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Takeda Hit With $2.3M Verdict In Philly Actos Case

Takeda Pharmaceuticals Inc. was hit with a $2.3 million verdict on Thursday after a Philadelphia jury concluded that the diabetes drug Actos had been a significant cause of a retired Pennsylvania teacher’s bladder cancer and that the man’s doctor had been inadequately warned about the risks. The jury returned a verdict after a little more than a day of deliberation, awarding John Kristufek $318,000 in past medical expenses plus $2 million in noneconomic damages in the second successful bid by plaintiffs in the Philadelphia County Court of Common Pleas to hold the Japanese drugmaker liable for injuries related to Actos.

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Over-the-Counter Drug Dangers

 Beware of over-the-counter medications that can affect your driving. Over-the-counter (OTC) drugs are serious medicines and if not taken as directed by the drug label, these medications can have lingering effects. It is important to follow the Drug Facts on each OTC label to ensure the side effects do not interrupt your daily activities, like driving. Dr. Ali Mohamadi, a medical officer at FDA, said OTC medicines can have ‘hangover-like’ effects. Specifically, taking OTCs without enough rest can cause drowsiness behind the wheel and can impair your driving skills.

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Lipitor Lawsuits are Centralized in Federal Court

Federal lawsuits claiming that Pfizer’s drug Lipitor caused patients to develop Type 2 diabetes are moving forward in federal court. Cases have been consolidated in federal court in South Carolina. The United States Judicial Panel on Multidistrict Litigation (“JPML”) issued an order centralizing all associated personal injury actions into IN RE: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II), MDL No. 2502. This order directs that all related federal lawsuits be transferred to the United States District Court of South Carolina and assigned to the Honorable Judge Richard M. Gergel for consolidated pretrial proceedings.

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The Dangers of Generic Drug Labeling – How You Can Help Make Drugs Safer

Consumer advocates are urging the public to join the effort to improve the safety warnings for generic prescription drugs. Consumers who support improved safety warnings are urged to sign a Petition to Make Drugs Safer. The majority of prescription drugs dispensed in the U.S. are generic drugs, and the companies that market them are not subject to the same warning label rules as their name brand counterparts.  Generic drugs are marketed as offering the same active ingredients and quality as their name-brand equivalents at a lower cost, which makes them a popular choice among consumers and doctors. In fact, more than 80% of prescriptions filled in the U.S. are generic drugs. Many insurance policies require pharmacists to fill prescriptions with generics. The Food and Drug Administration (FDA) regulates the manufacture and distribution of both branded and generic drugs, but does not hold manufacturers to the same standards. Brand name manufacturers are accountable for updating labeling to reflect any new side effects or drug reactions immediately after they are discovered, but laws governing the labeling of generic drugs are much more relaxed. The modern system of generic drug regulation was created by Congress in 1984. Generic drug manufacturers can get quick approval for their generic drugs as long as the manufacturers can prove the generic drug is chemically equal to the branded original drug. Generic drug manufacturers are not required to perform testing of their drugs, and the generic drug warnings just have to be the same as warning on the branded original. This loophole puts consumers at risk when new drug injuries and dangerous side effects are discovered.  Generic drug manufacturers are not held accountable for updating the warning labels on their products. Brand name drug makers must change the labels for the original drugs before generic manufacturers can begin the process of changing their labels, causing a time lag in getting safety warning information to the users of generic drugs! If a brand name drug goes off the market, but the generic equivalent does not, the manufacturers of the generic drug are not able to change their labeling, even if the drug is known to have new risks. Essentially, generic drug manufacturers can sell their products to unsuspecting consumers even if they know they are dangerous. The FDA has proposed a rule change that would require generic drug companies to follow the same process as name brand drug manufacturers to update warning labels. Under this fix, generic drug manufacturers would also be held responsible for injuries caused by their drugs in court. Cory Watson Attorneys has partnered with the Take Back Justice campaign to close the loopholes in FDA drug regulation to protect consumers. The rule change has been delayed once already and the Take Back Justice campaign has launched a petition to urge the FDA to take action and hold all drug companies accountable for providing current and accurate labeling on all drugs. Please join Cory Watson Attorneys in supporting safer drug labeling. Click here today to sign the petition to make generic drugs safer. The period for public comment ends April 27, 2015, so act today to make the marketplace safer for all.

