Compounding Pharmacy Regulations Put Patients in Danger

With the recent news that two Massachusetts compounding pharmacies were closed after failing a surprise state inspection, it has become increasingly clear that unsafe compounding pharmacies are, in many cases, a public menace.

Of course, as our Boston injury lawyers know, the biggest disaster to-date was a meningitis outbreak that caused more than 700 illnesses and 50 deaths as a result of products from New England Compounding Center (NECC), which were contaminated with fungus. However, the bad news just keeps coming and the FDA is now engaged in a fight with a compounding pharmacy that is refusing to recall products that could potentially lead to life-threatening infections. getting-the-needle-for-lockjaw-1090112-m.jpg

The fight between the FDA and a compounding pharmacy called NuVision not only underscores the fact that many compounding pharmacies are taking dangerous risks with people's health, but also shows the clear need for tougher regulations and better rules on who, exactly is responsible for regulating compounding pharmacies. Tougher regulations are necessary as NuVision has refused the FDA's request for an immediate recall because the company believes it is in compliance with all current legal requirements.

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Judge Releases New Case Management Order in Stryker Hip Implant Litigation

Throughout the United States, there are hundreds of lawsuits pending against Stryker based on its Stryker Rejuvenate and Stryker ABG II hip implant products. The lawsuits have been brought by individuals who had Stryker hip implants used in procedures prior to the July 2012 recall of these defective medical devices. balance-875413-m.jpg

Our Boston defective hip implant lawyers know that the outcome of pending cases are important because they can shape future litigation. While each of the different lawsuits will be resolved on their own merits if the cases proceed, verdicts or decisions that favor the plaintiff could make the company more likely to offer generous settlements to injured victims who have lawsuits pending.

Because the current litigation can have an impact on all plaintiffs, it is important to keep up-to-date with what is going on with Stryker cases, especially multi-district and multi-county proceedings. Recently, in one such proceeding in New Jersey, the court issued a new case management order.

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Massachusetts Birth Injury & the Risk of Larger Babies

It's been medically well-established that birth injuries are more likely in babies that are significantly larger in size.
Our Boston birth injury attorneys know that care of an infant begins before birth. Doctors have many tools at their disposal not only to anticipate the size of the newborn, but also to prepare and plan for any complications that might arise as a result of larger-than-average size.

That could mean ordering a C-section, rather than a vaginal birth. That could mean having specialists or others on hand in case additional efforts are necessary.

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Transvaginal Mesh Case Resolved in Plaintiff's Favor

Recently, our Boston transvaginal mesh lawyers reported that a mistrial had been declared in a bellwether transvaginal mesh case. While the need to restart the trial caused a delay in the resolution of this important case, WOWK TV now reports that the claim was resolved in the plaintiff's favor. gavel-952313-m.jpg

The case involved a Georgia woman who filed a lawsuit against C.R. Bard Inc., the manufacturer of the Avaulta Plus Posterior BioSynthetic Support system. The transvaginal mesh system was implanted in the plaintiff in an effort to treat pelvic organ prolapse, a condition that causes the organs in the pelvic area to intrude on the vaginal wall. Unfortunately, C.R. Bard's transvaginal mesh product failed to work as promised and caused serious harm to the injured Georgia woman.

As a result of the complications she experienced, the victim alleged that the company was negligent, that there was a design and manufacturing defect, that the company failed to provide adequate warning of the risks, and that both express and implied warranties were violated.

Transvaginal Mesh Case Resolved for Plaintiff
The Georgia woman taking action against C.R. Bard indicated that she had been seriously harmed as a direct result of problems with the mesh product. She alleged that she had suffered pain and permanent injury as well as developed a substantial physical deformity because of the mesh. Because of her injuries, she reportedly required multiple revisions surgeries.

The case brought by the plaintiff was one of more than 20,000 similar cases pending throughout the United States. Like the other cases, it was consolidated in a multi-district litigation, which means that one judge is able to hear multiple cases that are grouped together because plaintiffs were injured by a similar defective or dangerous product. The case was not a class action because each individual plaintiff maintains his or her own claim and seeks compensation for his or her own specific losses. It was, however, a "bellwether" case because its outcome could have an impact on future settlement or litigation.

