Articles Posted in Defective Drugs

In Cosmetic Procedures Clinic of North Dallas v. Ayub the Dallas Court of Appeal held that claims arising out of lazer hair removal are not healthcare liability claims governed by Texas Civil Practices and Remedies Code, Chapter 74. As non-healthcare liability claims these claims are not subject to the onerous expert report requirement designed to make many legitimate medical claims cost prohibitive.

Chapter 74 defines a healthcare liability claim as a claim (1) against a health care provider or physician (2) for treatment, lack of treatment, or other claimed departure from accepted standards of medical care, or health care, or safety or professional or administrative services directly related to health care, (3) which proximately results in injury to or death of a claimant, whether the claimant’s claim or cause of action sounds in tort or contract. Chapter 74 has been so broadly applied that even janitorial services in hospitals and the actions of the delivery services that transport patients to and from medical appointments have been held to be subject to its’ requirements. Indeed, the joke in Texas is that anything that happens in sight of a hospital would probably be held to be protected healthcare under Chapter 74.

The Ayub decision is a refreshing application of common sense that has been largely missing in the interpretation of Chapter 74. The Court reasoned that lazer hair removal did not pertain to any medical condition, was not performed by one licensed to render medical care by the State of Texas, and does not constitute medical treatment under the terms of Chapter 74.

The original Medicare statute, 42 U.S.C. 1395, contains no provisions for a Medicare set aside in liability cases. The original statute provided for a set aside in worker’s compensation cases and those provisions have been extended by policy but not by regulation to liability cases. The CMS website has memos which shed light on the CMS expectations regarding Liability Medicare Set Asides (LMSA) but these memos technically have only the power of persuasion.

The Big R Towing case blessed the establishment of a LMSA. The Schexnayder case held that CMS approval of a LMSA is not required. The Guidry case in 2011 again approved a LMSA proposal. The United States Supreme Court in Chevron, 467 U.S. 837 (1984), set forth the analysis for determining whether an agency policy is enforceable. To be enforceable Congress must have spoken clearly on the issue or the agency’s position must be a reasonable interpretation of the statute.

The Medicare statute is silent as to LMSAs and Congress has not otherwise addressed LMSAs. The MSP Act is at best vague and ambiguous regarding the issue of LMSAs. Medicare has not me the Chevron test. In Christensen v. Harris County, 529 U.S. 576 (2000), the United States Supreme Court held that internal agency interpretations and memorandums have the power of persuasion only. Nonetheless, the prudent practitioner would be well advised to thoroughly document their file including showing the factors considered in determining if a LMSA is appropriate and preparing an allocation showing the amounts allocated to each element of damages.

The Food and Drug Administration(FDA) has determined that a group of anti-depressants used to treat depression, anxiety and mood disorders, known as Selective Serotonin Reuptake Inhibitors, or SSRIs, can cause serious birth defects or even death when taken by certain pregnant women. The group of anti-depressants that causes birth defects includes Celexa, Fluvoxamine, Lexapro, Paxil, Prozac, Symbyax and Zoloft.

The most common birth defect is Neonatal Persistent Pulmonary Hypertension. Studies have repeatedly shown that pregnant women who took these SSRIs after the 20th week of pregnancy were six times more likely to have a baby with Neonatal Persistent Pulmonary Hypertension.

Other less likely birth defects caused by SSRIs include atrial septal defects(ASD), ventricular sepatal defects(VSD), tetralogy of fallot, heart valve defects, hypoplastic left heart syndrome(HLHS), cardiomyopathy, and patent ductus arteriosus(PDA).

Avandia is the marketing name of the drug Rosiglitazone patented by the pharmaceutical company GlaxoSmithKline as a drug for the treatment of Type II diabetes. Avandia’s side effects are so severe that the Food and Drug Administration (FDA) requires that the drug be accompanied by a “black box” warning advising that Avandia may cause fluid retention which could result in congestive heart failure. The lesser severe, but nonetheless well known, side effects of Avandia include large weight gain in a short period of time, shortness of breath, swollen feet, lower legs, ankles, arms, or hands, dry cough, and fatigue. Studies have shown that Avandia causes a 43% increase in the risk of heart attack, a 27% increase in the risk of stroke, an increased risk of bone fractures in females, and an increase in macular edema which causes retinal damage and partial blindness.

