Personal Injury News & Developments

Recall of Ventilators for Not WorkingYou’ve probably felt a sense of frustration if you ever purchased a device that suddenly failed to work and demanded a prompt refund or exchange from the manufacturer. You may be able to forgive the manufacturer if the device is an IPod or a cellphone, but imagine that your ability to breathe rested squarely on the device in question. CareFusion recently announced the global recall of nearly 16,000 ventilators citing that the devices may spontaneously stop working, causing “adverse health consequences or death.” It is purely terrifying to imagine that a device which you or a loved one may rely on for survival could simply stop working.

Recall Designated as Class I by the FDA

Avea ventilators mechanically control respiration in patients that are unable to breathe or have difficulty breathing without assistance. They are most frequently used during medical transport, as a component of home care or nursing care and during critical care. The Avea product line monitors oxygen levels and delivers a predetermined quantity of oxygen during ventilation. CareFusion highlighted the ability of Avea ventilators to monitor and regulate oxygen levels its ability to provide detailed information to medical professionals in its advertising of the devices.

Every one of the Avea ventilator models produced by CareFusion was found to contain a defect which may cause the device to stop operating. The defect in question is a faulty pressure transducer which may register a false extended high Ppeak or circuit occlusion alarm. When these alarms are triggered, the device stops performing its intended function and it could result in the death of the patient by asphyxiation.

In the statement released by CareFusion, it suggested “turning the machines off and then on again” to fix the issue and then sending them back if the devices fail repeatedly. The FDA classified the recall of the ventilators as a Class I recall, which means that the FDA has determined that the failure of the ventilators poses a significant risk of severe injury or death. You might think that it wouldn’t take an FDA ruling to reveal that you might die when your ventilator stops helping you breathe.

CareFusion Initiated the Recall and is cooperating with the FDA

When CareFusion was made aware of the potentially deadly defect in the Avea product line, it responded by promptly issuing warnings to its customers. It soon recalled nearly 16,000 of the devices internationally. Most of the machines that are affected were distributed abroad but there are still over 5,600 units within the United States. The ventilators that were included in the recall were manufactured between July of 2011 and March of this year and CareFusion sent out a letter to its customers making them aware of the issue and providing instructions on how to assess or return the devices.

A surprisingly piece of good news resulting from this recall is that, so far to date, no reports have surfaced of any fatal incidents involving the Avea product line of ventilators. What is more concerning, however, is that the FDA has issued 22 different Class I recalls of ventilation devices since 2011— the year that the Avea product line reached market. Six of the recalls were of ventilators manufactured by CareFusion, which suggests that there is an underlying design issue causing the failures of the devices.

In regard to transducer failure, however, there have only been eleven reports of this event in the FDA’s record of adverse events. Thankfully, the manufacturers have detected this issue quickly in the past and pulled the devices responsible to protect patients. This is a deviation from the norm when considering the historical behavior of medical device manufacturers and pharmaceutical companies in general.

If you find that you’ve been injured because of a medical device failure or lost a loved one in such an incident, it is understandable to be overcome with feelings of anger and to demand vindication for what has occurred. For more information about similar medical device product liability lawsuits or to learn about how these cases are handled, contact us for more information. We would be happy to answer any questions that you have about pending litigation and how it affects you, your personal rights and legal options and the chances you have of succeeding if you choose to file a claim.

Vaginal Mesh Recalls and What is Going on NowIt is normal to expect the FDA to step in whenever a product or treatment is known to cause harm to patients by mandating a recall of the defective or harmful products but this has not been the case after it was discovered that thousands of women suffered severe injuries and complications due to procedures that used transvaginal mesh products. Instead of recalling the products, most of the lines have simply been pulled from the market and are no longer being distributed. While this is a step in the right direction, a full recall of all defective transvaginal mesh products would be the optimal solution to the problem. Here is the status of all action being taken by transvaginal mesh manufacturers and the FDA in response to reports of mesh erosion and other complications which have resulted in injuries.

Ethicon Response Varied by Product Line

Ethicon is the transvaginal mesh manufacturer which has gained the most exposure and is the subsidiary of Johnson and Johnson. It produced four different product lines of transvaginal mesh products and the responses to reports of adverse events have been different for each line. The four product lines that have resulted in complaints and claims by injured patients are the following.

  • Gynecare Prolift Kit
  • Gynecare Prolift +M Kit
  • Gynecare Prosima Pelvic Floor Repair System Kit
  • Gynecare TVT Secur

Ethicon made the decision to cease distribution of three of the four product lines but has rebranded the fourth as Gynecare Gynemesh and included stricter warnings and specified the associated risks on the new product labeling. It has chosen not to recall any of the products that have already been sold or implanted, however, and has even claimed that the products were not removed from the market due to safety concerns.

Transvaginal Mesh Lawsuit Motivates C.R Bard to Take Issue Seriously

C.R Bard was the defendant in one of the earliest cases brought to court against the manufacturers of transvaginal mesh products and the case did not end well for C.R Bard. The plaintiff was awarded $5.5 million after C.R Bard’s Avaulta mesh implant was found to be the cause of lacerations to her colon and other complications— she needed to undergo eight surgeries to repair the damage and the ordeal ruined her ability to have physical relations with her husband.

C.R Bard has since removed the Avaulta Plus product line from the market but there have been no reports regarding a full recall of the device as women continue to come forward with claims after the products inflicted injuries similar to those suffered by the aforementioned plaintiff.

Boston Medical Becomes the First Manufacturer to Issue Recall

Boston Medical has a storied history and large role in the developing transvaginal mesh mass tort because it developed the first transvaginal mesh device to be brought to market in the 1990s. The product was pulled from the market and recalled only three years after its release but additional manufacturers have since released their own product lines— most of which have not been recalled yet.