The outcome of the case was thus important to the thousands of patients who are waiting to have their own day in court to hold manufacturers of transvaginal mesh responsible. Fortunately for those plaintiffs, the first bellwether trial had a positive outcome for the plaintiff. In fact, the jury awarded the plaintiff $250,000 in compensatory damages and another $1.75 million in punitive damages.

While this case does not guarantee that future plaintiffs making a claim will necessarily get the same outcome or similar results, it does bode well for injured victims.

Companies facing millions of dollars in compensatory and punitive damages may be eager to make a settlement offer with injured victims to try to limit the company's potential exposure to losses in a lawsuit. While injured victims can benefit from this, it is also important for victims to understand what a fair settlement offer is and to ensure that they don't accept less than they deserve.

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Stryker Awarded Contract for Hip & Knee Replacements Even as Lawsuits are Pending for Hip Implant Complications

In late August, Healio reported that the Department of Defense has awarded a contract to Stryker for hip and knee implant packages. The contract is for hip and knee implants, instrumentation sets and auxiliary products and it is valued at $85,469,865. The contract reportedly represents an agreement that sets pricing so the military can access needed products, but there is no guaranteed purchase amount required by the agreement. knee-replacement---side-view-1183622-m.jpg

While the contract will allow the military to access products and services as required, it is important to ensure that the hip and knee replacement products being offered to the military are safe. Our Boston Stryker implant lawyers know that there have been myriad problems with Stryker hip implant products in the past, with the problems so severe that a recall was actually required of the Stryker Rejuvenate in 2012. Hopefully, any future products provided by the company as a part of the contract with the Department of Defense will be safe products that live up to the manufacturer's promises.

Product Recalls Prompted by Dangerous Stryker Hip Implant Products
Stryker produced the Rejuvenate hip implant system as an alternative to traditional hip replacement products. Stryker marketed its products by promising that they would last longer and offer a better range of motion by allowing for more customization of the replacement joint.

With most hip replacement devices, there is one stem that fits inside of the femur and one head that goes on top of the femur to replace the patient's damaged hip joints. The Stryker Rejuvenate offered multiple heads and stems to chose from in order to make it possible for doctors to customize the hip replacement device to the individual patient.

Unfortunately, not only did the Rejuvenate fail to live up to the promise of being a better and longer-lasting alternative, it instead began to cause serious complications for patients. The Stryker Rejuvenate has a high failure rate, leaving many patients needing additional revision surgery within just five years of the initial hip replacement surgery. The Stryker system also can cause complications such as bone breakdown; tissue health; and a toxic build-up of metal in the body called metallosis.

Because of the serious problems, Stryker recalled the dangerous hip replacement product in 2012. Unfortunately, this was too late for the many patients who had undergone a hip replacement surgery and who were already experiencing complications or were left in fear that they will soon start to experience problems.

Stryker never should have released a dangerous hip replacement product onto the market and the problems that were uncovered once it was sold to the public should have been discovered during pre-market testing so the issues could be corrected or the patient's warned. The fact that Stryker did sell this product that turned out to be dangerous is an indicator that the manufacturer likely breached its responsibility to keep the public safe.

While lawsuits are still pending and the extent of Stryker's liability for injuries as a result of the Rejuvenate product is still unclear, one thing is certain: dangerous and defective medical products cause serious harm to patients. Hopefully, all the medical devices that Stryker is offering as part of its new contract with the Department of Defense will have been carefully tested and will not later turn out to cause unexpected side effects or complications for those who have hip and knee replacement surgeries.

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Second Transvaginal Mesh Bellwether Case Results in Settlement

Recently, our transvaginal mesh plaintiff attorneys reported that the first bellwether case in a transvaginal mesh lawsuit had been resolved, with the plaintiff being awarded $250,000 in compensatory damages and $1.75 million in punitive damages. Just a few short days later, WOWK TV reported that a second transvaginal mesh case settled. to-sign-a-contract-3-1221952-m.jpg

The terms of the settlement have not been released and are confidential, according to the reports. However, since this settlement closely follows the case resolved in favor of the plaintiff earlier this August, the cases thus far seem to be showing a trend of going in favor of the plaintiffs. Although past cases cannot guarantee future results, this could be a good sign for the injured victims who were harmed by transvaginal mesh devices.