Avandia’s side effects have lead to over 13,000 lawsuits against GlaxoSmithKline (GSK). GSK has reached settlement agreements in more than 10,000 of the lawsuits and has agreed to pay more than $500 million dollars in damages. Although Avandia has been withdrawn from the market in New Zealand and has been widely criticized in European countries a 2007 FDA Advisory Panel decided to leave Avandia on the American market.

With the FDA turning a blind eye to the dangers of Avandia users who have suffered complication have little choice but to turn to litigation. For more information about Avandia litigation contact a Tyler Defective Drugs Attorney today.

Accutane is a very potent medication originally intended to treat severe cases of acne. Accutane is a synthetic vitamin A which in simple terms works by causing a reduction in the production of oil in the skin. Accutane was very successful in controlling severe acne with the result that it began to be increasingly prescribed for less severe cases. Unfortunately, the benefits of Accutane come with a whole host of serious side effects including depression, hearing loss, stroke, suicidal thoughts, seizures, heart attack, inflammatory bowel disease, hair loss, cataracts, and serious birth defects. Accutane side effects are so severe that the Food and Drug Administration required its “black box” warning to be included on the label.

The list of Accutane side effects continues to grow. Because of the difficulty of bringing a lawsuit against a drug manufacturer for clearly disclosed and adequately emphasized side effects those claimants who have been most successful are those who took Accutane before the manufacturer issued warnings about the side effects which they experienced. Acutane users who experience serious side effects would be well advised to seek legal counsel. Accutane lawsuit verdicts have been in varying amounts up to $25,000,000.00.

For more information contact a Tyler Defective Drug Lawyer today.

Reglan is the marketing name for metoclopramide, a drug used to treat a variety of conditions but best known for its use to treat gastroesophageal reflux disease (GERD) symptoms such as the heartburn and ulcers which result from GERD. Because of it’s many complications and side effects Reglan is a secondary treatment for the symptoms and is used in situations in which primary treatments were unsuccessful. In simple terms, Reglan works by accelerating the flow of food through the digestive tract and thus reducing the time and opportunities for complications.

The disclosed Reglan side effects are far too numerous to list and discuss. The list of side effects is so exhaustive that it leads the ordinary user to believe the side effects have been exaggerated. However, notoriously absent from the disclosed side effects is the most serious known side effect, tardive dyskinesia. Tardive dyskinesia is a movement disorder which commonly involves the uncontrollable movement of the facial muscles. These uncontrollable facial movements include jaw clenching, chewing motions, lip puckering, grimacing, eyelid movements, and squinting. Reglan can also cause uncontrollable body movements to other parts of the body.

Reglan related movement disorders are usually associated with the use of Reglan over extended periods of time and are often permanent. Patients would be well advised to consider less risky alternatives to Reglan.

Bayer Healthcares’ contraceptive Yaz continues to cause gall bladder disease. Marketed under the names Yaz, Yasmin and Ocella, Yaz is a widely used hormone based contraceptive. Bayer claims that Yaz helps to control premenstrual dysphoric disorder symptoms, commonly referred to as PMDD, such as anxiety, irritability, moodiness, bloating, headaches, and muscle pain. Bayer also claims that Yaz suppresses acne.

Yaz hit the market with a host of known side effects including heart attack, stroke, blood clots, headaches, mood swings, and acne. Yaz apparently causes some of the same problems that Bayer claims that Yaz cures. Yaz is also known to cause gall bladder disease, a complication that is noticeably absent from any of Bayers’ disclosures. Yaz causes an increase in the production of gallstones which can become lodged and require the laproscopic removal of the gallbladder. Yaz victims must then deal with the complications of gall bladder removal.

For more information contact a Tyler Defective Drug Attorney today.

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