Do Sleep Aids Impair Driving Performance?

May 8th, 2018 by Rieders Travis in Car Accidents, Pharmaceutical Drugs

Do Sleep Aids Impair Driving Performance?
People who cannot sleep become desperate, so it is not surprising that sleep aids are used by approximately 60 million Americans each year. In addition to prescription drugs, there are many over-the-counter medications used for treating insomnia. Most common sleep aids help people fall asleep easier and potentially remain asleep for longer. Unfortunately, sometimes the sedative effects last too long and impair functions during the night and the morning after. People can be harmed by nocturnal activities such as sleep-walking and sleep-eating when they do not know what they are doing, and lingering drowsiness during the day can make activities which require alertness, like driving, very hazardous. If you or a loved one has suffered harm from a vehicle collision or other side effect from sleep-inducing drugs, you may be entitled to compensation for your medical and hospital bills, rehabilitation expenses, lost wages, lost future wage horizon, disfigurement, pain and suffering, and loss of life’s pleasure.  However, your case must be handled correctly and competently, or you may never collect the compensation you are entitled to. Problems With Sleep Aids While many people are helped by sleeping pills, there can…

RISPERDAL

February 9th, 2018 by Rieders Travis in Pharmaceutical Drugs

W.C. v. Janssen Pharms., Inc., 2017 Pa. Super. 356 (November 13, 2017) Panella, J.  Appellant W.C. appealed from the judgment entered following a jury trial in the Philadelphia County Court of Common Pleas in favor of Appellees, Janssen Pharmaceuticals, Inc., Johnson & Johnson and Janssen Research and Development. A new trial was granted to the issues of causation and damages.  Risperidone was developed for treatment of schizophrenia in adult patients, but the claim was that it caused breast enlargement.  Claims for punitive damages were dismissed.  The patient offered expert testimony through Mark Solomon, MD.  He said that the plaintiff suffered from gynecomastia solely due to the Risperdal ingestion during childhood.  The jury returned a verdict in favor of the pharmaceutical companies.  The jury did find the pharmaceutical companies negligent for failing to provide adequate warnings to prescribing physicians concerning the risk of gynecomastia associated with Risperdal use.  However, they failed to find that this negligence caused the gynecomastia.  The trial court did not abuse its discretion by permitting pharmaceutical companies’ counsel to display two tennis balls during his closing.  The trial court did not abuse its discretion by permitting pharmaceutical…

PHARMACEUTICALS-RISPERDAL

January 25th, 2018 by Rieders Travis in Pharmaceutical Drugs

Stange v. Janssen Pharmaceuticals, 2018 Pa. Super. LEXIS 11 (January 8, 2018) Ford Elliott, P.J.E.  Timothy Stange was the plaintiff against Janssen Pharmaceuticals, Johnson & Johnson, and others.  The jury returned a verdict of $500,000 plus delay damages.  Janssen raised Frye issues.  The case at issue was Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).  As Pennsylvania held in Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) en banc appeal denied, 847 A.2d 1288 (2004), Frye excludes evidence when a party wishes to introduce novel scientific evidence.  Under Frye, the relevant scientific community must have reached general acceptance of principles and methodology employed by expert witnesses before the trial court will allow the expert witness to testify about his conclusions.  However, the conclusions reached by the expert witness from generally accepted principles and methodologies need not also be generally accepted.  Thus, the court’s inquiry into whether a particular scientific process is “generally accepted” is an effort to ensure that the result of the scientific process, i.e., the proffered evidence, stems from “scientific research which has been conducted in a fashion that is generally recognized as being sound,…

Pharmaceuticals: Risperdal Causation and Damages

November 28th, 2017 by Rieders Travis in Pharmaceutical Drugs

W.C. v. Janssen Pharms., Inc., 2017 Pa. Super. LEXIS 909 (November 13, 2017) Panella, J.  Appellant, W.C., appeals from the judgment entered following a jury trial in the Philadelphia County Court of Common Pleas in favor of Appellees, Janssen Pharmaceuticals, Inc., Johnson & Johnson Company and Janssen Research and Development, LLC. Appellant argues the trial court abused its discretion in denying his request for a new trial due to erroneous evidentiary rulings at trial. We reverse and remand for a new trial limited to the issues of causation and damages. Appellees developed and manufactured risperidone, an atypical antipsychotic, for the treatment of schizophrenia in adult patients. In 1993, the Food and Drug Administration granted approval to Appellees to market risperidone for this purpose. Appellees brought their product to market under the brand name Risperdal.  At some time between 2006 and 2008, when Appellant was ten to twelve years old, Appellant’s mother, M.C. (“Mrs. C”), alleged she observed Appellant suffering from unexplained weight gain and gynecomastia. However, at that time, neither Appellant nor Mrs. C informed Appellant’s medical providers of his condition. The complaint claimed that Risperdal caused the gynecomastia.  The…

