Essure Lawsuit Plaintiffs Want Bayer Suit Tried in State Court

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A California federal judge has been urged by attorneys for 59 women suing Bayer over claims concerning faulty Essure sterilization devices, be sent back to state court, arguing the lawsuit brings only state law claims. The plaintiffs allege that Essure caused perforated uteruses among other severe problems.

The plaintiffs allege that the sterilization device that is a method to prevent pregnancy, may cause perforation of the uterus, device movement or breakage, chronic pain and ectopic pregnancy. An ectopic pregnancy occurs if an embryo implants somewhere other than the uterus, such as in one of the fallopian tubes.

How Essure Works

Essure is made up of small coils – stainless steel, wound with polyethylene terephthalate polyester fibers, and placed in a larger nickel-titanium coil. It is a non-surgical procedure, and is inserted in the fallopian tubes by way of a catheter through the vagina. The coils induce scar tissue which forms and blocks the tubes, stopping sperm from reaching the eggs, thereby preventing pregnancy. This process may take three months, during which time, an additional form of birth control should be used.

FDA Approval

The U.S. Food and Drug Administration (FDA) approved Essure for the market in the United States in 2002. The risks did not emerge until after the FDA approval, but the current lawsuit maintains that Bayer Corporation neglected its duty to give a timely warning to health care providers and the FDA.

Plaintiffs involved in the lawsuit claim that if Bayer had notified government regulators as soon as it became aware of the health risks and of quality control problems in its manufacturing process, the women would not have been harmed by the Essure device.

In October 2016, the FDA added a black box warning to Essure packaging to alert women of the potential injuries that may be experienced. The warning says that the “implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, causing persistent pain and requiring surgical removal.”

National law firm Parker Waichman has extensive and successful experience in product liability litigation, including Essure. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.

Question Surrounding the Case’s Location

Originally filed in Contra Costa County Superior Court in February, the case was removed to federal court one month later. The complaint maintains violations of California negligence, strict products liability, warranty, and fraud statutes. However, Bayer argued the case was correctly removed because it implicates the Federal Food, Drug and Cosmetic Act and the Medical Device Regulation Act, as well as federal negligence laws, sparking federal interest jurisdiction.

At the beginning of the recent hearing, U.S. District Judge William Alsup said he would remand the case, saying, “It should never have been brought here.” But as the hearing continued and each side presented contrasting U.S. Supreme Court precedent, the judge became less certain about how to rule. At some point, the judge suggested the parties ask for attorneys’ fees so they could appeal to the Ninth Circuit, saying, “This whole thing is going to turn on federal regulations anyway.”

“At trial, the plaintiff here will say negligence, and of course that’s a state law claim, so all day long that part will get remanded. But the plaintiffs are also saying they would like to point to violations of federal standards to how negligence per se,” he said. “So many people can dance on the head of a pin. … I don’t have an ax to grind with either of you. I just wish the law was clearer.”

It was noted that the judge could rely on the U.S. Supreme Court’s 2005 Grable & Sons Metal Products decision, which found a suit that brought only state law claims but turned on an interpretation of federal tax law should be considered in U.S. district court because federal issues “lie over some state-law claims.”

It was argued by the plaintiffs’ representation that Grabble self-identified as the exception, not the rule and said that more recent ruling did not affect the high court’s 1986 Merrel Dow Pharmaceuticals decision, another drug warning case, which the plaintiff’s attorneys said was more on point. That case showed that Congress’ intent with the FDCA was not to create a federal private cause of action, and even the subsequent Grable decision made mention of a congressionally approved balance of federal and state judicial responsibilities.

Legal Advice and Information Concerning Essure

If you or someone you know has been injured by a medical device, such as Essure, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

FDA Reviews Hepatitis A Tied to Frozen Tuna

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Contaminated Tuna Originated in Vietnam and the Philippines

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), are collaborating with state and local officials to assess the risk of exposure to the hepatitis A virus tied to contaminated frozen tuna sourced from the Sustainable Seafood Company, Vietnam and the Santa Cruz Seafood Inc., Philippines. If unvaccinated consumers have consumed the recalled product in June 2017, post-exposure prophylaxis (action taken to prevent disease) may help prevent contracting the hepatitis A virus infection.

