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Following a rash of serious medical complications allegedly caused by defective artificial hip implants, DePuy Orthopedics has been ordered to pay more than $1 billion. A federal jury in Dallas found the company, a subsidiary of Johnson & Johnson, negligent in its failure to adequately warn physicians and patients about the risks associated with their product’s defective design.

At least six patients had to undergo revision surgery to replace the defective implants with a properly-functioning implant and / or to repair damage to the tissue and bone. The Dallas jury awarded more than $30 million in damages to the six patients and more than $1 billion in punitive damages. The jury made the following ruling:

  • J&J and DePuy were negligent in their design of the implant
  • They failed to warn patients and doctors about known risks
  • They failed to recall the product when defects were discovered
  • They intentionally misrepresented the effectiveness of the product to both doctors and patients

If you have been harmed due to a DePuy hip implant, contact a Boston defective medical product attorney today.

Johnson & Johnson Appeals the Verdict

Following the verdict, Johnson & Johnson and DePuy announced that they will appeal the decision, denying any wrongdoing. “We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active and comfortable lives,” said DePuy spokeswoman Mindy Tinsley. “DePuy acted appropriately and responsibly in the design and testing of ULTAMET Metal-on-Metal, and the product is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain.”

Fourth Trial Scheduled for September 2017

This trial was the third bellwether trial for thousands of similar lawsuits. Earlier this year, a jury – also in Dallas – awarded more than $500 million in damages to a group who suffered medical complications from DePuy implants. However, the award was later reduced to $154 million. The companies are also appealing the reduced ruling in that case. The first trial, which took place in 2014, was decided in favor of J&J and DePuy. A fourth trial is on the horizon, scheduled for September 2017. If you have been injured due to a DePuy artificial hip implant, or any other type of defective medical product, contact a Boston injury attorney today.

Risks Associated with DePuy Hip Implants

Thousands of lawsuits have been filed against DePuy for medical complications arising from defective hip implants. The most commonly cited complications include:

  • Bone fractures – in many cases the bones surrounding the hip implant have weakened, resulting in fractures
  • Metallosis – this condition occurs when metal fragments release toxins into the body
  • Pseudotumors – the formation of tumor-like deposits have adhered to joints in some patients
  • Necrosis – the death of bone and tissue due to metallosis has been cited in multiple lawsuits
  • Revision surgery – due to defective implants, bone erosion, and tissue damage, thousands of patients have required revision surgery to replace implants and repair damage

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Since being approved in October of 2010, the prescription blood thinning drug, Pradaxa, has established itself as an upgrade to warfarin because it performed the same functions while also preventing strokes. Other competitors to warfarin, such as Xarelto, have also come onto the market.  While these drugs netted gigantic profits for their manufacturers and were used by millions of patients, it has been revealed over time that these drugs can pose a serious, and deadly, risk to certain types of people. In May of 2014 alone, Boehringer Ingelheim, the German manufacturer of Pradaxa, settled more than 4,000 lawsuits for a combined amount of $650 million.

Just two years after its introduction, Pradaxa was blamed for over 500 deaths stemming from uncontrollable bleeding and internal hemorrhaging. The aforementioned settlement came under the condition that Boehringer Ingelheim would have to admit to no fault regarding the deaths, stating that the benefits of the drug far outweighed the negative side effects.  While the benefits of the drug are certainly evident, should thousands of lawsuits and hundreds of deaths prompt, at the very least, more research, development, and awareness campaigns to ensure that the wrong people don’t take the drug and wind up in dire straits? Pradaxa costs about $3,000 a year and made $209 million in sales just in the first quarter of 2012, so it is not an issue of not having enough money.

What is Pradaxa?

Taxotere is a chemotherapy drug that treats patients by killing cancer cells, especially those of the breast, lungs, stomach, prostate, neck, and head. In addition to killing cancer cells, chemotherapy drugs also kill hair follicles. As such, hair loss is a well-known side effect of chemotherapy treatment. However, with most cancer-killing drugs, the expectation is that the hair will grow back once treatment has stopped. Unfortunately, that hasn’t been the case for many patients who have used Taxotere.  In one recent study, researchers found that permanent hair loss has occurred in 9.2 percent of women using Taxotere. The manufacturer, Sanofi-Aventis, had different results, claiming that only 3 percent of patients experience permanent hair loss. Women being treated for breast cancer account for the majority of the permanent hair loss cases linked to Taxotere.