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Vaccine Injuries and Paralysis Lawsuits

Each year, millions of Americans receive routine vaccinations from their local doctor, hospital, or pharmacy. Vaccines are commonly used to prevent illnesses such as influenza, human papillomavirus (HPV), hepatitis, tetanus, measles, mumps, and rubella. While these and other vaccines are an important part of maintaining good health, there is a serious risk associated with them. Severe injuries and side effects may result, including the following: Anaphylaxis and anaphylactic shock Chronic arthritis Encephalopathy or encephalitis Seizures Brachial neuritis Thrombocytopenic purpura Auto-immune disorders Wrongful death Most Americans are unaware that compensation is available for individuals who have suffered serious injuries as a direct result of a vaccine. The Vaccine Injury Compensation Program (VICP) is a federal program that was established by Congress in 1988 to compensate individuals harmed by vaccines. The program is administered by the U.S. Department of Health and Human Services, and is funded by a 75 cent fee that is charged with each and every vaccine that is given in the United States. Compensation awards have been made to approximately 4,000 claimants since the VICP was established in 1988, and more than $2.8 billion in compensation has been paid out. Filing and pursuing a claim with the VICP can be a complex and difficult process. All claims must be filed with the U.S. Court of Federal Claims in Washington, D.C., by a specific deadline set by the program. This court reviews all claims and determines which claimants will be compensated. If a claim is not filed according to the VICP’s strict guidelines, the claim may be lost forever. The vaccine injury lawyers at Cory Watson Attorneys are skilled in handling such claims and are available to review your potential claim today. Get Help With Your Immunization Injury Lawsuit If you or a loved one suffered paralysis or another serious injury and you suspect a vaccine is to blame, Cory Watson wants to hear from you. We are investigating claims for compensation linked to immunizations like the flu vaccine, which may cause paralysis, Guillain-Barré Syndrome, and more. For a free review of your case, call Cory Watson Attorneys at (877) 562-0000 or fill out our online evaluation form for help today.

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Benicar® Lawsuits Filed in Federal Courts Across the Country

On December 18, 2014, a motion was filed with the United States Judicial Panel on MultiDistrict Litigation (JPML) seeking consolidation and transfer of pending federal cases involving the pharmaceutical drug Benicar® (and other drugs containing the ingredient olmesartan). There are currently more than a dozen Benicar® lawsuits filed in federal courts across the country. The Motion seeks transfer of these cases to the Honorable Dan Aaron Polster of the United States District Court for the Northern District of Ohio for pre-trial proceedings.  Pending hearing by the JPML on this Motion, this matter has been designated as In Re: Benicar (and other olmesartan drugs) Products Liability Litigation, MDL 2606. This litigation includes the following pharmaceutical drugs: Benicar®, Benicar HCT®, Tribenzor®, and Azor®. These medications are prescribed for the treatment of high blood pressure and contain the ingredient olmesartan. Benicar®, Benicar HCT®, Tribenzor®, and Azor® are all brand name drugs which are manufactured by Daiichi Sankyo, Inc., a Japanese corporation. Recent studies have shown that these prescription medications can cause alarming injuries among users, including, but not limited to, the following: dehydration, severe weight loss, chronic diarrhea, vomiting, and sprue-like enteropathy. A 2012 study by the Mayo Clinic followed 22 patients who were taking drugs containing olmesartan and suffering from chronic diarrhea and weight loss, with most requiring hospitalization. All study participants showed significant improvement of their symptoms after they discontinued the use of drugs containing olmesartan. The study concluded that olmesartan was directly linked to the patients’ alarming injuries. In July of 2013, the United States Food and Drug Administration issued a Safety Announcement which warned of the link between the use of olmesartan and serious gastrointestinal side effects, such as chronic diarrhea and weight loss. Drug injury lawyer Andrew Jones of Cory Watson Attorneys is currently investigating claims by individuals who suffered severe gastrointestinal side effects after taking Benicar®, Benicar HCT®, Tribenzor®, and Azor®. Contact us today for a free case evaluation.

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Benicar® Safety Concerns

There is growing concern over serious side effects related to the following prescription medications: Benicar®, Benicar HCT®, Tribenzor®, and Azor®. These medications are prescribed for the treatment of high blood pressure and contain the ingredient olmesartan medoxomil. Benciar®, Benicar HCT®, Tribenzor®, and Azor® are all brand name drugs which are manufactured by Daiichi Sankyo, Inc., a Japanese corporation. Recent studies have shown that these prescription medications can cause alarming injuries among users, including the following: dehydration, severe weight loss, chronic diarrhea, vomiting, and spruelike enteropathy. A 2012 study by the Mayo Clinic followed 22 patients who were taking drugs containing olmesartan medoxomil and suffering from chronic diarrhea and weight loss, with most requiring hospitalization. All study participants showed significant improvement of their symptoms after they discontinued the use of drugs containing olmesartan medoxomil. The study concluded that olmesartan medoxomil was directly linked to the patients’ alarming injuries. In July of 2013, the United States Food and Drug Administration issued a Safety Announcement which warned of the link between the use of olmesartan medoxomil and serious gastrointestinal side effects, such as chronic diarrhea and weight loss. Drug injury lawyers at Cory Watson Attorneys are currently investigating claims by individuals who suffered severe gastrointestinal side effects after taking Benciar®, Benicar HCT®, Tribenzor®, and Azor®. Contact us today for a free case evaluation. Never stop taking any medication without consulting your doctor. Benicar® is a registered trademark licensed by Daiichi Sankyo, Inc. and is used herein only to identify the product in question. This law firm is not associated with, sponsored by, or affiliated with Benicar®, Daiichi Sankyo, Inc.

