Xarelto Bleeding Injury Help

Xarelto-Lawyer

Xarelto is a specific type of Factor Xa inhibitor anticoagulant that has been on the market since the U.S. Food and Drug Administration (FDA) approved its use in 2011.  The pharmaceutical company Bayer created the medication, and licensed the right to manufacture and market it to Johnson and Johnson affiliate Janssen.

Besides arthroplasty patients, Xarelto is prescribed to atrial fibrillation patients to help prevent strokes and other dangerous events that might result from blood clots, such as pulmonary embolism and heart attacks.

Unfortunately, Xarelto can at the same time produce a risk of serious internal bleeding, including hemorrhagic stroke, brain hemorrhage, and gastrointestinal bleeding.  Some have referred to these injuries as an Xarelto Bleeding Injury.

In 2014, the U.S. FDA approved additional language for Xarelto’s package labeling to warn about some but not all of the risks of bleeding events, including discouraging use of the drug in some kidney patients, pregnant women, nursing mothers, and patients with heart valves.  However, the label does not warn about wound infection risks or the lack of an antidote in the event of a hemorrhage.

To discuss a Xarelto Bleeding injury or other event, please call us at (800) 632-1404 or chat with us today.

TigerPaw Bleeding Injury Help

tigerpaw-system

 

As we previously mentioned, the FDA classified a recent recall of the TigerPaw System II medical device a class I recall.  This recall was issued due to potential TigerPaw Bleeding Injury and TigerPaw Tearing Injury to patients. The recall affects 4,154 devices distributed in the United States and is related to the possibility of incomplete closure of the device.

The TigerPaw System II was approved by the FD in May 2011 for occlusion of the left artrial appendage.  it is intended to be used in cases of left atrial appendage occlusion when the doctor can directly see the heart without the use of a camera or other devices. When implanted during heart surgery, the TigerPaw System II was indicated to seal the left atrial appendage (LAA), a small sac located in the top left chamber of the heart. The device’s intended purposes was to bind itself to this small sac so that blood could not collect in this area and form clots.

LAAx, Inc. began distributing the device in May 2013.

We would welcome the chance to discuss any questions you may have about your TigerPaw Bleeding Injury or other questions at (800) 632-1404.

 

 

TigerPaw System II Recall Injury Help

tigerpaw-system

Our firm is looking into the dangers of using the TigerPaw System II during occlusion of the heart’s left arterial appendage, a procedure that is at times performed in patients with atrial fibrillation to prevent blood clots from collecting and traveling to other parts of the body.

The U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database contains reports on injuries sustained by persons and failures of this medical device, which received 510(k) approval by the manufacturer, LAAx, Inc.

Injuries include tearing of cardiac tissue and/or patient bleeding.

On March 25, 2015, LAAx, Inc. issued a voluntary recall of the TigerPaw System II.  The FDA then, on April 23, 2015, classified this event as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.  Worth noting, the FDA Recall Notice states that the TigerPaw II system may cause tears and bleeding.  If you would like more information about the TigerPaw System II Recall, please contact us today.

There have been at least fifty one (51) adverse events and one death.

We would welcome the chance to discuss this event with you at (800) 632-1404 today.

Mirena Uterus Perforation Claims Dominate MDL Proceeding

Mirena Lawyer

A large number of Mirena lawsuits filed against Bayer claim serious injuries, including Mirena uterus perforation, associated with the IUD migration. The product labeling only informs of the minuscule risk of potential “uterine perforation at the time of insertion.” However, post-marketing surveys and product liability litigations confirm that the problem is much more common and Mirena uterus perforation takes place months or even years after the IUD implanted. Design defect in the T-shaped plastic intrauterine birth control device facilitates its displacement from the inserted site and migration, a subject of rampant complaint, resulting in complete or partial uterus damage, surgeries, adhesion, scarring, infertility, and harm to internal organs.