PHARMACEUTICALS-ZOLOFT

June 14th, 2017 by Rieders Travis in Pharmaceutical Drugs

In re Zoloft Products Liability Litigation, No. 16-2247 (3rd Cir. Op. Filed June 2, 2017) Roth, C.J.  This case involves allegations that the anti-depressant drug Zoloft, manufactured by Pfizer, causes cardiac birth defects when taken during early pregnancy. In support of their position, plaintiffs, through a Plaintiffs' Steering Committee (PSC), depended upon the testimony of Dr. Nicholas Jewell, Ph.D. Dr. Jewell used the “Bradford Hill” criteria  to analyze existing literature on the causal connection between Zoloft and birth defects. The District Court excluded this testimony and granted summary judgment to defendants. The PSC now appeals these orders, alleging that 1) the District Court erroneously held that an expert opinion on general causation must be supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect, and 2) it was an abuse of discretion to exclude Dr. Jewell's testimony. Because we find that the District Court did not establish such a legal standard and did not abuse its discretion in excluding Dr. Jewell's testimony, we will affirm the District Court's orders.  Central to this case is the question of whether statistical significance is necessary to prove…

Dangerous Drug Combinations

April 10th, 2017 by Rieders Travis in Medical Malpractice, Pharmaceutical Drugs

PA Drug Injury Lawyer
What happens when you become extremely ill after taking medicine your doctor ordered? Patients have every expectation that the medications prescribed for them will be beneficial and help get them well; but all too often, drugs -- and their interactions with other medications the patients are taking -- wind up making them more sick. According to the Centers for Disease Control and Prevention (CDC), pharmaceutical drugs kill over 40,000 people each and every year. Studies highlighted by the CDC estimate that more than 50% of all the drugs marketed to the American consumer have side effects that injure people, in spite of testing and FDA regulation. Sometimes, it is a new drug that ultimately proves defective or dangerous, but also there are times doctors or pharmacies fail to recognize that drugs which may be safe when prescribed on their own can become dangerous or even deadly in combination with other medications. Consider what happened when a Chicago Tribune reporter walked into an Evanston CVS pharmacy with two prescriptions: one for clarithromycin, a common antibiotic, the other for simvastatin, an anti-cholesterol drug. Each drug is relatively safe when taken alone, but…

Pharmaceutical Pre-Emption

April 5th, 2017 by Rieders Travis in Pharmaceutical Drugs

In re Fosamax Alendronate Sodium Prods. Liability Litigation, 2017 U.S. App. LEXIS 5075 (March 22, 2017) Fuentes, J.  Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax's FDA-approved drug label. Many Plaintiffs also brought a variety of additional claims including defective design, negligence, and breach of warranty. Plaintiffs' suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck's motion for summary judgment and dismissed all of Plaintiffs' claims on the ground that they were preempted by federal law. The District Court based its ruling on the Supreme Court's decision in Wyeth v. Levine,1 which holds that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that a plaintiff claims was necessary. We will vacate and remand. Preemption is…

Adverse Drug Events

September 13th, 2016 by Rieders Travis in Pharmaceutical Drugs

PA Drug Injury Lawyer
Pharmaceutical drugs, and medical devices, are highly risky and dangerous instrumentalities. Some drugs and medical devices should not be on the market at all, and others may cause an adverse event, which is an injury resulting from use of the drug or medical device. The law concerning pharmaceutical drugs is not the same as that relating to medical devices. There are important distinctions. The involvement of the Food and Drug Administration causes many complexities because of a legal doctrine called preemption. If you or someone you love has been injured by a pharmaceutical drug or medical device, you may have the option of filing a lawsuit for damages in connection with the injuries and compensable losses. Cliff Rieders at the law firm of Rieders, Travis, Humphrey, Waters & Dohrmann is one of the leading lawyers in this field of practice. Rieders has written “the book” that Pennsylvania attorneys use in medical liability areas, including cases concerning medical devices and pharmaceutical drugs. Rieders is a Board Certified attorney, Past President of the Pennsylvania Trial Lawyers, and lectures widely to other attorneys on the subject. Liability with respect to pharmaceutical drugs and…