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FDA Proposes Reclassification of Transvaginal Mesh Products

On May 1, 2014, the U.S. Food and Drug Administration (FDA) published two proposed administrative orders which seek to reclassify and heighten the approval standard for transvaginal mesh (TVM) products. The first proposed administrative order seeks to reclassify TVM from a class II (“moderate-risk”) to a class III (“high-risk”) device, over concerns that current precautions in place are not sufficient to guarantee these products’ safety and effectiveness. The second proposed order, built upon the first, would require a TVM manufacturer to file a premarket approval application (“PMA”) before its product could be placed on the market. The PMA process requires the manufacturer to provide the FDA with “reasonable assurance” that the device is safe and effective, which usually entails the conducting of clinical safety trials and testing. Currently, surgical mesh manufacturers are only required to file a 510(k) substantial equivalence application, which – when approved – allows them to bypass clinical safety trials altogether. IMPACT ON FUTURE TVM PATIENTS The potential enactment of these proposed FDA orders would be significant to future patients who might be implanted with TVM products. If the proposed orders are finalized, any new TVM used in surgery for feminine stress urinary incontinence (SUI) or pelvic organ prolapse (POP) repair will have undergone additional testing and scrutiny before reaching the marketplace. This testing, in theory, should mean that the products will be safer, more effective, and have better warnings than the current TVMs that are the subject of multiple litigations and over 60,000 lawsuits. The PMA process is not, however, entirely good news for the thousands of patients who might use these new TVMs in the future. MEDICAL DEVICE RECALLS The unfortunate reality is that there are still numerous recalls of PMA medical devices every year, and the men and women who are injured by those products end up having almost no recourse against the sometimes grossly negligent manufactures. Under the Federal Food, Drug, and Cosmetics Act (FDCA), which governs all medical devices sold in the United States, any potential plaintiffs are “preempted” from bringing claims for defective devices approved through the PMA process. Specifically, if a device has been subjected to the PMA process, the U.S. Supreme Court has ruled any claims that the device is defective are preempted under the Medical Device Amendments to the FDCA at 21 U.S.C. § 360(k). This issue came to a head with the Supreme Court’s 2008 ruling in Riegel v. Medtronic, 552 U.S. 312, 128 S. Ct. 999 (2008). In Riegel, the Supreme Court found that plaintiffs’ state-law claims for strict products liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of a medical device which had been approved through the FDA’s PMA process were not allowed to go forward under the FDCA (See Riegel, 128 S. Ct. at 1007-10). EFFECTS OF THE RIEGEL RULING The tragic cooling effects of the Riegel ruling were made clear through the words of Hon. Richard Kyle of the U.S. District Court in the District of Minnesota. In a January 5, 2009 order, Judge Kyle dismissed with prejudice the personal injury cases of approximately 15,000 claimants who had brought claims (including claims for wrongful death, unnecessary replacement surgeries, and for instances of being needlessly shocked up to 100 times) against Medtronic for its Sprint Fidelis lead wire products. In his Order, Judge Kyle stated: “[T]he Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. But Plaintiffs assert claims for which the Court simply cannot provide a remedy. Congress has decided to limit medical-device manufacturers’ liability in order to spur innovation, even though individuals are sometimes injured when using medical devices. Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court (or any other court).” In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 0:08-md-01905-RHK-JSM (Document 233) at 36 (emphasis added). WHAT THIS MEANS FOR YOU Ultimately, while the FDA’s proposed orders could provide potential additional safeguards against putting defective TVMs on the market, it appears upon deeper examination that these proposals might actually create more harm than good. Until Congress corrects and amends the current statutory language so that victims’ rights to a trial are not stolen from them, the FDA proposed changes will inadvertently serve to shield future TVM manufacturers of almost all consequences when one of them negligently designs and pushes through the FDA another product that injures thousands of women.

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Alabama Jury Awards Woman $850,000 For Death Of Husband Due To Medication Error

The Alabama drug injury lawyers at Cory Watson Attorneys explain that doctors have a responsibility to ensure patients receive the correct and appropriate dosages of medication needed to treat a certain condition. Any failure to do so that results in a patient being harmed could put the doctor, his staff, and the facility where the medication was administered at risk of being held liable for damages caused by the mistake. According to the Insurance Journal, a jury in Chambers County Circuit Court in Alabama recently awarded a widow $850,000 for the death of her husband. The award was given after a doctor’s error in failing to prescribe the correct dosage of a medication was found to be at fault for the patient’s death. The 62-year-old victim was admitted to a hospital for treatment of pneumonia and had taken a daily dosage of 900 mg of Lithium per day to treat his Bipolar Disorder. The doctor mistakenly prescribed the victim a dosage of 2700 mg of Lithium, causing the patient’s health to slowly decline, which ultimately led to his death as a result of Lithium toxicity. The personal injury lawyers at Cory Watson recognize how difficult recovering from the loss of a loved one due to a doctor’s negligence can be. That’s why the firm is hopeful the decision that was reached brings closure to the incident for the family of the victim.

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