Charlotte Personal Injury Lawyer - FDA & Prescription Drugs

FDA Starts Safety Review Of Weight Loss Drug Meridia

Greg Jones — Tue, 24 Nov 2009 09:25:09 GMT

The U.S. Food and Drug Administration has begun an expedited safety review of sibutramine based on a recent study showing that some patients have a higher rate of heart attacks, strokes and other cardiovascular events after taking the weight loss drug. Abbott Laboratories markets sibutramine as the popular weight loss drug Meridia.

Although the FDA has not made any conclusions, it is studying the initial data from a six-year study referred to a s the SCOUT study which examined the effects of the drug on overweight or obese subjects at risk of a cardiovascular event.

The SCOUT study results demonstrate the need for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke to avoid using sibutramine or Meridia.

The SCOUT data looked at roughly 10,000 patients who were at least 55, overweight or obese and had a history or heart disease or type 2 diabetes as well as at least one other cardiovascular risk factor. The study did not include those who had recently suffered a heart attack or stroke. The study was designed to demonstrate that weight loss achieved through sibutramine and "standard care" lowered the number of cardiovascular events more effectively than weight loss reached through a placebo and standard care.

The FDA said it "understands the serious nature of the preliminary data" and vowed to share its conclusions with the public as soon as it finishes its expedited safety review.

Originally posted at InjuryBoard by Greg Jones

Jury tags Pfizer another $28M In Punitive Damages For Prempro

Greg Jones — Tue, 24 Nov 2009 09:11:11 GMT

Three days after awarding $6.3 million in compensation, a Pennsylvania jury determined Pfizer Inc. will have to pay $28 million in punitive damages to a 66-year-old Donna Kendall claiming that the menopause drugs Prempro and Provera caused her breast cancer.

Kendall took the hormone replacement drugs between 1991 and 2002. Ms. Kendall was diagnosed with breast cancer that would lead to her double mastectomy.

Pfizer said it would appeal the Kendall verdict as well as a jury verdict in the same court ordering the company to fork over $75 million in punitive damages to bellwether plaintiff Connie Barton.

Wyeth, meanwhile, is also one of several defendants named in multidistrict litigation over Prempro. Other defendants named in the MDL include Bristol-Myers Squibb Co., Solvay Pharmaceuticals Inc., Watson Pharmaceuticals Inc. and Ortho-McNeil Janssen Pharmaceuticals Inc.

In that case, the plaintiffs claim that the drug company defendant, convinced doctors and the public that menopause was a chronic disease that required hormone drug treatment by an agressive and lengthy marketing campaign.

In cases like these, the jury send s a message that not only sure Pfizer and other companies not only compensate victims but should be punished by large punitive damages for ignoring the public health consequences in lieu of profits.

Members of the jury said after the trial that the evidence showed Pfizer units Wyeth and Pharmacia & Upjohn dismissed opinions that their hormone replacement drugs cause cancer, according to the Plaintiff's lawyer.

Originally posted at InjuryBoard by Greg Jones

Pfizer Popped With $6.3M Prempro Verdict

Greg Jones — Mon, 23 Nov 2009 11:14:33 GMT

A Pennsylvania jury has ruled that two Pfizer Inc. units areliable for at least $6.3 million in compensatory damages to an Illinois woman who developed breast cancer after she began taking the menopause drugs Prempro and Provera. The jury has yet to decide on punitive damages.

On Friday, that the jury in the Philadelphia County Court of Common Pleas had issued the verdict after finding that the combination of Wyeth’s Prempro and Pharmacia & Upjohn’s Provera substantially contributed to 66-year-old plaintiff Donna Kendall’s breast cancer.

Kendall, whose case is one of about 1,500 Prempro lawsuits pending in Philadelphia, took the hormone-replacement drugs for 11 years.

Wyeth and Upjohn have prevailed in the "vast majority" of hormone therapy cases set for trial.

Earlier in November, a jury in the same court ordered Pfizer to fork over $75 million in punitive damages to bellwether plaintiff Connie Barton, who developed invasive breast cancer after she began taking Prempro. The same jury had previously awarded Barton $3.7 million in compensatory damages.

Originally posted at InjuryBoard by Greg Jones

FDA Issues Warning Over Diabetes Drug Byetta

Greg Jones — Wed, 04 Nov 2009 10:03:34 GMT

The U.S. Food and Drug Administration has issued a warning about possible kidney problems associated with the use of Byetta, a diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. Byetta, known generically as exenatide, is used in patients with type 2 diabetes to lower blood sugar levels without the use of insulin, according to the manufacturer. The drug is supposed to imitate the effects of a human hormone and improves blood sugar levels by several mechanisms that work in concert on the stomach, liver, pancreas and brain.