Mirena Uterus Perforation claims

Of about 1,200 Mirena lawsuits consolidated under the federal MDL rules at a New York southern district court and over 2,000 under the New Jersey state MCL centralization, the highest number of claims are linked to IUD migration and perforation. Women injured by the device migration highlight that the IUD spontaneously dislodge, moves through uterine organs, and gets embedded in the pelvic cavity leading to pain, injuries, and surgical removal. Reproductive organs, such uterus and fallopian tube, due to their proximity, are injured, sometimes beyond repair, as the IUD gets struck in or perforate them. At least 2,000 women were forced to remove the damaged uterus as the device perforated them beyond the repair while more than double of that number were advised against pregnancy, as the uterus is injured significantly by the migrating Mirena.

More than two-dozen Californian women filed a lawsuit in 2014 claiming that they had uterus removal surgery following Mirena perforation. Lawsuits seek manufacturer’s liability for manufacturing defect and “marketing the IUD without sufficiently warning of potential risks and complications.”

Mirena perforation forced hundreds of women to opt for surgical removal of the IUD and undergo additional surgeries, including hysterectomy, appendectomy, and pelvic surgery. There are instances where women have been surgically induced menopause following vaginal hemorrhage caused by Mirena perforation. The Society of Laparoendoscopic Surgeons has acknowledged the problem and informed its members about the effects.

Second Mirena MDL Bellwether Trial

Mirena MDL Judge Cathy Seibel has selected five lawsuits in July to have a second round of bellwether trial. The submission of case specific reports this set of claims is expected to over by February 2016. Judge Siebel may decide on the trial date within a month. The MDL was established in April 2013 to cater to the surge in Mirena injury litigations. In August 2014, the Initial Disposition Pool was created with 12 litigations. The first Mirena bellwether trial involving six lawsuits is set for March 7, 2016. Court Judge Brian Matinotti heading the New Jersey Mirena MCL has also in the disposition pool and set in place the motion selection for the second bellwether trial.

Bellwether trials are expected to guide lawyers and claimants on potential evidence, defendant disposition, and juror response to accusations in the Mirena mass litigation. Potential decisions against Bayer may trigger settlement negotiations with plaintiffs.

Kentucky Court Accepts Strict Liability, Misrepresentation Claim

An August 7 order issued by a Kentucky federal court allowed the strict liability and negligent misrepresentation claim of a woman injured by Mirena IUD. The plaintiff had severe headaches and vision loss within six months of using the contraceptive device. She also had permanent injuries associated with the IUD side effects.

The court ruled that “an injured party can advance both a strict-liability claim and a negligence claim against the manufacturer of a product for injury suffered by that product because the strict liability claim focuses on the condition of the product, while the negligence action addresses the manufacturer’s duties to end-users.”

If you have or any of your relatives has experienced IUD injuries, including uterus perforation, contact our Mirena injury lawyer or call on 1-800-632-1404 to explore options to get financial compensation for physical suffering, trauma, economic losses, and non-economic damages.

Personal Liability on a Commercial Agreement in Tennessee

Tennessee business litigation attorneys

A recent case of MLG Enterprises LLC v. Johnson in the Middle Section of the Tennessee Court of Appeals discussed whether a representative who signs a commercial contract can be bound individually by the agreement.

In most cases, a representative who signs a contract is not personally bound to the contract. See Dominion Bank of Middle Tenn. v. Crane, 843 S.W.2d 14, 19 (Tenn. Ct. App. 1992); Anderson v. Davis, 234 S.W.2d 368, 369-70 (Tenn. Ct. App. 1950). However, a corporate representative who signs a contract may be personally bound “when the clear intent of the contract is to bind the representative.” 84 Lumber Co., 356 S.W.3d at 382-83 (emphasis added). “A cardinal rule of contractual interpretation is to ascertain and give effect to the intent of the parties.” Allmand v. Pavletic, 292 S.W.3d 618, 630 (Tenn. 2009). The clear intent of the parties “must be determined from the contract itself.” Lazarov v. Klyce, 255 S.W.2d 11, 14 (Tenn. 1953); see 84 Lumber, 356 S.W.3d at 383.