Prior to release of the FDA’s announcement, Hilo Fish Company sent out a direct alert to its customers and distribution partners on May18, 2017 to advise about the company’s recall of certain tuna products. The FDA indicated it had received records from the company or its distribution partners indicating that frozen tuna was sold to the establishments listed on the FDA’s website here.

The FDA indicated that it continues to work with Hilo and other distributors to ensure that the companies remove the contaminated tuna from the market. The FDA notes that it is Hilo Fish Company’s responsibility to advise its customers about the recall. Also, any company that received a recall notice from Hilo Fish Company is responsible to advise its customers. The establishments identified on the FDA’s website should have received a notice from Hilo Fish Company or their direct supplier. If not, they should reach out to their suppliers for additional information.

The first recall took place in Hawaii and involved imported raw frozen ahi tuna cubes sourced from PT Deho Canning Co. (JL. Raya Madidir, Bitung, Indonesia). That recall, by Tropic Fish, includes lot codes 609149 and 609187. No products are believed to remain on the market. The current recall resulted from follow-up after the Hawaii Department of Health advised the FDA of a frozen tuna sample, sourced from PT Deho Canning Co., which tested positive for hepatitis A on May 1, 2017. The initially recalled product has been removed from circulation and the newly recalled frozen tuna lots were not shipped to Hawaii; however, they were shipped to mainland United States.

The current recall, which began May 18, involves frozen yellowfin tuna steaks from Sustainable Seafood Company and yellowfin tuna cubes from Santa Cruz Seafood. The recall, implemented by Hilo Fish Company, includes Tuna Steaks in eight-ounce individually vacuum packed bags with production date code: 627152, lot number: 166623; expiration date: 2018-10-01. Frozen Yellowfin tuna cubes, random, were individually vacuum packed in 15-pound cases with the date code: 705342; lot number: 173448; and expiration date: 2019-04-01.

Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in food poisoning lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a contaminated food lawsuit.

What is Hepatitis A?

Hepatitis A is a contagious liver disease that is the result of an infection with the hepatitis A virus. The virus may range in severity from a mild illness that lasts a few weeks, to a severe illness that lasts several months. Hepatitis A may be spread when a person ingests the virus from contaminated food or water. The virus may also be easily passed from an infected person to other unvaccinated family members, sexual partners, and close contacts, according to the FDA.

The FDA points out that, symptoms of hepatitis A in adults include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine, and pale stool; individuals with hepatitis A may not have symptoms until 15 to 50 days after consuming a contaminated food or drink. The CDC reports that, while the hepatitis A vaccine is recommended for all children, vaccination rates are lower than for other recommended childhood vaccines. Unvaccinated children may become ill and not have symptoms. Any unvaccinated person who consumed recalled frozen tuna is at risk of contracting the hepatitis A virus, noted the FDA.

The CDC recommends providing post exposure prophylaxis (PEP) for any unvaccinated people who have recently eaten any of the recalled raw or undercooked tuna products. People who have consumed this fish fully cooked are at reduced risk of exposure, but consultation with medical professionals is suggested.

PEP involves receiving the hepatitis A vaccine for people between the ages of one and 40 years or the hepatitis A virus-specific immunoglobulin (IG) for people outside of this age range. The hepatitis A vaccine may be substituted if the IG is not available. Those with evidence of previous vaccination do not require PEP

If you have never received the hepatitis A vaccine, getting a single dose within two weeks of exposure may protect against illness. If you are unable to determine if you have been vaccinated, receiving an additional dose of the vaccine is not harmful.

In the event that retailers and/or other retail locations are found to have handled recalled or other potentially contaminated food in their facilities, wash and sanitize display cases and refrigerators where potentially contaminated products are stored; wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products; and wash hands with hot water and soap following the cleaning and sanitation process. Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products must be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products, according to the FDA.

