Articles Posted in defective drugs

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Patients trust that their doctors, pharmacists and other medical professionals are doing everything possible to keep them safe from harm. Unfortunately, a trend of over-prescribing painkillers has led to substance abuse and addiction. Safe Patient Awareness Week urges patients to be aware of potentially harmful drug prescriptions and long-term risks associated with drug use. The public awareness campaign also urges drugmakers, doctors, and other medical providers to make sure that patients are safely monitored while taking pharmaceuticals to prevent against addiction.

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According to the National Safety Council, the number of prescription related deaths has risen 300% since 1999. There are 45 deaths every day in the United States that are related to prescription overdose. Our Boston personal injury attorneys are dedicated to raising awareness to prevent serious injury and wrongful death related to prescription overdose. We are also committed to protecting the rights of patients and their loved ones who have been impacted by dangerous drugs or irresponsible medical providers.
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Anti-psychotic medications have been linked to potentially dangerous side effects, including an increase in the risk of suicidal thoughts; birth defects and miscarriages; and causing patients to experience severe withdrawal symptoms when discontinuing the use of the medications. While our dangerous drug lawyers know that sometimes the benefits of these drugs outweigh the risks, it is also clear that anti-depressants shouldn’t be prescribed unless the medications are truly necessary for the health of the patient. drugs-pills-1418717-m.jpg

Unfortunately, many medical professionals and industry-experts, including the American Psychiatric Association, have recognized that anti-psychotic medications are widely overused. To try to combat this problem and encourage doctors and patients to question whether the drugs are necessary rather than relying so much on these medications, a new campaign has been launched called “Choosing Wisely.”
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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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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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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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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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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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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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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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The New England Compounding Center caused widespread illness throughout the United States when the pharmacy released steroid medications that were contaminated with fungus. More than 749 people throughout the United States were made ill as a result of NECC’s contaminated drugs, according to the government’s accusations. The illnesses ranged from infections at the injection site to fungal meningitis. 818505_intramuscular_injection_2.jpg

Our Boston injury attorneys know that the victims sustained significant financial loss due to NECC’s medication. Unfortunately, the New England Compounding Center has limited funds available to compensate the victims who were harmed by the dangerous drugs. Now, however, the Tennessean reported that some victims have begun pursuing claims against sister companies related to NECC.

NECC Sister Companies Sued
The New England Compounding Center has filed for bankruptcy protection. Because the company is bankrupt, there are limited or even no funds available to provide compensation to the 749 people the compounding center injured. Whether the pharmacy had liability insurance will also be determined by the courts. There were a reported 61 deaths as a result of the fungal meningitis outbreak, and the family members of those who were left behind will need significant sums of money to compensate them for a lifetime of lost wages and lost companionship.

Those who were harmed by NECC still have bills to pay and need to get those costs covered. One woman, for example, spent more than a month in the hospital with fungal meningitis. She has now filed a lawsuit in federal court to try to obtain compensation for the medical bills and costs that she was forced to pay. The lawsuit has been filed not against NECC but against other companies with a common ownership link.

There are a number of different companies with common ownership links including Ameridose LLC, Medical Sales Management Inc., Medical Sales Management SW Inc., GDC Properties Management LLC and ARL Bio Pharma Inc. These companies could potentially be better financial targets for a lawsuit than NECC because they have more money available to cover losses.

The injured plaintiff is also pursuing a claim against a local clinic that used spinal injections as a method of treating chronic pain. The plaintiff alleges that the clinic switched to using medication from NECC because the prior supplier increased the price of a steroid that they used by $2.45 per vial.

The complaints have only been filed recently so it is unclear whether the clinic or NECC’s sister companies will be held responsible for the losses and damaged caused by the contaminated injections from the compounding center. However, the hundreds of patients throughout the country who were injured now have new options to explore as potential sources of compensation.

The patients who were harmed by NECC deserve to be compensated or “made whole,” for losses and since the compounding center does not have the money to pay for the damage it caused, it is natural and expected for plaintiffs to seek monetary damages from others who could be held responsible. An experienced attorney can help injured victims to determine all potential sources of compensation for their particular claims.
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