Second Transvaginal Mesh Case Resolved
The second transvaginal mesh case, like the first, was brought against mesh manufacturer C.R. Bard Inc. The injured victim in the case asserted that she had been implanted with a C.R. Bard mesh product called the Avaulta Solo Anterior Synthetic Support system as a method of treating her pelvic organ prolapse (POP). The procedure took place in 2008.

Unfortunately, the mesh quickly began causing serious problems. The plaintiff indicates that the C.R. Bard product caused her to experience mental and physical pain and suffering; physical deformity and permanent injury. The mesh also reportedly caused an infection, interfered with marital relations between the plaintiff and her husband and necessitated that she undergo six corrective revision surgeries.

The victim sought damages to cover the costs of medical bills and to compensate her for pain and suffering and mental anguish. Additional punitive damages were anticipated, especially after the initial trial resulted in such a large punitive damage award by the jury.

The trial for this second bellwether case was supposed to start on the August 21st, but since a settlement agreement was reached, there is no need for the claim to be heard in the courtroom. The confidential settlement means that other injured plaintiffs who were hurt by transvaginal mesh products will not know what amount of money the injured victim received in this case. However, the fact that the case did settle before trial could potentially indicate that the company is going to be more amenable to settling rather than risking another multi- million dollar jury verdict.

It is important to realize though, that while these early cases have been good news for plaintiffs, there are another two bellwether cases upcoming that could have different results. As the WV Gazette indicates, there is a chance that the next trial will result in an outcome that favors the defendant.

The next trial is scheduled to begin on October 8 and has been described as a case that the defendant's picked because of the thought that it was a winnable case for the defense. Even if the defense is successful in the next claim, however, future plaintiffs with proof of the harm the vaginal mesh caused them may be able to successfully settle their claims or receive large damage awards from a jury who finds in their favor.

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Johnson & Johnson Reportedly Considering $3 Billion Settlement to Resolve Hip Implant Cases

Johnson & Johnson is currently facing more than 11,500 lawsuits throughout the United States. Our Boston defective hip attorneys know that Johnson & Johnson is facing these lawsuits as a result of DePuy hip implant products. The DePuy products are manufactured by a Johnson & Johnson subsidiary and, unfortunately, have a high failure rate and can cause patients to experience serious complications. tightened-100-dollar-roll-1377964-m.jpg

Johnson & Johnson is reportedly considering making a large settlement offer to resolve as many of the lawsuits as possible. According to, the company hopes to resolve cases arising from DePuy hip replacement devices by early next year.

Johnson & Johnson Settlement Would Be the Largest To-Date Related to Hip Implant Defects
DePuy, a unit of Johnson & Johnson, is facing massive potential legal liability as a result of its defective hip implant products. In 2010, the company was forced to recall 93,000 implants, an estimated 37,000 of which had been implanted in patients in the United States. The recall was prompted by the fact that 12 percent of all of the DePuy hip implant and replacement devices had failed within five years (a much higher failure rate than for other hip replacement solutions).

Unfortunately, the failure rate of the DePuy products doesn't seem to be declining but instead appears to be getting worse in recent years. Further, the number of lawsuits has also been on the rise, with patients suing to recover monetary compensation for pain and for the cost of replacement surgeries when the DePuy hip products fail.

There is some good news for victims, however. In the first lawsuit arising from DePuy hip implant devices, the court found in the plaintiff's favor and Johnson & Johnson lost an $8.3 million verdict. While the second lawsuit saw Johnson & Johnson prevail, the company still faces many potential viable claims.

Johnson & Johnson wants to resolve cases by compensating those who have been harmed, rather than by going to trial. The company is reportedly considering payout out a settlement of more than $300,000 per case. This would result in a total settlement in excess of $3 billion, which is 50 percent higher than the settlement offer proposed in recent negotiations.

If the $3 billion settlement were to occur, this would be the highest amount of money paid to settle a hip implant claim, topping the prior record, which was set when a company called Sulzer agreed to pay $1 billion in 2001 to resolve lawsuits against it.

Whether Johnson & Johnson is actually able to resolve its cases through settlement will depend upon a number of factors, including how many plaintiffs are willing to accept the proposed settlement and how several product-liability trials go between September and January. The first of the seven pending claims that could have an impact on settlement is scheduled to begin on September 9 in Cleveland. The judge in Cleveland is overseeing approximately 8,000 federal cases that were consolidated.