The FDA notes that contaminated shellfish, fruit (berries), and salads are the most frequent foodborne sources of hepatitis A. Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Consumers should thoroughly wash their hands after using the bathroom and changing diapers to help protect themselves from contracting hepatitis A.

Filing a Food Poisoning Injury Lawsuit

If you or someone you know suffered injuries due to a contaminated food, you may have valuable legal rights. Our food poisoning lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

IVC Filters May Fracture If Not Removed In Established Time Frames

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C.R. Bard May Have Known About Issues with Recovery and G2 Filters

At least 27 deaths have been tied to a C.R. Bard blood clot filter named the Recovery. Allegedly, C.R. Bard replaced the device with a modified version. Soon after the modified medical device was approved, C.R. Bard allegedly knew that it had similar problems to the initial version of the device, according to NBC News.

Despite that C.R. Bard was aware of complications associated with its blood clot filter, the device maker continued to sell the medical devices. According to NBC News, just four months after C.R. Bard released the G2 Bard blood clot filter, the device maker was concerned about failure reports. The G2 was created to replace the Recovery Bard blood clot filter and, since that time, the device has been tied to more than one dozen deaths and many injury reports.

Dr. William Kuo, a specialist in removing blood clot filters that have failed, told NBC, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications.” The Stanford radiologist also said that, “[t]he number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

The attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

C.R. Bard Recovery Filter Background

According to a prior NBC News report, IVC filters—sometimes known as blood clot filters—are implanted in approximately 250,000 Americans annually. In the last decade or so, millions of filters have been implanted in Americans.

C.R. Bard is one of 11 makers of IVC filters and had hoped to gain traction in the profitable filter market when it introduced the Recovery filter, receiving FDA clearance to market the device in 2002. It was then that reports of deaths and injuries tied to the device moving and breaking steadily mounted, according to NBC News. A confidential study commissioned by C.R. Bard revealed that the Recovery filter had increased rates of relative risk for death, filter fracture, and movement when compared to its competitors. An outside doctor hired to conduct the study wrote that “further investigation … is urgently warranted.”

C.R. Bard opted against recalling the Recovery from the market and, in 2005, after the device had been sold for three years, Bard finally replaced the Recovery with a similar device, the G2 series of filters. Internal Bard records and hundreds of reports to the U.S. Food and Drug Administration (FDA) reveal that that the G2 series did not resolve the IVC device’s issues.

A confidential memo written in December 2005 by a Bard vice president after the G2 was cleared by the FDA reveals his concern about “problems with … migration,” “tilting,” and “perforation.” He noted that Bard had another filter on the market with virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he questioned. Another later document includes data through 2010 that reveals that the G2 series filters experienced even more fractures, migrations, and reported problems than any of its competitors, according to NBC News. The C.R. Bard G2 series filters remained on the market until 2010.

In 2010, a man underwent implantation with the Bard G2 Express due to his body’s propensity to develop blood clots. The patient, 69, asked his physician in October 2015 to check on how the filter was doing and learned it had moved. His physician told him that the Bard filter was “dangerously close to your heart,’” according to NBC News. Two surgeons declined to remove the filter given its precarious position. The patient asked Dr. Kuo, whose team developed an advanced technique to remove failed filters and filter pieces. During emergency surgery, Dr. Kuo found that three legs broke off the filter, traveling to the patient’s lungs. Dr. Kuo said that two partially broken legs completely broke away during the operation. One, he said, could have killed the patient. “It floated off right in front of our eyes,” said Dr. Kuo. “First into the right atrium and then into the right ventricle. He’s very lucky.”

Kuo told NBC News that, in the prior 10 years he has removed 1,000 failed filters and noted that he has removed more Bard filters than any other single make of filter. Dr. Kuo said that, the Recovery and G2 series filters should have been pulled from the market and that, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.” In addition with device companies, the FDA must take stronger action to protect patients. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” he said, according to NBC News.

What is an IVC Filter?

The FDA approved inferior vena cava (IVC) filters in 1979. The human body has large veins known as inferior vena cavas; these veins carry deoxygenated blood from the legs to the heart. The filters are “spider shaped” medical devices that look similar to a small cage, are approximately one-and-a-half-inches, are constructed of metal, and are inserted into the IVC. Once inserted, the filters are meant to capture blood clots that may travel to the heart, lungs, and brain.

