Cleveland Personal Injury Lawyer - FDA & Prescription Drugs

Yaz and Yasmin Birth Control Linked to Serious Injuries

Nick DiCello — Wed, 29 Jul 2009 18:44:34 GMT

For several years, Bayer HealthCare Pharmaceuticals, the manufacturer of the popular birth control pills Yaz and Yasmin, marketed the oral contraceptives as not only effective in preventing pregnancy, but also as the solution to a variety of other conditions associated with menstruation, such as acne, body aches and mood swings. That ad campaign has come under scrutiny by the Food and Drug Administration, which recently ordered Bayer to run a $20 million ad campaign to correct the misrepresentations made by the company. According to the FDA, Bayer overstated the benefits of Yaz while improperly downplaying its risks. In its letter warning Bayer about the ads, the FDA noted that Yaz actually has additional risks compared to other birth control pills because it contains a progestin called drospirenone, which can increase potassium levels. The side effects of drospirenone include an increased risk of serious heart and other health problems.

Yaz and Yasmin are already the subject of multiple federal lawsuits against Bayer, alleging that the pharmaceutical giant failed to warn women and their doctors of the increased risk of injury associated with the pills while overpromoting the benefits of the oral contraceptives. The most notable – and life threatening – of these injuries include deep vein thrombosis and pulmonary embolisms. Bayer’s irresponsible marketing of these oral contraceptives has left otherwise healthy young woman facing frightening health consequences caused by a drug that they and their physicians believed they could trust. If you or someone you know has suffered blood clots, pulmonary embolism, hyperkalemia (elevated potassium levels), hypertension, seizures/convulsions or kidney problems after taking Yaz or Yasmin, you should contact an attorney to review the circumstances surrounding your injuries and investigate whether you are entitled to compensation.

Originally posted at InjuryBoard by Nick DiCello

Spangenberg Attorneys Begin Distributing Vioxx® Settlement Payments to Clients

Nick DiCello — Wed, 04 Feb 2009 14:07:24 GMT

The product liability attorneys at Spangenberg, Shibley & Liber, LLP have begun distributing partial payments to several clients who sued drug maker, Merck & Co., Inc., over injuries allegedly caused by the once popular pain medication, Vioxx®.

On September 30, 2004, Merck & Co., Inc. withdrew its blockbuster painkiller, Vioxx®, from the market over concerns about the safety of the prescription drug. Specifically, data and studies surfaced suggesting an increased risk of stroke and heart attack associated with use of the drug. Prior to its recall, Vioxx® was widely prescribed for arthritis and pain, generating billions of dollars in sales each year.

The attorneys at SS&L fielded hundreds of Vioxx®-related inquiries in the months following the recall, and quickly put a team of attorneys, paralegals, nurses, and reviewing experts together to investigate these potential claims. In 2005, SS&L began filing suit against Merck on behalf of people claimed to have been injured as a result of taking Vioxx®.

Soon thousands of suits were pending against Merck across the country, the majority of which were consolidated in the United States Federal District Court for the Eastern District of Louisiana sitting in New Orleans. Years of litigation ensued during which Merck aggressively defended the claims asserted against it and a few select cases were tried to the Court in New Orleans.

In the fall of 2007, a global settlement was proffered, pursuant to which individual claims would be evaluated based on defined criteria by an independent Claims Administrator who would assign a value to the claim. The attorneys at SS&L recommended all their clients elect to participate in the settlement program. Because of SS&L’s quick response to the Vioxx® recall and thorough continued investigation, SS&L was able, on behalf of its clients, to submit all the necessary information to the Claims Administrator for prompt review.

Now, SS&L is happy to report that its clients’ claims are routinely being approved by the Claims Administrator and partial payments being issued, the remainder of which will be distributed by the Claims Administrator upon final administration of all claims.

The Vioxx® recall spawned nationwide complex litigation. By quickly responding to the recall and setting up a team of lawyers, support staff and experts dedicated to handling their clients’ Vioxx® inquiries and claims, the pharmaceutical and product liability attorneys at Spangenberg, Shibley & Liber were able to efficiently manage each client’s unique claim and see it through the claims administration process.

If you or someone you know believes you have been injured by a dangerous or defective product or drug, contact the product liability attorneys at Spangenberg, Shibley & Liber.

Originally posted at InjuryBoard by Nick DiCello

Recall for Oversized Narcotic Tablets

Halli Brownfield — Tue, 11 Nov 2008 15:39:47 GMT

Ethex Corporation and the FDA recently issued notice of a voluntary recall of five generic narcotic tablet products because they may be oversized and contain more than twice the intended level of the active drug ingredient. This can result in patients receiving as much as twice the expected dose of the drug which could cause serious life-threatening consequences.