In the meantime, Johnson & Johnson has already spent approximately $993 million on informing patients of the recall of the defective DePuy hip implants. The company also continues to provide a reimbursement program to patients who have DePuy hip implants and who require recall-related testing or treatment necessitated by the recall of the dangerous hip implant product. The high costs and large potential settlement should serve as a reminder to medical device companies of the importance of ensuring that medical products are safe.

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Two More Massachusetts Compounding Pharmacies Closed

Compounding pharmacies have been making headlines a lot in recent months, almost always with terrible news.

The most devastating stories related to the New England Compounding Center, which is blamed for a meningitis outbreak that caused more than 50 deaths and another 700+ people to suffer injuries across 19 different states. However, the NECC is not the only compounding pharmacy to be in trouble for failing to live up to its obligations to patients. medical-equipment-1342025-m.jpg

Our Boston injury lawyers know that efforts are being made to change how compounding pharmacies are regulated because many pharmacies are not currently following best practices and safety guidelines. Unfortunately, a new report this month shows that tougher regulations and better enforcement cannot come soon enough.

Compounding Pharmacies Shut Down for Violations
According to the Boston Globe, two compounding pharmacies were shut down in mid-August of this year. The pharmacies were located in Quincy and in Norwood and were shut down after a surprise state inspection.

The inspection of one of the pharmacies that was shut down had been conducted on the second of April. According to a media relations manager for the Massachusetts Department of Public Health, the inspectors found that the property was non-compliant with a myriad of regulations. This included board regulations such as a requirement that prescriptions be verified and requiring specific handling for expired medications and sterile compounding.

Following the inspection, the Board of Registration in Pharmacy ordered the pharmacy to halt its operations. However, despite the notice to the pharmacy, it continued to operate, violating the cease and desist order from the court. A cease and desist was subsequently sent to a sister company for assisting in violating regulations. The Board of Registration also suspended the licenses of the compounding pharmacies and of the managers of the pharmacies.

This August, the hearings on the cease-and-desist orders and on the license suspension began. The outcome of the hearing could result in the compounding pharmacies being forced to make changes to ensure that they are providing reasonable protection to patients.

The inspections that led to the hearings are part of an enhanced oversight program put into place following the disaster at the New England Compounding Center that prompted the fatal meningitis outbreak.

The need for these inspections has become quite clear, though both state and federal regulators did little enough to protect the public before the high-profile outbreaks began. As the Boston Globe reports, there were 37 compounding pharmacies in the state of Massachusetts that were inspected by state inspectors since the enhanced oversight rules went into effect. Only four of the compounding pharmacies that were inspected were actually able to pass the inspection. This means that another dangerous meningitis outbreak or similar outbreak could easily have occurred at any one of these pharmacies.

With tougher enforcement of laws and regulations, hopefully the compounding pharmacies will begin to step up and provide reasonable health and safety assurances. The unannounced inspections will reportedly continue for an indefinite period, which could also help to ensure that compounding pharmacies take extra steps to ensure safety.

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Signs a Stryker Hip Implant is Failing

Stryker is a manufacturer of hip replacement products including the Stryker Rejuvenate. The Stryker Rejuvenate was recalled in 2012 because the replacement hip joint proved to be unsafe and to have a high failure rate. Unfortunately, thousands of patients have already experienced complications while many more who had the Stryker Rejuvenate implanted prior to the recall may start to experience health issues over the next few years. im-still-mobile-1114180-m.jpg

Our Boston hip implant lawyers know that the Stryker Rejuvenate has an even higher failure rate than many metal-on-metal hip replacement systems as the Rejuvenate had a unique design. The Stryker hip replacement product promised flexibility to patients by offering six different stems to fit inside of the femur and by offering a choice of 16 different necks. Unfortunately, this design has only served to give the Stryker Rejuvenate multiple ways to fail.

How Can You Tell if a Stryker Hip Implant is Failing?
The Stryker Rejuvenate hip replacement system can cause significant health issues, including tissue death and metallosis, which is a build-up of toxins in the body from the breakdown of metal. It can cause damage to the kidneys, lymph nodes, muscles, heart, nervous system and liver. The Stryker is also prone to failing within the first five years of being implanted.

Some of the signs that you should watch out for may indicate that your hip implant is failing or that other complications have developed include:

  • Discomfort in the hip or pain around the hip area.

