Hood National Law Group https://www.nationalinjuryhelp.com Representing Injured People Worldwide Fri, 21 Jul 2017 19:12:39 +0000 en-US hourly 1 https://wordpress.org/?v=4.8 Poison Water on Tap in your Home, the new Flint MI is Wilmington NC. https://www.nationalinjuryhelp.com/defective-products/genx-poison-water-home-wilmington/ https://www.nationalinjuryhelp.com/defective-products/genx-poison-water-home-wilmington/#respond Fri, 21 Jul 2017 19:12:39 +0000 https://www.nationalinjuryhelp.com/?p=36604 July 21, 2017 – San Diego, CA  Back in 2014 the Flint water crisis started when the city of Flint, Michigan changed their water source to the Flint river. This had the effect of exposing over 100,000 people to lead poisoning.  Flint residences were told to use bottled water and use only filtered water for cooking, bathing, and cleaning.  This became a huge news story in 2016.

Homes that connected to the Flint River water system experienced contaminated pipes, leading some to not be able to sell their homes. Costly replacement pipes prevented many from fixing their homes.

It’s estimated to replace all the lead pipes will be completed no sooner than 2020.

The Environmental Protection Agency (EPA) “battled Michigan’s Department of Environmental Quality behind the scenes for at least six months over whether Flint needed to use chemical treatments to keep lead lines and plumbing connections from leaching into drinking water” and “did not publicize its concern that Flint residents’ health was jeopardized by the state’s insistence that such controls were not required by law”.  In 2015, EPA water expert Miguel A. Del Toral “identified potential problems with Flint’s drinking water in February, confirmed the suspicions in April and summarized the looming problem” in an internal memo circulated on June 24, 2015.

New GenX Water Contamination in Wilmington, North Carolina

The Chemours Company, referred to as Chemours, is an American chemical company that was founded in July 2015 as a spin-off from chemical giant DuPont.

What is contaminating the water?

The contamination chemical found by researchers is called GenX.  GenX is a fairly new chemical that is used for flourpolymer resin (Teflon) manufacturing.  This is used in many applications from non-stick pans to stain-resistant carpets and furniture.

In 2005, the EPA asked seven of the world’s largest chemical companies, including DuPont, to phase out the use and manufacture of PFOA by 2015. The companies agreed and according to the federal agency, met the program’s goals on time.  This is the reason why GenX was developed by DuPont’s spin-off company Chemours.

It’s a highly stable chemical that virtually never deteriorates. This is why it’s so dangerous. The EPA has not fully studied the health effects of this emerging contaminant. The EPA has no current guidelines for this chemical.

This chemical was developed to replace the known cancer causing chemical C8 which was halted after DuPont faced a large lawsuit action.  DuPont has faced thousands of lawsuits regarding its Teflon products and PFOA exposure since the late 1990s.

Farmland, private property, rental properties, ranches, and homes all affected by GenX contamination!

It’s believed that GenX has entered into the local aquifers in the surrounding areas of southeast North Carolina in the last 10 years.  A recent news story from WECT 6, tells of local real estate companies feeling the effects of the GenX scare.  Local real estate broker Todd Turner states:  “A number of folks have been calling in and asking if this water quality issue that we are facing is going to hurt their family when they move here,” Turner said. “They want to know if their families health is at risk and rightfully so.”  He further goes on to say:

“It is very disconcerting,” Turner said. “When folks are booked for our properties for just a weekend or a week and suddenly they call before they come and decide to cancel, I mean, yes, that’s a huge problem for us.”

Like in Flint MI, home pipes are now contaminated by GenX.

Just like the thousands of people in Flint, MI who are faced with the costly replacement of all pipes in their homes, the same now applies to possible 70,000 customers in the Cape Fear water shed. Part of the problem is the local water authority has no current method of filtering out GenX.

GenX could even upset or cancel some home sales since GenX could contaminate the homes pipes.  WECT 6 reached out to local real estate companies and found many have lost deals that weren’t currently under contract.

GenX contamination levels could also affect the locally grown food supply.

The southeast North Carolina area contains farmland that could be greatly impacted by GenX that began entering the local deep water aquifers that farms draw water from.

The local government should start testing produce from nearby farms for GenX contamination. This type of contamination has recently happed in Dordrecht, a city in Netherlands.

DutchNews.NL broke the story today about the GenX problem.

Martin van den Berg, a toxicologist at the University of Utrecht says people living near the plant should stop eating produce from their gardens and the government should carry out further analysis as soon as possible to find out how great the risk is to public health.

‘The poison is not only in the leaves but in the entire crop, because the plant also absorbs contaminated water through the roots,’ he told the Volkskrant.

Last weekend the AD reported that GenX had been identified in tap water in at least six places in Zuid Holland province.

Lawsuits should start for GenX Contamination – offering Help for Victims.

Can I sue Chemours for GenX drinking water exposure? YES!

You have legal rights to sue if you were exposed to GenX, and we want to hear from you!  Like the past Teflon, C8 and other PFOA lawsuits, the company responsible has paid out multi-millions in fines and settlements to victims. Our law firm intents to hold Chemours responsible for placing people in harm’s way from this massive contamination of the Cape Fear River water shed.

If you’re one of suspected thousands who are now faced with not being to sell your land, house, or farmland due to GenX contamination, we want to hear from you, please contact us to share your story of GenX. You also have many rights to compensation and can sue for damages from this Chemours GenX spill. Call us today at 1-800-214-1010.