The Protogen received approval through a loophole in FDA policies and was able to reach the market without any human testing. The numerous complaints received in such a short time following its release motivated Boston Medical to take the right course of action and recall the products but the Protogen should never have been marketed to begin with.

Mentor Corporation ObTape Rejected by the Body Post Implantation

The ObTape manufactured by Mentor Corporation was found to illicit an immune response because the device didn’t allow the body to heal or grow properly. In addition it was found to erode and cut surrounding tissue and organs, requiring surgical intervention to treat the resulting injuries. While doctors have ceased to use the ObTape product line, no reports have been released indicating Mentor Corporation’s intent to recall or remove the device from the market.

FDA Slow to React Amid Demands to Ban All Transvaginal Mesh Products

The Food and Drug Administration has dragged its feet in responding to the onslaught of adverse events that have been linked to transvaginal mesh products. An advisory committee failed to recommend a recall of existing products but it did require the devices to be classified as Class III devices which require a much more exhaustive process of testing and trials prior to receiving approval. Meanwhile, thousands of women are still suffering from severe physical and emotional trauma that has been wrought upon them because of the products.

Activists have called for an outright ban of all transvaginal mesh products and are encouraging women to file transvaginal mesh lawsuits in order to hold manufacturers responsible for their carelessness and disregard for the health and wellbeing of the people who are implanted with their products.

If you were implanted with a transvaginal mesh device and later suffered injuries and complications, you may be entitled to compensation. The Rosenfeld Injury Lawyers’ team of transvaginal mesh attorneys specializes in these types of cases and has represented the interests of hundreds of women just like you. Contact us now to schedule a free consultation with one of our lawyers who will gladly review the details of your case, explain your rights and legal options and help you formulate a recovery plan that includes receiving the medical care and treatment that you need and deserve while taking on the manufacturer of your defective device so that your bills are covered.

We will only collect payment once we have successfully secured the compensation to which you are entitled and if we are unable to do so, our services will be free of charge.

Drugs for Other UsesOff label drugs are medications that are prescribed by doctors for purposes other than what they were originally intended or received approval for. The practice of prescribing off label medications is far more wide spread and common than most people believe and as an increasing number of people are experiencing adverse effects of medications that were rushed to market, the question of who has the responsibility and oversight of regulating these forms of prescriptions becomes more prevalent. You may be alarmed or even angry once you understand the answer to this question and the manner in which big pharmaceutical companies get away with marketing medications that are harmful or deadly while making enormous profits off of the infirm without a care in the world about the repercussions.

How are Off Label Medications Prescribed?

The nagging question that most people have concerning medications that are prescribed for reasons other than they were designed or intended is how or why doctors are allowed to place patients on the meds in the first place. In truth, the process of gaining approval by the Food and Drug Administration and subsequent oversight over the prescribing and administration of medications is so full of loop holes that it may require a complete overhaul for the sake of the average person’s wellbeing.

Once a pharmaceutical company has created a new drug, the company is required to conduct its own research and trials— the results of which are submitted to the FDA. It is the information that is provided by the drug companies that influences the FDA’s decision to approve or deny the marketing of the medication and the FDA does not conduct any research of its own or demand independent research to confirm the conclusions that are presented by the pharma company peddling the new medication. This makes it far too easy for drug manufacturers to omit, fabricate or misrepresent data when submitting trials.

Once a medication has been approved, doctors are given the discretion to prescribe the medication for any purpose that they feel will benefit their patients. Where things often go awry is that pharmaceutical companies will then make erroneous claims about how the medications may be used or the associated risks. In some cases, doctors will even be enticed with kickbacks or other incentives for prescribing certain medications.

How common are Off Label Prescriptions?

Almost twenty percent of prescriptions written in the United States are for off label medications and there is absolutely no oversight or regulations that disallow doctors to continue this practice. The FDA does not govern the practice of medicine and is only responsible for preventing hazardous drugs and substances from reaching the market and removing those that are already on the market. Your doctor has full discretion to place you on the medication that he or she feels will best address your symptoms or condition and the majority of the information influencing his or her decisions in this regard is provided by the pharmaceutical companies, which have a growing track record of concealing, omitting or denying risks that are associated with their medications.

What is more alarming is that children are exposed to far more off label prescriptions than adults and are treated as test subjects in the process. One study showed that 38% of patients under the age of sixteen were prescribed medications for off label purposes and in as many as 84% of cases, the medications were prescribed with very little or no scientific support for their use.

Off Label Medications and Pregnancy

The FDA has designated a specific category system for the rating of medications prescribed for pregnant or nursing women. There are five categories with varying degrees of risk and providing different forms of advice to doctors who are considering prescribing a medication to pregnant women. These classifications range from being considered completely safe to warning of specific risks and severe harm that may be caused to the unborn child. The key flaw in the category system, however, is that the FDA relies on data submitted by the pharmaceutical companies rather than independent researchers— this is how Zofran was prescribed off label for decades despite its manufacturer knowing of the potential risks, for example.

Who is at Fault When Off Label Prescriptions Cause Adverse Effects?

It can be argued that doctors have the largest burden of ensuring the safety of their patients and that they should know better than to prescribe medications that are harmful or deadly. However, doctors must rely on the information that is provided to them and often weigh the benefits and risks of every medication before writing prescriptions. They cannot be blamed in many cases for making decisions based on information that was inaccurate or erroneous but in some cases, they should know better than to place patients on medications that lack specific data to support their benefits and safety.