  • Problems walking.

  • Inflammation.

  • The formation of a pseudo-tumor, which is a bulging collection of metal flakes and fluid that can form due to the metal of the Stryker hip implant coming off in the body.

If you experience these or other symptoms that indicate your Stryker hip implant may be failing, you should visit a doctor right away. A qualified medical professional can perform an X-ray in order to observe the position of the replacement hip joint and to observe the bone and joint.

An MRI or blood test can also be performed in order to measure the level of metal ions in the body. An elevated level of metal ions can be a good indicator of whether the Stryker hip implant has begun to cause problems.

Unfortunately, sometimes there are few symptoms associated with a Stryker hip implant failing until the problems become severe and until there is damage to the surrounding tissue or loss of bone. The longer it takes to make a diagnosis, the more damage is likely to occur in the body and the more difficult it is going to be to remove the defective hip implant and to resolve the health issues that the Stryker Rejuvenate caused. Regular screenings for problems, therefore, may be advisable if you had a hip replacement procedure using a Stryker product.

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More Evidence That Metal-on-Metal Hip Implants are Prone to Fail

Metal-on-metal hip replacement products were sold to doctors and patients with promises that these medical devices would be better than the alternative. Manufacturers who released these products said that unlike traditional replacement joints with ceramic parts, the metal-on-metal products would last a long time and be great for young and active people. 1031747_hospital.jpg

Unfortunately, our Boston defective hip attorneys know that not only did the devices not live up to the claim of being longer lasting, but they are actually more prone to fail than the other types of hip joint replacement systems. This has been confirmed time and again and now yet another study has come to light highlighting the high failure rate of metal-on-metal devices.

Canadian Institute for Health Reveals Problems with Metal-on-Metal Devices

According to CBC News Health, the Canadian Institute for Health recently conducted an in depth study on metal hip replacement products. The study was one of the largest to-date and it compared the outcome of patients who received a metal-on-metal hip replacement product with those who receive other types of replacement joints.

Researchers looked at more than 56,942 hip replacement surgeries that were performed throughout Canada from 2003 through 2011. These included:

  • Patients who had received a metal-on-plastic hip replacement (23 percent of patients who had a procedure during this time period)
  • Patients who received a metal-on-metal hip replacement (nine percent of patients)
  • Patients who received a ceramic-on-ceramic hip replacement product (eight percent of patients)
  • Patients who had received a ceramic-on-plastic hip replacement product (five percent of patients)

Of those included in the research, the vast majority of patients who received a metal-on-metal implant were under the age of 55, reflecting the aggressive marketing of the products to younger people getting hips replaced. Most of the metal-on-metal products were also implanted in either 2007 or 2008, as this was the time when the devices were most aggressively marketed and before reports of problems began to surface.

The purpose of the study was to determine the failure rates for each of the different kinds of hip replacement products. Hip replacement systems should last anywhere from ten to fifteen years on average, but since the metal-on-metal devices promised to last longer, they would have a very low failure rate if they lived up to the hype. Unfortunately, however, they clearly did not offer the lasting solution that was promised.

Although it has been just a few years since most of the patients included in the study had their metal-on-metal hip implants put in, many have already had to have the hip joint replaced. In fact, the study revealed that the metal-on-metal products had a 5.9 percent failure rate during the first five years after implantation. This was almost the 2.7 percent failure rate for metal-on-plastic devices.

Having a hip replacement fail is painful, and the surgery to correct the problem can be expensive and can seriously impact a patient's quality of life. Those patients who had their devices fail didn't deserve to experience these complications and should take legal action against the medical device manufacturers who released the dangerous products onto the market. With new studies surfacing regularly to reveal the dangers associated with these devices, plaintiffs should have more evidence than ever to build a strong case.

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Bellwether Transvaginal Mesh Trial Underway Following Previous Mistrial

A new trial is underway in the transvaginal mesh case of Cisson et al v. C.R. Bard, Inc, after the case had ended in a mistrial last month.
Our Boston transvaginal mesh attorneys recognize that this case is significant because it is the first of some 23,000 cases set to go before the U.S. District Court for the Southern District of West Virginia. The court is handling the cases, which each claim the mesh devices caused complications that were both painful and serious.