Source: http://www.dutchnews.nl/news/archives/2017/07/dont-eat-garden-veg-toxicologist-tells-chemours-plant-locals/

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Docetaxel Hair Loss – Chemo Drug Risks https://www.nationalinjuryhelp.com/dangerous-drugs/docetaxel-hair-loss-risks/ https://www.nationalinjuryhelp.com/dangerous-drugs/docetaxel-hair-loss-risks/#respond Thu, 13 Jul 2017 18:39:50 +0000 https://www.nationalinjuryhelp.com/?p=36578 July 13, 2017 – San Diego, CA.  Docetaxel is the generic name for the brand name drug Taxotere. Women who are being treated with this drug should know of some of the potential complications of this medication.  The main side effect is hair loss associated with Docetaxel.

Docetaxel is an intravenous injection used to treat mostly breast cancer patients but can also be used for neck, head or prostrate cancers. It should be noted that women who are planning on becoming pregnant should not use Taxotere (Docetaxel) as it may harm the fetus.

Taxotere is administered usually in a clinic or hospital over the course of an hour and usually for a 3 week term.

Sanofi-Aventis the maker of Taxotere gained FDA approval of its cancer fighting drug back in 1996.Docetaxel Hair Loss

It wasn’t until December of 2015 that the FDA forced the company to change its package label warning women of possible permanent hair loss known by its medical name alopecia (baldness).

However before the edits made to the Taxotere label it read: “hair generally grows back”. Failure to warn women of the possibility of permanent hair loss is the basis of this Taxotere lawsuit.

What are the most common adverse reactions and side effects associated with Taxotere (Docetaxel)?

According to the drug’s label, the most common adverse reactions are:

  • Infections
  • Neutropenia (low white blood cell count)
  • Anemia (low red blood cell count)
  • Febrile neutropenia (development of fever with low white blood cell count)
  • Hypersensitivity
  • Thrombocytopenia (low platelet count)
  • Neuropathy (weakness, numbness and pain from nerve damage, usually in the hands and feet)
  • Dysgeusia (persistent foul, salty or metallic taste sensation)
  • Dyspnea (difficult or labored breathing)
  • Constipation
  • Anorexia
  • Nail disorders
  • Fluid retention (edema)
  • Asthenia (abnormal physical weakness or lack of energy)
  • Pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Mucositis (painful inflammation and ulceration of the mucous membranes in the lining of the digestive tract)
  • Alopecia (permanent hair loss)
  • Skin reactions
  • Myalgia (pain in a muscle or group of muscles)

Other possible side effects of Taxotere (Docetaxel) include:

  • Swelling of hands, feet or face
  • Decreased appetite
  • Mouth or lip sores
  • Watery eyes, redness of the eye
  • Muscle, bone, joint pain
  • Increases in blood tests measuring liver function
  • Allergic reactions like rash, flushing/hot flashes, fever, lowered blood pressure
  • Infusion site reactions like darkening of the vein, inflammation, redness or drying of the skin, swelling of the vein

What is alopecia and how is it associated with Taxotere (Docetaxel)?

Docetaxel Hair Loss

 

Alopecia is a possible side effect reported by a number of women who were treated with Taxotere for breast cancer. Alopecia is a type of hair loss that occurs when the immune system attacks hair follicles, resulting in hair loss. Alopecia is usually not permanent; about 10 percent of people with the condition may never re-grow hair.

How often is Taxotere prescribed?

About 1 in 8 women (about 12 percent) will develop invasive breast cancer in her lifetime. In 2016, it is estimated over 246,000 new cases of invasive breast cancer will be diagnosed, including an additional 61,000 new cases of non-invasive breast cancer, according to the American Cancer Society.

Taxotere is the most widely prescribed drug in its class to treat breast cancer. Up to 75 percent of breast cancer patients in the United States use Taxotere during their treatment.

If you or someone you love has suffered from permanent hair loss from using Taxotere, we can help ease the burden. Read about the Taxotere lawsuits here.

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IVC Filter Use Drops After FDA Safety Communication – But still high in the U.S. https://www.nationalinjuryhelp.com/defective-products/ivc-filter-fda-communication/ https://www.nationalinjuryhelp.com/defective-products/ivc-filter-fda-communication/#respond Tue, 11 Jul 2017 18:05:21 +0000 https://www.nationalinjuryhelp.com/?p=36567 July 11, 2017 – San Diego, Ca.  Science Daily reports IVC usage has decreased after FDA advisory.

Citing the study done by the Temple University Health System, they found a significant drop in vena cava filter (IVC) implantations after the FDA issued a safety communication on the devices.

What is an IVC Filter?

IVC filters are small, cone-shaped, metal devices placed in the inferior vena cava (IVC), the large vein in the abdomen that returns blood from the lower body to the heart. They help prevent blood clots from traveling from the legs to the heart or lungs.  While some blood clots are beneficial, such as those that form to stop a cut from bleeding, others can be life-threatening. If a blood clot forms in your veins or arteries where it is not needed it can cause serious, often life-threatening conditions, including heart attack or stroke.

Are IVC Filters Safe?

While this is great news the use of IVC filters in the U.S. remains very high compared to other countries. Riyaz Bashir, MD, and his team studied utilization rates of IVC filter placements and published their findings in the July 10, 2017 issue of JAMA Internal Medicine.