The pharmaceutical companies carry far more of the blame for the consistent practice of circumventing the process of acquiring FDA approval for the use of medications to treat specific conditions and constantly finding loopholes that allow them to profit off of the harm of other people. Aside from pushing to amend the laws and requiring more oversight, the only method left of obtaining justice for this gross lack of concern for our safety when creating and marketing medications is to take the matters before a civil court. The Rosenfeld Injury Lawyers are a leading group of pharmaceutical complication attorneys who are dedicated to holding these mega corporations to account for their sins and if you have been harmed through the use of a medication issued in such a manner, we’d love to have the opportunity to defend your interests.

Contact us today to arrange a free consultation where you can speak with an attorney about any pending litigation involving cases similar to your own and how it may impact the value and outcome of your case as well as to learn about your rights and legal options and to launch an investigation into your matter to determine your best course of action. Our lawyers are dedicated to serving your interests above all else and we only receive compensation when our clients do. If we cannot assist you or fail to collect compensation on your behalf, our services are free.

Michelle J Case

Court of Appeals Courtroom in Pioneer Courthouse

While most of the theatrics in a case goes on between lawyers and the jury, much of the real drama takes place on paper between lawyers and judges. There they try and convince the court that certain people or things should be excluded from the trial and away from the ears of the jury. This extends to expert witnesses-who should qualify as one and what they should be allowed to say. Many states and federal courts follow the Daubert standard to determine these issues. Under this test, the court tries to establish if the basis for the supposed witness’ testimony has a scientific foundation and uses several factors in this analysis, including the following: the ability to test the theories proffered, extent of peer review, potential errors, existing standards, and acceptance in the relevant medical community.

On the other hand, Illinois and a few other states use the Frye standard to decide these crucial, threshold questions in court. This asks if the manner in which the evidence that the testimony purports to submit was obtained via a method that is generally accepted in the relevant field. Thus, the Frye standard is critical to a lot of Illinois litigation but related, tangential questions emerge from this regime as well. One topic that continues to trickle to the surface of the Illinois legal landscape is the quality and kind of expert testimony needed to commit a person to a mental health facility. A review of one case discussing a facet of that topic now follows.

In the Illinois Supreme Court case of In re Michelle J., the State sought to involuntarily extend a patient’s stay at a mental health facility and to involuntarily admit another patient into a different mental health facility. Before delving into the legal issues and reasoning underlying the eventual ruling on these matters, however, some exploration into the background of both cases is critical.

Facts Involved Assessing Involuntary Admission to Facility

In the case of the first patient, Sam S., the controversy surrounded around whether or not his stay at the mental health facility should continue. He had already been involuntarily admitted several years earlier under the Mental Health and Developmental Disabilities Code (the Code). In 2001, the State initiated a hearing to establish that his stay should be extended. Pursuant to the Code, Sam decided to waive his right to attend the hearing. At the hearing, the State called the chief psychologist, Debra Ferguson, of the Alton Mental Health Center to lay a basis for his continued involuntary confinement. She stated she had never treated him at any facility, that she could have interviewed him for the hearing in question a few weeks prior but failed to do so, and that her determination for recommending his continued confinement was based solely on a review of his medical records.

The case of Michelle J. was a bit different than that of Sam S. She was admitted to a mental health center on an emergency basis. So, her controversy rested on whether she should be involuntarily confined there at all. At her hearing, the State called Lenora Brown, a clinical psychologist at the same Alton Mental Health Center. She testified that she attempted to interview Michelle J. but that the patient appeared to lack the capacity to answer her questions. However, Brown also actively took part in the treatment of Michelle J. and had personal knowledge of the medical issues affecting her.

Issues Presented Before the Illinois Supreme Court

As was mentioned earlier, both cases were governed by Mental Health and Developmental Disabilities Code. The pertinent and controversial part provides as follows:

“[N]o respondent may be found subject to involuntary admission unless at least one psychiatrist, clinical social worker, or clinical psychologist who has examined him testifies in person at the hearing. The respondent may waive the requirement of the testimony subject to the approval of the court.” 405 ILCS 5/3–807 (West 2000).”

Therefore, the issues presented to the Illinois Supreme Court were 1) absent a waiver of the testimony rule, was the State’s proffer enough to satisfy 3-807 and justify the confinement of Sam S. and 2) absent a waiver of the testimony rule, was the State’s proffer enough to satisfy 3-807 and justify the confinement of Michelle J.?

Reasoning Court Utilized When Making Their Decision

Taking a cue from the appellate court’s ruling, the State offered several points to justify the continued detainment of both Sam S. and Michelle J. First, while the mandate of 3-807 is “highly desirous,” it argued that an actual in-person consultation is not completely necessary to fulfill the requirements of the statute. Also, referencing In re Barbara H., the State noted times where the Court did not always require such expert testimony. 183 Ill.2d 482 (1998). Finally, it argued that neither Sam S. nor Michelle J. invoked or cleared the clear and convincing standard found within 3-808 of the Code.

The Court responded to each of these in turn, but analyzed all of them under the rubric of strict statutory construction. Section 3-807 requires either expert testimony in person at the hearing by someone who has examined the patient, or a waiver by the patient of such testimony. The language offered by the appellate court ran afoul of the statute’s actual words. The testimony is more than “highly desirous,” it is required. Further, the case of Barbara H. presented distinct factual differences than that of either Sam S. or Michelle J. There, despite trying on a number occasions, an examination with the patient was impossible. The Court emphasized that this was an exception to the general rule requiring examinations prior to 3-807 testimonies. Finally, absent the State’s clearing the threshold of 3-807, the Court realized that the patients should not be obligated to pass the 3-808 clear and convincing hurdle.

