Surgical pain pumps became popular among orthopedic surgeons in the 1990’s as an alternative to longer hospital stays and prescription narcotics. The pain pumps, a post surgical medical device that delivers local anesthetics to the area through a plastic tube, were used to alleviate pain after joint surgery, particularly shoulder surgery. However, some of the patients who received pain pumps have developed an ailment known as chondrolysis where the cartilage in the joint dies, leaving joint bones to grind on each other.
According to an article in the NY Times, some studies have linked chondrolysis to the insertion of these pain pumps. In spite of their popularity, the pain pumps were never authorized by the FDA for such use. Those who are critical of the pain pumps note that by exposing cartilage to local anesthetics for up to 72 hours, the medications used to soothe pain turn toxic and lead to the deterioration of the cartilage. Last November, the FDA issued a warning about the pain pumps so as to discourage doctors from using them in joints.
The NY Times article stated, “In late 2006, after a handful of studies indicated that the pain pumps might be causing chondrolysis, the I-Flow Corporation, the largest pump manufacturer, changed its directions in package inserts to advise doctors to avoid placing the pump catheters in joints. In 2007, I-Flow posted a bulletin on its Web site notifying physicians of the risk.
The first lawsuits against pain pump companies were filed about two years ago. It is difficult to know the exact number of suits, but I-Flow reported in November that it was a defendant in 191 chondrolysis cases involving 412 patients. Of those, the company said, 80 suits were dismissed. Kay Jackson, a spokeswoman for the Kimberly-Clark Corporation, which purchased I-Flow last year, declined to comment, citing the pending litigation.
AstraZeneca, which until 2006 sold a local anesthetic that was used in the pumps, is a defendant in 68 active cases, said Tony Jewell, a company spokesman. AstraZeneca did not promote the drug, bupivacaine, for use in pain pumps inserted in the joint, nor did it seek approval for such a use, he said.

In Sunday’s edition of the NY Times, highlighted the growing problem of radiation overdoses in the United States. Radiation therapy has become increasingly popular, especially in the treatment of cancer. Since 1980, the lifetime dose of radiation a person receives has increased seven fold. However, radiation is not without its risks and potential for serious injury. Dr. John J. Feldmeier, a radiation oncologist at the University of Toledo estimates that 1 in 20 patients will be injured by radiation therapy. As part of its investigation, the NY Times researched the issue in NY state hospitals from 2001 to 2008 and found 621 radiation mistakes including radiation applied to the wrong area of the body.
One particularly gruesome example highlighted in the Times article concerned a 43 year old man who received radiation to treat tongue cancer. In this case, the hospital failed to detect an equipment error which directed radiation at his brain stem and neck rather than the intended area. He died in excruciating pain, unable to see, hear, and unable to swallow. The man died in 2007.
Because such medical errors are not disclosed to the public in NY state, prospective radiation patients aren’t able to know which hospital has had radiation errors in the past. This lack of accountability leaves patients in the uncomfortable situation of having to place blind trust in hospitals or institutions that may have committed serious radiation errors in the past. It also doesn’t force such hospitals to correct errors or prevent them from occurring in the future.

The first federal court hearing on the Chinese Drywall lawsuits will be heard by US District Judge Eldon Fallon. The hearing is crucial because it involves remediation procedures as well as how much such remediation measures will cost. Most likely, the discrepancy concerning the cost of remediation will be large. The hearing will also set standards for federal Chinese drywall cases beginning in March.
Chinese drywall has damaged homes across the country but has had the most severe impact on southern states such as Florida, Virginia, and Alabama. The contaminated drywall has been associated with the corrosion of electrical equipment and has filled homes with a strong sulfur-like odor. One defendant, Taishan Gypsum Co. Ltd., has already been found in default for failing to respond to lawsuits naming the company as a defendant in the Chinese drywall lawsuits. Taishan Gypsum is controlled by the Chinese government.
The Consumer Products Safety Commission has received 2,800 complaints about Chinese drywall. The Chinese drywall was imported due to a shortage of drywall following the 2004-05 hurricanes. It’s estimated that 500 million pounds of the contaminated drywall was imported during the housing boom, perhaps affecting 100,000 US homeowners.

Meridia, the diet drug marketed by Abbott Laboraties, Inc, will receive a warning label for an increased risk of heart attacks and strokes in patients who’ve had prior cardiac history, including cardiac failure, hypertension, and irregular heart beats.
The FDA originally approved Meridia as a weight loss drug to be used in conjunction with regular diet and exercise. Meridia is related to the amphetamine family of stimulants.
On the same day that the FDA added the warning label to Meridia, the FDA counterpart in Europe has called for an outright ban of the substance sibutramine – sold in Europe under several names, including Reductil, Reduxade and Zelium. The European ban suggestion came in the wake of a study of 10,000 patients who had shown an increased risk for heart disease after taking a form of sibutramine.
The FDA plans to study the SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) report after it’s received from Abbott. The federal agency will most likely issue their own findings in a new report concerning Meridia sometime in March.

