Recent Case Results
The patient’s right hip joint replaced by a metal head and a plastic cup. (Photo credit: Wikipedia)
A recent Consumers Report investigation has revealed some startling news regarding medical devices. One would expect that, because medical devices are inserted into a person’s body, they are tested and retested to ensure adherence to stringent safety standards. But the Consumer Reports revealed that this may not be the case. In fact, the report found that many medical devices are not clinically tested at all.
According to this ABC News article, some medical devices, including defibrillators, joint replacements and surgical mesh, have not been clinically tested prior to approval by the U.S. Food and Drug Administration and use by physicians throughout the country.
In the article, Dr. Stephen Tower reveals that his artificial hip replacement because to cause him so much pain and exhaustion that he decided to have it removed. When it was removed, they found that the “tissues around the hip had been destroyed and that metal debris was spreading down [his] thigh.” Friction in the artificial joint had caused cobalt, which is a toxic metal, to be released in his body, which eventually led to serious tissue, heart, brain and thyroid problems.
Tower’s hip replacement – the ASR XL – had never been clinically tested before the FDA approved the medical device to be sold and inserted into patient’s bodies.
In addition to dangerous hip replacements, “[h]undreds of thousands of women have had mesh slings inserted to support internal organs as they age, like the uterus and bladder,” says Nancy Metcalf, Consumer Reports senior editor. “Again, these products were never clinically tested before being marketed for this use.”
Despite the fact that the FDA’s database shows thousands of complaints about transvaginal mesh, the medical device is still on the market.
In the article, Metcalf states, “We strongly believe that the FDA should require rigorous testing for implantable devices just like they do for prescription drugs now.” Consumer Reports suggests that the creation of a national registry for medical devices is necessary in order to track implanted medical devices and alert patients of any problems with the devices. Currently there is no such tracking program for medical devices in the country, and many suspect that only a small portion of problems with medical devices actually get reported.
Last April, we reported that two U.S. Senators – Sens. Michael Bennet (D-Colo.) and Lamar Alexander (R-Tenn.), both members of the Senate Committee on Health, Education, labor and Pensions – asked the FDA to increase their oversight of medical product manufacturers following product recalls at Triad Group. The senators had submitted a letter to the FDA in which they expressed their concern that the FDA was aware of manufacturing sterility and contamination problems at Triad Group as early as July 2009, but failed to take appropriate action to protect the public until late 2010. In their letter, the Senators urged the FDA to review its oversight procedures with respect to medical product manufacturing to ensure that manufacturers comply with recommended safety measures.
Steinberg Goodman & Kalish (www.sgklawyers.com) is dedicated to protecting victims and their families. We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.
Pfizer recently recalled about 1 million packets of birth control pills due to a packaging error that could increase the likelihood of pregnancy. The recalled pills included 14 lots of Lo/Ovral-28 birth control pills and 14 lots of generic Norgestrel and Ethinyl Etstradiol pills, all of which were marketed by Akrimax Rx Products and have expiration dates between July 31, 2013 and March 31, 2014.
Birth control pills typically contain 21 days of active pills and 7 days of placebo pills, but some of the recalled packets contained too many active pills, others contained too few active pills, and still other packets contained active and inactive pills that were out of sequence.
“As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy,” Pfizer said in a statement. “…Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.”
Pfizer first learned of the problems with the pills when a customer complained to the company last October that she noticed that her package of pills did not contain the right amount of active and placebo pills. Upon further investigation, Pfizer learned that some packages of pills contained an extra active pill at day 22 or 28, one pack lacked an active pill at day 10, and another pack lacked an inactive pill at day 24. Pfizer notified pharmacies and distributors of the affected birth control pills on December 28, 2011 that it was recalled the pills.
Neither the U.S. Food and Drug Administration (FDA), nor Pfizer, have received any reports of adverse events, such as unintended pregnancies, but the FDA is investigating the matter. Women who do not take the correct amount of active pills in a one month cycle risk unintended pregnancy because they could ovulate without the proper hormonal dosage designed to prevent ovulation. Pfizer is advising women who have used the affected pills to consult with their doctors.