In the Cisson case, the plaintiff, a 54-year-old public health nurse, alleges that the surgical device, known as the Avaulta Plus vaginal mesh, made by C.R. Bard Inc., was implanted in her and caused her to suffer internal pain and bleeding. She had to undergo several surgeries in order to have the device removed.

This company alone faces some 3,600 claims. Other companies facing significant transvaginal mesh litigation include Johnson & Johnson, Boston Scientific Corp. and Endo Health Solutions Inc.

Plaintiff attorneys in the Cisson case are arguing that C.R. Bard ignored warnings from the manufacturer of the plastic compound used in the device that it was not intended for permanent implantation in human beings. In the previous trial, defense lawyers had attempted to argue that the plastic compound used in the device and the final product were not one in the same, and therefore C.R. Bard hadn't violated any safety standards.

Last month, the trial was only two days in when U.S. District Judge Joseph Goodwin halted the proceedings, in the midst of testimony from a Florida gynecological expert who strayed into testimony regarding the marketing of the devices. The information came in response to a question from a plaintiff attorney, who had asked what evidence exists to support the opinion that the Avaulta Plus mesh product is dangerous and defective. The witness testified that the basis for this opinion is rooted partially in the fact that he is called upon to remove so many of them and also that they are no longer available on the market for implantation.

Previously, the judge had ruled that plaintiffs weren't allowed to mention that the defendants had withdrawn their products from the market last year. The judge said the "bell could not be unrung," and the jury would be hard-pressed to disregard that information. It was the first time in the judge's 20 years on the bench that he had declared a mistrial, he said.

In the opening statements of the new trial, plaintiff attorneys have asserted that C.R. Bard:

  • Knew of the risks associated with the transvaginal mesh products and did nothing to warn doctors;

  • Failed to do clinical testing or studies in order to fully know the risks of the product;

  • Did not conduct studies on how to remove the products;

  • Marketed and sold the products knowing that the material used to make it wasn't designed for implantation in humans;

  • Failed to tell doctors that the product was unfit for human use.

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Understanding Multi-District and Multi-County Litigation in the Stryker Rejuvenate Cases

Stryker Rejuvenate was a metal hip replacement product manufactured and sold by Stryker Orthopaedics from 2008 through 2012. Unfortunately, the Stryker Rejuvenate was recalled in 2012 because of a myriad of health problems and complications caused by the hip replacement device. The device not only had a high failure rate, necessitating revision surgery, but also caused health problems including metallosis, pseudo-tumors and necrosis. 1409592_gavel_2.jpg

Our Boston defective medical device lawyers know that following the recall, thousands of injured victims began to take action against Stryker Orthopaedics, making claims for compensation to cover their losses. If there is a clear proven link between Stryker's Rejuvenate and the health problems patients are suffering (as the recall suggests there is), then injured patients can be compensated for pain and suffering as well as for all financial losses they endured because of the defects in the hip replacement product.

Today, many of the cases against Stryker have been consolidated into multi-district litigations or multi-county litigations. This is done in order to make it simpler for claims to be processed in an expedient manner.

Understanding Multi-District and Multi-County Litigations in the Stryker Cases

According to Harris Martin Publishing, a multi-district litigation against Stryker is moving forward in Minnesota. The case arose out of problems with the Stryker Rejuvenate and an initial pre-trial order was issued in July, appointing interim lead counsel for the plaintiffs. The Judicial Panel on Multidistrict Litigation also issued conditional transfer orders in an additional 61 cases arising from problems caused by the Stryker Rejuvenate.

As this case moves forward, more legal actions are also going on nationwide. For example, at least 273 Stryker lawsuits have reportedly been filled in Bergen County Superior Court following the establishment of multi-county litigation in New Jersey. In this multi-county litigation, a Case Management Conference was scheduled for the 13th of August.

These are just a few examples of many different cases moving forward against Stryker Orthopaedics. Cases are consolidated into multi-district and multi-county litigations so that certain issues of fact can be decided more quickly by a judge who is familiar with the case.

Rather than having every issue, every request of the court and every legal matter litigated over and over again for the thousands of patients who were hurt by the defective medical devices, multi-district and multi-county litigations allow for a consolidation of cases with one judge. The judge can then process claims much more quickly, ensuring that patients get justice in a more timely manner and that the courts time is not taken up with hearing and deciding thousands of cases from start to end.

