Personal Injury and Social Security Disability Blog

Supreme Court Ruling Protects Vaccine Makers from Lawsuits

Print media widely covered the Supreme Court ruling in a case which sought to hold a drug maker liable for the side effects of a childhood vaccine. Most sources considered the Court's decision a victory for vaccine makers.

The Los Angeles Times reported, "The Supreme Court on Tuesday shielded the nation's vaccine makers from being sued by parents who say their children suffered severe side effects from the drugs."

The AP reported, "By a 6-2 vote...the court ruled against the parents of a child who sued the drug maker Wyeth...in Pennsylvania state court for the health problems they say their daughter, now 19, suffered from a vaccine she received in infancy."

USA Today reported that the ruling was rendered in a case brought by "the parents of a child who suffered seizures after a routine vaccination." Notably, the "American Academy of Pediatrics, which along with the US government had urged the court to bar such lawsuits, said the decision will enhance the national immunization system and ensure 'that vaccines will continue to prevent the spread of infectious diseases in this country.'" But, "lawyers who represent children who have suffered adverse effects, including the American Association for Justice and Public Citizen, said the ruling is a disincentive for manufacturers to put safer vaccines on the market."

Similarly, Valerie Nannery of the Center for Constitutional Litigation "said the decision holds vaccine makers to a lesser standard for accountability," the National Journal reported. Nannery went on to say, "We are disappointed because the tort system is there to hold pharmaceutical companies accountable for vaccine design. Now these companies don't have to defend themselves in court for drug design."

The Washington Post reported, "The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed." In an opinion for the majority, Justice Antonin Scalia wrote, "The National Childhood Vaccine Injury Act of 1986 'reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.'" But, "Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products."

The Christian Science Monitor reported that the dissenting judges argued that "the high court was imposing 'its own bare policy preference over the considered judgment of Congress," and added, "The decision 'leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing and distributing their products.'"

The Wall Street Journal reported Wyeth praised the ruling, noting that a flurry of vaccine suits would jeopardize childhood vaccine supplies. In a statement, Pfizer general counsel Amy Schulman said the vaccine law rightly assigns responsibility for the design of childhood vaccines to Federal agencies. Wyeth's stance received support from the Obama Administration.

Bloomberg News reported, "The ruling is a victory for the four companies that supply vaccines for the US market -- Wyeth, GlaxoSmithKline Plc, Merck & Co. and Sanofi-Aventis SA. A ruling letting the parents sue Wyeth might have allowed suits by thousands of families that say vaccines caused autism in their children." Still, "since 1988, the no-fault process has led to almost $2 billion in compensation to more than 2,500 families.

From the American Association for Justice news release.

Toyota Recalls Two Million More Cars for Accelerator Pedal Problems

Here's more trouble for Toyota. The company has recalled more than two million Toyota and Lexus vehicles to correct problems that can cause gas pedals to become stuck in floor mats.

You can see a list of vehicles included in the recall at Toyota's recall site.

Friday Fun

This spoof of the song Memories is a perfect description of my life these days...

Parents Continue to Give Cough and Cold Medicines to Infants Despite FDA Warnings

The Los Angeles Times ran an article last week reporting that dire warnings from the food and Drug Administration have not stopped parents from giving potentially dangerous cough and cold medicines to infants. Here are excerpts:

More than half of parents continue to give over-the-counter cough and cold medicines to children under the age of 2, despite warnings from the Food and Drug Administration that the medications are not effective and that they have poisoned or killed hundreds of children, according to a new poll released Tuesday by C.S. Mott Children's Hospital in Ann Arbor, Mich. Surprisingly, more than half of physicians also told parents that the drugs were effective, despite evidence to the contrary, the poll found.

The FDA warned about the medications in 2008, which prompted a voluntary recall of many of the products. "We wanted to see how well parents and physicians were adopting those recommendations," said Dr. Matthew Davis, director of the hospital's National Poll on Children's Health and an associate professor at the University of Michigan Medical School. "Unfortunately, this latest poll indicates that the FDA warnings have gone unheeded by the majority of parents and, surprisingly, many physicians."