He states: “The findings of this study are noteworthy as they reflect the critical need for publications reflecting safety issues related to medical therapies even after they have been approved by FDA. The significant decrease in IVC filter implantations after the FDA communication reflects that such communications are a very powerful means of affecting contemporary practice patterns around the country,” says Dr. Bashir.

“Since venous thromboembolism (VTE) is a diagnosis that includes both DVT and PE, in this study we also evaluated VTE-related hospitalization rates during the same period in order to determine whether any change in IVC filter implantation could be accounted for by changes in VTE-related hospitalizations.”

How many people get an IVC Filter?  Usage by the Numbers.

  • It’s estimated that 1,131,274 people had an IVC filter placement in a 10 year study period.
  • A 22.2% increase in IVC filters from 2005 – 2010.
  • After FDA safety communication they found a 29% decrease in IVC filter placements.
  • The rate of VTE related hospital visits remained steady between 2010 and 2014.

IVC Filter Use in America – Still too High?

“In the United States, the IVC filter implantation rates are 25 fold higher than in Europe. The hospitals across this country collectively are spending close to a billion dollars on these devices every year without a known significant benefit. With current level of evidence we believe that the appropriate implantation rate in the U.S. should be similar to, or lower than, the rate observed in Europe” states Dr. Bashir.  JAMA IVC Filter Study

What are IVC Filter lawsuits about?

Hundreds of lawsuits against the makers of some IVC filters have already been filed in U.S. courts in the past few years. To streamline the process, many of those cases have been consolidated in federal court into multidistrict litigation (MDL). MDLs are unlike class action lawsuits, in which one party represents a large group, and settlements or judgments are divided evenly among all participants. In MDL, each case is heard individually, but a company may choose to settle multiple MDL cases at once after the first couple are tried in court.

Currently, more than 380 cases are pending in a multidistrict litigation (MDL) in the U.S. District Court for the District of Arizona against Bard Peripheral Vascular. The lawsuit alleges Bard’s IVC filters were defective and the company is liable for selling them to consumers.

The Bard MDL is presided over by U.S. District Judge David G. Campbell.

There are also more than 340 cases pending in an MDL in the U.S. District Court for the Southern District of Indiana against Cook Medical. This lawsuit alleges Cook not only sold defective products but it engaged in deceptive sales practices.

The Cook MDL is presided over by U.S. District Court Chief Judge Richard L. Young.

Sources:

https://www.sciencedaily.com/releases/2017/07/170710113657.htm

http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2643346

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Actemra arthritis drug – Failure to warn and hundreds died https://www.nationalinjuryhelp.com/dangerous-drugs/actemra-heart-failure/ https://www.nationalinjuryhelp.com/dangerous-drugs/actemra-heart-failure/#respond Fri, 07 Jul 2017 17:22:53 +0000 https://www.nationalinjuryhelp.com/?p=36556 July 7, 2017 — San Diego, CA.  Once again we have to ask:  did the FDA fail us in not taking action against maker Genentech, a wholly owned subsidiary of Roche, for not telling doctors and patients that Actemra could lead to heart failure?

When STAT News broke the story on this drug, the FDA had already received reports of 1,128 deaths from Actemra. Actemra report

Is the FDA is trying to fast track these new drugs to the market.  Is it pressure from Bug Pharma looking to increase its ever growing revenue? Or is the FDA so bloated as a bureaucracy that it simply can’t keep up?

Let’s look at what Actemra is

Actemra (Tocilizumab) was developed and marketed starting in 2010 by Genentech (Roche Inc.) it is an immunosuppressive drug and can be used to treat both moderate and severe rheumatoid arthritis.

It was later approved by the FDA in May 2017 for the additional use in treating Giant Cell Arteritis (GCA).

Method of administration is intravenous (in monthly injections).  It’s estimated that close to one million people have used Actemra.  Genentech has reported $1.7 billion in Actemra sales for 2016.  Actemra logo

Rheumatoid arthritis is an inflammation in hands, wrists, and knee joints.  This condition affects 1% of Americans.  Physicians aren’t sure of the cause of this fairly common disease.

Most of the drugs used to treat rheumatoid arthritis are classified as NSAIDS (Nonsteroidal anti-inflammatory drugs). Most of these drugs carry warnings of heart attack and other heart risks on their labels, Actemra does not.

The FDA knew of Actemra deaths and adds a new approval

When STAT was looking at the data, it appeared that the rate of risks of heart attack and other side effects was as high as or even higher than other rheumatoid arthritis drugs.  So again we ask: Is the FDA doing enough long term studies on this and other drugs?  What about post market studies, were they done for Actemra?

Even when faced with a mountain of data, on May 22, 2017 the FDA grants and expands approved use of subcutaneous Actemra (tocilizumab) to treat adults with Giant Cell Arteritis.

Badrul Chowdhury, M.D., Ph.D., and director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research states:  “We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options.”

Is there an Actemra lawsuit?

The basis of this Actemra lawsuit is fairly simple: Genentech, a wholly owned subsidiary of Roche, failed to warn both doctors and users of the potential side effects including lung disease, increased stoke risks, myocardial infarction (heart attack), heart failure, and even death in some patients.

We intend to fully hold Genentech, a Roche company responsible for not warning both the medical community and patients of the risks of heart attack, heart failure, lung disease or pancreatic cancer.