Multi-district litigations are different from class actions, which also allow for many plaintiffs' claims to be heard at once. In a class action, unlike a multi-district litigation, every plaintiff's case is consolidated into one big case. The judge issues a ruling that applies to the whole class of people involved. Class actions are appropriate when plaintiffs are all injured in a similar way by a similar harm. Multi-district litigations, on the other hand, work best when plaintiffs were harmed by a similar cause but all suffered different types of hurt or complications.

In the Stryker cases, individual plaintiffs have their own unique complaints against the medical device manufacturer based on the dangerous Rejuvenate hip replacement devices. The multi-district litigations will allow them to get the compensation that they deserve for their individual losses while still making sure that justice is done in a timely and efficient manner.

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Lawsuits Move Forward Against Stryker Prosthetics for Stryker Rejuvenate

In 2012, Stryker Orthopaedics recalled its Stryker Rejuvenate hip replacement system. Since that time, thousands of cases have been filed against Stryker Orthopaedics as a result of complications caused by the metal hip replacement product. Cases are currently moving forward in Connecticut, New Jersey and nationwide to hold the medical device manufacturer accountable. 1380377_the_human_skeleton.jpg

Our Boston injury lawyers know that patients who had the Stryker Rejuvenate hip replacement device implanted during their hip replacement procedure are facing a high failure rate, as well as the risk of many other health problems. Stryker Orthopaedics must be held responsible for the design, marketing and sale of this defective medical device.

Why the Stryker Rejuvenate is Dangerous

The Stryker Rejuvenate suffers from many of the same problems that are affecting metal-on-metal hip replacement devices from many different manufacturers. The different components of the hip replacement device rub against each other as you move around, causing little bits of metal can begin to come loose and float and lodge surrounding tissue. This can cause discomfort, swelling, pain, the formation of pseudo-tumors, tissue death and metallosis.

Like other metal-on-metal hip replacement devices, the Stryker Rejuvenate also has a higher failure rate than other hip replacement products that are not made of all metal components. Unfortunately, the failure rate is significantly higher within the first five years, and when the device fails, the patient may need to undergo multiple surgeries to correct the problem and put a new hip joint into the body.

These consequences are bad enough, especially in light of the fact that Stryker marketed the Rejuvenate as a better alternative to existing hip implant products -- claiming it was longer lasting and better for younger and more active people.

However, unfortunately, the Stryker may be even more prone to problems than other metal-on-metal devices. This is because the Rejuvenate has a different design than most products. While most hip replacement devices were standard products and the same components were used for all patients, the Rejuvenate offered greater customization. This has proven problematic.

Design Features of the Rejuvenate Cause Problems for Patients

The basic components of a hip replacement joint include:

  • An acetabular cup that fits inside of a concave indentation in the pelvis, which is called the acetabulum.

  • A stem that fits inside of the femur bone.

  • A replacement hip joint that fits atop the femur (femoral head) and slides into the acetabular cup.

The Stryker Rejuvenate is unique because it offered a choice of 16 different necks that fit on top of the femur and because it offered a choice of six different stems that fit inside of the femur. This customization allowed doctors to better fit the hip joint to patients... or at least that was the plan.

Unfortunately, the increased customization has resulted in an increased chance of swelling, pain and problems with the hip replacement system.

Patients coping with discomfort, a failed hip joint or other complications have to cope with the discomfort they feel, and also are forced to undergo corrective surgical procedures. Stryker needs to be held responsible for this and the lawsuits against the company are aimed at making sure that patients aren't going to be forced to pay out-of-pocket for the harm the defective product caused.

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Bicyclists Asked to Walk throughout Boston

Officials with the Boston Parks and Recreation Department recently announced that the prohibition on bike riding will remain in effect for Boston Common, Commonwealth Avenue Mall and the Public Garden because of the all the events held at the sites and because of the volume of foot traffic. Bicyclists are still able to travel on the properties -- if they're walking their bikes through, according to the City of Boston.
This announcement comes after a number of discussions between property abutters, bicycling advocates, Walk Boston, the Friends of the Public Garden and various other groups.

Our Boston bicycling accident lawyers understand that, although these meetings were very productive, there are still some disagreement that lingers regarding these areas and the nature of bicycling. The problem that officials see is that bicyclists come up quietly and swiftly behind pedestrians and are likely to catch them off guard. And that's no good when you consider that these areas are some of the busiest for pedestrian traffic in the city.

