Articles Posted in defective drugs

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

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

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

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

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

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

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

The company is likely to continue to be willing and eager to settle cases when possible in order to avoid claims going to court and juries rendering verdicts for plaintiffs who were harmed. Settlements allow injured victims to avoid having to go through the process of a trial in order to obtain monetary damages, but plaintiffs should speak to an attorney before accepting a settlement to ensure they are getting the full amount of compensation they deserve.
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Consumers, especially patients with medical conditions, are often in the position of blindly trusting their doctors, pharmacists, and the manufacturing companies that develop and distribute drugs. While most of the drugs on the market have been tested, there are always potential dangers. Since the outbreak of meningitis associated with steroid shots last year, the Food and Drug Administration has been scrutinizing the manufacturing plants of similar products.

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

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

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

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

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

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

The consequences of a dangerous or infected drug can cause significant and permanent health conditions and in some cases, death. Victims and their families in New England or nationwide may be entitled to significant compensation for those losses and should contact an experienced advocate who can initiate an immediate investigation.
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Patients who take regular medications or multiple medications are at risk of injury caused by dangerous drugs. According to some health and medical experts, there are some ways you can help to avoid the consequences of dangerous drugs or dangerous drug interactions. Our Boston injury attorneys are experienced in these medical-legal cases and are dedicated to helping patients protect themselves and their loved ones from medical negligence.

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

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

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

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

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

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

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

You should never share medication or take a prescription without a doctor’s consent. This could also result in serious side effects and injury. As always, when you are the victim of a dangerous drug interaction, you should consult with a legal-medical professional who can help you assert your rights.
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The pharmaceutical company, Ranbaxy, has been held criminally liable for a number of injuries and wrongful death caused by dangerous drugs produced in overseas factories. The manufacturing company failed to follow federal safety guidelines and lied to authorities. Now the company has pleaded guilty to criminal charges and will be forced to pay a record $500 million fine.

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

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

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

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

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

It has been reported that the company’s executives demonstrated an extreme lack of empathy for patients dependent on their drugs. The company has admitted that during the summer of 2007 a batch of gabapentin, also known as Neurontin, had tested positive for impurities. This meant that the shelf life for this batch of drugs was unreliable and that the drugs were essentially unusable. The drug is used to treat epilepsy and is a necessary part of life for patients. According to reports, there had been several issues with the batch for month. Despite this knowledge, the company intentionally delayed notification to the FDA. The end recall involved nearly 75 million pills.
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Boston Scientific is a medical device company that has produced a number of products including transvaginal mesh. Transvaginal mesh is a type of surgical mesh that was used to treat women suffering from conditions including stress urinary incontinence and pelvic organ prolapse. Boston Scientific was a pioneer in the creation and sale of transvaginal mesh products, releasing a product called Protegen in 1996.

Our Boston transvaginal mesh lawyers know that transvaginal mesh products have turned out to be very dangerous and that these TVM products cause significant health issues for many women. Boston Scientific’s Protegen was one of the first of the transvaginal mesh products to begin to cause complications. As a result of problems with the product, Boston Scientific settled Protegen lawsuits back in 2003.

Understanding What Settlement Means

In 2003, Boston Scientific settled a reported 738 lawsuits that had been brought by women who had Protegen implanted. When a company settles a case, the company agrees to provide some benefit or compensation to the plaintiffs. In exchange for this compensation, the plaintiffs who suffered injury or who were harmed give up any and all future rights to file a lawsuit that arises from the same harm.

In other words, when Boston Scientific settled the 738 lawsuits related to Protegen after the transvaginal mesh products turned out to be defective, the plaintiffs received compensation as determined by the settlement agreement and were not able to make any further claims for damages if they accepted that compensation.

After Boston Scientific settled these lawsuits, the company went on to produce and sell other transvaginal mesh products including the Lynx Suprapublic Mid-Urethral Sling system; the Obtryx Transobturator Mid-Urethral Sling; the Pinnacle Pelvic Floor Repair Kit; the Prefyx PPS Pelvic Sling System, and the Solynx SIS Vaginal Sling system. Unfortunately, these products didn’t really turn out to be any safer than Protegen (nor did any of the other transvaginal mesh devices made by other manufacturers).

As a result of the fact that their new transvaginal mesh products are just as dangerous as their old ones, Boston Scientific is now being sued again. Boston Scientific will thus again have to make the choice about whether to try to settle the claims or risk going to court.