IVC filters are typically prescribed for patients unable to take anticoagulants; when a patient is diagnosed with a recurrent pulmonary embolism (PE); a blood clot, especially a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); or if a patient suffered a significant accident or injury. Blood clots from the lower body may take place after knee or hip replacement surgeries.

For the most part, IVC filters are only meant to remain in the body on a temporary basis and should be removed when the threat of clots is over. Previously, some IVC filters were left in patients’ bodies permanently or for extended time periods, which may lead to life-threatening complications.

In 2010, the FDA warned that long-term use of IVC filters should be discontinued given risk of IVC filter damage, noted that IVC filters are intended as a temporary measure, and warned physicians to consider risks when discussing removal of these devices with their patients. The agency updated its warning in 2014, recommending that retrievable IVC filters be removed 29 – 54 days following implantation. Research shows that IVC filter risks outweigh their benefits when the filter remains in the body for more than two months. In one FDA warnings, it indicated that IVC implants may break in a patient’s body, potentially traveling through the bloodstream and into vital body areas with fragments potentially puncturing veins and organs. Pieces may become lodged in high-risk areas, according to NBC News.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

Herbal Coffee Recall After FDA Finds Viagra-like Ingredient

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The U.S. Food and Drug Administration announced mid-July that the Grand Prairie, Texas-based Bestherbs Coffee LLC, is voluntarily recalling all lots of the “New of Kopi Jantan Tradisional Natural Herbs Coffee” due to undeclared ingredients. The ingredients include desmethyl carbodenafil and milk, sold between July 2014 and June 2016, according to the Washington Post.

“Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction,” the FDA said in a statement, reports the Washington Post. The “undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels,” the FDA noted.

Potential Adverse Effects

“Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates,” said the FDA. The coffee also contains undeclared milk, the recall announcement stated. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product, reports CNN.

National law firm Parker Waichman LLP has extensive experience and success representing clients in product liability litigation. Our lawyers are actively reviewing potential lawsuits on behalf of individuals and are available to answer questions for anyone seeking information for a potential lawsuit.

No illnesses related to consumption of the coffee have been reported. People who have experienced problems that may be related to the product are advised to contact their physician or a healthcare provider.

The instant coffee was promoted as a male enhancement product and sold or distributed in 13-gram packages via individuals or online nationwide. The company is contacting customers by phone, the FDA said. Customers are asked to return the products to Bestherbs Coffee LLC for a full refund, according to CNN.

FDA Warning in 2016

The FDA advised the public in 2016, not to purchase a similar product, Stiff Bull Herbal Coffee, with undeclared desmethyl carbodenafil. In May, Caverlo National Herbal Coffee, a coffee containing undeclared ingredients, similar to those in erectile dysfunction drugs, was recalled. In its warning notices, FDA noted a growing trend of dietary supplements or conventional foods with undeclared medications and/or chemicals.

The producers of Stuff Bull Herbal Coffee claimed the coffee sellers mixed in desmethyl carbodenafil to cut down on high costs of the root. Ong Boon Kean, a senior researcher at the Forest Research Institute of Malaysia, told ABC, that Tongkat Ali can boost low testosterone and sperm count.

“These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being ‘all natural,’” the agency said. “FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.” However, in May, the recall of a similar product made by was linked to at least one death.

This will be the FDA’s latest recall involving coffee laced with other ingredients. Stiff Bull Herbal Coffee faced a similar recall in 2016, as did the sellers of Caverlo Natural Herbal Coffee in May.

In both cases, the sellers advertised the inclusion of Tongkat Ali, the root of a tree found in Malaysian rain forests and distilled to pill form, or concentrated and mixed with coffee or tea. In 2014, ABC News sent a reporter into the bush to scout for the root, which can only be extracted with tools to partially topple the tree. This makes the root particularly difficult to harvest for mass production. The producers of Stiff Bull Herbal Coffee claimed the coffee sellers mixed in desmethyl carbodenafil to cut down on high costs of the root.

