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Archive for the category: Drug Industry
  • Medical Marijuana Access Extended to Children in Illinois

    Starting this year, children in Illinois who struggle with severe medical conditions such as cancer, muscular dystrophy and epilepsy will now have access to medical marijuana. The change comes after parents lobbied lawmakers to expand the 2014 legislation which legalized marijuana as a medical treatment for adults. While the debate over medical marijuana has grown in recent years, research shows that as far back as the 1980s the drug was shown to be effective for people suffering with epilepsy. According to Medical News Today, Epilepsy is a condition that affects the electrical activity of the brain. Within the human brain electrical signals are constantly sent and received by cells. These signals control everything from breathing to memory to muscle control. Epilepsy causes these electrical signals to increase and this creates a communication error to occur between the cells. When this happens, the person experiences what is known as a seizure. It is estimated that epilepsy affects 2.5 million Americans and many of these are children. Epilepsy has many causes including birth injury, brain tumors, an infectious illness, strokes, prenatal brain malformation and chromosome disorders. It is also thought that a genetic condition can cause epilepsy to develop in families. Some forms of epilepsy can even raise a child’s mortality rate by 15 or 20 percent. While there are many drugs on the market, these can cause severe side effects for children which include the following: blistering, heart rhythm changes, sleeping problems, cognitive slowness, hyperactivity and even large skin areas that peel off. Additionally, many of the drugs are ineffective. Medical researchers discovered that the marijuana plant contains a chemical compound called Cannabidiol. This is the compound often used in medical marijuana products and has been proven as an effective treatment in epilepsy as well as cancer and other serious conditions. In epilepsy, medical marijuana has been proven to reduce the number of seizures that a child has and appears to have no negative side effects, including a psychoactive “high.”  Recently, researchers at the University of Utah recommended that all children with severe epilepsy as well as other conditions have access to the drug. Under the new Illinois law, children can only receive medical marijuana in food or through liquid. Furthermore, parents or legal guardians must give their consent and two doctors’ recommendations are required. To receive the medical drug, photos of the children must be submitted and as well as[READ MORE…]

  • Misbranding Depakote

    A recent headline announced that Abbott Laboratories must pay over $1.6 million for misbranding the prescription drug Depakote. The total included a criminal fine and civil settlements with the states and federal government. In addition, Abbott has agreed to pay 45 states in order to resolve liability under state consumer-protection laws. Acting Associate Attorney General Tony West stated that Abbott put “profits ahead of patients.” This article coincided with a recent expose from ProPublica about an apparent lack of oversight by the FDA of medical devices including artificial hip replacements and pacemakers. According to the May 3rd report, the FDA primarily depends upon voluntary reporting from manufacturers, hospitals, doctors, and patients for notification of problems with devices already on the market. If manufacturers are notified by a doctor or hospital about a death or injury resulting from the use of their product, they have a legal obligation to investigate as well as notify the FDA. A report published last year by members of the Institute of Medicine suggested that only a small number of doctors actually contact manufacturers and that even when incidents are reported to the FDA it may be months before devices are recalled. While the FDA does have a website area devoted to recalled medical devices http://1.usa.gov/Vqkk1 the site is confusing for consumers, as well as medical providers, to navigate. According to the ProPublica article, the FDA does maintain adverse event reports in a searchable database but does not have system for systematically or analytically reviewing reports. The FDA is working on the Sentinel Initiative, a national electronic system for tracking drugs and medical devices, but it has been in development and testing stages since 2008. In March of 2012 bill S.2193 – Ensuring Safe Medical Devices for Patients was introduced in the Senate which would, among other items, expedite the implementation of the unique device identification system for medical devices. While manufacturers and the FDA claim that every medical device carries a potential risk, but the vast majority of devices perform well and improve patient health, as a patient you should be able to rely upon the safety of all medical devices used by your physician. If you believe you have been injured because of a faulty medical device please contact Ankin Law Office. We have experience in both medical malpractice as well as class action suits.  

  • Tracking Medical Device Implants

    In an attempt to protect consumers from the dangers of defective medical devices, the U.S. Senate recently proposed draft legislation that would require manufacturers to conduct ongoing safety studies of medical devices even after the device has obtained the approval of the U.S. Food and Drug Administration (FDA).  The legislation was drafted, in part, as a response to the increasing number of lawsuits that have been filed against the manufacturers of defective medical devices, particularly vaginal mesh implants. Currently, the FDA permits certain medical devices to be approved under its 510(k) system, which requires only that manufacturers demonstrate that their product is substantially similar to one already on the market.  The Senate pointed to the 2010 recall of the DePuy ASR hip implant system, which was approved under 510(k) procedures, as evidence that the current guidelines are ineffective in protecting the public from dangerous and defective medical devices. With respect to the specific dangers associated with transvaginal mesh implants, the FDA has also requested that manufacturers of vaginal mesh implants, such as Bard and Johnson & Johnson, provide additional information regarding the companies’ safety inspections and recall procedures. Since 2008, the FDA has warned consumers and health practitioners since 2008 about serious complications associated with vaginal mesh implants that are used to treat pelvic organ prolapse and stress urinary incontinence.  According to the FDA, more than 1,000 reports from nine surgical mesh manufacturers, including American Medical Systems, Bard, Boston Scientific, Caldera, Ethicon, Gynecare, Johnson and Johnson, Mentor and Sofradim, have been filed with the FDA’s adverse events reporting database.  The American of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint statement last November recommending that the use of transvaginal mesh be limited.  Although the FDA is continuing its safety review of vaginal mesh implants, there are currently no plans to issue a recall of these products. Hundreds of lawsuits have been filed against the manufactures of transvaginal mesh implants, as well.  C.R. Bard and Johnson & Johnson face hundreds of lawsuits from women claiming that their transvaginal mesh implants caused scarring, pain, bleeding, blood vessel damage and other complications. If you have been injured by a medical device, such as transvaginal mesh or a hip replacement system, you may wish to consult with an experienced product liability attorney.  At Ankin Law Offices, LLC, our knowledgeable Chicago product liability attorneys focus on protecting the victims of dangerous and[READ MORE…]