Boston Scientific may wish to settle the claims if bellwether trials, or test trials, show that the company is likely to be held legally responsible for all injuries arising from itsTVM devices. If the bellwether trials result in large verdicts for the plaintiffs, Boston Scientific may be even more likely to try to settle in order to keep control on the company’s litigation costs and to get more certainty as far as what legal issues the company faces.

Whether Boston Scientific decides to be serious about settling transvaginal mesh cases this time around remains to be seen. However, any plaintiff who is offered any type of settlement should always consult with an experienced attorney for assistance in how best to protect his or her interests.
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When a person does not have functioning kidneys that can remove waste from the body, dialysis is generally the only viable treatment unless or until a kidney transplant takes place. Dialysis can keep a patient alive for a long time, even indefinitely, provided that the patient’s medical care is provided by professionals in accordance with best practices.

Efforts are continually being made to improve the health and safety of dialysis patients to ensure these patients remain as healthy as possible. UPI, for example, reports that the CDC has recently provided tools and guidelines to dialysis centers in order to help prevent bloodstream infections from occurring. As a result, a 32 percent decrease in bloodstream infections occurred in dialysis patients in facilities that used the federal prevention guidelines.

Our Boston dialysis injury attorneys know that tougher guidelines protecting patients can have a major impact on saving lives. However, dialysis patients still remain at risk of complications, including the potential of infection or the chance that a drug will later turn out to be dangerous, as so many have before.

Dialysis Infections Down

According to UPI, the CDC and participating dialysis centers first began working together in 2009 in order to create and implement interventions and guidelines that would prevent or reduce the number of bloodstream infections in dialysis patients.

There is a real need to fight bloodstream infections because these types of infections are far too common in patients who undergo dialysis. As many as 8 out of every 10 dialysis patients has a central line implanted. A central line is a tube that a doctor puts in a patient’s chest or vein in order to administer medical treatment.

Unfortunately, central lines can become dirty or can be put in incorrectly. When and if this occurs, the central line can provide a way for germs to enter into the body, where the germs cause infections.

To fight infection, the CDC made several recommendations including using an antiseptic for the skin called chlorhexidine. The CDC also issued guidelines related to catheter exit-site care; training for staff; and testing methods to determine if staff uses proper aseptic techniques and cares for the catheter properly. Finally, vascular access care audits, hand hygiene protocols and feedback systems are also part of the CDC guidelines.

Dialysis centers that implement the CDC guidelines can do a lot to protect patients, thus reducing some of the potential dangers. With a 32 percent decrease in bloodstream infections, every dialysis center should try to implement the CDC guidelines in order to reduce the risk to patients. If a patient does develop an infection and these best practices are not followed, then it could be argued that the dialysis center was negligent and is responsible for the injuries that the patient suffered due to the infection.

Of course, even when a dialysis center is able to reduce infections, this doesn’t mean patients are guaranteed smooth sailing. From the risks of dangerous drugs such as the GranuFlo and NaturaLyte disasters, which caused thousands of deaths, to the risks of blood clots or uncontrolled bleeding, dialysis patients face many potential dangers. Doctors and care providers need to do everything possible to reduce the dangers from these complications and to keep patients safe.
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Throughout the United States, women have been taking action against medical device manufacturers that showed a callous disregard for their health and safety. These women had transvaginal mesh implants using surgical mesh that was approved by the FDA through a special shortcut process called 501(k) clearance.

Recently, yet another transvaginal mesh lawsuit has been filed. This time, the claim was filed by a Wisconsin woman against Boston Scientific Corporation. The lawsuit was filed on April 30 in the U.S. District Court for the Southern District of West Virginia, Charleston Division. Our Boston transvaginal mesh lawyers know that this lawsuit is not the first against Boston Scientific and it won’t be the last. The outcome of all of these lawsuits could help to shape the rights of women in the future.

Lawsuits Against Boston Scientific Corporation

According to the most recent April lawsuit filed against Boston Scientific, the plaintiff had the company’s Pinnacle Pelvic Floor Repair Kit and the Aris Trans-Obturator Tape implanted in her in 2010. The plaintiff, like many women, had the transvaginal mesh device implanted because manufacturers had promised that these products would revolutionize the way certain medical conditions were treated.