These properties host some of the city's most popular events, which makes sharing this space tough.

With today's announcements, residents and visitors should note:

-There are signs that state where bicyclists are allowed to travel. These signs are located at these entrances.

-If you've got a bicycle, you're still welcome. You're just asked to walk your bike through instead of riding.

-Officials will continue the discussion on cycling in the area and will continue to push for safe routes for everyone.

-Bicycling is allowed in City of Boston parks only on those paths that are designated for bike riding.

But don't think that bicyclists are getting shut out. There are still many bicycling events throughout the area. Coming up in the near future are the Hub on Wheels ride, September 22nd, and the TD Bank Mayor's Cup Pro Race, September 21st.

Since Mayor Menino launched Boston Bikes in 2007, ridership in the City has more than doubled. Many other important strides have been made in safety, education, and facilities.

Both Commonwealth Avenue and Massachusetts were ranked as the most dangerous roads in the entire city. Close to 10 percent of the bicycling accidents in the city involved a pedestrian. About 35 percent reportedly involved a motor vehicle. Unfortunately, both men and women cyclists perceive cycling on off-road paths as significantly safer than biking on Boston streets. But we see here that that's not oftentimes the truth.

When you're riding out there, make sure you're riding in a safe and designated area. Some roads have marked bike lanes to the right side of the road. In ideal circumstances, cyclists should stay to the left side of the bike lane in order to avoid potential road debris and to stay outside the radius of the doors of parked cars.

Continue reading "Bicyclists Asked to Walk throughout Boston " »

Transvaginal Mesh Pain Excruciating, Women Say

Transvaginal mesh implants were supposed to provide relief to women suffering from pelvic organ prolapse and stress urinary incontinence.
These are conditions that often plague women after they have undergone a hysterectomy, menopause or child birth. SUI is a leakage of urine during certain moments of physical activity, while POP is when the pelvic muscles weaken to the point that the bladder, rectum and uterus drop into the vagina.

As awful as these conditions are, our Boston transvaginal mesh injury lawyers have heard patients describe the one-time remedy as even worse.

Transvaginal mesh, also known as bladder slings, have been shown to result in major, long-lasting complications for patients. It's believed the number of transvaginal surgery patients is somewhere in the neighborhood of 550,000 to 600,000.

A number of doctors with patients who have undergone the transvaginal mesh surgery have reported that their patients have suffered pain so severe that they have contemplated taking their own lives. Sadly, in a few cases, they have done so.

The implants, ineffective for their intended purpose, have also caused a long list of complications on their own. Those complications, urinary problems and infection. In some cases, blood vessels, bowels and the bladder were perforated during the actual insertion. The erosion of the materials, which we now know in many cases were never suitable for human implantation in the first place, has led to severe vaginal scarring and further injuries. This has led to excruciating pain for many patients.

Some of the descriptions given by sufferers:

  • A feeling as if one is sitting on razor blades;

  • An intense burning and tearing sensation anytime one attempts to engage in sexual activities;

  • A sharp scratching feeling as the mesh protrudes through the vaginal walls;

  • An intense pain so severe it feels like a migraine that stretches from the knees to the navel;

  • Dagger-like, stabbing pain anytime one attempts to urinate.

Even powerful pain medications often do little to alleviate these symptoms long-term. Some women report being unable to sit, drive and in some cases even work.

Some mesh patients report being told for years that despite their pain, nothing was wrong. This only served to further deepen their depression.

While there is revision surgery available to have the mesh removed, it's rare that eroded mesh can be removed completely. In addition to surgery, patients may require IV therapy, blood transfusions and drainage of hematomas or abscesses.

Endo Health, one of the primary makers of the mesh products used on patients, recently settled a small portion of their lawsuits for about $54.5 million, following an $11.1 million verdict in favor of a South Dakota woman. The plaintiff had alleged the product was defective and the company failed to warn, leaving her to cope with permanent scarring and ongoing bouts of extreme pain.

While the jury did not find the product to have been defective, they did find that the defendant failed to offer an adequate warning about the potential dangers of the product and also made fraudulent representations regarding the product to both the doctor and the patient.

Continue reading "Transvaginal Mesh Pain Excruciating, Women Say " »