Applied to the particular circumstances of Sam S. and Michelle J., there was mixed results. With the former, the Court noted that the only experience Debra Ferguson had with the patient was secondhand, through a review of his medical records. She did not treat him, she did not examine him for the purposed of the hearing, and she did generally know his condition other than through the information provided by others. The Court found that this could not comport with the 3-807 expert testimony requirement. On the other hand, Lenora Brown had significant experience with Michelle J. She was a part of the treatment plan provided to this patient and had consultations near in time to the hearing. The Court found this distinct from Sam’s case and in compliance with 3-807.

Holding

Regarding the issues presented, the Court ruled in the following manner:

  • 1) Without a waiver, the State’s offering of Ferguson’s testimony was not enough to fulfill its 3-807 requirement, and thus continue to hold Sam S. involuntarily, because Ferguson did not have any personal experience with or examinations of the Sam S.
  • 2) The State’s offering of Brown’s testimony was enough to fulfill its 3-807 requirement, and thus admit Michelle J. involuntarily, because Brown personally treated Michelle J. and consulted with her near to the time of the hearing.

Morcellator Procedures may be Stopped by InsurersWhile not the first to do so, Aetna is the most noteworthy medical insurance provider to announce that it will no longer provide coverage for power morcellator procedures, citing significant health concerns including the spread of cancerous tissue to the uterus. Aetna is the third largest medical insurer in the nation and its announcement is expected to precede announcements from other major carriers as mounting evidence of severe medical complications and action by the FDA have prompted the manufacturers of the devices to pull them from the market. Doctors are being recommended to discourage patients from undergoing hysterectomies that incorporate the use of power morcellators unless there is no other viable option available and as insurance companies pull coverage for these procedures, there will be very little incentive left for patients to elect to have them done.

Cancer Threat Linked to Power Morcellation

Regardless of health, all people have some cancerous cells contained throughout their body and the immune system is normally able to eliminate them before they become a serious concern. It has been discovered that power morcellators may carry cancerous cells to the uterus by cutting and disseminating flesh during hysterectomies. Uterine sarcoma and other cancers of the uterus are notoriously difficult to detect in early stages and the dissemination of an undetected fibroid can cause the spread of cancer to other parts of the body. This not only increases the severity of the cancer but makes it more difficult to treat.

The Food and Drug Administration issued a warning advising doctors to cease morcellator procedures in women and its warning prompted Johnson and Johnson to pull the devices off of the market in response. Johnson and Johnson has since processed and allowed the return of the devices from doctors who have chosen to cease all procedures requiring their use. Its Ethicon subsidiary is currently under fire and the subject of numerous potential lawsuits that are expected to be filed once more women come forward following the diagnosis of cancer and other severe conditions following power morcellator procedures that were peddled as noninvasive and safe.

Aetna Not Making Stand Alone

Aetna has decided to decline coverage of procedures requiring the use of power morcellators as a stand against the manufacturers of the devices in an effort to prevent additional harm to women electing to undergo hysterectomies. It is not the first insurer to do so and is certainly not going to be the last. Blue Cross and Shield of Massachusetts, Highmark, Inc., AmeriHealth Caritas, Health Care Service Corp and Blue Shield of California have also announced that they will no longer provide coverage for power morcellator procedures for women unless the procedures and the doctors performing them are preapproved to do so. Aetna’s announcement has been the most high profile one to date and a flood of subsequent announcements by other major insurers is all but anticipated in the near future.

Aetna’s cessation of coverage for the procedures went into effect on May 15, 2015.

If you underwent a procedure involving the use of a power morcellator and experienced medical complications or were diagnosed with cancer since undergoing the procedure, you may be entitled to compensation for the treatment of your injuries, your pain and suffering and other financial losses associated with your injuries. The Rosenfeld Injury Lawyers are reputable and successful team of attorneys who have represented clients just like you and defended their best interests against greedy corporations and negligent individuals. We would love to answer your questions and explore your legal options with you during a risk free consultation— contact us today to arrange a meeting at your time and place of convenience.

Our lawyers work strictly on a contingency basis, so if for any reason at all we are unable to assist you or fail to secure damages in your favor, you will owe us nothing for our time, advice and services.

Trials for DePuy are MovingFollowing an upsetting defeat in 2014, litigators everywhere are paying close attention to a series of DePuy lawsuits set to be heard this year as they are to be the bellwether trials by which all others are to be weighed against. The cases all allege that the DePuy Pinnacle product line of hip replacements provided to be unreliable and resulted in numerous injuries to patients similar to those experienced by patients receiving the ASR hip replacement line. Johnson and Johnson, DePuy’s parent company, remains brazen in its defense of the Pinnacle product line and has not recalled the devices as it had with ASR devices that caused injuries due to metal on metal components grinding against one another.

DePuy Wins First Battle but not the War

The first bellwether case was heard in Texas in 2014 which alleged that the Pinnacle hip replacements were the source of metalosis, infections, degradation of the hip socket and that patients required revision surgeries to repair the damage caused by the devices. DePuy struck an early win in the case as the company was exonerated from blame, causing Johnson and Johnson to become more emboldened in its defense of the product line. If the upcoming cases have similar results, it may not bode well for the numerous victims who are part of the developing mass tort being filed against Johnson and Johnson.

Bellwether cases are not only an indicator of whether future lawsuits may hold up in court but they also influence the decisions and behavior of the defendants. Johnson and Johnson sung a much different tune following early defeats in bellwether cases alleging its ASR hip replacements caused similar injuries. The DePuy parent quickly agreed to a settlement of over $2.5 billion and if the ten cases that are to be heard over the next year go in favor of the plaintiffs; Johnson and Johnson will be forced to cut its losses once again and negotiate an out of court settlement.

