December 2010 Archives

Gadolinium-Based Contrast Agents Get Black-Box Warning: Consumers may be at Risk of Developing Nephrogenic Systemic Fibrosis, the FDA Says

December 30, 2010

On September, 2010, and after years of investigation, the Food and Drug Administration (FDA) finally concluded that a black-box warning was necessary to inform patients and health care professionals of the risks of using certain Gadolinium-based contrast agents (GBCAs).

More specifically, the FDA said, GBCAs are "inappropriate for use among patients with acute kidney injury or chronic severe kidney disease." The agency arrived at this conclusion after studies suggested that Gadolinium, an intravenous drug for use with magnetic resonance imaging (MRI), can cause a potentially-fatal condition known as nephrogenic systemic fibrosis (NSF) when administered to patients with kidney disease.

But not all GBCAs are equally risky. Instead, available medical data indicates that Magnevist, Omniscan, and Optimark, are associated with a greater risk of NSF than other GBCAs - the consequences can be devastating, as NSF creates excess fibrous connective tissue in the skin, joints, eyes, and internal organs, leading to an inability to move and even death.

Other symptoms associated with NSF are scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. So dangerous are these symptoms that the FDA has recommended that health care professionals estimate kidney function through laboratory testing before administering GBCAs, and that they avoid the use of GBCAs in patients with kidney disease, among other precautions.

For more information about Gadolinium visit www.fda.gov.

Merck & Co. is Found Guilty of Fraud: Boston Jury Awards 4.6 Million to Commonwealth of Massachusetts

December 27, 2010

Little did Merck & Co. know that when it purchased drug manufacturer Warrick Pharmaceuticals the purchase would end up costing the company a verdict of guilty in federal court.

But the jury spoke loud and clear. On September 2010, and after a three-week trial, a Boston jury found Merck guilty of fraud and awarded the state of Massachusetts approximately $4.6 million in compensatory damages--the punitive damages award could be exorbitant.

The verdict came after evidence strong enough to convince the jury indicated that Warrick Pharmaceuticals, now Merck & Co., had overcharged Massachusetts pharmacists for generic versions of the asthma medication albuterol.

But Merck won't go down without a fight: The New Jersey company intends to appeal the verdict and hopes the court of appeals will find the prices Warrick reported to other government entities were accurate.

Unfortunately, this is not the first time Merck gets in trouble with the law. Just last month, the company was ordered to pay $1.5 million to a Florida woman whose consumption of Fosamax, an osteoporosis drug, caused her to develop osteonecrosis of the jaw - a condition marked by pain, swelling, infection and exposed bone. Merck also manufactures Gardasil, a popular cervical cancer vaccine that has been linked to blood clots, fainting, and seizure-like activity.

DePuy Hip Replacements Recalled: High Failure Rate Drives Manufacturer to Take the Product off the Market

December 23, 2010

The success of DePuy Hip Replacements was short-lived. After only a few years in the market, on September, 2010, Depuy Orthopedics, Inc. had to take its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System off the market due to a relatively high failure rate within five years of surgery, which required patients to seek additional surgery.

The recall, which was voluntary, is expected to be a big expense for the company, which has reportedly suggested that patients utilizing the recalled products see their implant surgeons for a full evaluation of performance. The cost of any doctor visits, tests and procedures associated with the recall will be carried by the company.

This, however, will not be DePuy's only expense, as those affected by the defective product have already started filing suit. Indeed, so many lawsuits have been filed, that a Multi-District Litigation (MDL) has been established in the Northern District of Ohio to hear all DePuy hip replacement claims filed in federal court. Canada patients have also started demanding compensation for their failing hip replacements.

The countless lawsuits and the additional expense are only some of the problems these devices have brought to the company. Last summer, DePuy came under the scrutiny of the Food and Drug Administration for its marketing practices, which violated the Federal Food, Drug, and Cosmetic Act. According to the FDA, the company violated the Act when it advertised some of its hip replacements without obtaining the required marketing approval.

What would happen to the company next has yet to be seen, but one thing is clear: DePuy's hip replacement will leave their mark on the company's pockets which will have to carry the expense of litigating hundreds of suits.