According to the manufacturer's recall notice, the involved lots were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

Taking these oversized tablets can result in various life threatening conditions including arrhythmias (irregular heartbeat), low blood pressure, fainting, difficulty breathing, and rapid heart rate. Anyone who experience any adverse reaction to these drugs should contact their physician/health care provider immediately.

Notably, this is not the first time Ethex Corporation has had to recall tablets due to a manufacturing problem in which pills contained twice the intended dosage. In June of 2008, Ethex originally recalled a single lot of morphine pills believing that the problem was limited only to a lot of pills manufactured during the period from April 16 to April 27, 2008. Only a few days later, Ethex greatly expanded the recall to include additional lots.

For more information, please visit:

http://www.fda.gov/oc/po/firmrecalls/ethex11_08.html

Originally posted at InjuryBoard by Halli Brownfield

Doctors Agree Lawsuits Protect Consumers

Halli Brownfield — Thu, 02 Oct 2008 09:50:53 GMT

In an issue set to come before the United States Supreme Court this fall, the editors of the New England Journal of Medicine have weighed in. The case Wyeth v. Levine will be heard later this year and will decide the issue of whether the manufacturer of a drug approved by the FDA can be sued under state tort law for injuries caused by that drug. In an amicus brief submitted to the Supreme Court, the Journals' editors state that lawsuits serve as "a vital deterrent" that protects consumers from drug companies: "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety. . . . the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against phamaceutical company misconduct."

The resolution of Wyeth will have wide ranging effects for both consumer safety and the pharmaceutical industry. Not suprisingly, this issue is closely watched and highly politicized. The Bush administration supports drug manufacturer Wyeth's position, while 47 state attorney general and two former FDA commissioners support Levine and an injured consumer's ability to seek justice for drug manufacturer negligence and misconduct.

For more information see http://www.usatoday.com/news/health/2008-08-15-drug-lawsuits_N.htm

Originally posted at InjuryBoard by Halli Brownfield

Gadolinium- based MRI Contrast Agents Linked to Severe Skin Disorder NSF/NSD

Halli Brownfield — Wed, 04 Jun 2008 16:08:00 GMT

Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy(NFD) is a skin and joint disease associated with the use of gadolinium based contrast agents in patients with renal insufficiency. The Clinical Journalof the American Society of Nephrologystates that "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles." NSF/NFD is characterized by areas of tight and rigid skin that makes it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inabiltiy of body organs to work properly and can lead to death.

Other signs of NSF/NFD also include:

Burning
Itching
Swelling
Hardening and tightening of the skin
Red or dark patches on the skin
Yellow spots on the whites of the eyes
Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
Pain deep in the hip bones or ribs
Muscle weakness

Gadolium-based contrast agents are used in MRIand MRA scans. An MRI scan is performed to take a clear detailed picture of a patient's internal organs and tissue and an MRA is used to take a detailed picture of a patient's blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into the patient's vein so blood vessels can be distinguished from other nearby tissues. Five gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:

Omniscan
OptiMARK
Magnevist
ProHance
MultiHance

None of these agents are approved by the FDA for MRA. The dose of gadolinium-based contrast agent given to patients undergoing an MRA is often higher (up to three times) than the approved dose for MRI.

The United States Food and Drug Administration (FDA) in 2006 acknoweldged in a Public Health Advistory that, at the time, there were 200 reports worldwide of NSF/NFD. These cases developed following patient exposure to various gadolinium-based contrast agents. The report conceded that many of these were serious and some fatal. In May of 2007, the FDA advised manufacturers of gadolinium-based contrast agents to place a "Boxed Warning" in their product directionsabout the risks of NSF/NFD. The FDA said that warning should state that use of the contrast agents in patients with severe renal insuffciency increases the risk of NSF/NFD, that the disease is debilitating and sometimes fatal, and that it affects skin, muscle, and internal organs. The FDA instructs that these gadolinium based contrast agents should be avoided unless diagnostic information is essential and cannot be obtained without a non-contrast enhanced MRI. Helath care professional are also advised to screen patients for renal disfunction before administering these gadolium-based drugs, not to exceed the recommended dosage, and to discuss with "at risk" patients the risk and symptoms of NSF.

Lawsuits against the manufacturers of these gadolinium based contrast agents have beenfiled across the country alleging that these manufacturers knew or should have known of the risks of developing NSF/NFD. These lawsuits also allege thatgadolium manufacturersshould have warned consumers and health care providers of these risks. These cases have been consolidated and transferred to federal court in Cleveland, Ohio.

For a recent news report on NSF/NFD see:

http://www.myfoxcleveland.com/myfox/pages/Home/Detail;jsessionid=8A340206B2CE23E3B64759771A510297?contentId=6580262&version=1&locale=EN-US&layoutCode=VSTY&pageId=1.1.1&sflg=1

Anyone who has undergone an MRI or MRA and exhibits symptoms of NSF/NFD should contact a lawyer immediately in order to preserve their legal rights.

Originally posted at InjuryBoard by Halli Brownfield