  • Johnson & Johnson Recalls 12 Million Bottles of Motrin

    Healthcare and pharmaceutical giant Johnson & Johnson (J&J) recently issued a recall of approximately 12 million bottles of its popular pain reliever, Motrin, due to concerns that the Motrin IB pills may not dissolve and begin working as quickly as intended, resulting in delayed pain relief, as the pills approach their three-year expiration date.  The recall only affects Motrin IB from retailers, and not those in the hands of consumers, since there is no safety risk. The recalled bottles of Motrin were sold in 24 or 30 count packages that were distributed in the United States, Puerto Rico, the Bahamas, Fiji, Belize, St. Lucia and Jamaica.  There are 59 affected lot numbers, all of which are listed on the product’s Web site at http://www.motrin.com.  The affected bottles of Motrin were manufactured between February 2009 and July 2011. J&J’s Prior Recalls J&J has been plagued by safety problems and efficacy concerns with respect to its products for the past several years.  Since September 2009, J&J has recalled a number of prescription and over-the-counter medications, including children’s and adult Tylenol and Motrin, Benadryl, Zyrtec, Rolaids, Simply Sleep pills, Prezista (an HIV medication), Levaquin (an antibiotic) and Topamax (an epilepsy medication).  The manufacturer has also recalled a number of its medical devices, including hip replacement systems, contact lenses and diabetes test strips. As we reported, earlier last year, J&J was ordered to pay $1.8 million to an 82-year-old man from Minnesota who claimed that he was injured by Levaquin, an antibiotic used to treat infections such as pneumonia and chronic bronchitis, as well as sinus, urinary tract, kidney, prostate and skin infections.  Levaquin has been known to cause complications including tendon damage, Achilles tendon rupture, inflammation, Achilles tendonitis, and injury to the rotator cuff, biceps, hand and thumb that may require extensive surgery and could leave the patient incapacitated and facing large medical bills. J&J’s recalls cost the company $900 million in 2010 alone as a result of lost revenue from products pulled from store shelves, factory renovation costs, and legal expenses.  J&J’s Consumer Healthcare factory in Fort Washington, Pa., has been closed since spring 2010 when serious health problems forced the company to undergo a comprehensive renovation and rebuilding of the facility. J&J’s safety and efficacy concerns have sparked the interest of the federal government as well.  The U.S. Food and Drug Administration (FDA) and Congress are both investigating how the company’s[READ MORE…]

  • Pfizer Agrees to Pay $14.5 to Settle False Claims Act Lawsuit for Improperly Marketing Detrol

    Pfizer has agreed to pay $14.5 million to settle a lawsuit alleging that it violated the False Claims Act by improperly marketing its prescription drugs Detrol and Detrol LA.  The lawsuit was filed by whistleblowers on behalf of the United States under the False Claims Act, which allows individuals (known as relators) with knowledge of fraud against the federal government to sue on its behalf.  The relators receive a portion of any funds received by the federal government as a result of the lawsuit. The lawsuit had claimed that Pfizer improperly marketed the drugs to men suffering from the signs and symptoms of benign prostate hyperplasia (BPH), which is commonly referred to as an enlarged prostate, despite the fact that Detrol treats detrusor muscle overactivity and does not have any therapeutic effect on males whose symptoms are caused by BPH.  Detrol and Detrol LA are prescription drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of “over active bladder with symptoms of urge incontinence, urgency and frequency.” The settlement resolves the last of a group of 10 whistleblower suits filed against Pfizer since 2003. The other nine lawsuits were settled or dismissed in 2009 when Pfizer agreed to pay $2.3 billion to resolve civil and criminal claims regarding multiple drugs.  Pursuant to that settlement, Pfizer paid $1 billion to resolve False Claims Act allegations that the company had illegally promoted four drugs – Bextra, Geodon, Zyvox, and Lyrica – and had caused false claims to be submitted to government health care programs for uses of the drugs that were not medically accepted and not covered by those programs.  The settlement also resolved allegations that kickbacks were made to health care providers to induce them to prescribe the drugs. The Chicago unsafe pharmaceutical drug attorneys at Ankin Law Offices, LLC represent clients throughout Illinois and the United States. We have significant experience handling class action lawsuits regarding unsafe pharmaceuticals and are familiar with the complex legal issues that these kinds of lawsuits generally involve.   Contact us at (800) 442-6546 for more information on the improper marketing of Detrol or unsafe pharmaceuticals.   Howard Ankin of Ankin Law Office LLC (www.ankinlaw.com) handles workers’ compensation and personal injury cases. Mr. Ankin can be reached at (312) 346-8780 and howard@ankinlaw.com. ANKIN LAW OFFICE LLC Chicago Workers Compensation | Chicago Personal Injury | Chicago Motor Vehicle Accidents Chicago Wrongful Death |[READ MORE…]

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    Our firm handles workers' compensation and personal injury claims in Chicago, Berwyn, Joliet, Cicero, Waukegan, Chicago Heights, Elgin, Aurora, Oak Park, Oak Lawn, Schaumburg, Bolingbrook, Glendale Heights, Aurora, Niles, Schaumburg, Arlington Heights, Naperville, Plainfield and all of Cook, DuPage, Lake, Will, McHenry, LaSalle, Kankakee, McLean and Peoria Counties.