The Food and Drug Administration (FDA) added warnings about permanent alopecia (hair loss) to the drug’s label in 2015.

Failure to Warn

There are more than 2.8 million women who have, or have had, breast cancer currently living in the United States. Recent estimates reveal that about 75 percent of those women may have been given a prescription for Taxotere. Fighting cancer can take a serious emotional and physical toll on a woman’s body. Adding permanent hair loss to an already difficult and painful situation can be devastating. Taxotere is currently under investigation for its failure to warn physicians and patients about the link to permanent hair loss. Living with permanent hair loss after battling cancer can be a constant reminder of something you just want to forget. If you have suffered chemo-induced alopecia after taking Taxotere, contact a Boston drug injury lawyer today.

Earlier this year, all Taxotere lawsuits alleging permanent alopecia were ordered to be consolidated into a multidistrict litigation (MDL) in the Eastern District of Louisiana. There are currently at least 33 pending federal complaints that accuse Sanofi-Aventis of continuing to market Taxotere as a superior alternative to other chemotherapy medications, despite knowing that the drug was linked to permanent hair loss.

In 2014, researchers at the National Cancer Conference made the following statement: “Long term significant scalp alopecia (here lasting for up to 3.5 years following completion of chemotherapy) may affect 10-15% of patients following docetaxel for EBC [early breast cancer]. This appears to be unrelated to other patient and treatment characteristics.” With 9.2 percent of women experiencing permanent hair loss, and up to 15 percent experiencing long-term significant hair loss, there is obvious cause for concern. If you have suffered hair loss after taking Taxotere, contact a Boston injury lawyer today. Continue reading

The FDA has warned that fluoroquinolone antibiotics, including Levaquin and Cipro, are linked to serious, potentially permanent medical conditions. According to reports, manufacturers of these drugs knew about the risks but failed to properly warn physicians and patients. As a result, many lawsuits have been filed. If you are experiencing painful or debilitating side effects after taking a fluoroquinolone, contact your healthcare provider immediately.

What is a Fluoroquinolone Antibiotic?

Fluoroquinolones belong to a family of synthetic antibiotics, which kill bacteria by interfering with the replication of DNA. The types of fluoroquinolones on the market are:

  • Ciprofloxacin (Cipro)
  • Moxifloxacin (Avelox)
  • Levofloxacin (Levaquin/Quixin)
  • Ofloxacin (Ocuflox/Floxin/Floxacin)
  • Norfloxacin (Noroxin)
  • Gatifloxacin (Tequin)

Hospitals routinely use fluoroquinolones for treating opportunistic infections in patients. However, frequent or routine use of this type of antibiotic can have harmful side effects, including tendon damage and nerve damage. According to the FDA, fluoroquinolones should only be used when no other options are available. In addition, physicians should notify patients of the associated risks prior to administering the medication. Considering that most fluoroquinolones are distributed by a pharmacy and that pharmacies are required to provide notification of side effects, the manufacturers are usually held liable when harmful side effects develop. If you are suffering from side effects after taking a fluoroquinolone antibiotic, contact a Boston drug injury lawyer today.

Side Effects Linked to Fluoroquinolones

The fluoroquinolone family is linked to multiple side effects, but the most commonly-cited serious side effects include:

  • Nervous system problems, including a condition called peripheral neuropathy, pain, tingling, numbness, weakness, headaches, loss of memory, loss of concentration, and anxiety.
  • Musculoskeletal problems, including tendonitis, tendon ruptures, tendon weakness, and swelling of the joints.
  • Sensory symptoms, including problems with hearing, sight, and smell.
  • Cardiovascular problems, including chest pain, palpitations, and shortness of breath.
  • Skin problems, including rashes, intolerance to heat or cold, and excessive sweating.
  • Gastrointestinal problems, including nausea and vomiting, diarrhea, and severe abdominal pain.