A party‟s signature is presumed to be in a representative capacity, as distinguished from a personal obligation, if it is preceded by the corporation‟s name and the words “by” or “per” and followed by the officer‟s title. See Creekside Partners, 2013 WL 139573, at *3; Cone Oil, 669 S.W.2d at 664; see also Bill Walker & Associates, Inc. v. Parrish, 770 S.W.2d 764, 770 (Tenn. Ct. App. 1989) (“A corporate officer‟s signature, preceded by the corporation‟s name and followed by words denoting the officer‟s representative capacity, binds only the corporation.”); Anderson, 234 S.W.2d at 369 (“A correct form of signature which is uniformly regarded as imposing no personal liability upon the officer signing is that of a signature containing the corporate name, followed by the word „per‟ or „by‟, which, in turn, is followed by the name of a corporation officer.”). Moreover, a party also clearly indicates his or her intent to sign in a representative capacity when the signature is followed by his or her title, the word “for” and the name of the corporation. See Cone Oil, 669 S.W.2d at 665 (“The use of the work [sic], „for‟, is as clearly indicative of intent as the words „by‟ or „per‟.”). However, without the word “for” or similar language, corporate designations that follow a party‟s signature simply describe the person who signed without altering the capacity in which she signed. Id. (quoting 17-A C.J.S., Contracts, § 347, p. 341).

In one case (84 Lumber), the Supreme Court held that the parties intended to hold the defendant personally liable based on a guaranty provision that was written in capital letters and set off from the rest of the contract. 84 Lumber, 356 S.W.3d at 381-82. Subsequently, this court decided another case that involved a guaranty provision. Creekside Partners, 2013 WL 139573, at *5. In that case, this court determined that the defendant was not personally liable because the guaranty provision in question was not written in capital letters, indented, or otherwise distinct from the rest of the contract. See id. at *5-6.

Arkansas Testosterone Injury Lawyer Discusses Liability of Low-T Drug Makers for Heart Attack Side Effects

Low T

Thousands of upset men and their families look forward to October 2016 when the first testosterone lawsuit will be tried as a bellwether trial. They feel cheated by the makers of androgel, androderm, and similar low-T supplement makers who sold them “the fountain of youth” only to harm them. Our Arkansas testosterone injury lawyer is currently evaluating fact patterns where plaintiffs had strokes, heart attacks, and even paralysis within months of taking these patches, gels, and injections containing the androgenic hormone.

A majority of the more than 2,000 testosterone heart attack lawsuits are against seven manufacturers, who account for about 90 percent of the $2 billion “disease sold” to consumers every year. The direct promo pitch for testosterone replacement without informing its side effects promises to restore youthful energy and overturn a sagging libido in men unsure of hypogonadism, the disease treated with these drugs. Misinformation is even forcing healthy middle-aged men to reverse normal aging effects. Those swayed by these disease mongering ads suffered from blood clots, heart attacks, and arterial blockages to death.

Cheated, Harmed by Low-T Makers

Daniel Weber, a 44-year-old resident from Fort Smith, Arkansas, took to Low-T supplements after TV ads forced him to think that he had testosterone deficiency. The promos never divulged that the drugs are only for those with hypigonadism and not for age-related decrease in the sex hormone.  The ads neglected to mention the drugs could have side effects. His Arkansas testosterone injury lawyer claims that he had a stroke after having the low-T gel therapy for about seven months. He became partially paralyzed and diagnosed with lung embolism.

The low-T lawsuit filed by this Arkansas resident blames Androgel, the supplement he used to improve testosterone levels, for his condition. In March this year, the FDA announced changes to the drug label to include warning about potential thromboembolic events, clots, and strokes in those using testosterone supplements. There are countless stories telling heart attack side effects linked to low-T injections, gels, patches and other forms of supplements.

Studies Negate Low-T Supplement Makers, Warns Side Effects

A recent finding reported in the Journal of the American Medical Association negates the manufacturer’s claim of restoration of youthful vigor and sexual appetite following testosterone replacement therapy. Researchers discovered no assured “improvement in overall sexual function, partner intimacy, and health-related quality of life” after these supplements are used. This may leave many users to face only heart attack risks without any benefit. A 2013 report in the same journal was scathing in its attack on supplement makers for their unethical promotional campaign that misled healthy men on diseases treated with these drugs.

Multiple studies reported in the last two years warned about a clear increase in the risk of cardiac problems and death in older men treated with low-T drugs.