The FDA received 78 reports of kidney problems in patients using Byetta from April 2005 through October 2008, in Tuesday's warning.

Byetta's most common side effects include nausea, vomiting and diarrhea, which may have contributed to the kidney problems reported. Kidney malfunction can lead to serious or life-threatening illness, according to the FDA.

This is not the first warning issued concerning Byetta. In August 2008, the FDA issued warnings after it received reports of two deaths and six cases of severe pancreatitis.

Byetta should be promptly discontinued if pancreatitis is suspected, the warning said.

Our law firm encourages anyone taking Byetta and experiencing any of the symptoms listed above to check with their doctor. Simple tests may be able to detect if any problems exist. We have been investigating Byetta cases for over a year and continue to review possible cases.

Originally posted at InjuryBoard by Greg Jones

More Levaquin lawsuits filed.

Greg Jones — Tue, 22 Sep 2009 12:32:45 GMT

Another person has joined the nearly 150 lawsuits in multi district litigation involving Johnson & Johnson's antibiotic drug Levaquin. An elderly man alleges that Levaquin caused him to suffer a ruptured tibial tendon.

William Dowling filed a lawsuit Thursday against J&J and its units Ortho McNeil Pharmaceutical Inc. and Johnson & Johnson Pharmaceutical Research and Development LLC.

The complaint alleges that the phamacuetical companies were negligent, failed to warn the public about issues with the drug, and breached implied and express warranties in the making, marketing and sales of Levaquin.

Levaquin, generic know as levofloxacin, is approved for the treatment of a variety of infections. The lawsuits allege Levaquin causes tendon injuries, including tendon rupture. Adults 60 and older or others on corticosteroid therapy are especially prone to injury.

A trial date is set for August 2010.

In July 2008, the U.S. Food and Drug Administration called for a boxed warning on Levaquin. The announcement came after several requests from the consumer advocacy group Public Citizen to add warnings.

Additionally, our firm is invesigating cases that involve Levaquin and the onset of Stevens Johnson Syndrome commonly known as SJS as well as Toxic Epidemal Necrosis or TEN. If you or a loved one experiences these problems, seek medical help immediately.

Originally posted at InjuryBoard by Greg Jones

Investigation of Dilantin and Stevens Johnson Syndrome & Toxic Epidermal Necrolysis

Greg Jones — Fri, 18 Sep 2009 09:48:25 GMT

Stevens-Johnson Syndrome and Toxic epidermal necrolysis are life threatening skin diseases that are characterized by skin rash, peeling, and open wounds and sores on the epidermis. These diseases are caused by bacterial infection and even more importantly, certain over the counter medical drugs. These two diseases have been linked to the use of Dilantin, which is a medication used to reduce seizures in epileptic patients. In fact, over eighty percent of the cases of Stevens Johnson Syndrome (SJS) or Toxicepidermal necrolysis (TEN) are caused by use of medication. Females are affected almost twice as much with these diseases as a result of the use of medication as males, and children taking other medications along with anticonvulsants have been shown to have a higher incidence of the diseases.

SJS and TEN symptoms are similar, and include body aches, pains, fevers, and more noticeably, red rash, blisters, and peeling skin. With patients affected by SJS, the blistering is more prevalent than with TEN. SJS blistering can occur in the mouth, eyes, and genital areas. TEN is most commonly characterized by large areas of skin “sheeting” off of the body.

Both diseases, although severely detrimental to a patient’s health, coupled with an increased possibility of death, are treatable. Those that show symptoms of these diseases should be hospitalized immediately. The drugs that the patient was taking, including any anti-epileptic drugs such as Dilantin must be discontinued immediately. Most patients suffering from these diseases are treated in burn units and once treated; the affected skin should grow back normally and have no need for skin grafts. Intravenous fluids and salts are fed to the patient as they are normally severely malnourished as a result of the disease, and in some cases are treated with corticosteroids, although this treatment is still very controversial.

If you, or anyone you know, suffer from epileptic episodes, and are taking an anti-epileptic drug such as Dilantin, please consult your doctor immediately to discuss the adverse health affects that you might incur as a result of the medication. If you are suffering from any of the above symptoms of SJS or TEN, please consult a physician immediately and seek legal counsel shortly thereafter. Protecting you and your loved ones, through the medical and legal profession, is the first step towards a healthy future.

