Articles Posted in defective products

In 2007 Senator Pat Roberts and Senator Edward Kennedy attempted to pass legislation to expand the power of the Food and Drug Administration (FDA) to regulate compounding pharmacies. Compounding pharmacies where medications are mixed or altered fell into a regulatory gap where it wasn’t really clear whether the FDA or state boards of pharmacies were in charge of oversight and safety compliance. The 2007 legislation would have changed that, but Congress failed to pass it.

Unfortunately, the consequences of the lack of oversight and the consequences of the regulatory gap became far too clear in recent months when contaminated drugs from New England Compounding Center (NECC) caused more than 50 deaths and made more than 700 Americans sick. Our Boston injury attorneys know that the lack of oversight played a direct role in contributing to the deaths and injuries caused by deadly fungal infections in patients taking drugs from NECC. Something needs to be done to prevent this from happening in the future and the Senate is now trying again to take action.

Senate Considers Expanding FDA Regulatory Authority
According to the Boston Globe, the Senate recently introduced a bill intended to prevent future outbreaks like the one caused by the contamination at NECC. The legislation proposing rule changes is bipartisan and was drafted with support from Democrats and Republicans on the Senate Health, Education, labor and Pensions Committee.

The legislation would make clear that large compounding operations — called compounding manufacturers — are subject to direct federal oversight by the Food and Drug Administration. Traditional small compounding pharmacies would continue to be regulated by state pharmacy boards but would still be subject to new federal standards on the ingredients used. Traditional small compounding pharmacies that will remain under state control include pharmacies that mix or produce medication for a specific patient to match a specific prescription.

The bill identifies “compounding manufacturers” who are subject to federal oversight as pharmacies that produce injectable drugs without patient-specific prescriptions from physicians. To be considered a compounding manufacturer, the compounding operation would generally have to ship across state lanes.

This bill will make clear exactly what role the FDA plays in regulating and monitoring compounding manufacturers, which had previously been undefined. The issue is that these manufacturers became much bigger and took on a different role than anyone had originally anticipated. Thus, they need to be more tightly regulated because their new role means that serious and widespread injury can result when a mistake is made.

Now that the bill has been proposed, hopefully it will actually make it through both the Congress and will become law. Unfortunately, several Democrats in the House of Representatives who introduced similar laws have not been successful as Republicans in the House have shown little interest in moving the measures forward.

Hopefully, this Bill will not meet the same demise as the 2007 bill and lawmakers will actually be able to do something to prevent another tragedy occurring like the outbreak caused by the New England Compounding Center’s negligence.
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A massive recall by some of the largest name brand auto manufacturers in the world is due to faulty airbag inflators.

Our Boston defective product attorneys understand that the issue is specifically with the front passenger airbags, where the bag has the potential to deploy with too much pressure. If that happens, the inflator casing could burst, which could result in debris being spewed at the passenger and subsequently result in a serious injury.

Among the vehicle makers affected:

• Toyota: 1.7 million vehicles (including the Tundra, Matrix and Corolla models);
• Honda: 1.1 million vehicles;
• Nissan: 480,000 vehicles;
• Mazda: 45,000 vehicles.

Additionally, both BMW and General Motors are planning to issue similar recalls in the near future.

The majority of the vehicles being recalled are from model years 2001 through 2003.

Although none of the automakers have reported any serious injuries or deaths resulting from this defect, that doesn’t mean they didn’t happen – or won’t in the future. The fact is, accidents happen at lightning speed. If a person is injured in a wreck, their first thought may not be to question the high pressure deployment of the airbag.

Honda did report that it was aware of one incident in which the casing of an airbag exploded after it had been activated under high pressure. However, that incident did not result in a serious injury.

This very same problem was responsible for a series of previous Honda recalls that started back in 2008, though those involved problems with the driver’s side airbags.

Meanwhile, Toyota – king of recalls in recent years, with 5.3 million vehicles recalled last year in the U.S. alone – said it has noted five reports of malfunctioning airbags in recent years. However, there have been no major injuries reported as a result, at least according to the company.

Earlier this year, Toyota had issued another airbag recall due to inadvertent deployment, which could cause serious injury in the event of a crash.

Although this latest recall is sizable, it’s not the biggest in the auto industry. Just last October, Toyota recalled nearly 7.5 million vehicle worldwide because of a power window issue that had the potential to result in a fire.

And in 2009-2010, the company recalled some 8 million vehicles across the globe due to a problem with accelerator pedals that stuck.