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Hernia mesh is a medical device used to repair hernias by either covering the hernia or acting as a plug. Hundreds of thousands of hernia surgeries are performed annually; some use hernia mesh and some do not. In most of these surgeries, patients recover quickly and little to no complications arise. However, the Food and Drug Administration (FDA) has received numerous reports of complications involving hernia mesh.

The FDA has reported various complications associated with hernia mesh products, including intestinal adhesions (occurs when parts of the intestine adhere to the mesh), reactions to the mesh, infection, severe and chronic pain, injuries to organs and nerves, and the need for revision surgery. Although most of these complications have been linked to hernia mesh products that have already been taken off the market, some products are still being used today. If you have been injured by hernia mesh or any other type of medical device, contact a Boston defective medical products lawyer today.

What is a Hernia?

A hernia occurs when part of an organ, typically the intestine, pushes through a weakened spot in the groin or abdomen. The most obvious hernia symptom is a visible bulge in the abdomen or groin area. It is often painful. Additional symptoms include bloating and constipation, back pain, and bloody bowel movements. Hernias are often caused by activities that require overexertion, such as lifting, carrying, or pushing heavy objects. Certain factors can increase your risk of developing a hernia, including obesity, smoking, and age. If you think you may be suffering from a hernia, contact your health care provider immediately.

Types of Hernia Mesh Linked to Injuries

There are multiple types of hernia mesh associated with complications, but most lawsuits involve the following four types:

Ethicon Physiomesh: Recalled in 2016, Ethicon Physiomesh was linked to a high rate of failure. The company has demanded the return of all unused inventory, and has no plans of bringing the product back to market.  Atrium C-Qur Mesh: This polypropylene mesh product has been linked to multiple complications. In 2012, the FDA issued a warning to the manufacturer, claiming it had failed to respond to and investigate complaints. If you have been injured by an Atrium C-Qur Mesh product, contact a Boston injury lawyer today.

Kugel Hernia Mesh Patches: Multiple Kugel hernia products have been recalled following reports of injuries. A coil ring within the mesh may break, causing internal injuries and severe pain.

AlloDerm Regenerative Tissue Matrix: A hernia patch manufactured from human cadaver tissue, the AlloDerm Regenerative Tissue Matrix has been linked to multiple complications. Apparently, the patch requires pre-stretching, a crucial step which was not effectively communicated to health care providers. When proper pre-stretching does not occur, the patch can expand after implantation, causing severe pain and injuries. Continue reading

A woman suing pharmaceutical titan Johnson & Johnson has been awarded $70 million as the result of a case brought before court in St. Louis. The case was reportedly swung by the revealing of written communications between Johnson & Johnson and their supplier of talcum powder, Imerys, which “proved that the company was aware of the dangers for over 30 years.”  Medical professionals have known for years that repeated use of talcum powder is dangerous to both infants and children, causing symptoms such as difficult breathing. Now, with the help of this court ruling, it has been revealed that repeated talcum use can actually cause a dramatic increase in the likelihood for a woman to develop ovarian cancer.

Approximately one in 70 women will develop ovarian cancer on average. However, women who use talcum powder – which is made from the naturally-occurring clay mineral, talc – as part of a daily feminine hygiene regiment are reportedly 30 to 60% more at risk of developing ovarian cancer than women who do not use talcum powder regularly.  It is the third major payment issued to a plaintiff suing on the grounds that Johnson & Johnson’s talcum powder has caused them life-threatening health complications. The other plaintiffs, which filed in 2014, were awarded $55 million and $72 million. With this verdict, it is almost certain that more cases will come to light.

Aside from these high-profile litigations, Johnson & Johnson is now the subject of multiple class-action lawsuits on behalf of women who used talcum powder. Although not every woman who has used talcum powder regularly has or will develop ovarian cancer, the lawsuits stand as an indication that people are furious that Johnson & Johnson could continue to sell a product with known links to such a deadly disease. Despite the situation, Johnson & Johnson continues to sell its talcum powder products without any warning labels.