If you or someone you love has suffered a heart attack, heart failure or death, please contact us today, you have rights and we may be able to get you the financial compensation you deserve. 

Read more on the Actemra lawsuit in 2017.

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What are Essure Birth Control Coils made of? https://www.nationalinjuryhelp.com/defective-products/what-are-essure-coils/ https://www.nationalinjuryhelp.com/defective-products/what-are-essure-coils/#respond Thu, 06 Jul 2017 15:33:09 +0000 https://www.nationalinjuryhelp.com/?p=36551 July 6, 2017 — San Diego, CA.  Women from around the world are coming forward to talk about their negative experiences with Essure, a permanent birth control. For most women, the only option to relive the constant pain is to have a hysterectomy. Please read the following information before you decide to get Essure.

What are Essure Birth Control Coils made of?

The Essure device consists of two small metal coils that are placed inside each fallopian tube. The metal coils are made of an outer nickel titanium alloy coil and an inner stainless steel coil. Wrapped around the inner stainless steel coil are PET (polyethelene) fibers.

The PET fibers stimulate the growth of scar tissue by acting as an irritant to the fallopian tubes. The inner coil holds the PET fibers in place while the outer coil is intended to act as an anchor and hold the entire device in the fallopian tubes.

Bayer’s Essure product contains polyethylene terephthalate (PET) fibers. It’s well known that PET fibers are dangerous to our bodies, but it was still approved by the F.D.A. PET fibers Essure

One manufacturer of PET has published a Material Safety Data Sheet (MSDS) that warns against the use of its products in medical procedures that require implants in the body.

It clearly states: “CAUTION: Do not use in medical applications involving permanent implantation in the human body”

So why does Bayer still market this device, when they clearly knew PET fibers are dangerous in this internal birth control device?

What is a nickel allergy?

A nickel allergy is one of the most common causes of allergic contact dermatitis, which is an itchy rash that appears when your skin touches a usually harmless substance. Nickel allergy is normally associated with earrings and other jewelry, and can be found in everyday items such as coins, zippers, and even cellphones or eyeglasses.

Nickel allergies can affect people of all ages and usually develops after repeated or prolonged exposure to items containing nickel. Approximately 10-20% of the population is sensitive to nickel. Once a nickel allergy is developed, you will always be sensitive to the metal and need to avoid contact.

Symptoms 

If you have a nickel allergy and you’re exposed to a nickel-containing item, the allergic reaction, or contact dermatitis, normally begins within 12 to 48 hours after exposure. This reaction may continue for as long as two to four weeks. Some nickel allergy signs and symptoms include:

  • Rash or bumps on the skin
  • Itching, which may be severe
  • Redness or changes in skin color
  • Dry patches of skin that may resemble a burn
  • Blisters and draining fluid in several cases

How is a nickel allergy linked to Essure?

The Essure insert is made of materials that include a nickel-titanium alloy. Once the inserts are placed inside the body, small amounts of nickel are released from the inserts. Women who are allergic to nickel could potentially have a severe allergic reaction to the inserts.

According to a study reviewing reported adverse events associated with nickel hypersensitivity in patients with Essure implants, the suspected nickel hypersensitivity is small, but is reported as very painful and severe. Reports were reviewed from 2001 through July 21, 2010 and over 650 patients results were tested.

Are there lawsuits against the manufacturer of Essure?

Yes. The first lawsuit was filed in a Philadelphia court against the manufacturer of Essure in 2014. Despite falling under the FDA’s preemption provision, which says certain medical devices approved under the agency’s premarket approval program are exempt from product liability lawsuits, a Philadelphia judge allowed several lawsuits to proceed in court last March. Since then, hundreds of lawsuits have been filed by women harmed by the controversial birth control device.

If you or someone you love has suffered from Essure, please contact us today for a free case review. There may be substantial cash awards from this Essure lawsuit.

 

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Cancer, hair loss and Taxotere – One Woman’s Tragic Story of Deceit https://www.nationalinjuryhelp.com/dangerous-drugs/cancer-hair-loss-taxotere-womans-story/ https://www.nationalinjuryhelp.com/dangerous-drugs/cancer-hair-loss-taxotere-womans-story/#respond Thu, 29 Jun 2017 16:47:04 +0000 https://www.nationalinjuryhelp.com/?p=36522 June 29, 2017 San Diego CA — Today we are pleased to have a new guest blogger Shirley Ledlie, who has written a book and created a Taxotere support group for women who have suffered hair loss.

She is sharing her personal story about her fight with breast cancer and her use of the chemotherapy drug called Taxotere. It’s a powerful story.  Feel free to share this!

Cancer has touched most of us, at some point in our lives, either in our own diagnoses or that of a loved one.

For those of us who have battled this terrible disease, we remember only too well that dreadful appointment that confirms our fears. The numbness, the room spinning and the instant deafness that we experience will always stay with us; hopefully fading deep into the background as we get on with our lives. And if we are one of the lucky ones that are expected to go into remission at the end of our treatment, well, we grab that with both hands!

When we accompany a loved one, different emotions are experienced but you have to put on a brave face for their sake and you suddenly become their voice.

The ‘cancer world’ is undoubtedly a very scary place, no matter what side of the cancer story you’re on.

Then there is our medical team that we have to place all our trust in. Our lives are in their hands aren’t they? What happens when something doesn’t go according to plan?