FDA Needs Assurance on Safety

Low-T supplements have been on the market since the 1950s, but the market started expanding manifold in the 2000s. AbbVie, the maker of Androgel, reported about four million users of low-T products in 2000. The numbers grew five times in 2003 and over 25 times by 2014. One of the litigants claims that “the number of men with the conditions for which AndroGel is indicated, which are believed to be substantially smaller” and the most of the users are driven by lifestyle purposes. And the reason? AbbVie had spent close to $150 million in promotions in 2012 and 2013.

The March 2015 warning by the FDA acknowledged side effects that many plaintiffs and consumer groups have been complaining of for years. In August, the New England Journal of Medicine published a research report prepared by the FDA’s Office of Drug Evaluation. The report expressed concerns over abuse of low-T supplements by men without “classic hypogonadism” symptoms and called for more safety trials. The agency also issued a statement after reviewing several complaints and findings. “Testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging and the benefits and safety of this use have not been established,” reads the statement.

The FDA also acknowledges that at least 28% of users take the supplements without any testing. “Given these patters of use, it appears that a majority of men prescribed testosterone may have age-related hypogonadism rather than classic hypogonadism and the findings is troubling in light of evidence from recent large observational studies that suggests potential cardiovascular risk associated with testosterone use,” it observed.

Contact us or call on 1-800-632-1404 for evaluation of your potential low-T lawsuit claim by our Arkansas testosterone injury lawyer.

Essure Attorney Reports on Study Results

Essure Attorney

As an Essure Attorney, I wanted to spend a minute posting on some research studies on the Essure device for our readers.

In April 2015, the Journal of Minimally Invasive Gynecology published a long-term monitoring report based on larger trials involving Essuer birth control device. The data, though, pertains to monitoring of volunteers between 2002 and 2007, it was not published eight years. Of 518 volunteers, only 366 were monitored for full five years. Among them, 38 percent suffered from menstrual bleedings, 5 percent experienced pelvic pain, about 7 percent had painful menstruation, and 4 percent complained of pain during sex. Fifteen women had hysterectomies.

The FDA has received at least 5,000 Essure injury complaints, including four deaths and dozens of fallopian tube or uterus perforation reports. A citizens’ petition presented to the regulator, highlights 16,047 adverse events associated with the transcervical birth control device reported to Conceptus, the original manufacturer and now part of Bayer, between 2011 and 2013.

A Florida woman, through her Essure attorney, has sued Bayer citing negligence and misrepresentation. Five more lawsuits are pending in a Pennsylvania federal court claiming that manufacturers “breached warranty and committed fraud during the clinical trials to get the device approved by the FDA.”

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and seek compensation and damages for suffering from complications associated with the birth control device.

Essure Injury: Expect Many Injury Lawsuits To Be Filed

Essure Attorney

 

The fear of Essure injury was not even in the slightest imagination of Angie Firmalino when she had the birth control device implanted in 2009. Like many, the mother of four believed in the promotion of the transcervical device as a breakthrough sterilization option completed in just 10 minutes. However, the results were something unexpected and now 42, the New York mother shivers to recollect her painful experience.

After having the Essure birth control, Angie suffered from severe pain and bleeding for two years. Diagnosis revealed that the transcervical birth control had broken apart and embedded in her uterus. The injury and complications forced her to undergo multiple surgeries, including surgical removal of the uterus.

“If I had any idea of the possible consequences of Essure, I would never have chosen it,” says Angie, who now has to take daily dosages of ibuprofen to prevent the pain from impacting her activities. She now runs a Facebook page “Essure Problems” that has more than 19,900 members and become a popular medium of “posting pictures and sharing nightmare stories about Essure side-effects.”

Essure, a metal and polyester coil, is inserted into the fallopian tubes through the vagina. Made of “polyethylene terephthalate and nickel titanium alloy,” the coil causes inflammation and formation of scar tissues that block the entry of sperms to the fallopian tube. It had a fast-track FDA approval in 2002. However, the horrific stories of injuries after 13 years put a serious question on its safety aspects.

Trial Data Reveals Essure Injury Risk

Essure injury side effects were found during the early in clinical trials. A Cleveland woman, one of the volunteers selected for human trial, filed an Essure lawsuit seeking $1 million in damages. The plaintiff suffered from hip and joint pain, fatigue, migraine, and painful menstrual periods after using the birth control device. Another volunteer had surgery to stop menstrual bleeding.