Talcum powder dangerous for women and infants

Talcum powder is a product that nearly everybody can remember either their parents, grandparents or themselves using at one point or another. The seemingly innocuous product is used in baby powders and adult powders meant to prevent odor and itching in areas of the body prone to sweating and heat. Many women use the products in their private area, which has been revealed to lead to a potentially increased risk for ovarian cancer.  A Harvard doctor, Daniel Cramer, studied the link between talcum powder and ovarian cancer for 30 years and testified in court that talcum powder “was likely a contributing factor in 10,000 cases of ovarian cancer annually.” The testimony was part of a lawsuit filed by a South Dakota woman in 2006, which ruled that Johnson & Johnson was negligent about the dangers of its product but awarded no damages to the woman, who did develop ovarian cancer as the result of her talcum powder use. Continue reading

The Stryker Corporation, a multi-billion dollar medical technology and joint replacement manufacturer, is once again making headlines for all the wrong reasons, as their LFIT V40 CoCr Femoral Head is generating reports of catastrophic failures necessitating painful and expensive surgery for some patients who received the implant.  The LFIT V40 device is a hip implant that utilizes a metallic shaft, which attaches to the patient’s femur, leading up to the “head” of the device that attaches to a joint connected to the patient’s hip. The problematic area of the V40 device lies in the head, which has been reported to corrode over the course of its life and eventually weaken to the point where the head may slip out of the joint or snap off completely.

As the metal of the head corrodes, tiny metallic particles (which could be a combination of cobalt, nickel, chromium or titanium) may be released into the patient’s bloodstream, causing a type of blood poisoning known as “metallosis.” Advanced metallosis can result in complete bone and tissue death, leading to severe pain and other medical issues in the affected patient.

Symptoms of metallosis include:

For a while, Risperdal seemed to be the solution to a very challenging problem. Young men and boys with bipolar disorder and schizophrenia were finding greater relief from their symptoms than they had experienced with any other medication. In addition to treating these disorders, Risperdal also proved effective at reducing aggressive behavior and irritability in children with autism. Unfortunately, as time passed, some very serious side effects began to appear. The most disturbing of these side effects is the enlargement of male breasts, a condition known as gynecomastia. As troubling reports of serious, and often traumatic, side effects began to rise, so did Risperdal lawsuits.

Since complications including male breast enlargement and problems with sexual function were first reported, thousands of lawsuits have been filed against Risperdal manufacturer Janssen Pharmaceuticals. Breast enlargement is the result of an increase in levels of prolactin, a hormone responsible for milk production in humans. Risperdal use in boys with autism is linked to gynecomastia at double the rate of boys without autism. These same children are 14 percent more likely to experience sexual dysfunction, linked to Risperdal, as well. If you child has developed any of these side effects, contact a MA injury lawyer.

Substantial Jury Awards

Due to the nature and severity of these side effects, some awards have been substantial. Earlier this year, Andrew Yount, a boy who developed gynecomastia after taking Risperdal, was awarded $70 million by Janssen Pharmaceuticals. According to reports, evidence showed that Janssen manipulated data within Risperdal studies to downplay the risk of gynecomastia in adolescent boys. In fact, the pharmaceutical giant may have known about the link to male breast enlargement as early as 2003, but failed to warn physicians and patients. Had this risk been made public, patients would have had the option to take another drug with no such side effects. If you have developed side effects after taking Risperdal, contact a Boston drug injury lawyer today.

The recent lawsuit mentioned above is not Risperdal’s first run-in with litigation. In 2012, Janssen’s parent company, Johnson & Johnson, settled a Medicaid fraud lawsuit for $158 million. Prosecutors claimed J&J misled the public about Risperdal’s cost, effectiveness, and safety. And in 2011, J&J and Janssen paid more than $300 million in fines for a letter sent to physicians which stated that Risperdal was superior to its competitors, among other violations.