My story of breast cancer and Taxotere:

After I was diagnosed with breast cancer and given my treatment plan I was so thankful to have such a good medical team behind me. I had my surgery and was about to start my chemotherapy treatment.  I had previously watched a television programme about a cancer patient having the ‘ice cap’ or ‘cold cap’ so I asked about its availability, hoping this would enable me to hang onto my hair.

My doctor informed me it didn’t work with my prescribed chemo drug Taxotere so wasn’t an option for me, but ‘don’t worry your hair will grow back when the chemotherapy has finished.’  Unbeknown to me those words would come back to haunt me.

hair loss from taxotere

Taxotere, Carboplatin, Herceptin x 6
Age at time of chemo: 29 (2011)

“My Hair never grew back after Taxotere”

My hair did not grow back; some did around the sides and back but not much on top.  My oncologist told me that he’d spoken to Sanofi Aventis and they said they were sorry, it does happen very rarely and it’s permanent. Apparently I was the third or fourth woman in the world this had happened to.

I felt like a freak!  Feeling devastated and angry about the whole ‘male pattern baldness’ nightmare, I decided to search for the other women.  It didn’t take me long to find the first one, Pam.  We decided to start a support group, because it was our belief there were plenty more permanently disfigured women out there. Our thoughts sadly proved to be correct. There was a constant stream of ‘freaks’ joining our support group; our own private club, with a life-time membership. Image shows taxotere hair loss victims

There are thousands of women worldwide that have been affected this way with Taxotere, and for whatever reason, the oncologists are still in denial about it, even dismissing it as a rare incident when various studies prove it to be ‘common and frequent’.

Some might say that it’s better to have not much hair than lose your life.

Another options for breast cancer treatment – Taxol

Firstly, we are all very grateful to be alive; that’s not the issue here. Nor should it have been that choice. There is another drug, Taxol, that’s equally if not more effective than Taxotere which doesn’t have this problem but doctors are reluctant to offer this drug. Secondly, women should be informed about the very real possibility of this happening to them. It’s about quality of life and you have a right, as a patient, to be warned. You have to give informed consent for your treatment, but how can you do that when life-changing side effects are kept from you?

Get the Support you need – Taxotere Support Group

The women in our support group http://aheadofourtime.org/  have been informing the drug company for over ten years but they constantly ignored us, wanting us to shut up. The group members in the US have been complaining to the FDA for more than ten years. And finally oncologists have not been reporting individual cases, which they are obliged to do.Taxotere Support Group

If it has happened to you, I’m so sorry. The only way to stop it happening to others is to make sure all doctors report it to the relevant medical bodies, whichever country you are in. Check they have done it! It’s not a case of being ungrateful for your treatment.  Please don’t feel that. And just remember that the drug company knew about this many, many years ago. They wanted us to shut up and go away, which won’t happen until the industry acknowledges this issue and ensures all patients are warned of the potential consequences of this drug.

Thank you,

Shirley Ledlie

Visit our Taxotere Support Group: http://aheadofourtime.org/

Read the whole story in my book, available on Amazon:

Naked in the Wind: Chemo, Hair loss and Deceit. https://www.amazon.com/Naked-Wind-Chemo-Hairloss-Deceit/dp/1500136549/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=1498747199&sr=8-1

——End——–

If you or someone you love has suffered from hair loss from Taxotere, you have rights! We intend to hold Sanofi Aventis responsible!  Contact us today to learn about how we can help get you the compensation for your hair loss.

Read more on the Taxotere lawsuit here. 

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My Sex Life Died after Essure https://www.nationalinjuryhelp.com/defective-products/sex-life-died-essure/ https://www.nationalinjuryhelp.com/defective-products/sex-life-died-essure/#respond Thu, 22 Jun 2017 19:20:05 +0000 https://www.nationalinjuryhelp.com/?p=36509 June 22, 2017– San Diego, CA.  We’ve heard from many women in the last few years their stories on Essure.  We’re sharing another recent story today.

Six years ago, a 38-year-old woman had Essure implanted. She had decided, with her husband, not to have any more children and her gynecologist convinced her that Essure was the best bet. Her doctor told her that this device was easier and cheaper than having your tubes tied. Since there were no Essure side effects reported at the time, and no discussion of complications, she didn’t think about the possibility of removing the device.

Essure Complications

Six months after having Essure implanted, she was a regular at the local pain management clinic. The woman claims she had been healthy all her life, never having any back problems. However, after having Essure implanted, she got terrible lower back and leg aches. While her doctor ordered MRI’s and CT Scans, nothing showed up. It got so bad that she wasn’t able to sleep, even with the help of painkillers.

Essure Causes Painful Sex

Not only was this woman plagued with lower back and leg pain, but her sex life was drastically affected. She was bleeding heavily and sometimes her periods would last an entire month. Sex was just about nonexistent. A healthy sex life is important in any marriage, and taking that away can put quite the strain on a relationship. In an article from Bitch Media about Essure, the author speaks of Essure and the importance of having a sex life:

“She also addresses how important our sex lives are to all of us, and how stress about and fear of unplanned pregnancy can significantly alter your relationship with your partner. I always felt lucky that I could afford birth control pills, but the side effects that I experienced—namely, that the hormones exacerbated my already difficult lifelong struggle with migraines—eventually didn’t balance out. Nothing sexy about a migraine, and there was no reason to live with that kind of pain when I could both opt out of chronic headaches and do away with any real statistical chance of becoming unintentionally pregnant.”