Information Regarding a Coffee Fatality

CaverFlo advertised Natural Herbal Coffee as an “all-natural” sexual supplement in an instant coffee packet. It actually contained sildenafil and tadalafil, the active ingredients in Viagra and Cialis for men with erectile dysfunction, according to a laboratory analysis by the FDA.

One death was reported in an individual who drank the coffee. No further details were provided, but combining sildenafil or tadalafil with other medications may cause a sudden drop in blood pressure. These drugs interact with nitrates that are found in many medications for diabetes, high blood pressure, high cholesterol, or heart disease.

Some men with these health problems also have erectile dysfunction, so they turn to “all-natural” aphrodisiacs, believing them to be safe. The problem is that supplements may contain dangerous hidden ingredients that are not on the label, reports the Daily Hornet.

Legal Information and Advice Concerning Bestherbs Coffee Recall

If you or someone you know suffered adverse effects involving the use of Bestherbs Coffee, you may be eligible for compensation. Parker Waichman LLP personal injury lawyers offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

Popular Heartburn Drugs Linked to a Risk of Premature Death

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Among the best-selling drugs in the country are proton pump inhibitors (PPIs) with brand names including Nexium, Prevacid, and Prilosac. These acid blocking medications are among the best-selling drugs in the United States, with more than $10 billion spent annually giving the appearance that “half the country must suffer from acid reflux,” according to CBS2’s Dr. Max Gomez.

However, evidence keeps mounting that PPIs might increase the risk of premature death. There are some antacids that are not considered harmful such as Tums and Rolaids, according to Dr. Gomez. Also, older acid blockers, including Pepcid and Zantac are H-2 blockers and are not considered to have adverse effects.

National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation, including heartburn medications. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.

Acid Reflux

Two women with heartburn-like symptoms were interviewed. One patient said, “I couldn’t breathe. My ribs were hurting the cough was so hard and dry.” Another said, “I had shortness of breath. I was completely exhausted. I had terrible post-nasal drip.” Although both patients did not have typical heartburn symptoms, both women suffered from stomach acid reflux.

“Reflux actually comes in two forms: the heartburn people, the indigestion people, and those that have respiratory reflux, in which there’s asthma, allergies, chronic throat clearing, post-nasal drip,” Dr. Jamie Koufan, of the Voice Institute of New York, remarked.

Department of Veterans Affairs Study

Despite the symptoms the patients experienced, neither of the women wanted to take the popular and powerful acid-blocking PPIs. This was probably a positive thing, when considering a new study of patients in the Veterans Affairs system. Scientists conducting the study collected data from the U.S. Department of Veterans Affairs databases. There were 275,933 people who were prescribed a PPI and 73,355 who had been prescribed an H2 blocker. The study took place from October 2006 through September 2008. It was conducted by researchers at the Washington School of Medicine in St. Louis and published in the BMJ Journal (British Medical Journal) in June 2017.

The study tracked deaths for five years and researchers found a 25 percent increased risk of death in the patients who took PPI compared with those who took H2 blockers. This meant about one extra death for every 500 people taking PPIs for a year, reports CBS News.

“The results were very clear. We were startled by this,” said study author Dr. Ziyad Al-Aly. “However we sliced the data, analyzed it, there was always a consistent relationship between PPI use and risk of death.”

This most recent study from St. Louis indicated the need for monitoring and limiting the use of PPIs in some cases. “The results suggest excess risk of death among PPI users. Risk is also increased among those without gastrointestinal conditions and with prolonged duration of use. Limiting PPI use and duration to instances where it is medically indicated may be warranted,” according to the study.

The Veterans Affairs study is the latest of many linking PPIs to negative side effects including hip fractures, kidney disease, dementia, infections, and esophageal cancer, CBS News reports.

PPI Background

Over the past several years, the U.S. Food and Drug Administration (FDA) has issued numerous warnings concerning long-term use of PPIs. Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole), can have severe side effects, reports the New York Times. They “are not the benign drugs the public thinks they are,” according to Dr. Shoshana J. Herzig of Harvard Medical School.