Similar Cases Involving Other Product Lines Keep Plaintiffs Hopeful

DePuy and Stryker are the two largest manufacturers of hip replacements named in mass torts regarding the sale of defective replacement devices containing metal on metal parts that caused conditions such as metalosis, infections, severe pain, erosion of the hip socket and surrounding tissue. Victims who received ASR devices manufactured by DePuy and the Rejuvenate and AGBII systems made by Stryker have received settlements nearing an average of $200,000-$250,000 per patient. It is expected that if the Pinnacle lawsuits being heard over the following months break in the favor of the plaintiffs that similar terms could ultimately be reached.

If you received a defective hip replacement and were injured as a result, you may be entitled to compensation for the cost of revision surgery, your pain and discomfort, additional medical procedures and ongoing testing required to treat conditions such as metalosis and your out of pocket expenses. The Rosenfeld Injury Lawyers is a leading law firm with a dedicated team specializing in medical device liability cases and we would be happy to answer your questions about pending cases and how they may impact your own. Contact us today to schedule a free consultation so that we may evaluate the details of your case, answer your questions about the legal process and begin our investigation so that we may advise you properly on how best to proceed.

We aim to serve every client who has been injured and deserves representation and compensation for their injuries. Therefore, we will never require upfront payment for our services and our lawyers only receive payment when we have successfully acquired compensation on your behalf in the form of a settlement or judgement in your favor. Should we be unable to assist you or fail to secure the compensation that you are entitled to, you can be assured that our resources, time and legal advice will be free of charge.

Zimmer Hip RecallsZimmer is the latest manufacturer of hip replacement devices to issue a recall of its products due to the risk of severe complications and health concerns. The M/L Taper Hip Prosthesis with Kinectiv Technology was designed to be a versatile option for use in minimally invasive surgical procedures. Zimmer’s recall was the result of discovery that the products were linked to unhealthy levels of cobalt in the blood, resulting in metal toxicity and conditions such as metalosis. The recall was one of three Class One recalls mandated by the FDA affecting Zimmer, HeartWare and Maquet Holdings.

Metal Toxicity is a Common Concern for those Receiving Hip Replacements

The M/L Taper Hip Prosthesis is one of many artificial hip replacements that have caused health concerns due to cytotoxicity, which occurs when elevated levels of heavy metals enter the blood stream. What many of the devices that have been recalled have in common is that metal components in the devices are able to grind against each other, resulting in injuries when metal shavings enter the affected joint or the heavy metals in the devices reach the blood stream and are carried to the rest of the body. Symptoms of metalosis— a form of metal toxicity— include the following.

  • Infection of the affected joint which may spread to other areas of the body. When the infection reaches the bloodstream, it becomes what is referred to as sepsis, which is an advanced infection that can reach vital organs.
  • Sudden changes in hearing or sight. Metal poisoning can impact the sense of sight or hearing and result in temporary or permanent vision and hearing loss.
  • Tissue necrosis, which is defined most simply as the death of tissue surrounding the joint. This can result in damage to nerves and muscles that require corrective surgical procedures to address.
  • Damage to the thyroid gland. The thyroid is primarily responsible for managing the body’s metabolism and metal toxicity can result in symptoms of thyroid problems which can include weight gain or loss and the development of goiters.
  • Kidney disease or renal failure. Metalosis may adversely affect the kidneys resulting in infection or renal failure, in some cases requiring dialysis or a kidney transplant.
  • Respiratory problems. Some patients suffering from metal toxicity experience breathlessness or difficulty breathing. Other respiratory diseases may follow, especially if the lungs become infected.
  • Heart tremors, cardiomyopathy and heart failure. Toxic levels of metals such as chromium or cobalt can directly harm the heart or cause death due to sudden heart failure.
  • Cognitive disorders. Those suffering from metalosis may find it difficult to concentrate, experience problems with memory, suffer from seizures or exhibit other symptoms of cognitive impairment.
  • Severe pain at or near the site of the implant. If metal on metal parts produce metal shavings, this can cause great pain and discomfort that is exacerbated by the risk of infection and the pain that may accompany the other symptoms listed above.
  • Death. Elevated levels of heavy metals are poisonous and if the metals accumulate over a significant period of time undetected, it could ultimately result in death due to metal poisoning or one of the other serious complications that are the result of metalosis.

Zimmer Named with Two Other Manufacturers in Recalls

In May of 2015, Zimmer sent an urgent medical device recall of 752 patients who received an M/L Taper Hip Prosthesis warning of the potential complications and providing instructions on how to respond to the recall. Existing devices are to be quarantined and Zimmer may ultimately pull the product from the market if it is determined that the current recall is not sufficient. This recall comes as the FDA also issued Class One recall orders to Maquet Holdings and HeartWare, citing health serious concerns over their medical devices.

The number of medical device recalls has been continuing to rise at an alarming rate in recent history, making it even more important to put products through extensive trials and clinical research before allowing them to make it to market. Zimmer’s recall is a symptom of a larger problem. There is a lack of oversight and too many avenues for medical device manufacturers to rush products to market before understanding the potential risk that patients will endure harm.

If you received a defective hip prosthesis and were injured as a result, contact the Rosenfeld Injury Lawyers to learn more about current legal proceedings and how they might impact your own rights should you decide to pursue legal action.

Nail Salon Workers and ToxicityNail salon workers have collectively earned the reputation of a cheerful worker class that is quick to please and slow to voice dissent, regardless of being taken advantage of and having to sacrifice their health and that of their families in order to please their employers and clients. Recent revelations have exposed a culture of disregard for the safety of nail salon workers and the industry is strongly resisting any changes that might benefit workers in order to maintain the status quo and keep the bottom line intact. It is our responsibility to stand up to any industry or employer who will so willfully allow workers and their families to suffer in exchange for profits and the victims deserve the utmost vindication for what they have been put through.