Originally posted at InjuryBoard by Greg Jones

Drug Company Pleads Guilty to Bribing Doctors to Prescribe

Greg Jones — Wed, 16 Sep 2009 09:37:06 GMT

A subsidiary of Biovail Corp. has pled guilty to bribing doctors to prescribe Cardizem, a blood pressure drug, after a plea agreement to pay $24.6 million in criminal and civil fines arising from conspiracy and kickback charges brought by the U.S. Department of Justice on Monday, and was sentenced to pay a $22,243,590 criminal fine. Because some of the prescriptions were paid for by Medicaid, Biovail has agreed to pay an additional $2,404,286 plus interest in civil fines to resolve allegations that its conduct caused the submission of false claims to the United States.

Through a marketing effort called “proving LA through clinical experience,” or PLACE, Biovail paid thousands of doctors and other medical professionals as much as $1,000 apiece to prescribe or recommend Cardizem.

This shows how each person should be an advocate for their own health as large pharmaceutical companies continue to put profits over people.

Originally posted at InjuryBoard by Greg Jones

Developments in the Bellwether Fosamax Case

Greg Jones — Tue, 01 Sep 2009 15:12:49 GMT

Merck & Co. Inc., the manufacturer of the osteoporosis drug Fosamax, has asked a federal judge to dismiss the remaining claims in a product liability and personal injury. The Plaintiff, Boles, a 71-year-old Florida woman, claims that Fosamax caused her to develop a degenerative bone disease known as osteonecrosis of the jaw, or ONJ. Further, the Plaintiff has moved for partial judgment on several of Merck's affirmative defenses.

Both sides have asked the presiding Judge to rule on the motions before the jury could return a decision in this first case in a multidistrict litigation against Merck.

In its motion, Merck alleges the Plaintiff did not prove her failure to warn, personal injury, fraudulent misrepresentation or design defect claims because she could not demonstrate that she developed osteonecrosis of the jaw, or ONJ, prior to Oct. 1, 2003, and did not introduce any expert testimony to show that Fosamax was defectively designed.

Boles claims she developed ONJ, a disease where the jawbone partially rots, in 2003 after having taken Fosamax since 1999. The Plaintiff suit claims Merck overstated the drug's benefits and concealed its harmful effects.

Approximately 900 Fosamax product liability cases remain nationwide, consisting of about 1,280 total plaintiff groups, according Merck.

Originally posted at InjuryBoard by Greg Jones

First Fosamax trial to begin

Greg Jones — Thu, 13 Aug 2009 14:32:36 GMT

Merck faces the first trial due to lawsuits based on its osteoporosis drug Fosamax allegedly causing the death of jawbone tissue. The Fosamax plaintiffs claim Merck misrepresented the drug’s safety and failed to that it might impede blood flow to the jaw, causing jawbone-tissue death. This condition called osteonecrosis of the jaw, or ONJ can lead to partial removal in some patients. Jawbone tissue death is . Fosamax, available in pill or liquid form, is part of a group of medicines known as bisphosphonates. The only cases of jaw necrosis have been found in the drugs’ users and cancer patients receiving chemotherapy, according to Mahyar Etminan, a pharmacy expert for the patients. http://www.bloomberg.com/apps/news?pid=20601103&sid=aN.O.OLorMnc

Originally posted at InjuryBoard by Greg Jones

FDA Panel Urges Ban on Vicodin, Percocet

Greg Jones — Wed, 01 Jul 2009 10:47:48 GMT

Following the release of an FDA report last month that found severe liver damage, and even death, due to consumer's lack of awareness that acetaminophen can cause serious injury, an FDA panel is urging that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned. The FDA panel is also urging the lowering of the the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin.

The panel showed a rear concern with the potential abuse of Vicodin and Percocet but went further to caution on the OTC, over the counter, drugs as well. The panel believed that people often consume more of the recommended dose of acetaminophen mistakenly thinking that taking more will be better against pain without posing any health risks

The FDA is not obligated to follow the recommendations of its advisory panels, but it usually does.

Please be diligent with your intake of medicine, either over the counter or prescription, that contain acetaminophen. Especially in the case of children, side effects can be quite serious if over adminsitered. This should hlep remind us all that even seemingless harmless drugs that must of us keep in our medicine cabinets have potentially harmful side effects that should not be ignored.

Originally posted at InjuryBoard by Greg Jones