For this recall, the automakers say they will be contacting owners if their vehicle is affected. However, you can’t always rely on it. If you want to check whether your vehicle is on the recall list, you can visit Safecar.gov.

The airbag manufacturer believed to be responsible for the defect is a Japanese supplier called Takata Corp.
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Transvaginal mesh is a type of surgical mesh product that became a popular choice for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Both SUI and POP are conditions that are caused by muscle weakening and doctors traditionally had to perform surgery to strengthen the muscles. Transvaginal mesh presented an easier alternative by permitting doctors to use the surgical mesh to fashion a sling to hold the pelvic organs in place where they belonged.

Unfortunately, Transvaginal mesh turned out to be far from the easy solution that was promised to patients. The mesh began to cause very serious complications including significant pain for women as well as infections and recurrent POP. Often, revision surgeries were required and the entire process of treating the complications became a painful and expensive one.

In light of the many problems, thousands of transvaginal mesh lawsuits were filed, including around 1,800 claims against Ethicon, a manufacturer of Transvaginal mesh and a subsidiary of Johnson & Johnson. The first of these cases went to trial in February and our Boston transvaginal mesh lawyers have been closely monitoring the case as the outcome can affect transvaginal mesh compensation for all injured plaintiffs.

Accusations of Intentional Complications

On February 16, the Herald Online reported an update in the transvaginal mesh case. According to the Herald Online, the attorneys for the plaintiff in the case against Ethicon showed emails and video tapes revealing that Ethicon had ignored reports of complications caused by Transvaginal mesh.

According to the evidence presented, at least one doctor expressed grave concerns about whether the transvaginal mesh products were safe. Ethicon executives, however, apparently ignored these concerns because they were so eager to get their product onto the market and start selling it.

In one of the emails that an Ethicon executive wrote, the doctor expressing concerns was told that his opinion was respected and that Ethicon would be following up. Of course, Ethicon never did follow up and the product was released on the market in order to compete with AMS mesh, a product that was being offered by a competitor.

The Responsibility to the Consumer
The information on the video and in the emails about Ethicon ignoring possible problems with their product is strong information that shows the company should be held responsible for the damages that their product caused.

All manufacturers of products are expected to release only reasonably safe items to the public. In fact, a tough standard called strict liability is used to impose responsibility on manufacturers whenever their products cause harm when used as they should be, regardless of whether a manufacturer was negligent or intentionally did anything wrong.

In this case, Ethicon did more than just fail to identify a potential problem. The evidence indicates that the company had at least one warning that their product caused complications and that they ignored that warning. This is egregious behavior and the company should be responsible for all of the harm they caused to thousands of women.
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If you have or had stress urinary incontinence or pelvic organ prolapse (POP), then you may have been treated using transvaginal mesh (TVM) or your doctor may recommend that TVM be used as part of a surgical correction of your problem. Unfortunately, it has become clear that TVM presents some serious medical complications. If you are suffering from these complications, you may be able to take legal action. If you have not yet had your procedure, you should know what types of complications can arise from TVM so you can make a fully informed choice about whether to take the risk of having the mesh implanted.

Our Boston personal injury attorneys have been closely following the FDA updates as well as monitoring other research, news and information about TVM complications. We want every patient to understand the potential medical complications that so often go along with the use of TVM.

Types of TVM Medical Complications
TVM is implanted to support the organs of the pelvis that are prolapsing. Prolapsing means that the organs are no longer sufficiently supported and they are intruding on the walls of the vagina. TVM is also implanted to provide support and strength for vaginal muscles in women that are experiencing stress urinary incontinence. The complications, however, can begin shortly after the mesh has been implanted. The medical complications associated with TVM can include:

• Chronic pain
• Mesh erosion or a breakdown of the vaginal mesh
• Serious infection
• Scarring
• Urinary problems
• A recurrence of prolapse
• Bowel, bladder and blood vessel perforation
• Pain during sexual intercourse
• A narrowing of the vaginal wall

In many cases, a revision surgery is necessary in order to try to correct the TVM medical complications or to correct the problem of recurrence of prolapse. Some women even have to undergo multiple surgeries and even with these repeated surgeries may not be able to eliminate the painful side effects they are experiencing.

Does TVM Always Cause Medical Complications?
TVM does not necessarily cause complications or problems in every single case when the mesh is used. However, the FDA has become increasingly concerned about how common the complications are. In 2008, the FDA issued a warning reporting that it had been notified of approximately 1,000 adverse reactions to the mesh. Based on the reports of the problems, the FDA indicated that while there were potential complications, those complications were rare.