Consistent Exposure to Toxic Materials

Most people who enjoy the relaxation and pampering that accompanies a nail and spa treatment might take pause once they are informed of the toxicity of materials used. When exposed to these materials sparingly, there is a much lower risk of long term health complications but salon workers immerse themselves in the presence of chemicals and fumes that are often trapped in poorly ventilated store fronts. Evidence has shown that exposure to these chemicals not only impacts the health of the victims but the risks are passed onto the unborn as well, robbing these workers’ children of health and happiness as well.

  • Dibutyl phthalate— this substance is used to keep products such as nail polish malleable so that they can be applied to the nails smoothly without clumping or hardening too quickly. Products containing this compound have recently been labeled in other countries with warnings that exposure may cause infertility and harm to unborn children.
  • Toluene— this ingredient is also used in products to help keep polishes smooth so that they can be easily applied. Studies have linked ongoing exposure to toluene to kidney disease and diminished cognitive function. It is also linked to miscarriage and developmental problems in the unborn.
  • Formaldehyde— most of the ingredients in nail polish keep the paint from hardening, but once it has been applied, it must harden. This is the purpose of formaldehyde, which is also a common embalming agent and is dangerous enough to warrant a ban by the European Union of its use in cosmetic supplies that is to go in effect in 2016.
  • Acetone— nail polish remover contains many forms of acetone or similar compounds including acetonitrile, butyl acetate and ethyl acetate. Exposure can cause numerous side effects that include migraines, irritation to the skin, eyes or nose, trouble sleeping, fatigue, respiratory problems and vomiting.

While governments overseas are beginning to make strong stands against the use of these compounds in cosmetic products, a strong effort is being made in the United States to lobby against regulation of these products and to allow greedy distributors and employers to maintain the status quo. Legal action can be taken to force changes, however, as it is the responsibility of every employer to provide a safe working environment for every employee and not to knowingly exposure workers to harm.

Health Concerns Related to Nail Salon Products

Nail salon workers are not only at risk of personal health complications but the risks extend to their families— namely the unborn or infants who are exposed through the worker’s exposure while pregnant or through clothing. The list of medical conditions that have been linked to exposure is exhaustive and includes serious conditions such as the following.

  • Asthma— chemical fumes have been reported to make it extremely difficult for workers to breathe and it is common for workers who have no history of respiratory problems to be diagnosed with asthma and other breathing deficiencies.
  • Cancer— long term exposure can result in cancers. The most common cancers associated with exposure to these chemicals are lung and skin cancer but other cancers may also be linked to long term proximity to cosmetic products.
  • Skin irritation— victims have reported long term damage to their skin after using nail salon products as some of the products may have corrosive properties.
  • Reproductive harm— the chemicals commonly used in nail salon products are being reported to possess links with infertility and with harm to unborn children when exposed during pregnancy. This commonly results in miscarriage or the birth of children with developmental problems, neurological conditions, mental retardation or brain damage.

The American Dream is that any person can achieve whatever he or she puts his or her mind to through hard work and dedication and all people have the right to be able to pursue their dreams without risk to their health and safety. The Rosenfeld Injury Lawyers are a team of lawyers who were founded with the purpose of protecting that dream and those who have had it taken away because of the greed or negligence of others. If you or your child has been harmed following long term exposure to cosmetic products, we would like the opportunity to seek justice on your behalf.

As the victim, you may be entitled to compensation for the cost of medical treatment, wages lost due to your injuries, the long term care required for your child’s health conditions, out of pocket expenses associated with your injuries and recovery and the mental and physical pain and suffering you have endured. Contact us today to arrange a free consultation so that you can learn more about your rights as we collect the information from you required to launch a thorough investigation into your case. We’ll only ever demand compensation for our services once we have successfully recovered damages on your behalf, so in the event we fail to do so, our advice, resources and time will be free of charge.

Long Island RailroadThe scene is a loud and bustling railroad station on East Long Island almost one hundred years ago. Dozens of people are shuffling about to get to work and countless other places. A whistle blows, an engine begins to gather steam, and the nearest train starts to crawl down the tracks away from the station. When out of nowhere, a man darts out of a throng of people and races towards the departing locomotive. Onlookers soon realize that he probably will not make it in time.

So, two guards-one on the train and one on the platform-rush to his aid. With all their might, they grab him and together try to launch him up onto the vehicle. Maybe they noticed, or maybe they did not, but under the man’s arm was a nondescript package wrapped in the morning’s newspaper. However, as it became dislodged in the heat of the tussle none would fail to ignore it any longer because its fall onto the train tracks below makes such a tremendous explosion.

In fact, what the man was carrying was a bundle of fireworks merely 15 inches long. After the initial shock of the burst, its ripples went way down the station’s structure. It was shaken to the core, so shaken actually that it forced scales off their resting place onto a one Mrs. Helen Palsgraf on the side of the station opposite the explosion. Naturally, Mrs. Palsgraf sued except instead of suing the young man with an appetite for danger, she sued the railroad. She claimed that its employees’ negligence injured her and that she was entitled to damages. Believe it or not, at the end of the day, she was actually obligated to pay the railroad compensation but how the story got to that point first involves digressing into one of the most famous cases in history.

Case Analysis: How the Court Interpreted a Defendant’s Duty to Plaintiff in Personal Injury Litigation

Before delving into the particular key facts, reasoning, and holdings of this case, it is first critically important to review the prima facie case that the plaintiff, Mrs. Palsgraf, needed to set out to obtain relief. She stated a claim of negligence against the railroad employees and thus the railroad as their employers. She never stated that the railroad employees intentionally tried to hurt her. In her negligence claim, then, she had to prove duty, breach, causation, and damages.