The Human Reproduction journal reported in 2003 that nine of about 250 women suffered of fallopian tube perforation and a few others had device migration issues during a safety trial. One in every 10 complained of pain during sexual intercourse. Eight volunteers reported painful menstrual periods.

In another trial, 21 of 449 volunteers suffered from reproductive organ perforation. Surgeries performed on eight to remove the displaced device. Many other had abdominal pain and painful sexual intercourse. In 2002, the FDA approved Essure on the condition that “investigators monitor volunteers for four years.” However, only 171 women were monitored for five years and others were abandoned after the first two years.

A report by the FDA acknowledges that at least five women volunteers underwent hysterectomies after the birth control trial while 270 had adverse events, including painful menstrual.

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and seek compensation and damages for suffering from complications associated with the birth control device.

 

Court Rejects Bayer’s Objection, Allows Delayed Mirena Lawsuit

Mirena Lawyer

Amid calls to withdraw the Mirena IUD from market in the face of risks the birth control device could cause, Mirena lawsuit counts continue to grow. The IUD contraceptive once a favorite of women across all ages is now in the thick of controversy for complaints of migration and surgical injury associated with it.

Mirena Lawsuit Not Dismissed

A recent Mirena lawsuit filed in a Minnesota federal court highlights how a 26-year-old woman suffered uterus damage and other complications even after the IUD was removed. In another instance, a New Mexico court allowed a Mirena migration and perforation claim to proceed despite delayed filing considering the gravity of the case.

Judge William P. Lynch of New Mexico overruled Bayer’s objection highlighting delayed submission of notice to allow plaintiff Melissa Beauprez to proceed with her Mirena lawsuit. The court acknowledged “a certain sloppiness and inattention to detail” on the part of the Mirena attorney representing the plaintiff, but refused to dismiss the claim.

Melissa had a Mirena IUD implant in 2009. She went for removal after having persistent back pain and other symptoms for two years. According to her Mirena lawyer, X-ray and CT scans revealed that she was a victim of IUD migration and doctors performed an invasive surgery to remove the device embedded in her abdomen. The Mirena lawsuit seeks strict liability citing “defective product, failure to warn consumers, concealment of information, breach of implied warranty, and fraudulent practice.”

The litigation was first filed by Beauprez’s Mirena attorney in July 2014 without complying with the procedure of “serving a copy of the claim notice to IUD manufacturer Bayer.” The court ordered the plaintiff to provide the defendant a copy of the notice “no later than Dec. 17, 2014, Plaintiff must either effect service or provide the Court with a written explanation why service has not been effected.” But technical problems resulted in the notice reaching to Bayer five days later on December 22.

The defendant made the delay an issue and sought the dismissal of the Mirena lawsuit. However, the court ruled over the objection and accepted the contention of plaintiff’s Mirena lawyer that there was no deliberate delay in serving the notice and it was due miscommunication between him and another out-of-state attorney.

CDC Report Confirms Mirena Pregnancy Complication Risk

According to a recent report by the U.S. Centers for Disease Control, women getting pregnant while using Mirena IUD face the enhanced risk of abortion and other complications. This makes it hard a choice for women who accidentally become pregnant as the birth control device slips away and migrates. If they go for surgical removal of the displaced IUD, the injury and complication risks are high. If they do not, they face equally danger of suffering from abortion and other serious complications.

The report cites the potential risk of septic abortion, pre-term delivery, and serious infections, such as chorioamnionitis, in women becoming pregnant following Mirena migration. Prepared by the Reproductive Health Division, it warns that presence of the device may expose the fetus to synthetic hormones and 80 percent such pregnancies end up in abortions. There are many Mirena lawsuits filed claiming fetal death, miscarriages, and ectopic pregnancy.

However, a 2013 report in the American Journal of Obstetrics and Gynecology cited the risk of complications endangering both mother and child when a Mirena removal surgery is performed on a pregnant woman. There are also instances where strings could not be located and no removal surgery was performed.