More complaints began to flood the FDA, however, with 2,874 additional reports of problems coming in between January 1, 2008 and 2010. The additional complaints as well as a review of scientific literature on TVM dating back to 1996 prompted an FDA investigation and a revision to its warning in 2011. In the updated TVM warning, the FDA indicated that complications were not rare. Further, the FDA indicated that the risks presented by TVM were not present in more traditional treatment methods and that it was not clear that there was any overall benefit to using the mesh instead of more traditional treatment.

What Should Women Do?
Based on the new information by the FDA as well as other relevant medical studies, women who have experienced transvaginal mesh medical problems or complications should consider filing a lawsuit against the manufacturer of the TVM used in their procedure. Those women who have not yet had transvaginal mesh procedures should consider carefully whether to allow this potentially dangerous product to be used in their bodies.
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Pelvic organ prolapse and stress urinary incontinence are two conditions that many women suffer from. Pelvic organ prolapse (POP) occurs when the organs in the pelvis, such as the bladder, the uterus, the urethra or the small bowel prolapse or drop out of their normal place and start to push against your vagina. Stress urinary incontinence, on the other hand, refers to difficulty preventing involuntary urination, especially when you cough or laugh. Both conditions occur when the muscles become weak, and are a common consequence of childbirth, although aging and other factors can also play a role.

Many women who suffer from POP or stress urinary incontinence thought they had found an answer in transvaginal mesh (TMV). More than nine manufacturers released various transvaginal mesh products, which were surgically implanted and used to keep organs in place. Women throughout the country had operations with transvaginal mesh. Unfortunately, problems soon came to light.

Today, physicians still use TVM as a method of treating POP and stress urinary incontinence. Unfortunately, the dangers of these products have increasingly come to light. Our Boston injury attorneys want to make sure that every woman is aware of the risks of transvaginal mesh before making the choice to take a chance on using this treatment method.

The History of Transvaginal Mesh Complications
Transvaginal mesh began causing complications for women shortly after it became a widespread treatment option. In October of 2008, the FDA issued a warning indicating that they had received more than 1,000 complaints of adverse events related to TVM. When the FDA released this initial report, it described the complications as “rare.”

Despite the complaints and the increasing number of women experiencing serious infection, recurrence of prolapse and other medical problems, physicians continued to use TVM products for treatment of POP and stress urinary incontinence.

Unfortunately, from January 1, 2008 to December 31, 2010, the TVM continued to create serious health problems for women. The FDA received 2,874 new complaints of adverse events during this time. The problems were occurring both when the mesh was used to repair POP (1,503 complaints) and when the mesh was used to repair SUI (1,371 complaints).

The frequency of the complaints and the reports of serious complications prompted the FDA to conduct a systematic review of the scientific literature that was published from 1996 to 2011 that related to the TVM products. The FDA made some upsetting determinations when doing this review. It noted, for example, that using TVM to repair POP did not significantly improve the results or the woman’s quality of life as compared to other traditional treatment methods. The scientific literature also revealed that there were risks of using the TVM that did not exist with traditional treatment methods.

In July of 2011, the FDA updated its communications to warn that complications were not rare and to let women and physicians know that TVM can expose patients to significant risk.

Every patient needs to be aware of the new FDA position and of the fact that complications are very common. If your physician recommends that you treat your POP or stress urinary incontinence with TVM, you need to consider the danger carefully and have a detailed discussion with your physician about why this risk is acceptable given your medical condition and the other treatment options available.
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Transvaginal mesh is a surgical mesh product that is used to treat women who are experiencing stress urinary incontinence or pelvic organ prolapse, a condition where pelvic organs shift and begin to protrude through the vaginal wall.

Unfortunately, although widely used, transvaginal mesh has some very serious and significant complications, many of which patients were not warned about or were unaware of before having the mesh implanted.

Although transvaginal mesh has now proven dangerous for many women, the product remains on the marketplace with strict FDA warnings about side effects. In December of 2012, it was announced that a new system is available to help doctors assess whether the use of surgical mesh is appropriate to repair a particular case of pelvic organ prolapse. The information on the new imaging system was reported in Optical Coherence Tomography News.

Despite possible advancements and despite improved warnings as required by the FDA, our Boston transvaginal mesh attorneys remain concerned about the potentially serious side effects associated with the use of transvaginal mesh. We believe that every woman needs to think very carefully about whether having transvaginal mesh implanted is a risk she wants to take.

