Aren't These People Suppose to Make Stuff That Helps Us?

On February 17^th, the U.S. Food and Drug Administration, (FDA), and McNeil Consumer Healthcare, a division of Johnson & Johnson, jointly announced a voluntary national recall of 574,000 bottles of grape-flavored, liquid infant Tylenol, due to pervasive complaints that newly designed bottles- released just three months ago, touted as a big improvement in dosage measurement- included a protective cover on the bottle tops that didn't work correctly, resulting in variable and faulty dosage measurements. When a plastic dose syringe was inserted into the top, the cover was pushed into the bottle, restricting medication flow. This problem, while significant enough to warrant the recall, is not life-threatening. But, it comes on the heels of an astonishing 25 J & J product recalls, since September, 2009, which have cost the company an estimated $1 billion in revenue. So, it is seen by analysts as a yet another symptom of a serious quality control problem endemic to the entire medication industry. As a result, the recall has raised eyebrows, nationwide.

The FDA is an agency of the U.S. Department of Health and Human Services, one of the cabinet-level executive departments of the federal government. It is charged with the protection and promotion of public health, through the regulation and supervision of food safety and a number of health related goods and services, including both prescription and non-prescription (over-the-counter) drugs. Headquartered in White Oak, Maryland, the FDA has 223 field offices and 13 laboratories, dispersed throughout all fifty states and American territories, including offices in several foreign countries. To regulate more than $1 trillion worth of consumer goods, about 25% of total annual consumer expenditures, nationally, it has over 9,300 employees and an annual budget of over $2.5 billion. However, given J & J's abysmal track record over the last 3-4 years, one wonders just how well all those assets are being administered, in the interests of such an important aspect of national health.

Johnson & Johnson began in 1886, as a small medical products company, in New Brunswick, New Jersey, which made sterile surgical supplies. It has since grown into an immense corporation which owns over 250 companies operating in 60 countries, making medications, medical devices, and a wide range of consumer health-related products, like sanitary goods, baby shampoo and dental floss. But, for all its success, it has had numerous recent set-backs. In April, 2011, the company pleaded guilty to bribing European doctors and agreed to pay a whopping $70 million fine. Additionally, it has been repeatedly hit with revenue and public-relations debacles, as product after product has been recalled. A review of these problems likely makes its executives reach for some as-yet unrecalled Tylenol.

In August, 2008, consultants for the company bought up large quantities of defective Motrin from stores. The FDA admonished the company for not notifying it of this "phantom recall". In November, 2009, McNeil pulled 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico. In January, 2010, McNeil expanded the withdrawal to include Benadryl Allergy, Tylenol, Children's Tylenol Meltaway, and Rolaids. Just three months later, in April, 2010, J & J recalled 135 million bottles of meds made in Fort Washington, Pennsylvania, and closed the entire plant; which resulted in a threat a month later of criminal prosecution. In June, 2010, McNeil expanded its Puerto Rico recall to include five more lots of Benadryl and Tylenol. In July, 2010, facing numerous additional recalls, McNeil submitted a remediation plan to the FDA regarding production standards for all its plants. A month later, the company appointed a quality-control czar; but the same month, J & J pulled 100,000 boxes of 1-Day Acuvue TruEye contact lenses, and days later DePuy recalled defective ASR hips. In December, 2010, the company closed its dismal year by recalling 13 million packages of Rolaids softchews, after several customers reported finding wood chips and metal particles in them.

2011 got off to a ripping start, again as, in January, J & J withdrew 43 million bottles of Rolaids, Tylenol, Benadryl and Sinutab. That same month, J & J announced its 2010 losses, from product recalls and plant closures, at a staggering $900 million. In February, 2011, J & J units announced a recall of 70,000 potentially cracked syringes preloaded with the antipsychotic medication Invega. The next month, it withdrew 585,000 surgical sutures due to concerns about compromised sterile packaging. The same month, the president of DePuy resigned as the furor over defective artificial hips escalated; while J & J's Animas unit announced a recall of 384,000 insulin-pump cartridges that leaked. Capping that disastrous month, the FDA and McNeil announced a Consent Decree giving the agency extended oversight of three production plants.

Despite this appalling record, J & J and its subsidiaries are not the only bad boy on the block. In January, 2012, Pfizer recalled one million packets of birth control tablets with incorrect dosages. And, just since 2006, literally thousands of recalls have occurred, including not only non-prescription products, but critical prescription medications, implants, surgical supplies and devices, and more. Consequently, there is growing concern that the FDA is just not up to the enormous tasks before it. A 2006 Institute of Medicine study found major deficiencies in the current FDA system for insuring drug safety. Following the Bush II years, nine FDA scientists even appealed directly to newly elected President Obama, to stop data manipulation and corrupt methodologies in pursuit of medical device approval. Conversely, many criticize the FDA as being biased in favor of pharmaceutical giants, squeezing out start-ups and small companies. And there are outright claims of incompetence. A recent, prestigious medical report found that most medical devices recalled over the last five years were fast-tracked by the FDA and approved despite serious health concerns.

It's unclear where all this leaves the average American citizen, who simply wants good care and quality for a fair price. Companies can't be completely trusted to deliver, as time and again, they disappoint. The government agency charged with our safety has a mediocre record at best; and Congress is utterly clueless about either the problem or any solution. So, guess what: the best defense, however belittled by big business, insurers and the radical right, is an offense, in the form of the trial bar. The best way to bring wayward companies to account is to sue them, when their greed, inattention, negligence and indifference disrupt your health, security and very life. If you are the victim of a defective medication, a botched medical procedure, a faulty medical device, or some other abuse, do not be afraid to hold those responsible fully accountable. It's the only medicine that really works.

Continue reading: http://articles.boston.com/2012-02-17/lifestyle/31072014_1_tylenol-plastic-syringe-mcneil-spokeswoman

http://www.foxbusiness.com/industries/2012/02/17/jj-recalls-574000-infant-tylenol-bottles-citing-dosage-issues/.