Stryker had been in the news the last few years over lawsuits filed against the medical company for its defective artificial hips. Now, Stryker faces lawsuits concerning its pain pump medical device. One such lawsuit filed in federal court in Las Vegas alleges that Stryker officials have been marketing the pain pump for uses other than those approved by the FDA.
Stryker pain pumps are inserted into the joint space of the shoulder and have been associated with damage to the surrounding cartilage. The lawsuit filed in Nevada alleges, “Stryker knew or should have known that its pain pumps, when used with aesthetic medications in the joint space, could be toxic to shoulder cartilage.”

Federal prosecutors have charged Johnson & Johnson in a huge kickback scheme and the FDA has been critical of the pharmaceutical company for its slow response in recalling some of its most popular drugs. Both are serious public relations set backs for a company that had been considered the gold standard for responding to crises. Since the company’s handling of the Tylenol recall in 1982, Johnson & Johnson has fallen from its lofty perch.
The latest recall involves Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph. The recall has been expanded and involves a moldy odor that appears to have been caused by a chemical that’s used to treat wood pallets used to store and transport the OTC drugs. Those affected by the pills have reported nausea and stomach problems. However, none of the reports have mentioned serious health concerns.
According to the American Chemical Society, “The chemical 2,4,6 tribromoanisole (TBA) is closely related to 2,4,6-trichloroanisole (TCA), the culprit behind wine’s Cork Taint. 2,4,6 tribromoanisole is the reason for the McNeil Health nationwide recall of all lots of Tylenol Arthritis with the red EZ OPEN CAP. This chemical is responsible for a musty odor, as well as gastrointestinal distress.”

Muscle Master has issued a voluntary recall of 17 of its body building supplements after the FDA informed the company that these products contain steroids. The products that contain ingredients the FDA believes have steroids include “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” Acute liver injury has been associated with products containing steroids. Symptoms of such injury include shrinkage of the testes and male infertility; masculinization of women; breast enlargement in males; short stature in children; a higher predilection to misuse other drugs and alcohol; adverse effects on blood lipid levels; and increased risk of heart attack, stroke, and death.
The recalled products are as follows:
• Advanced Muscle Science Dienedrone, 60 caps
• Advanced Muscle Science Liquidrone, 60 ml
• Anabolic Formulation M1, 4AD, 60 caps
• Anabolic Formulations 1, 4 AD, 60 caps
• Anabolic Xtreme Hyperdrol X2
• Anabolic Xtreme 3-AD, 90 caps
• BCS Labs Testra-Flex, 90 caps
• Competitive Edge Labs M-Drol, 90 Caps
• Competitive Edge Labs P-Plex, 90 caps
• Competitive Edge Labs X-Tren, 90 caps
4Ever Fit D-Drol, 60 caps
• Gaspari Novedex XT 60 Caps
Gaspari Halodrol Liquigels, 60 gels
• iForce 1,4 AD BOLD 200, 60 Caps
• iForce MethaDROL, 90 caps
• iForce Dymethazine, 60 caps
• Monster Caps, 60 caps

Scott Reuben, a Massachusetts anesthesiologist, is seeking a plea deal with federal prosecutors over charges that the doctor faked research intended to support the benefits of Merck and Pfizer drugs. The drugs include Vioxx, Bextra, and Celebrex. According to the Associated Press, Reuben has agreed to plead guilty in exchange for a more lenient sentence. Federal prosecutors have said Reuben faced up to a 10 year prison sentence and a $250,000 fine.
The federal prosecutors have charged Reuben with receiving payments from the pharmaceutical companies in exchange for favorable research about the companies’ drugs.
The allegations against Reuben call into question the veracity and independence of research performed at the behest of pharmaceutical companies. Many doctors have depended upon such “scientific” research in order to properly prescribe drugs and therapies for their patients.

Federal prosecutors have charged pharmaceutical company Johnson & Johnson with paying tens of millions of dollars to Omnicare Inc as an inducement to buy their products and recommend them to nursing homes. The payments were made from 1999 to 2004 when Omnicare purchases tripled to $280 million. The federal complaint alleges that a “substantial portion” of these were charged to Medicaid.
According to the Wall St. Journal, “Omnicare was in a unique position to encourage sales of preferred products, prosecutors said. The company’s pharmacists reviewed the medical charts of nursing-home patients monthly and their drug recommendations were followed by doctors more than 80% of the time, they said.
In November, Omnicare agreed to pay $89 million to settle charges related to the alleged kickback scheme. IVAX Pharmaceuticals, a unit of Teva Pharmaceutical Industries Ltd., agreed to pay $14 million to settle related allegations.”

In 1982, Johnson & Johnson was hailed for its efforts to deal with a catastrophic event-the lacing of its product with cyanide. Years later, the company has been hailed for its proactive approach in dealing with a cataclysmic crisis. Yet, in 2010, the same company has been hit with an allegation that it ignored consumer complaints that its pills smell “musty”. According to the FDA, the company disregarded consumer complaints about the funny smell. It took more than five months and and FDA investigation for the company to respond to the allegations.
What happened in the intervening years for such a collapse to occur? Perhaps, complacency or the perception of a lack of federal oversight led Johnson & Johnson to delay action on an important consumer complaint. The FDA is saying the problem is systemic within the company. One would think the huge pharmaceutical company would jump on such a potential health safety nightmare.