A Mirena lawsuit filed by an Alabama couple a few months ago demonstrated how a pregnancy with Mirena IUD inside could cause havoc. The displacement of the T-shaped IUD led to the accidental pregnancy and the mother did not undergo the removal surgery for fear of fatal risk to both mother and the fetus and also the strings were not there. The newborn child had “preterm delivery, right-sided diaphragmatic hernia, pulmonary hypertension, degenerated right pulmonary artery, a large patent ductus-arteriosis (PDA), and persistent fetal oxygenation” attributed to exposure to artificial hormone released by the IUD. The baby died within 36 hours.

Contact Our Mirena Attorney Today

If you have or any of your relatives has experienced IUD injuries, including uterus perforation, contact our Mirena injury lawyer or call on 1-800-632-1404 to explore options to get financial compensation for physical suffering, trauma, economic losses, and non-economic damages.

A History of Tennessee Medical Malpractice Changes Since 2008

Memphis Medical Malpractice

There have been a number of changes to Tennessee Medical Malpractice law since the initial tort reform efforts began in 2008.  Here is an update:

2008 Amendment to Tennessee Medical Malpractice Act

In 2008, the Tennessee Medical Malpractice Act was amended, introducing new requirements into medical malpractice litigation. See Act of April 24, 2008, ch. 919, 2008 Tenn. Pub. Acts 434; see generally Rebecca C. Blair, Med-Mal Obstacles, 44 Tenn. B.J. 14 (2008). The 2008 amendment required a party initiating a medical malpractice claim to give sixty days‟ pre-suit notice to the implicated health care providers. See Tenn. Code Ann. § 29-26-121(a)(1) (Supp. 2008). Furthermore, the amendment contained a certificate-of-good-faith provision requiring a plaintiff filing a medical malpractice action, in which expert testimony was required, to file a certificate of good faith within ninety days of the filing of the initial complaint. Id. § 29-26-122. This certificate served to confirm that one or more experts had been consulted and provided a signed written statement of their belief that there was a good faith basis for filing the complaint. Id.

2009 Amendment to Tennessee Medical Malpractice Act

One year later, in 2009, the Act was again amended to clarify these new requirements. See Act of June 4, 2009, ch. 425, 2009 Tenn. Pub. Acts 472; see generally John A. Day, Med Mal Makeover: 2009 Act Improves on „08, 45 Tenn. B.J. 14 (2009). Tennessee Code Annotated section 29-26-121(a)(1) was amended to require that pre-suit notice only be given to persons or entities named as defendants in the action, see Tenn. Code Ann. § 29-26-121(a)(1) (Supp. 2009), and section 121(a)(2) was amended to specify what information was required to be included in the pre-suit notice. See id. § 29-26- 121(a)(2). Additionally, Tennessee Code Annotated section 29-26-122 was amended to require the filing of the certificate of good faith with the complaint instead of within ninety days after its filing. See id. § 29-26-122.

2011 Amendment to Tennessee Medical Malpractice Act

The Legislature then passed the Tennessee Civil Justice Act of 2011, further amending the Tennessee Medical Malpractice Act. See Tennessee Civil Justice Act of 2011, ch. 510, 2011 Tenn. Pub Acts 1505 (codified at Tenn. Code Ann. § 29-26-101 et seq. (Supp. 2011)). Notably, the Tennessee Civil Justice Act of 2011 amended the existing Tennessee Medical Malpractice Act by removing all references to “medical malpractice” from the Tennessee Code and replacing them with “health care liability” or “health care liability action” as applicable. See id. Furthermore, section 29-26-101 was added to the Code which defined “health care liability action” as “any civil action, including claims against the state or a political subdivision thereof, alleging that a health care provider or providers have caused an injury related to the provision of, or failure to provide, health care services to a person, regardless of the theory of liability on which the action is based.” Tenn. Code Ann. 29-26-101(a)(1) (Supp. 2011) (emphasis added). This same section went on to provide that “[a]ny such civil action or claim is subject to the provisions of this part regardless of any other claims, causes of action, or theories of liability alleged in the complaint.” Id. § 29-26-101(c).

For help with a Memphis, Tennessee Medical Malpractice case evaluation, please call us today at (800) 632-1404.