In the two clinical trials done for Essure’s safety and efficacy, they sampled just 745 women over a period of supposedly five years. Because it takes about three months for Essure to be fully effective, the trials tracked the women for 15 months after the device was implanted. The problems that were reported from this period of time included back pain for 67 women, abdominal pain for 28 women, and painful sexual intercourse for 27 women.

In the comments of an Urban Milwaukee article about the device, women shared their stories about Essure and their painful sex lives after the device was implanted:

“The pain of having sex was like giving birth. Afterwards, I would lay and moan and cry and just two years into my marriage we stopped having sex because he felt he was hurting me when it was the alien nickel metal springs that was causing the pain. But the doctors kept saying it was all in my head, all the while writing scripts for pain meds that did nothing for the pain. Four years after marriage, three years after implants, my husband and I separated. He was having an affair. I could not blame him very much. We were unable to be physical. I too very much wanted to be with him but the flood of blood and the terrible pain stopped me.”

While this is an extremely sad, and intense case of how Essure can deeply damage a marriage, it’s something that shouldn’t be overlooked. On the importance scale, sex registers around 90% in any relationship, so when it becomes a source of frustration, it can be a gigantic issue and can potentially lead to infidelity and divorce. These women who’ve had Essure implanted went into the procedure with the belief that this implant would strengthen their family, not break it apart.

If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.

Essure form

Sources: Urban Milwaukee

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Facts about Taxotere, Side Effects of Taxotere https://www.nationalinjuryhelp.com/dangerous-drugs/facts-taxotere-side-effects/ https://www.nationalinjuryhelp.com/dangerous-drugs/facts-taxotere-side-effects/#respond Thu, 15 Jun 2017 14:55:55 +0000 https://www.nationalinjuryhelp.com/?p=36490 Overview of Taxotere – Taxotere (generic name: Docetaxel) is an intravenous injection used to treat mostly breast cancer patients but can also be used for neck, head or prostrate cancers. It should be noted that women who are planning on becoming pregnant should not use Taxotere as it may harm the fetus.

Taxotere is administered usually in a clinic or hospital over the course of an hour and usually for a 3 week term.

Sanofi-Aventis the maker of Taxotere gained FDA approval of its cancer fighting drug back in 1996.

It wasn’t until December of 2015 that the FDA forced the company to change its package label warning women of possible permanent hair loss known by its medical name alopecia (baldness).

However before the edits made to the Taxotere label it read: “hair generally grows back”. Failure to warn women of the possibility of permanent hair loss is the basis of this Taxotere lawsuit.

What are the most common adverse reactions and side effects associated with Taxotere?

According to the drug’s label, the most common adverse reactions are:

  • Infections
  • Neutropenia (low white blood cell count)
  • Anemia (low red blood cell count)
  • Febrile neutropenia (development of fever with low white blood cell count)
  • Hypersensitivity
  • Thrombocytopenia (low platelet count)
  • Neuropathy (weakness, numbness and pain from nerve damage, usually in the hands and feet)
  • Dysgeusia (persistent foul, salty or metallic taste sensation)
  • Dyspnea (difficult or labored breathing)
  • Constipation
  • Anorexia
  • Nail disorders
  • Fluid retention (edema)
  • Asthenia (abnormal physical weakness or lack of energy)
  • Pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Mucositis (painful inflammation and ulceration of the mucous membranes in the lining of the digestive tract)
  • Alopecia (permanent hair loss)
  • Skin reactions
  • Myalgia (pain in a muscle or group of muscles)

Other possible side effects of Taxotere include:

  • Swelling of hands, feet or face
  • Decreased appetite
  • Mouth or lip sores
  • Watery eyes, redness of the eye
  • Muscle, bone, joint pain
  • Increases in blood tests measuring liver function
  • Allergic reactions like rash, flushing/hot flashes, fever, lowered blood pressure
  • Infusion site reactions like darkening of the vein, inflammation, redness or drying of the skin, swelling of the vein

What is alopecia and how is it associated with Taxotere?

Alopecia is a possible side effect reported by a number of women who were treated with Taxotere for breast cancer. Alopecia is a type of hair loss that occurs when the immune system attacks hair follicles, resulting in hair loss. Alopecia is usually not permanent; about 10 percent of people with the condition may never re-grow hair.Hair loss lawsuit

Hair loss is often associated with chemotherapy. However, the hair usually grows back once treatment has stopped.

Women who suffer from permanent alopecia after treatment with Taxotere may never re-grow their hair. Some women report the loss of their eyebrows and eyelashes, too. The makers of Taxotere estimate alopecia occurs in about three percent of patients, but some studies suggest that number is higher.

A study conducted by the Rocky Mountain Cancer Center in Colorado suggested about 6.3 percent of patients experienced alopecia when Taxotere was used in combination with other cancer-fighting drugs.

A survey conducted by the Clatterbridge Cancer Centre in the UK found 15.8 percent of respondents reported experiencing alopecia after using the generic version of Taxotere, docetaxel.

In December 2015, the FDA issued a warning about the possible risk of alopecia when undergoing treatment with Taxotere and its generic docetaxel. The FDA issued the warning in response to numerous adverse event reports submitted to the agency by patients and doctors.

Will my hair grow back after I stop treatment with Taxotere?

The majority of women will re-grow their hair after chemotherapy with Taxotere. On average, women who undergo chemotherapy with any drug will experience hair re-growth within a few weeks to a few months after ending treatment.

