Recent Case Results
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.
Another fruit juice is the subject of health concerns – orange juice. Several weeks ago Coca-Cola found a fungicide called carbendazim, a toxic pesticide, in orange juice imported from Brazil and reported the problem to the U.S. Food and Drug Administration (FDA). In response, the FDA has halted imported shipments of orange juice while it tests orange juice shipments for possible contamination of carbendazim.
The FDA has indicated that it is not concerned about the safety of orange juice that is currently on store shelves, but if the tests reveal a public health concern, the FDA could take action to remove the product from retailers.
Some experts have expressed concerns that the presence of fungicide in imported orange juice highlights holes that exist in the FDA’s regulatory system. Although the U.S. has taken measures to prevent the presence of carbendazim and other pesticides in U.S. food sources, these measures have limited effect when other countries have not taken the appropriate measures to ensure that their products are free from dangerous chemicals. Accordingly, some experts recommend that the FDA take additional steps to prevent the importation of unsafe food products.
The orange juice scare comes on the heels of recent health concerns over levels of arsenic in apple juice. As we recently reported, 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.
Consumers can be proactive about limiting potential exposure to dangerous chemicals by taking the following precautions:
- Drinking domestic, rather than imported, orange juice
- Drinking certified organic juice
- Eating fresh oranges and other fruit instead of drinking juice
The Chicago product liability attorneys at Steinberg, Goodman & Kalish are dedicated to promoting safe food sources and protecting the victims of product liability cases and foodborne illnesses.
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) launched a new website on April 4, 2011 to help consumers and the food industry better track food recalls. The website – http://www.fda.gov/Safety/Recalls/default.htm – was created pursuant to a mandate in the Food Safety Modernization Act requiring the FDA to create a more user-friendly recall search engine.
The website combines data from news releases and other product recall announcements since 2009. The information is organized by product brand name, product description, the recalling company, reason for the recall and whether the recall was voluntary or pursuant to a mandatory order.
The FDA is also looking for ways in which to better handle recalls and is considering hiring an outside firm to ensure that food companies resolve food recall issues and remove the recalled products from store shelves. According to Michael Landa, acting director of the FDA’s food center, the FDA plans to assemble an outbreak response team by this summer to better coordinate outbreaks by overseeing surveillance of the food industry, as well as response time after outbreaks, in order to determine the root cause of the food contamination.
According to the FDA, the agency consulted with stakeholder groups, including the Center for Science in the Public Interest, Consumers Union, Food Marketing Institute, Grocery Manufacturers Association, the Pew Health Group, and Safe Tables Our Priority in order to gain insight on how to most effectively and easily communicate recall information to consumers.
The experienced Illinois product liability attorneys at Steinberg, Goodman & Kalish are committed to protecting consumers from defective products and tainted food. If your or a loved one has been injured or killed by a defective product, including contaminated food, contact one of our Chicago area personal injury attorneys to discuss a possible product liability or wrongful death claim.
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.
Two U.S. Senators have asked the U.S. Food and Drug Administration (FDA) to increase their oversight of medical product manufacturers following product recalls at Triad Group. On April 1, 2011, Sens. Michael Bennet (D-Colo.) and Lamar Alexander (R-Tenn.), both members of the Senate Committee on Health, Education, labor and Pensions, 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.
According to a Milwaukee Journal Sentinel article, Triad has been sued by a Texas couple who allege that the company’s alcohol wipes were the cause of a bacterial infection that caused the death of their 2-year-old son. In January 2011, Triad recalled all of its swabs and wipes due to suspected contamination with the bacteria Bacillus cereus, which can lead to life-threatening infections in at-risk populations, including surgical and immune-suppressed patients. According to Triad, the recall was being done out of an “abundance of caution” and was not linked to an illness or death.
According to the Journal Sentinel, on March 29, a Colorado hospital confirmed that two-thirds of the Triad-made alcohol prep pads it tested were contaminated with Bacillus cereus and a recent FDA inspection report revealed numerous issues at the Triad plant, including employees packing acne pads into product containers with their bare hands and children’s multi-symptom cold medicine made without a necessary active ingredient.
Earlier this week, the FDA asked Triad Group to voluntarily stop production of its drug products. The company has not said whether it would comply with the request.
According to Sen. Bennet’s communications director, Adam Bozzi, “[t]he Senators are hoping the FDA will shed some light on what they knew about the problem and review both the agency’s and the company’s role in oversight, manufacturing practices and enforcement of compliance measures. They also hope to find ways moving forward that this type of incident does not happen in the future.”
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.