Within the last year, according to the poll, 61% of parents with children ages 2 and under had given their children such medications. Usage was highest among blacks (80%) and lowest among Caucasians (57%). Usage was also highest (80%) among families with an income of less than $30,000 and lowest (41%) among families with an income of $100,000 or more.

Two-thirds of the parents reported wanting their children to be able to sleep better at night or to be more comfortable during the day; 57% said having their child's doctor recommend the medicine was very important.

"Physicians are a valuable source of information for parents about this issue, but it appears that physicians are not heeding warnings about OTC cough and cold medicines either," Davis said. "Kids will be safer when parents and doctors are all on the same page in limiting these medicines to older children."

AlloDerm May Cause Hernia Surgery Failures

AlloDerm is a type of skin graft material made from decellularized human cadaveric dermis (meaning it’s made from donated skin that’s been processed to remove the cells). AlloDerm was first introduced into the market in 1994 for use treating burn victims by skin-grafting over the burn. AlloDerm is made by LifeCell Corporation. Since that time AlloDerm has been used in various other surgical applications including hernia repair surgery.

Recent studies have revealed a disproportionately high failure rate in hernia patients that have had AlloDerm products implanted during surgery. The failure of the AlloDerm product may cause the following:

- the recurrence of hernias requiring additional surgery

- abscess

- pain/soreness

- inflammation/swelling

If you are contemplating hernia repair surgery, you may want to discuss this situation with your physician before the surgery.

Almost 10,000 Infants Injured in Crib Accidents Annually

USA Today reports, "More than 9,500 babies and toddlers" go to the emergency department (ED) each year because of injuries related to "cribs, playpens and bassinets," according to a "19-year" study in the journal Pediatrics. The researchers found that an average of "113 children die each year from these accidents." Lead author Dr. Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children's Hospital in Columbus, Ohio, says the "true number of crib-related injuries and deaths is probably much higher," because the study included only children treated in EDs and "not those seen at doctor's offices or urgent-care centers."

According to the AP, the researchers analyzed "national 1990-2008 data on ER-treated injuries" from the Consumer Product Safety Commission (CPSC). Overall, the data showed "181,654 infants were injured"; and of the injured children who received ED treatment, there were "2,140 deaths."

The Washington Post, in its "The Checkup" blog, notes that an "average of 26 such injuries per day occurred during the time studied, with most (66%) involving falls, usually from cribs (83%) and most commonly affecting the head or neck (40%)." The study calls for "creation and implementation of safety measures in the design and construction of cribs, playpens and bassinets. It also recommends that parents be told how to safely use such equipment and made aware of dangers they may pose." Notably, the CPSC in December "voted to ban the manufacture and sale of drop-side cribs."

MedPage Today adds that crib injuries were "followed by playpens (12.6%) and bassinets (4.2%)." The most common diagnosis was "a soft-tissue injury (34.1%), followed by a concussion or closed-head injury (21.1%)"; and the face (27.5%) followed "head or neck" as the most frequently injured body parts. The majority of children were treated at the ED and "released (93.9%); 4% were admitted, transferred, or held for observation"; and 0.9% left "against medical advice." Most of the deaths "occurred in infants younger than 6 months and involved a diagnosis of cardiopulmonary arrest or sudden infant death syndrome (SIDS)."

Meanwhile, CNN in its "The Chart" blog notes that although the study found a "statistically significant decrease in the rate of crib-related injuries over the 19-year" period, both Dr. Smith and the CSPC "say more can be done." In a statement to CNN, the CPSC wrote that this year, it "plans to 'use the Consumer Product Safety Improvement Act and our Safe Sleep team to establish new and improved safety standards...and recall products that can pose a danger to children in their nursery.'"

Iowa company recalls half-million collapsible bassinets. The AP reported Iowa-based Burlington Basket Co. recalled 500,000 bassinets Wednesday "amid concerns that they could collapse if not assembled properly." The Consumer Product Safety Commission "says the bassinets can collapse if the support rails that hold the basket are not fully locked into place." Burlington and the CPSC have received ten incident reports, including two injuries. Burlington is offering "free repair kits to show exactly how to install the rails" instead of taking back the products. The bassinets were manufactured before June 2010.