There is a percentage of women who may never re-grow their hair after treatment with Taxotere.

The makers of the drug estimate permanent hair loss occurs in about three percent of patients. Some studies estimate this percentage is much greater and could be anywhere from six percent to almost 16 percent.

Has the FDA issued any warnings about Taxotere?

The FDA has issued several warnings regarding Taxotere since the drug was approved 20 years ago.

Taxotere carries a “black box” warning, the FDA’s strongest warning about a drug or medical device. Black box warnings indicate there is a serious risk of hazard or even death associated with the product.

Taxotere’s black box holds several warnings for consumers and doctors including the risk of:

  • toxic death in patients with abnormal liver function
  • hepatoxicity in patients with high bilirubin concentrations
  • low white blood cell counts
  • hypersensitivity reactions and fluid retention

The FDA has also issued numerous safety communications in the past several years regarding Taxotere. Some of those warnings include the risk of:

  • renal (kidney) failure
  • respiratory problems, including failure
  • metabolism and nutrition disorders
  • eye disorders
  • permanent alopecia

What other chemotherapy drugs are used to treat breast cancer?

Taxotere is not the only chemotherapy drug on the market used to treat breast cancer.

The following are also used to treat early and locally advanced breast cancer (brand names are listed in parentheses):

  • Cyclophosamide (Cytoxan)
  • Doxorubicin (Adriamycin)
  • Epirubicin (Ellence)
  • Methotrexate (Maxtrex)
  • Paclitaxel (Taxol)

The following are also used to treat metastatic breast cancer (brand names are listed in parentheses):

  • Capecitabine (Xeloda)
  • Carboplatin (Paraplatin)
  • Cisplatin (Platinol)
  • Cyclophosamide (Cytoxan)
  • Doxorubicin (Adriamycin)
  • Epirubicin (Ellence)
  • Eribulin (Halaven)
  • 5-Fluorouracil (Adrucil)
  • Gemcitabine (Gemzar)
  • Ixabepilone (Ixempra)
  • Liposomal doxorubicin (Doxil)
  • Methotrexate (Maxtrex)
  • Paclitaxel (Taxol)
  • Paclitaxel, albumin bound (Abraxane)
  • Vinorelbine (Navelbine)

Both Taxol (paclitaxel) and Taxotere are in the same taxane drug class. Both are derived from the yew tree.

How often is Taxotere prescribed?

About 1 in 8 women (about 12 percent) will develop invasive breast cancer in her lifetime. In 2016, it is estimated over 246,000 new cases of invasive breast cancer will be diagnosed, including an additional 61,000 new cases of non-invasive breast cancer, according to the American Cancer Society.

Taxotere is the most widely prescribed drug in its class to treat breast cancer. Up to 75 percent of breast cancer patients in the United States use Taxotere during their treatment.

If you or someone you love has suffered from permanent hair loss from using Taxotere, we can help ease the burden. Read about the Taxotere lawsuits here.

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How far can Essure coils migrate through the body? https://www.nationalinjuryhelp.com/defective-products/essure-coils-migrate-body/ https://www.nationalinjuryhelp.com/defective-products/essure-coils-migrate-body/#respond Fri, 09 Jun 2017 18:20:13 +0000 https://www.nationalinjuryhelp.com/?p=36466 June 9, 2017 San Diego, CA — Essure has been making headlines ever since thousands of women began speaking out against the permanent form of birth control and the serious side effect of device migration. Learn more about the controversial contraceptive that has both patients and lawmakers fighting to get it pulled from the market. Read about the pending 2017 Essure lawsuits here.

What is migration of the Essure device?

Device migration is a relatively common adverse events reported by women who have problems with the device.  When the Essure device migrates, it means the device moves from the proper place of insertion inside the fallopian tubes. Sometimes, the device moves only slightly from its intended position; in other cases, the device may migrate completely out of the fallopian tube into the uterus or the abdominal cavity. This usually happens when the doctor inserts the coils too far into the fallopian tube or not far enough.

Symptoms of device migration include:

  • Abnormal bleeding
  • Abdominal pain
  • Lower back pain
  • Tiredness
  • General feeling of discomfort, illness
  • Nausea, vomiting
  • Headaches
  • Fatigue
  • Anxiety

According to the abstract in its “Case Reports in Obstetrics and Gynecology”, from Hindawi Limited based in the UK:

The Essure device is a method of permanent sterilization widely used in the US that has proven to be safe and effective in most cases. However, there have been reports of device migration that have led to failed tubal occlusion as well as several other serious complications resulting from the presence of the device in the abdominal cavity.

Case. This paper represents two cases of failed tubal occlusion by an appropriately placed Essure device without signs or symptoms of further complications related to device migration. Conclusion. Although there have only been 13 reported cases of abdominal device migration since November 2014, this case indicates that the actual number may be higher than reported since it is possible for migration to occur without additional complications. In the majority of reported cases of abdominal migration a major complication requiring surgical correction occurred, such as adhesions, small bowel obstruction, bowel perforation, or persistent pelvic pain. To avoid these complications it is recommended that migrating implants be removed; however, this case also represents an example of when a migrating device may remain in situ in an asymptomatic patient.  

X-rays show Essure Device Migration

In this dramatic X-ray, Figure 6: Patient Number 2, postpartum pelvic X-ray 10/13/15: Essure (circled in yellow) in the right upper quadrant around the liver. The 2nd Essure insert (circled in red) is seen by lumbar vertebra.