Emotional Trauma

Risperdal is linked to a wide array of side effects, but gynecomastia can be especially traumatic. In addition to physical symptoms, gynecomastia can result in emotional trauma for young boys. In some cases, reconstructive surgery is necessary to reverse male breast enlargement. If your child has suffered from gynecomastia, he may need counseling and therapy to overcome emotional distress. Continue reading

Xarelto, a blood-thinning medication, was deemed in 2011 to be a safe alternative to traditionally-used warfarin medication in preventing blood clots, which can lead to life-threatening strokes and other ailments. Despite the drug being tested and approved as safe, thousands of cases have emerged over the years that suggest the drug is anything but safe in all applications.  The appeal for a warfarin replacement drug is obvious. Warfarin requires those who take it to adhere to a special diet and mandates keen attention by the patient and doctors to ensure that it is having the intended effect. Xarelto was marketed as a more simplified version of warfarin, achieving the same results but without the drastic change in lifestyle.

 

Xarelto is intended to thin the blood to prevent a blood clot condition known as deep vein thrombosis, which can occur in many places throughout the body but can also lead to developing blood clots in the lungs (known as a pulmonary embolism, a potentially fatal condition.) The most common applications of Xarelto are in people who have just underwent surgery, or people with atrial fibrillation, a heart condition which increases the risk for strokes.   Xarelto has worked successfully for many patients, but conversely, thousands of patients taking Xarelto have experienced excessive bleeding and even blood clots as a result. There is no easy cure for somebody who has a negative reaction to Xarelto and, as a result, there have been thousands of lawsuits filed as a result of the pain, suffering and medical expenses incurred by those taking Xarelto and their families.

Xarelto is a multi-billion dollar cash cow both for its manufacturer, Bayer, and for its pharmaceutical marketing company, Janssen Pharmaceuticals (a subsidiary of Johnson and Johnson). Despite the legal trouble and real cases of patients having life-altering consequences from taking the drug, the FDA recently reiterated that the drug is safe to be taken by patients with heart complications.

Do not take Xarelto if…

  • You have an artificial heart valve
  • You have an established history of uncontrollable bleeding
  • You have underwent spinal surgery or had a spinal tap
  • You are on a regular regiment of nonsteroidal anti-inflammatory drugs (NSAIs) such as Motrin, Advil, Aleve, etc.
  • You experience stomach or intestinal bleeding
  • If you are already on a regiment of aspirin, warfarin, Plavix, or certain antidepressants

The only way to know for sure if you are going to be okay taking Xarelto is to have an in-depth and detailed discussion with a doctor. The problem with Xarelto is not that it is inherently unsafe, but rather it is that there are a multitude of side effects and other conditions that can cause patients to have a life-threatening reaction. Continue reading

Inferior vena cava (IVC) filters are surgical devices that are threaded into the body through the skin and are intended to prevent life-threatening blood clots from forming after a medical procedure or accident. IVC filters can be implemented permanently or temporarily and removed once the patient’s risk of blood clotting is reduced. Over 250,000 of these devices have been installed as of 2012.  However, even though an IVC filter is intended to be retrieved, there is no guarantee that it can be successfully removed. In fact, in a recent study of patients who had plans to have their temporary IVC filters installed, over 25% of them were unable to have their filters successfully removed. The longer that a temporary filter is left in the body, the higher the chance of something going terribly wrong.

Dangers of IVC filters

Despite being approved by the FDA decades ago, it has been revealed in recent years that these delicate devices are prone to malfunctioning and even breaking. As a result, pieces of the IVC filters can then travel through a person’s body causing serious or even deadly injuries such as piercing internal organs or causing blockages in the blood stream.

Other side effects of a malfunctioning IVC filter device include:

  • Irregular heartbeat
  • Loss of consciousness
  • Irregular breathing and chest pain
  • Heart damage
  • Fluid buildup around the heart

Currently the FDA is collecting more analytical information to assess the risks versus benefits of temporary IVC filters. In the meantime, many people who have suffered as a result of these devices are filing suit against the manufacturing companies. These include Boston Scientific, C.R. Bard and Cook Medical, the latter of which has had over 100 suits filed against them. Continue reading

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