Heartburn is what a person experiences when stomach acid splashes up and out of the stomach, according to WebMD. The term “heartburn” is sometimes used interchangeably with “acid reflux.” Stomach acid plays a vital role in the breakdown and the absorption of nutrients. It also kills bacteria and microbes, reports the Times. Daily use of acid-suppressing drugs such as PPIs over the long-term may disrupt these processes and make the users more susceptible to nutritional deficits and infections.

Alternatives to PPIs

Dr. Koufman’s program for alternative methods of acid reflux control and the avoidance of PPIs includes advising patients to basically change their diets and lifestyles. “We eat too late, we eat too much fatty food, we tend to overeat. You know, miss breakfast and lunch and eat huge dinner,” Dr. Koufman explained.

Dr. Gomez agrees that some patients really do need acid-blocking drugs. For those people, experts are beginning to lean toward H-2 blockers, which are not as potent and must be taken more often, but “have a 40-year safe history.”

Legal Information for Heartburn Medication Users

If you or someone you know has been injured by adverse effects of heartburn medications, you may be eligible for compensation. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

Recalls and Lawsuits Continue Over Metal-on-Metal Hip Devices

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Examples of Recent Recalls, Lawsuits, and Settlements

A number of device makers are having issues with their hip devices such as Accolade, Smith and Nephew, DePuy Orthopaedics, Zimmer Biomet, and Stryker. Over the past year, Stryker has been named as a defendant in another round of hip implant lawsuits. Also, its device, the LFIT Anatomic Cobalt-Chromium V40 Femoral Head, was recalled in October 2016 for the third time in five years. The device maker’s hip settlement expanded.

The latest Stryker lawsuit was filed in April 2017 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiffs, a couple, allege that injuries over failure of the implant in which the head of the stem was displaced and began to corrode. The plaintiffs are holding Stryker Orthopaedics responsible for failure to warn of the implant’s possible corrosion.

Another lawsuit was brought against Zimmer Biomet last spring. The plaintiff alleges that her Trilogy hip implant is defective and was unable to bond with her hip bone over an “improper pore size and/or porosity,” according to the lawsuit. The lawsuit was filed four years following implantation with the device. She underwent the surgery just prior to the device’s being recalled in June 2012. Federal Judge Wendy Beetlestone, in Pennsylvania, granted one strict liability claim to a plaintiff who brought a lawsuit against Stryker. The judge also allowed the plaintiff’s strict liability manufacturing defect, breach of warranty and loss of consortium claims to progress after Stryker’s motion to dismiss the plaintiff’s strict liability design defect and negligence claims.

According to The Legal Intelligencer, Judge Beetlestone ruled that the plaintiff’s allegations were sufficient to argue that the Stryker Gamma3 Nail System was defectively manufactured. The plaintiff was implanted with the device in March 2015. X-rays later revealed a broken nail in the implant. The plaintiff underwent a total hip replacement and suffered an infection following that surgery.

In another case, five patients implanted with metal-on-metal hips manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, were awarded $502 million. Because of a cap on punitive damages, the award was reduced to $150 million. According to Law360, the plaintiffs have complained to the Fifth Circuit that the cap is unconstitutional.

The nationwide attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip implant lawsuit.

New DePuy Orthopaedic Hip Implant Lawsuit

In May 2917, a new lawsuit was brought against DePuy Orthopaedics over its Pinnacle hip implant. The lawsuit was filed by a couple who alleged significant hip implant complications that required additional procedures to correct.

The plaintiff underwent a total right hip replacement on December 9, 2005, with a Pinnacle Device with an Ultamet liner. Soon after the procedure, the patient allegedly began experiencing severe pain, inflammation, and discomfort in the implant area. Testing revealed that the Pinnacle Device was experiencing wear and friction and was allegedly causing metal ions to be shed into the patient’s bloodstream, causing metallosis (blood metal poisoning), which compounded the damage in the area tissue and bone of the hip implant. The patient was left with no alternative but to undergo revision surgery on June 7, 2016, to explant and replace the Pinnacle Device. The woman chose to file her DePuy Pinnacle hip implant lawsuit after learning the manufacturing company may have been aware of potential complications tied to metal-on-metal hip implants.