Judging the Suitability of Transvaginal Mesh
According to Optical Coherence Tomography News, the new imaging system available was developed by researchers at North Shore Long Island Jewish Health Systems and their studies were presented at the annual meeting of the American Urogynecological Society.

The new imaging device, according to researchers, makes it possible to measure the thickness of the epithelial tissue. This is helpful information in determining a woman’s suitability for a vaginal mesh placement procedure.

The new imaging technique may also allow vaginal mesh manufacturers to comply more easily with the FDA’s requirements for follow-up studies and testing on the efficacy of vaginal mesh. This is because the device allows doctors to take images of mesh that has been previously placed at the vaginal epithelium. Existing imaging techniques, including X-rays, MRIs, ultrasounds, CT scans and MRIs, cannot reach a sufficient resolution that is needed to effectively monitor the epithelium.

By making it possible to do these post-operative studies, hopefully manufacturers of transvaginal mesh products will be able to identify problems and complications more easily and will be able to obtain essential safety information on their products. The ability to monitor the mesh at the epithelium can also be useful to women who have had surgical mesh implanted and who want to screen for postoperative complications.

The new device has been cleared by the FDA and many hospitals in the U.S. are currently using it in pre and post-op evaluations of women who are considering or who have undergone procedures with transvaginal mesh.

While our Boston transvaginal mesh lawyers fully support the use of the new device to help women and manufacturers more carefully monitor for complications and problems, we remain concerned about any woman having transvaginal mesh implanted unless she has a full understanding of the potential dangers and complications that could result.

If you are considering transvaginal mesh, make sure your doctor has discussed all possible risks with you. If you have already had transvaginal mesh implanted and you are experiencing complications, consult with an attorney to learn your legal options.
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In 2005, a company called Ethicon, a subsidiary of Johnson & Johnson, made a medical device available for use. The product, which was a transvaginal mesh, was released without any testing.

This was possible under a special FDA rule called the 510(k) rule, which allows for a fast-tracked release of medical devices that are substantially similar to devices already on the market. The transvaginal mesh they released was called Gynecare Prolift propylene mesh and the prior device that it was based off of was a product called Gynecare.

Unfortunately, it would later turn out that there were significant problems with the Prolift transvaginal mesh product. Further, when Ethicon later applied for approval for a next generation product called Prolift M+, the FDA would subsequently conclude that the original Prolift Product from 2005 had never really been approved. In other words, an untested, dangerous and problematic drug was thrust upon the public in 2005 by Ethicon.

Our Boston transvaginal mesh attorneys have become very familiar with Prolift and with the stories of women who were harmed by this medical product and by other transvaginal mesh products. Now, the first trial against Ethicon has entered the courtroom. This trial is important both because it provides the opportunity for the injured patient to get justice and also because it could set the stage for subsequent legal actions.

The Transvaginal Mesh Case
Prolift, like other transvaginal mesh products, is a surgical mesh that was used to treat women with pelvic organ prolapse and with stress urinary incontinence. Women, especially those who have been through pregnancy, can suffer from pelvic organ prolapse wherein the pelvic organs (such as the bladder) drop and begin to press against or protrude into the vaginal wall.

Transvaginal mesh products are used to essentially keep the organs in place. Unfortunately, the transvaginal mesh products soon began to cause significant complications. Many women experienced pain, disintegration of the mesh products, painful sexual intercourse, contraction of the mesh and other side effects. These complications were not properly identified due to Ethicon’s insufficient and negligent testing of the product. There was also no warning of these or other potential complications for women who underwent surgical procedures with the mesh products.

Unfortunately, women may need multiple surgeries to correct the problems caused by Ethicon’s Prolift and by other transvaginal mesh products — if the problems can even be corrected. Many women who are coping with medical care costs, pain and discomfort are taking legal action against the manufacturers of transvaginal mesh products.

Many of the cases based on the transvaginal mesh products are pending, and many plaintiffs have organized into class actions. Now, however, the first case against Ethicon has gone to trial. The outcome of this trial should shed significant light on the mistakes that were made and can have a major impact on future settlements or lawsuits based on transvaginal mesh.
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When a tire defect occurs on a car or motorcycle, a serious or even deadly accident can occur. Recently, accidents have begun occurring as a result of new motorcycle tires suddenly deflating. Two separate cases are currently pending against Goodyear Dunlop Tires, who manufactured the allegedly defective tires that led to injury.

In November of 2012, a federal court ruled on a motion in cases against Goodyear, giving the plaintiffs permission to inspect the manufacturing facility of the defendant. The court also ruled that the defendant would have the opportunity to inspect the tires and rims belonging to the plaintiffs at its plant. The plaintiffs are permitted to be present during the inspection.