The two medical conditions designed to be treated by transvaginal mesh products were Stress Urinary Incontinence (involuntary urination) and Pelvic Organ Prolapse (pelvic organs shifting out of place and protruding into the vaginal wall). Previously, these conditions had been treated by tightening the muscles but the transvaginal mesh products provided an easier alternative. The mesh products were essentially used to hold organs in place.

Unfortunately, the mesh began to create many problems once implanted in female patients. These problems included the mesh eroding through the vagina; the mesh causing infections, bleeding or significant pain; discomfort during sex; perforation of organs and urinary issues.

The plaintiff in this new lawsuit alleges that she suffered serious injuries and complications, including several of the side effects listed above that have been linked to transvaginal mesh devices. Her lawsuit indicates that the Boston Scientific products were defective and that they led to a number of serious injuries.

The plaintiff alleges that the harm she and other women are suffering occurred as a result of the negligence of Boston Scientific and other companies that make transvaginal mesh. Because these cases are product liability cases, strict liability rules apply to make manufacturers liable if there is some problem with their products that causes injury. The plaintiff is actually suing based on three counts of strict liability including design defects; defects in the manufacturing of the Boston Scientific Mesh products; and a failure to warn patients of the product defects. The plaintiff’s new lawsuit against Boston Scientific also alleges breach of express warranty and breach of implied warranty and fraudulent concealment since Boston Scientific may have known about the dangers and kept quiet.

The plaintiff’s newly filed lawsuit becomes part of a pending multi-district litigation action with many other patients who were also harmed by transvaginal mesh. The outcomes of these cases could encourage the company to settle and pay damages to all of the victims or the cases could be decided by judges and/or juries and each plaintiff would be awarded an appropriate amount of damage given her unique injuries.
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When a patient is prescribed a drug, that patient has the right to know about any potential side effects the drug may cause. Doctors need to be aware of the potential side effects and risks so that patients can be kept informed, and it is essential that no important details be left out when a prescription is written.

This is why it is so disturbing that a recent study shows drug reps are rarely forthcoming about harmful side effects of the drugs they are promoting to physicians. Our Boston drug injury attorneys know that doctors are more likely to prescribe drugs that are promoted to them by sales reps. Unfortunately, this means that many patients may be dosed with drugs without full and complete information about the risks.

Drug Reps Silent on Dangerous Side Effects

According to Futurity.org, a new large scale study on drug reps was conducted by surveying doctors in Canada, France and the United States. The study, which was published in the Journal of General Internal Medicine, showed that sales reps routinely failed to be forthcoming with doctors.

In fact, in 59 percent of all sales visits to doctors’ offices, drug reps did not volunteer details on:

• Common side effects.
• Serious side effects.
• Patients who should not use their drugs.

Failing to provide this information is egregious. In fact, a U.C. Davis professor of medicine and one of the study’s co-authors indicated that the interactions between the sales reps and the doctors “failed to meet even a minimum standard for the information needed for safe prescribing.”

Patients are Put at Risk
This failure on the part of drug sales reps to keep doctors informed is a serious and large scale problem. The study involved more than 255 physicians who were asked to complete a questionnaire every time a drug sales rep visited their office. During the course of the study, these doctors were subject to more than 1,692 promotional visits from drug sales reps.

The reps were promoting medications for a variety of different conditions including Type 2 diabetes; hypertension; osteoporosis and depression. In some cases, these drugs had “black box” label warnings, which indicated that there were potentially serious or life-threatening risks associated with the medications.

Yet, despite the dangers of the drugs, drug reps mentioned serious side effects in only six percent of promotions. In 57 percent of the promotions that had a black box or governmental warning, no risk of harm was mentioned to physicians at all. These drug reps were keeping silent despite the fact that the laws require sales representatives to explain both the harms and the benefits of the drugs they are encouraging doctors to prescribe.

Tragically, this means that the drugs most prescribed by doctors may be offered to patients without essential information being shared. Patients who experience side effects may have a cause of action against doctors or drug companies for their failure to disclose side effects, but this is small comfort after a serious injury or death has resulted from an adverse drug reaction.
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Thousands of transvaginal mesh lawsuits have been filed by women across the country who are suffering from complications as a result of transvaginal mesh products.

With the first transvaginal mesh trial resulting in a verdict of $11 million awarded to a transvaginal mesh plaintiff, many manufacturers are nervous about the potential compensation they will have to pay out to all those who were hurt.

One such company, C.R. Bard, recently released financial information that showed just how serious a problem these lawsuits are for the makers of transvaginal mesh products. However, the same data also showed that the drug company still remains very profitable and well-equipped to pay out compensation to injured victims.