As with other patients who opted for the DePuy Pinnacle device, the Pinnacle was recommended to the patient by her physician after reviewing the product’s packaging. All metal hip implants have been marketed to be overtly superior to ceramic and plastic models because of their durability and customizable features. The metal hip implants are particularly popular with younger orthopedic patients who live a more active lifestyle.

Metal-on-metal hip implants are composed of all metal components with no ceramic or plastic parts to prevent fretting. When the implant surfaces rub together, even during normal activities such as walking, the devices may release metal debris, leading to complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device.

Specifically, when the ball and socket joint of the metal device interact, nothing prevents metal ions from entering the patient’s bloodstream, which may ultimately lead to metallosis. This may impair the patient’s condition by potentially leading to infection, fretting, corrosion, tissue death, and the formation of pseudotumors. When this occurs, patients are generally forced to undergo revision surgery to explant the defective device and undergo implantation with a different device. Revision surgeries are considered risker, costlier, and more complex than the original surgeries and call for more intense and long physical therapy. In some cases, insurers do not cover revision surgeries. Despite the devastation to patients, DePuy allegedly failed to warn patients and physicians of these risks.

Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range-of-motion.

According to this DePuy Pinnacle hip implant lawsuit, the company either knew or should have known about the risks associated with its metal hip implants. At all times relevant, the woman involved in the lawsuit alleges that she only used the device for its intended purpose and did not deviate from medical instruction. She also noted that she would never have chosen the DePuy Pinnacle device if she had been aware of the potential complications associated with the DePuy Pinnacle metal hip. The woman’s husband joined her DePuy Pinnacle hip implant lawsuit with a claim for loss of consortium.

This DePuy Pinnacle Hip Implant Lawsuit is being heard in the U.S. District Court for the Northern District of Texas, Dallas Division.

Filing Defective Medical Device Lawsuit

If you or someone you know suffered injuries related to the use of defective medical device or device component, including metal-on-metal hip replacement device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman

Eliquis Focus of Mounting Lawsuits

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Plaintiffs Allege Drug Makers Misrepresented Eliquis Safety

Bristol-Myers Squibb Co. and Pfizer Inc. are the creators of the anticoagulant (blood thinner) Eliquis (apixaban). Eliquis has been found to cause irreversible bleeding events and the drug makers are accused of misrepresenting the safety of the treatment, according to three recent, lawsuits filed in New York state court and brought on behalf of patients who suffered significant blood loss after taking Eliquis, according to Law360.

The three plaintiffs allege that the drug maker and marketer misrepresented the risks of the Eliquis anticoagulant by hiding their knowledge of the treatment’s deficiencies, including a lack of a reversal agent for those patients who start bleeding after taking Eliquis, Law360 reported.

The complaint indicated that, “Upon information and belief, defendants concealed and failed to completely disclose their knowledge that Eliquis was associated with, or could cause, life-threatening bleeding in specific patient populations, and failed to fully identify and convey the risks of use of Eliquis at the same time as other blood-thinning agents, such as aspirin,” the complaint indicated.

The plaintiffs also allege that the U.S. Food and Drug Administration (FDA) approved Eliquis in 2012. Approval was largely based on a clinical trial entitled “Aristotle” that was allegedly conducted by “incompetent and untrustworthy” parties in China in which certain side effects, a death, loss of subjects to follow up, dispensing errors, poor quality control, and falsified records were hidden, wrote Law360.

When Bristol-Myers Squibb Co. and Pfizer Inc. began to market Eliquis in the United States, its label did not disclose the lack of a reversal agent that competing treatments such as Coumadin (warfarin) have, according to the filing. Yet, the drug makers proceeded with an “aggressive marketing campaign” for the treatment, claiming that, unlike Coumadin, patients taking Eliquis do not require blood level monitoring, do not need to limit their diets, and would be able to take a set dose of the Eliquis treatment, according to the complaint, according to Law360.