The defendant must owe the plaintiff some duty. This can arise from statute or whether reasonable believe (a jury in the end) would deduct that a duty existed in a set of circumstances to act in a particular way. For negligence to occur, the defendant must have breached that duty or gone against what reasonable people would have done under the circumstances. Further, that breach must have actually and reasonably caused damages to the plaintiff. The interplay of these four factors largely determined the outcome of this case.

The man who wrote the majority decision in Palsgraf, Benjamin Cardoza (see also: 248 N.Y. 339; 162 N.E. 99; 1928 N.Y. LEXIS 1269; 59 A.L.R. 1253), would not go gently into history. Cardoza was a leading jurist on New York’s highest court, the Court of Appeals, and authored many influential opinions from that perch. Yet, only a few years later, Cardoza would go on to the Supreme Court and play a major role in the judiciary for most of the 1930s. As written by him, the two major issues that presented themselves in this case were the following:

  • 1-How should the duty of care be defined?
  • 2-To whom is the duty of care owed?

While the plaintiffs and the dissent tried to skip ahead to other parts of negligence (such as causation and damages), Cardoza stuck to a methodical approach of the situation and stated before any other issue, a duty of care to the plaintiff must be found. He stated that, “Proof of negligence in the air, so to speak, will not do.” In other words, it is not enough to point to an unlawful or wrongful act and cry foul. He expounded upon this later on by saying, “What the plaintiff must show is ‘a wrong’ to herself…not merely a wrong to someone else, nor conduct wrongful because unsocial, but not ‘a wrong’ to anyone.” Basically, the court stated that because it was agreed to that this was not an intentional act, duty must be established before anything else. While it might easily be argued that the employees had a duty and were negligent to the man and his package, this does not transfer to Mrs. Palsgraf automatically because people are not vicarious beneficiaries of other’s negligence. If there was a duty of care leads to the questions of how it should be drawn and that will be discussed now.

Writing for the majority, Cardoza stated that people should be responsible for their acts-lawful or otherwise- to the extent that they could reasonably portend danger and only to that extent. He articulates this in the middle of his opinion when he says, “The orbit of the danger as disclosed to the eye of reasonable vigilance would be the orbit of the duty.” This precisely defines what the duty of care is and all those falling within that orbit are owed it. Of course, embedded within this standard is the assumption of reasonableness, the perception of danger at the time of the act from a reasonable person’s perspective as determined by a jury. Of course, the situation here was complicated by the fact that they employees were ostensibly doing a lawful and good act: helping a passenger board a departing train. Cardoza states that this does not transform into a tort because the good act has some removed consequence outside the bounds of foresight. (“If no hazard was apparent to the eye of ordinary vigilance, an act innocent and harmless, at least to outward seeming, with reference to her, did not take to itself the quality of a tort because it happened to be a wrong…”). Thus, this case has largely been read to state that people owe a duty of care to others for the consequences that might reasonably be foreseen from it. It is a reasonable and causal determination. Using the language of the majority, the duty of care can be described in the following manner:

“The risk reasonably to be perceived defines the duty to be obeyed, and risk imports relation; it is risk to another or to others within the range of apprehension… Without any perception that one’s actions could harm someone, there could be no duty towards that person, and therefore no negligence for which to impose liability.”

Of course, this range of reasonableness rule has exceptions. One exception includes unexpected consequences. If you do something wrongful but do not perceive the outcome you are still liable. An example of this is if you throw an object into a crowded environment trying to hit someone and it actually hits someone else, you are still liable. Another exception includes things that are by their nature dangerous such as shooting or handling toxic materials. Public policy and other forces impose a duty of care to even those who may remotely come in contact with these actions and Cardoza suggests that in this way the law has made people conducting these activities quasi-insurers to the surrounding public. However, for most actions, especially those that are lawful and/or unintentional, we are held to a standard of what is within a range of reasonableness at the time of acting.

The author of the dissent in Palsgraf was also a legal titan, Justice William Andrews. Justice Andrews sat on New York’s highest court for most of the 1920s and dissented from Justice Cardoza in other famous instances, including Meinhard v. Salmon. In his dissent, Andrews agreed that people owe a duty to avoid acts that might unreasonably put others in danger. However, instead of focusing on the duty prong of negligence, he focused on causation. Rather than asking if the person harmed and complaining was within the zone of danger, Andrews asks, first, whether there was an unbroken chain of events from the triggering act to the injury and, second, whether it was not too remote in terms of time and space to render the consequence unforeseeable from the defendant’s position. In other words, the defendant should be liable if his or her actions proximately caused the plaintiff’s injury. As a practice point, Andrews thought these issues should have been left to a jury to decide, whereas, the question of duty that Cardoza espoused was left to a judge. Therefore, the majority opinion left open the possibility that many future defendants could short-circuit cases by proving no duty existed to a judge-an often easier and by far much less expensive task than proving no proximate causation existed to a jury.

Palsgraf: Meaning and Future Applications

Palsgraf greatly influenced the future of American common law on negligence and torts. It defined the boundaries of negligence by drawing the scope of duty around foreseeable harms and, thereby, shaped the contours of legal practice for the coming decades. However, many see this battle as one that still wages. Many lawyers around the country to this day use Cardoza’s and Andrews’ opinions to support their cases, even though Andrews lost. Typically, those arguing duty use Cardoza and those arguing causation use Andrews.

Stepping out of the past, however, one can begin to see how Palsgraf could continue to impact society for many years to come. For instance, we are living in ever-increasingly urban and concentrated areas. People in the United States are flocking to cities and rubbing shoulders at greater rates than ever before. The ability to predict the consequences of your actions is diminishing with every new skyscraper and track of public transportation. Of course, the wise and legitimate alternative is to slow down and proceed cautiously but those words of wisdom are normally much quieter than the drums of profit and capitalism. Put plainly, Palsgraf will inject extraordinary risk and potentially costs into the modern economy, especially infrastructure and development. Accidents and crashes can have impacts well beyond what Cardoza contemplated in his opinion, but his rule still generally applies.