Our Boston injury attorneys know that these manufacturers will likely end up paying out millions in damages via settlements or lawsuits and we urge plaintiffs to take action to hold these hugely profitable medical device manufacturers accountable for the harm that they caused.

C.R. Bard’s Q1 Profits Plunge

According to Mass Device, profits plunged during the first quarter for the medical device company C.R. Bard. Mass Device indicates that profits declined as a direct result of $26 million in legal fees paid out as a result of transvaginal mesh lawsuits.

Despite the decline in profits, however, C.R. Bard still exceeded Wall Street expectations and posted profits of $90.7 million on sales of $740.3 million. These millions of dollars in profits are made from a variety of different medical devices sold by the company.

Holding Transvaginal Mesh Manufacturers Responsible
While the legal fees were a major expense for C.R. Bard, the fact is that the company is still immensely profitable, just as many medical device manufacturers are. These companies make huge profits from selling medical products to people who need care.

Unfortunately, sometimes these companies put profits over people. This was the case when manufacturers sold dangerous transvaginal mesh products without proper testing and without ensuring that the products were safe for users. The products were rushed to the market under special 501(k) clearances that allowed for minimal testing and, even in light of ever-increasing problems, they have not been universally pulled from the shelves by all manufacturers.

Transvaginal mesh products, therefore, were implanted in thousands of women throughout the country and put these women at risk. Drug companies made millions off of these untested and dangerous products and drug companies continue to make profits that far exceed their legal costs.

These drug companies and medical device manufacturers need to pay for the harm they caused. Those who have experienced complications should consult with an experienced transvaginal mesh attorney in order to explore options for collecting compensation including joining a multi-district litigation. Such cases may be resolved in trial or may be resolved in out-of-court settlements, but in any case, C.R. Bard and the other manufacturers have huge profits available to help them pay for the costs of the plaintiff’s losses.
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As our Boston transvaginal mesh attorneys know, many hospitals and health professionals throughout the country have taken action to ban transvaginal mesh (TVM) products in light of the serious dangers presented by these medical devices. The FDA has also mandated that manufacturers conduct further studies to determine the danger of TVM, and some manufacturers including Johnson & Johnson have voluntarily pulled their products from the shelves as more and more patient complications arise.

Yet, even with mounting concerns and with thousands of patient lawsuits throughout the country, some officials are actually making an argument that transvaginal mesh should not be banned. This argument comes from officials at the American Urogynecological Society (AUGs).

The Banning of Transvaginal Mesh Products
According to Ob.Gyn. News.com, the American Urogynecological Society believes that decisions on the use of transvaginal mesh should be made in consultation with a physician and should be made on a case-by-case basis. The Society recognizes that transvaginal mesh does present some very significant dangers but has issued a strong opposition to a blanket ban on the use of the products.

The Society released their statement after a medical malpractice company, state medical organization and health care system all either considered a ban on the use of transvaginal mesh or adopted a ban.

It is important to note that these bans are issued with very good reason. Transvaginal mesh products, which are used in the treatment of stress urinary incontinence and pelvic organ prolapse, have proven to be very dangerous.

Many women who have had these transvaginal mesh products implanted have experienced serious complications including pain, infection, erosion of the mesh and a repeat prolapse that necessitates further surgery. Further, when complications do develop, multiple revision surgeries are normally required because the mesh becomes part of the tissues of the body and is hard to remove.

Taking a risk of experiencing these side effects is often not worthwhile, especially with the high failure rate of transvaginal mesh products and when most evidence indicates that using transvaginal mesh is generally not any more effective than other methods of treating pelvic organ prolapse or stress urinary incontinence.

The bans, therefore, exist in order to try to protect women from a dangerous product.

AUGS Guidelines
AUGS suggests that hospitals and healthcare providers follow specific guidelines that have been issued in order to determine on a case-by-case basis when transvaginal mesh products should be used. These guidelines address auditing surgeons who perform procedures, using special credentialing procedures before a physician performs surgery, and creating special hospital review boards to review cases and complications.

AUGS also stresses the importance of obtaining informed consent from patients before transvaginal mesh products are used. While these are good principles to employ in practice and while no surgery should ever be performed with uninformed patients, it seems there are very few situations where the added risk of a transvaginal mesh product would be justified in light of the serious potential issues that may arise.
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