Many experts have begun speculating about whether the Pfizer recall could potentially lead to individual or class action lawsuits for any unwanted pregnancies. Product liability laws protect consumers from dangerous or defective products, including unsafe pharmaceuticals, due to design defects, manufacturing errors, or failures to warn the public of a potential risk associated with the product.
The Chicago product liability and medical malpractice attorneys at Steinberg, Goodman & Kalish are dedicated to protecting victims of personal injury, medical malpractice and product liability claims, including medical device recalls and unsafe pharmaceuticals.
Source: Pfizer Cites Packaging Flaws in Birth-Control Pill Recall
Steinberg Goodman & Kalish (www.sgklawyers.com) is dedicated to protecting victims and their families. We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) found no evidence of Cronobacter, the bacterial infection responsible for the recent deaths of two infants, in sealed cans of Enfamil Infant Formula, prompting the agencies to issue a joint statement indicating that there was need to recall the baby formula manufactured by Mead Johnson.
Prior to the FDA and CDC investigation, several stores, including Wal-Mart, had pulled Mead Johnson’s Enfamil Infant Formula from store shelves in the latter half of December 2011 following the death of a 10-day-old baby from Missouri and another baby from Florida. Two other babies, one from Illinois and one from Oklahoma, were also infected with the Cronobacter bacteria, but they recovered. The four infections prompted the FDA investigation, which included testing factory-sealed containers of the powdered formula mixed with nursery water with the same lot numbers as the opened containers collected from Missouri. The tests revealed no Cronobacter bacteria in any of the containers.
According to the FDA and the CDC, the Cronobacter bacteria, which is commonly found in the environment, hospitals and homes, can multiply in powdered baby formula after the product is mixed with water. The FDA has said that it is continuing to investigate the four cases of Cronobacter infections, but that the Enfamil products that were pulled from store shelves are safe for use.
Since powdered infant formula is not sterile, some experts have expressed concerns regarding the lack of adequate methods to remove or kill all bacteria that may find its way into the formula before and during production. The FDA and CDC has said that Cronobacter-related illnesses are rare and that increased awareness has led to 12 reported cases in 2011, whereas the CDC typically learns of four to six Cronobacter infections each a year.
Steinberg Goodman & Kalish (www.sgklawyers.com) is dedicated to protecting victims and their families. We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.
The controversy over arsenic in apple juice is brewing again. Fears over arsenic in juice first reached the headlines in Dr. Mehmet Oz, the host of “The Dr. Oz Show,” told viewers in September 2011 that the results of tests that he had commissioned revealed that 10 of the three dozen apple-juice sampled had total arsenic levels exceeding 10 parts per billion (ppb). There is no federal arsenic threshold for juice or most foods, but the limit for bottled and public water is 10 ppb. After Dr. Oz revealed his results, the U.S. Food and Drug Administration (FDA) tried to reassure consumers about the safety of apple juice, claiming that most arsenic in juices and other foods is of the organic type that is “essentially harmless.”
But additional data now supports the original claims of arsenic in apple juice. An investigation conducted by Consumer Reports of apple and grape juice found that:
- Approximately 10 percent of the juice samples, from five brands, had total arsenic levels that exceeded federal drinking-water standards of 10 ppb, most of which was inorganic arsenic, a known carcinogen.
- One in four samples had lead levels higher than the FDA’s bottled-water limit of 5 ppb. (There are currently no federal limits for lead levels in juice, only water.)
- Apple and grape juice make up a significant source of dietary exposure to arsenic.
- Thirty-five percent of children 5 years of age and younger drink juice in quantities that exceed pediatricians’ recommendations.
- Mounting scientific evidence suggests that chronic exposure to arsenic and lead – even at levels that are below the limits for water – can result in serious health problems.
- Inorganic arsenic has been detected at alarming levels in other foods.
The reports have been particularly confusing and controversial since arsenic comes in two forms – organic, which is relatively harmless, and inorganic, which is can be particularly harmful and is often found in pesticides. The FDA recently stated in a letter to the “Dr. Oz Show” and consumer groups that it is “seriously considering setting guidance or other level for inorganic arsenic in apple juice.”
Steinberg Goodman & Kalish (www.sgklawyers.com) is dedicated to protecting victims and their families. We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.