Essure Migration

Figure 3: Patient Number 1, postpartum abdominal X-ray 8/30/2014: Essure (circled in red) in the abdomen.

This last X-ray is the most disturbing – this is an Essure coil that has traveled all the way to the woman’s jaw.

Essure Migration jaw

What is Essure?

Essure is a form of permanent birth control (sterilization) that involves placing two metal coils in a woman’s fallopian tubes. Essure is the only non-surgical form of permanent contraception available today. The procedure is performed in a doctor’s office usually in less than 30 minutes.

How does Essure work?

Essure works by blocking the fallopian tubes so sperm cannot reach an egg to fertilize it. The Essure device consists of two metal coils that are inserted into each fallopian tube by a doctor. The coils cause the body to create scar tissue, which blocks sperm from entering the fallopian tubes. This process is intended to be permanent and usually cannot be reversed; women who may want more children in the future should not get Essure.

How is the Essure insertion procedure performed?

Essure is inserted into each fallopian tube by a doctor. The coils are inserted through the vagina so no incision is necessary. The doctor first inserts a small camera called a hysteroscope through the vagina, into the cervix and up the uterus until he or she can see the fallopian tubes. The doctor then passes the Essure coils through the hysteroscope and into the fallopian tubes.

The correct placement is essential in order for Essure to work as intended. About three to eight rings should extend into the uterine cavity; the rest of the coils should be inside the fallopian tubes.

How do I file an Essure Lawsuit?

Read about the pending 2017 Essure Lawsuit here.  If you or someone you love has had problems related to the Essure device, act now the lawyers and attorneys at Hood National Law Group are experienced in claims and cases involving Essure.

If you had the Essure device inserted and have experienced adverse effects, call us today for a free case evaluation at 1-800-214-1010. You may be entitled to compensation.

Use our online Essure Claims Evaluation Here.

 

Source: https://www.hindawi.com/journals/criog/2015/402197/

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Is Bayer Pharmaceuticals now ignoring the FDA for its Essure birth control device? https://www.nationalinjuryhelp.com/defective-products/bayer-ignoring-fda-essure/ https://www.nationalinjuryhelp.com/defective-products/bayer-ignoring-fda-essure/#respond Tue, 06 Jun 2017 19:14:04 +0000 https://www.nationalinjuryhelp.com/?p=36457 June 6, 2017 San Diego, CA –Bayer is not acting on an FDA demand for a 522 Postmark study on Essure birth control device.

In our opinion, Bayer is dragging its feet on further clinical testing of this problematic device and in doing so is exposing even more women to its harmful potential side effects.

The FDA official, Mr. William Maisel states, “So Bayer is – we expect Bayer to submit a study protocol to us within 30 days. By law they must begin their clinical trials within 15 months. And failure to do so could result in the agency taking action such as issuing a warning letter and declaring their device misbranded. We have taken those actions in the past and we will do so in the future if Bayer does not meet its requirements.”  

This means that Bayer needed to start the new clinical trials and study by May 2017. That date has now past.

What is an FDA 522 order?

We scanned the FDA website and found:  “A manufacturer must submit a postmarket surveillance plan within 30 days of receipt of the 522 order (section 522(b)(1) of the Act and 21 CFR 822.8) and commence surveillance not later than 15 months after the day on which FDA issues the 522 order.”

At the end of May, Bayer announced that it has decided to remove Essure from the Finland stating slow sales in that European county. Brazil also took Essure off the market.  We anticipate other EU nations to pull Essure off the market.

However Bayer continues to sell this product in the US despite all of the FDA data illustrating the problems associated with the device.  The latest move from the FDA was to ramp up its consumer warnings to Black Box Warning status, which is the highest level of warning to consumers, generally after that comes either the FDA banning the device, or Bayer may choose to remove Essure from the US market.

Victims Speak Out Against Essure Problems

In a New York Times article posted May 5, 2015, one 42 year old woman was quoted, “If I had any idea of the possible consequences of Essure, I would never have chosen it.” She experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009. Her doctors found the device had broken apart and lodged in her uterus. She underwent surgery to have the broken bits removed.

Data from the FDA site on Postmarket Surveillance Study:

This shows the most common problems reported to the FDA from its Adverse Event’s reporting system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=356&c_id=3854

FDA Main Safety Endpoints:
– Chronic lower abdominal and/or pelvic pain
– Abnormal uterine bleeding (new onset or worsening)
– Hypersensitivity and allergic reactions, and autoimmune disorders (new onset) or autoimmune- like reactions
– Invasive gynecologic surgery including Essure insert removal

Secondary Safety Endpoints:
– Other adverse events
In the event of a device removal or event of interest, additional data collection may include bloodwork, pathology, histology, and metallurgic testing, as appropriate

Effectiveness:
– Pregnancy

Essure Implant Lawsuits Forming

Because we feel strongly that Bayer HealthCare rushed this product to market and the FDA did fast-track the process, women have been the unwilling victims of profit over safety. We intend to hold Bayer Healthcare responsible for the pain and continued suffering of thousands of women who have had the Essure Contraceptive device implanted. If you, or someone you love, has had the Essure Contraceptive Implant and has had ANY adverse side effect we’re on your side. Contact our lawyers and attorneys today for a FREE case review.

Learn about the Essure Lawsuit here.

Source:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

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