Another significant consideration is the effect that technology has had on society. Computers, phones, and the internet have connected the world like never before. A person in Indiana can connect with a person in Australia instantaneously. The awesomely positive implications this has equals the awesomely negative implications it could have as well. Should we hold someone liable for things they say on Facebook because it hurts the reputation or feelings of some person or group far and away from what the speaker meant? Should we be able to sue others for causing damage or disruption to servers or other modern, technological equipment through their completely legal uses? Thus, it is completely clear that Palsgraf has stark applications and consequences now and in the future, it just is not totally apparent what they are yet!

Vaginal Mesh ComplicationsTransvaginal mesh products became extremely popular around 2005 as alternatives for the treatment of conditions that include pelvic organ prolapse and incontinence but evidence later surfaced questioning the safety of the devices and whether they could cause serious injuries to the patients implanted with them. By October of 2008, the FDA needed to issue a warning to surgeons conducting transvaginal mesh procedures due to over a thousand reports of significant complications associated with the devices. At the moment, we are on the brink of a wave of litigation being brought against major transvaginal mesh manufacturers due to the damage that has been caused and the failure of the manufacturers to provide sufficient warnings about their risks.

Types of Transvaginal Mesh and Uses

The primary purpose of transvaginal mesh products is to treat pelvic organ prolapse and stress urinary incontinence which are caused when pressure is placed against the bladder from reproductive organs which have fallen into the pelvis. In both cases, the mesh products are used to return the affected organs to their correct positions and reinforce the pelvic floor to keep them there. There are two different forms of mesh cited in transvaginal mesh litigation.

  • Transvaginal mesh— this is used to hold organs into place after that have been pushed back into their intended position. It also holds the pelvis in the desired position.
  • Transvaginal sling/bladder sling— this device is similar to a hammock that supports the bladder and its primary function is in the treatment of incontinence.

Complications Caused by Mesh Erosion

Mesh erosion is the main cause of the complications which have been reported by thousands of women and the damage that is caused may be severe enough to warrant additional surgeries to remove the mesh, repair the damage or address medical concerns brought on by the complications. These complications include but are not limited to the following.

  • Organ perforation— when the mesh erodes, it becomes sharp and cuts into the surrounding flesh. This becomes a serious concern when the mesh cuts into organs nearby such as the bowel or the bladder, which can cause severe pain, infections and septic shock.
  • Stress urinary incontinence— while the transvaginal mesh devices are designed to prevent and treat this condition, they can actually become the source of new and more severe incontinence.
  • Loss of consortium— mesh erosion can make intercourse extremely painful and the damage can result in the inability of a couple to continue normal sexual relations either due to the pain, embarrassment or a combination of both.
  • Internal bleeding and infection— the sharp edges created by eroding mesh can result in internal bleeding, which may result in a serious infection if the bleeding is undetected or untreated.
  • Recto-vaginal fistula— this is the result of a hole in the vaginal wall leading to the rectum and way result in bowel matter being excreted from the vagina, which is a horrifying and embarrassing condition for any woman to need to endure.
  • Abscess— usually caused by inflammation or infection, an abscess is a pus filled sore where the flesh has begun to necrotize.
  • Pain and discomfort— the pain associated with mesh erosion can be debilitating and make it difficult for victims to live normal lives or enjoy the things they once did.

Warnings Required of Surgeons

By 2011, the FDA had received over 2,800 reports of complications associated with transvaginal mesh products and surgeons are now required to receive special training prior to performing procedures using the products as well as to provide specific warnings and aftercare. Women must be notified that the mesh is a permanent device and that it made erode, potentially resulting in infections, organ perforate and other complications. Surgeons must monitor patients for signs of these complications after patients have undergone the procedures and patients must be aware that revisionary surgery may be required to remove the devices or to repair damage caused by erosion.

Thousands of women have surfaced, the first fruits of what may be an expansive wave of future lawsuits against the manufacturers of transvaginal mesh devices, citing the lack of proper warnings of potential complications and the marketing of the products without any evidence to suggest that they are more effective than traditional means of treating pelvic organ prolapse or stress urinary incontinence. The companies involved in the initial onslaught of lawsuits include Johnson and Johnson, Boston Scientific Corp, American Medical Systems and C.R Bard, Inc. There are over forty companies that manufacture the devices, however, and these companies are simply the most high profile plaintiffs to date.

Representing the Victims of Transvaginal Mesh Products

If you have suffered serious medical complications, pain and suffering and the inability to enjoy a reasonable quality of life because of adverse events following a transvaginal mesh procedure, you are not alone and you have the right to receive compensation for your injuries, including the cost of medical treatment, loss of income, pain and suffering, out of pocket expenses and other financial considerations. The Rosenfeld Injury Lawyers have a special team of lawyers specializing in and dedicated to representing those who have claims for medical device liability and medical negligence. Contact us to arrange a risk free consultation to receive answers to all of your questions regarding how current litigation affects your own case, your rights and legal options and how the legal process works.

Following a deep and thorough investigation of your case, our attorneys will have a greater understanding of the value of your case, the chances of its success and how best to proceed with a lawsuit, if it is in your best interest. In order to allow all people to have access to our services regardless of their financial concerns, we promise only to receive payment upon successfully securing compensation on your behalf. If we are unable to negotiate a settlement in your best interest or win your case in court, our services, time, resources and advice will all be free of charge.