients who understand the risks can take steps to reduce the chance of drug injuries and fatalities. The Food and Drug Administration has indicated that there are three main drug interactions: drug-food interactions, drug-condition interactions, and drug-drug interactions.

Drug-food interactions may result in dangerous side effects, such as when a drug is mixed with alcohol. Drug-condition interactions may have dangerous consequences if a doctor prescribes a drug without knowing a full medical history and other conditions that could be impacted by the use of a drug. Mixing two drugs or drug-drug interactions can be dangerous or fatal.

As a consumer, you should be aware of these various kinds of drug interactions. Pharmacists have offered the following tips to help you avoid some interactions and keep your family safe:

1) Stick with a regular pharmacy. Choosing one pharmacy and picking up all of your prescriptions can reduce the possibility of error and ensure that your pharmacist has a full record of your prior health conditions or other medications. When you see a regular pharmacist your doctor can also check for any risk of drug interactions.

2) Communicate regularly with your doctor. If you have a new or resurfacing health condition, always make changes known to your doctor. Your primary physician as well as any specialists you are seeing should have a list of your conditions and prescription medication. You should also indicate whether you are taking supplements and over the counter medication. Always ask questions if you have dietary restrictions, habits, or a history of food-drug interactions.

3) Ask questions and pay attention. When you get a prescription filled, you should have a clear understanding of the dose, potential side effects, name of the drug, and the drug instructions. Following directions can reduce the likelihood of error or a dangerous drug interaction. Always follow directions and drink water or eat food with a drug as indicated on the label. When you have questions, do not hesitate to ask your doctor or your pharmacist about concerns.

You should never share medication or take a prescription without a doctor's consent. This could also result in serious side effects and injury. As always, when you are the victim of a dangerous drug interaction, you should consult with a legal-medical professional who can help you assert your rights.

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Oklahoma Tornado Raises Awareness for Storm Preparation

Hurricanes, tornadoes and other weather disasters can be extremely dangerous. As victims of the recent Oklahoma tragedy know, nothing can prepare you for such upheaval. While the consequences of a storm are never predictable, taking precautions in advance can help to prevent injury and to create an environment of survival before, during and after the storm.

Some preparations may include creating an emergency plan, learning how to identify warning signs before a severe storm, and how to monitor tornado warnings. Experts agree that knowing the warning signs can help you stay safe during a storm. Even though tornadoes don't usually strike the New England region, our Boston personal injury attorneys realize that disaster preparedness can also help prevent injury after storms like Hurricane Sandy.

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Businesses, schools, hospitals, nursing homes and other organizations should take necessary steps to prepare for a storm. In addition to creating a safe environment for clients, residents, students, or other occupants, employers should be concerned about the safety of their workers. Creating an emergency plan is a necessary blue print to determine where residents, students or employees should take shelter. It should also outline policies to ensure that individuals are accountable. Depending on the premises, there should be specific procedures to deal with any hazardous materials that could pose an additional threat.

After a storm, there could be additional dangers posed to workers, including electrical lines, sharp debris, heat illness, and the potential injury caused by equipment used during a recovery effort. Portable generators can create the risk of electrocution, burn, or fires. Immediately after a storm, workers should take every necessary precaution to stay safe, whether in an office building, on a construction site, or facing the elements.

Workers who are assisting with recovery efforts may face additional dangers on the job. Unstable premises, electrical hazards, and other unknowns can pose a serious risk to workers involved in recovery or restoration efforts. While employers are responsible for providing equipment, training workers, and providing necessary information to successfully complete a recovery effort, workers should always be wary of latent risks or dangers.

Employers are responsible for the safety and health of workers. Companies should create emergency strategies and give workers the information they need to anticipate any hazards associated with response or recovery after a storm. OSHA has provided information for workers and employers to prepare for a storm. Though storm personal injury cases can be complicated, it is important for victims to have a clear understanding of their rights and recovery options.

In the event of a storm-related workplace accident, victims and their families may be entitled to compensation. Workers who suffer an injury during or after a storm do not need to prove negligence, they only need to demonstrate that they were injured while in the course of performing work-related duties. In addition to workers' compensation benefits, all storm victims may also be able to pursue third-party claims against negligent individuals or entitles.

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Criminal Penalties for Foreign Drugmaker Ranbaxy

The pharmaceutical company, Ranbaxy, has been held criminally liable for a number of injuries and wrongful death caused by dangerous drugs produced in overseas factories. The manufacturing company failed to follow federal safety guidelines and lied to authorities. Now the company has pleaded guilty to criminal charges and will be forced to pay a record $500 million fine.

Consumers in the United States and worldwide should be able to trust that the company's they depend on are held to the highest standards. Our Boston dangerous drug lawyers are dedicated to helping victims of drug injury protect their rights against Ranbaxy and similar negligent drug manufacturing companies.

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Lofton, et.al. v. McNeil Consumer & Specialty Pharmaceuticals, et al., was initiated in 2000 after the death of Christopher M. Lofton. The company received its first warning in June 2006 and the Department of Justice initiated legal proceedings against the company in 2008. Many critics believe that the $500 million fine is minimal compared to the damage caused by the company and the egregious acts that led up to the criminal charges.

Foreign drug makers are difficult to regulate and the FDA faces a number of challenges when reviewing how the drugs are manufactured or distributed in the United States. According to reports, this is one of many foreign drugmakers that was able to produce drugs cheaply and under the radar of the FDA. The company has pleaded guilty to felony charges after admitted to selling adulterated drugs with the intent to defraud. Ranbaxy failed to meet drug specifications and made intentionally false statements to the government.

Ranbaxy was finally scrutinized after evidence of harm to consumers and the FDA found that the drugs had extremely high rates of impurity, creating significant risk to patients. In November, Ranbaxy had to withdraw its anti-cholesterol drug after the pills were found to be contaminated with glass powder. Many of the drugs would become unusable when exposed to hot or humid conditions, even when necessary to patient survival. Many of the drugs were prescribed to patients suffering from AIDS, bacterial infections, or epilepsy.

According to reports, Ranbaxy is guilty of failing to follow standards of manufacturing prescribed by the FDA as well as fraud. In addition to breaching patient trust, the company also defrauded an entire system. Some critics of Ranbaxy have suggested blacklisting a number of the drugs that are still under investigation. Many believe that the Indian government is also to blame for failing to investigate or charge the company with a crime. India's regulation agency has also failed to probe the company.

It has been reported that the company's executives demonstrated an extreme lack of empathy for patients dependent on their drugs. The company has admitted that during the summer of 2007 a batch of gabapentin, also known as Neurontin, had tested positive for impurities. This meant that the shelf life for this batch of drugs was unreliable and that the drugs were essentially unusable. The drug is used to treat epilepsy and is a necessary part of life for patients. According to reports, there had been several issues with the batch for month. Despite this knowledge, the company intentionally delayed notification to the FDA. The end recall involved nearly 75 million pills.


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