The recent court decisions regarding the inspection of the plant and the inspection of the tires illustrate the complications inherent in defective tire cases. Our Boston defective tire attorneys are well-versed in the technical aspects of representing clients in defective tire cases and we urge injured drivers to understand where the challenges lie in these types of legal actions.

Proving Tire Defects Requires Technical Expertise
In the recent tire defect case, the judge who ruled that the Goodyear Dunlop manufacturing plant could be inspected did so because the plaintiffs needed to visit the plant in order to gather evidence that defects in the plant and its operations were the cause of the tire defect. Likewise, Goodyear Dunlop needed the opportunity to inspect the tires of the plaintiff to determine if there really was a defect or problem with the tires.

Answering the questions raised by either the plaintiff or the defendant will require a high level of technical expertise. After all, the average person who visited a tire plant would not be able to tell if there were defects in the plant that led to defects in the tires. Likewise, the average person couldn’t look at a tire and determine if there was a design or manufacturing defect or not. An expert who understands tire manufacturing and tire construction and design would need to be consulted to come up with answers.

When cases hinge on the testimony of an expert as to whether there was a tire defect or not, the case often comes down to a battle of the experts. The defendant might put forth a witness who argues that there were no problems with the tires and that there was no tire defect that caused an accident or any type of harm for the driver. The plaintiff, on the other hand, might have a witness that argued that there was a problem with the tire that created a serious accident risk. Both sides would present these experts and it would be up to the jury to decide who to believe.

Because plaintiffs and defendants usually both have expert witnesses with opposing viewpoints, the jury may make the decision on whether a plaintiff can recover compensation or not based on the jury’s opinion of the qualifications and knowledge of the experts. If you are a plaintiff in a defective tire case, therefore, you need to have the right expert witness representing and speaking up for you.
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The New England Compounding Center (NECC) has been subject to intense public scrutiny in recent months and faces legal liability as a result of negligent practices that led to an outbreak of meningitis.

The job of NECC was to produce a compound steroid drug, which was sent throughout the United States and administered to the public. Unfortunately, NECC failed to follow sterilization procedures and failed to ensure that their steroids would pass sterility tests before sending the steroids to hundreds of medical facilities nationwide. The steroids were contaminated and when injected into people’s spines to treat pain, they cause an outbreak of meningitis.

The outbreak was a devastating one, with 656 cases so far across 19 states. The outbreak also left 39 people dead as a result of contracting meningitis. NECC had to shut its doors and cease operation because of the dangerous product they released onto the market and they are now being sued by those who were injured or by the families of those who were injured.

The NECC case, however, is not over yet. Our Boston injury attorneys have updates.

NECC Trying to Hold Cleaners Responsible
According to CNN, NECC has stated that it intends to establish a fund to provide compensation to those impacted by the meningitis outbreak. Both injured victims and the family members of people killed by the meningitis will be able to recover compensation from the fund.

However, NECC does not want to bear the financial losses all by themselves. CNN reports that NECC claims the cleaning contractor responsible for cleaning their facility should also be held responsible and should share the blame for the meningitis outbreak. If this is the case, then the cleaning company could also be the subject of lawsuits.

Since NECC has declared bankruptcy, if the cleaning company is to blame, this would be helpful to injured victims of the meningitis outbreak who could file an independent action against the cleaning company rather than dealing with the bankruptcy court in order to take action against NECC.

The cleaning company, however, denies that it has any responsibility for what occurred. The company provides only once-a-month service. Since their job is to clean and NECC was the company responsible for the actual production of the compound steroid, it might be a stretch to assert that the cleaner was really at fault.

New Laws Aim to Prevent Further Outbreaks
As NECC and those injured by the outbreak try to work out who is responsible and what NECC will pay to compensate victims, the outbreak has also prompted some other legal action as well. This legal action comes from the governor of Massachusetts who, according to The Tennessean, has proposed changes to regulations governing compound pharmacies.

The changes would give greater power to the state board responsible for licensing compounding pharmacies. New rules would also change the composition of this board, which is currently dominated by registered pharmacists. Under the new proposed rules, a registered nurse, a pharmacy technician, three people from the public and a physician would instead sit on the board. Finally, compounding centers would not only be subject to more supervision by this board but would also be required to obtain special licenses to handle certain sterile compounds.

These changes, hopefully, could prevent serious public health crises in the future and could help to ensure that compounding centers like NECC don’t do anything to put people in jeopardy.
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