“In the course of these direct-to-consumer advertisements, defendants overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Eliquis, and that such irreversibility would have life-threatening and fatal consequences,” the filing further alleged.

Even after the drug makers became aware of “serious hemorrhaging” in patients, they did not publicize the complete details of the Aristotle study, the patients allege. The patients seek compensatory, economic, and punitive damages; prejudgment and post-judgment interest; and costs. The cases are being heard in the Supreme Court of the State of New York, County of New York.

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving alleged drug injuries, including excessive, deadly bleeding associated with Eliquis. The firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.

Prior Eliquis Lawsuits Filed

In September 2016, another Eliquis uncontrollable bleeding lawsuit was filed in the Superior Court of the State of California, County of San Diego. The lawsuit was brought by a couple who allege that the Eliquis drug makers and marketers did not warn consumers and the medical community of the adverse bleeding effects associated with Eliquis. The plaintiffs also alleged that taking Eliquis caused uncontrollable, near-fatal bleeding.

The lawsuit also includes allegations that the wife was prescribed Eliquis to treat her atrial fibrillation, a condition caused by an abnormal heart rhythm. Atrial fibrillation may lead to an increased risk of blood clots and related injuries, including stroke. Eliquis was meant to minimize the risk of blood clot injuries; however, the woman suffered internal bleeding complications.

The woman and her physician reviewed various anticoagulants to treat her condition and chose Eliquis based on the marketing materials presented by Pfizer and Bristol-Myers Squibb. Eliquis is one of the new-generation anticoagulants meant to compete against warfarin, which is sold under the brand, Coumadin, the original blood thinner. Warfarin has been on the market for decades and requires routine and ongoing blood monitoring and dietary restrictions. Patients who take Eliquis or other newer anticoagulants do not have these limitations; however, they present different risks because there is no antidote to stop bleeding events.

Anticoagulants are prescribed to reduce the risk of a life-threatening blood clot; however, the mechanism that reduces life-threatening blood counts may also lead to risks that the blood will not clot when necessary.

A prior lawsuit was filed over allegations that Eliquis led fatal hemorrhaging. The wrongful death lawsuit was filed against Pfizer and Bristol-Myers Squibb alleging that Eliquis was to blame for a Mississippi man’s fatal injuries. The lawsuit was filed on behalf of the man’s surviving spouse. The plaintiff’s husband began taking Eliquis in June 2015 to treat his atrial fibrillation. The lawsuit alleges that the drug makers neglected to warn about the lack of an antidote for Eliquis and the risk of uncontrollable bleeding.

According to lawsuit allegations, the plaintiff’s husband suffered from internal bleeding less than three months after starting Eliquis; he died in September 2015. The plaintiff alleges that these injuries were caused by Eliquis and that Pfizer and Bristol-Myers Squibb were aware of the risks, but continued to sell the medication and failed to warn consumers.

Eliquis is among a newer generation of anticoagulants that include Pradaxa and Xarelto. When these drugs were released, according to the lawsuit, they were marketed as being far superior to warfarin as they do not require blood monitoring or dietary restrictions.

Anticoagulants reduce the risk of life-threatening blood clots, but that may also mean that it is more difficult for blood to clot when necessary. One of the most important aspects of drug safety is assessing a drugs risks versus its benefits. When doctors prescribe a drug to a patient, they need to have all current information to help make the best decision for their patients. The lawsuit alleges that Eliquis did not adequately warn about the lack of an antidote for Eliquis, meaning there is no way to stop the bleeding once it starts. Warfarin, on the other hand, may be reversed with vitamin K. The Cleveland Clinic Journal of Medicine published an article placing Pradaxa, Xarelto, and Eliquis in the same risk category, writing that doctors had serious difficulty managing bleeding that occurs in patients taking these drugs.

Questions about Filing an Eliquis Drug injury Lawsuit

If you or someone you know is interested in filing a lawsuit involving serious bleeding injury or death associated Eliquis. Parker Waichman LLP offers free, no-obligation case evaluations. For more information call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman