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Family settles defective heater case for $18.275 Million

A defective heater caused a fire which caused the deaths of two and severe injuries to one family member. After filing product liability wrongful death and survivial lawsuit against Lakewood Engineering & Manufacturing Co. for manufacturing the defective heater, the defendant company paid a settlement of more than $18 million.

Heart Medicine Multaq (Dronedarone) Can Cause Severe Liver Damage

FA has issued a new safety warning on the heart medicine Multaq (dronedarone) which is used to control atrial fibrillation or heart flutter. Multaq has been found to cause rare but severe cases of liver damage, and at least two patients have required liver transplants after taking Multaq.

Does treatment of acne with drugs increase risk of suicide attempts?

New research indicates a connection between suicide attempts and severe acne treated with forms of Isotretinoin. Isotretinoin is also sold under brand names including Accutane, Claravis and Sotret. Caution and monitoring are recommended.

Adulterated drugs including Paxil and Bactroban sold for years by drugmaker

GlaxoSmithKline manufactured adulterated drugs for years at its plant in Puerto Rico. It has paid fines of $750 million to settle allegations that adulterated drugs were manufactured and sold for years, including the popular antidepressant Paxil and the antibiotic Bactroban, as well as a diabetes medicine and an antinausea drug.

FDA Restricts and Warns on Diabetes Drug Avandia: Heart Attack and Stroke Risks

Avandia, a popular Diabetes Type 2 drug, and related drugs, has now been made subject to restrictions and warnings by the U.S. Food and Drug Administration because it increases risks of stroke and heart attack.

Botox jury awards $15 million to injured patient

The manufacturer of Botox is Allergan, being sued for negligence in multiple lawsuits. In a recent Oklahoma case, the jury found Allergan negligent and awarded $15 million in damages to a woman who fell ill and could not work after she received a course of Botox injections for wrinkles.

Severe Liver Injury Alert -- Xenical and Alli Weight Loss Products

Rare but severe liver injuries are possible in users of two weight loss products which contain a potentially dangerous ingredient, Orlistat. Xenical is a prescription drug, while Alli is over the counter and widely marketed nationwide.

Drug Trial Test Results More Favorable in Trials Funded by Pharmaceutical Industry

Drug trial studies more likely to show that the drug works when trials were funded by the pharmaceutical industry.

Taking Calcium Supplements Can Significantly Increase Heart Attack Risk Study Says

Study suggests that those at risk for heart attack should not take additional calcium supplements.

Drug company agrees to settle Paxil birth defect cases

GlaxoSmithKline, which manufactures the antidepressant Paxil, has reportedly agreed to pay $1 billion to settle lawsuits alleging that Paxil caused birth defects in children of women who took the drug. The settlement does not cover all of the pending Paxil birth defect cases.

FDA Issues Warning for Body Building Products

A warning was issued by the U.S. Food and Drug Administration (FDA) for consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

A Warning Letter was issued to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances.  The products listed in the Warning Letter to American Cellular Laboratories Inc., include "TREN-Xtreme," "MASS Xtreme," "ESTRO Xtreme," "AH-89-Xtreme," "HMG Xtreme," "MMA-3 Xtreme," "VNS-9 Xtreme," and "TT-40-Xtreme," and are sold on the Internet and in some stores.

The FDA has received reports of serious adverse events associated with the use of these products which includes cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung).

For a free consultation, see the medical malpractice attorneys of Pennsylvania.

FDA Recalls Hydroxycut Products

The Food and Drug Administration (FDA) warned dieters and body builders Thursday to immediately stop using Hydroxycut.  The FDA said that the manufacturer of the dietary supplement has agreed to recall 14 Hydroxycut products which are available in grocery stores and pharmacies.

These supplements which are used by people trying to shed pounds or by body builders to sharpen their muscles have been linked to cases of serious liver damage and at least one death.

Hydroxycut is advertised as made from natural ingredients and accounts for about 90% of the market for weight loss supplements.

Dietary supplements are not as tightly regulated by the government as medications. Manufacturers don't need FDA approval ahead of time before marketing their products.

 

If you or someone you love suffered injury as a result of taking a diet pill, contact the medical malpractice attorneys of Pennsylvania for a free consulation.  Berger & Lagnese specializes in cases involving dangerous products.

You Need to Read This If You Take Diet Pills

According to the FDA, many diet pills that are marketed as "all natural" actually contain undeclared potent pharmaceutical drugs that could have dangerous side effects or harmful interactions with prescription drugs you may be taking.  In the coming weeks, the FDA will be adding to this list of diet pill brands to avoid because they are that are spiked with drugs, so check back frequently.

If you or someone you love suffered an injury as a result of taking a diet pill, contact the lawyers at Berger & Lagnese for a free evaulation of your situation.

FDA Alerts Public About Danger Of Skin Numbing Products

The FDA has issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.

Skin numbing products are used to desensitize nerve endings that lie near the surface of the skin, causing a numbness of the skin. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. When applied to the skin surface, they can be absorbed into the blood stream and, if used improperly, may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma, or even death.

The FDA has received reports of adverse events and deaths of two women who used topical anesthetics before laser hair removal.

The FDA strongly advises consumers not to:

- make heavy application of topical anesthetic products over large areas of skin;
- use formulations that are stronger or more concentrated than necessary;
- apply these products to irritated or broken skin;
- wrap the treated skin with plastic wrap or other dressings; and
- apply heat from a heating pad to skin treated with these products.

Report Finds FDA Lax on Oversight of Doctors During Clinical Trials

According to an investigation conducted by the inspector general of the Department of Health and Human Services, the FDA does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects.  The investigation revealed that in 42 percent of clinical trials, the FDA did not receive the required forms disclosing doctors’ financial conflicts and did nothing about the problem.  In 31 percent of the trials in which the FDA did receive the required conflict forms, agency reviewers did not document that they looked at the information.  And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the FDA nor the sponsoring companies took any action to deal with the conflicts.

This investigation provides further evidence that money doctors routinely collect from drug and device makers may hurt patients and skew studies.

FDA Approving High Risk Medical Devices without Thorough Review of the Devices

Congressional investigators said yesterday that some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review.

The Government Accountability Office said in a report that the Food and Drug Administration approved 228 medical devices without a full scale review from 2003-2007.

New Report Faults the Way the FDA Approves Medical Devices

In a report released Thursday, the Government Accountability Office ("GAO") recommended that the FDA fulfill promises it made 14 years ago to fix its system for approving complex medical devices. The report was mandated by Congress in legislation passed in 2007 to reform the FDA.

Most medical devices are given quick approvals with minimal testing because manufacturers tell the FDA that the products operate just like older, already-approved devices.  The GAO report recommends that complex and potentially risky medical devices be thoroughly tested before they are approved for widespread use.

New Study Finds Risperdal, Zyprexa and Seroquel Double Patient Risk of Sudden Heart Failure

A new study published in The New England Journal of Medicine has found that the popular drugs known as atypical antipsychotics, prescribed for an array of conditions, including schizophrenia, autism, and dementia double patients’ risk of dying from sudden heart failure.

The finding is the latest in a succession of recent reports contradicting the long-held assumption that the new drugs, which include Risperdal, Zyprexa and Seroquel, are safer than the older and much less expensive medications that they replaced.

Stork Craft Baby Cribs Recalled Due to Suffocation Hazard

The makers of Stork Craft baby cribs is recalling more than a million cribs in Canada and the United States because of a potential suffocation hazard.  The U.S. Consumer Product Safety Commission says the metal brackets used to support the mattress and mattress board can crack and break. The cribs were sold at major retailers like Kmart, Wal-Mart and J.C. Penney.

FDA Announces Recall of Device Used in Eye Surgery

The U.S. Food and Drug Administration has announced a recall of a device used in eye surgeries.  The device was manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, California.  The device that was recalled is used to maintain space in the eye during surgery. Typically, such devices are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of the device bearing lot no. UD30654, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS).  TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens), and has been linked to the use of devices such as the device that has now been recalled.

If you underwent eye surgery within the last six months and developed TASS, you may be entitled to money damages.  Contact the lawyers at Berger & Lagnese for more information.

New Study Links Osteoporosis Drugs to Painful Jaw Condition

Previous reports had indicated that the risk of developing osteonecrosis of the jaw (ONJ) from taking bisphosphonates in pill form were "negligible".  However, a new study published in the January 2009 issue of the Journal of the American Dental Association suggests that the proportion of people taking these widely prescribed oral osteoporosis drugs who develop ONJ may be much higher than previously thought.

ONJ is characterized by pain, soft-tissue swelling, infection, loose teeth and exposed bone.  Use of bisphosphonates has been associated with other problems in the past, including an increased risk of atrial fibrillation (a type of abnormal heart rhythm), unusual fractures of the thigh bone, and inflammatory eye disease.  Fosamax (alendronate) is the most widely prescribed oral bisphosphonate.

Evenflo Majestic High Chair Recalled

Evenflo Company Inc. has recalled about 95,000 Evenflo Majestic High Chairs because plastic caps and metal screws on both sides of the high chair can loosen and fall out, causing a falling and choking hazard to children. The high chairs were sold nationwide at major retailers from January 2006 until May 2007.

If you own such a high chair, or if you have any questions, you can contact Evenflo at (800) 233-5921 or visit Evenflo's website by clicking here.

Berger & Lagnese is your premier law firm for cases involving injury due to defective and dangerous products.  Contact the lawyers at Berger & Lagnese for a free consultation.

Breast Cancer Fund Links BPA With Cancer

The Breast Cancer Fund is out with its fact sheet that links the chemical known as BPA (which is found in the urine of 93% of Americans tested) to cancer.

FDA to Reconsider BPA Risk

Weeks after the FDA's own advisory board accused the FDA of failing to adequately consider research showing the dangers of bisphenol-A (BPA), a chemical found in many plastic baby bottles, plastic food containers, and metal can linings, the FDA has announced that it will reconsider the issue.

The FDA issued a draft risk assessment in August 2008, finding the chemical safe as it is now used.  This assessment was controversial because it stood out against a tide of recent scientific opinion to the contrary.  For example, the National Toxicology Program, part of the U.S. Department of Health and Human Services, is of the opinion that there is reason to be concerned that BPA could harm the brain, behavior and the prostate gland in fetuses, infants and children.  This year, Canada added BPA to its list of toxic substances and plans to ban BPA from the plastics used to make baby bottles.  A study published in the Journal of the American Medical Association in September 2008 found that adults with high levels of BPA in their urine were more prone to heart disease, liver disease and diabetes.  As if that were not enough, more than 200 animal studies have linked minute amounts of BPA to a range of reproductive problems, brain damage, immune deficiencies, metabolic abnormalities, and behavioral oddities like hyperactivity, learning deficits and reduced maternal willingness to nurse offspring.

FDA Warns Consumers About Multiple Diet Pills Due to Risk of Serious Injury or Death

The FDA has announced a recall of 23 different diet and weight loss pills because they contain undeclared active pharmaceutical substances that may pose serious health risks to consumers.  The following pills and supplements are subject to this recall:

• Fatloss Slimming
• 2 Day Diet
• 3x Slimming Power
• Japan Lingzhi 24 Hours Diet
• 5x Imelda Perfect Slimming
• 3 Day Diet
• 7 Day Herbal Slim
• 8 Factor Diet
• 7 Diet Day/Night Formula
• 999 Fitness Essence
• Extrim Plus
• GMP
• Imelda Perfect Slim
• Lida DaiDaihua
• Miaozi Slim Capsules
• Perfect Slim
• Perfect Slim 5x
• Phyto Shape
• ProSlim Plus
• Royal Slimming Formula
• Slim 3 in 1
• Slim Express 360
• Slimtech
• Somotrim
• Superslim
• TripleSlim
• Zhen de Shou
• Venom Hyperdrive 3.0

If you are taking any of these pills, stop immediately.

If you suspect that you have been injured as a result of taking one of these diet pills, you should call the lawyers at Berger & Lagnese at 412-471-4300 or toll free 800-350-6161, or email us.  Berger & Lagnese has an experienced team of lawyers that specializes in dangerous and defective product lawsuits.