From the American Association for Justice news release.

Consumer Group Seeks Ban on Caramel-Colored Soft Drinks

I don't care what color my Diet Coke is, but please don't change the taste!

NBC Nightly News reported, "Something a lot of us take a lot of in, caramel coloring, the stuff that makes Coke and Pepsi and other soft drinks so dark. ... A consumer group says some versions of caramel coloring contain chemicals that could cause cancer and should be banned."

The Atlanta Journal-Constitution reports that the Center for Science in the Public Interest (CSPI) is asking the Food and Drug Administration to "ban the 'caramel coloring' used in Coca-Cola, Pepsi, and other soft drinks." The CSPI contends that the coloring is "contaminated with two chemicals, 2-methylimidazole (2-MEI) and 4-methylimidazole (4-MEI)," which it says are produced with "ammonia and cause cancer in test animals." According to the Los Angeles Times "Booster Shots" blog, the CSPI filed a petition with the FDA on Feb. 16, calling for a ban on the "two cancer-causing chemicals."

Reuters quoted from a statement released by the CSPI in which the organization said that although soda's greatest health threat is obesity, the chemical reaction in the caramel coloring "may be causing thousands of cancers in the US population." The watchdog group substantiated its claim by referencing animal studies conducted by the National Institutes of Health's National Toxicology Program. Notably, the study results prompted NIH researchers to send a letter to the FDA, urging the agency to prohibit the use of 2-MEI and 4-MEI, which caused lung cancer in the laboratory mice.

Meanwhile, WebMD reported that "representatives from the beverage industry and from the Coca-Cola Company" rejected the CSPI's claims that the "additives are dangerous." In a statement to WebMD, Coca-Cola contends that "4-MEI 'forms normally in the 'browning reaction' while cooking, even in one's own kitchen.'" California, however, has "added 4-MEI to its list of carcinogens and is pursuing legislation that requires any product containing elevated levels to carry a warning label."

According to ABC World News, the American Beverage Association "said it is suing the State of California to get the chemical off its cancer list. Meantime, the FDA tells us tonight that it and the World Health Organization is already studying the chemical and its potential effect on humans.

From the American Association for Justice news release.

Friday Fun

OK, this site isn't really "fun," but it sure is an interesting idea. Have you ever lost a camera? I have, but fortunately it did not have any photos on it that had not been transferred to a computer. Some people are not nearly as fortunate. They get lazy about transferring photos, and can lose dozens of pictures if they misplace their digital camera.

To the rescue comes the I Found Your Camera site. The idea is that if you find a camera and can't determine the owner, you copy a few photos from it and upload them to this site. The site posts the photos, and with luck, the rightful owner will see the photos on the site and be reunited with the camera.

 

Over 200 Patient Deaths Linked to "Alarm Fatigue"

In a front-page story, the Boston Globe reported, "With the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses become desensitized -- sometimes leaving patients to die without anyone rushing to their bedside." In some cases, busy nurses "have not heard or ignored alarms warning of failing batteries or other problems not considered life-threatening." Overall, the deaths of more than "200 hospital patients nationwide" between January 2005 and June 2010 have been linked to "problems with alarms on patient monitors that track heart function, breathing, and other vital signs." In a separate story, the Boston Globe reported that "nurses, doctors, and healthcare leaders are concerned about staff in hospitals across the US becoming desensitized to the noise."

Solutions for "alarm fatigue" remain elusive. The Boston Globe said, "Hospitals, monitor manufacturers, researchers, and federal regulators are similarly grappling with how to reduce the rash of unheard and ignored alarms and other patient monitor problems." Solutions being explored range from "relatively simple fixes to sophisticated technology." Some, such as "UMass Memorial's effort to reduce the number of monitored patients," are being tried out in hospitals "while others are being tested in labs or debated by regulators." However, most fixes are expensive, "and may not be practical, patient safety experts say, at a time when hospitals are under enormous pressure to cut costs."

From the American Association for Justice news release.

Recalled Medical Devices Were Mostly Untested

Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."

The CBS Evening News reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."

On the front of its Business Day section, the New York Times reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."

"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."

On its front page, the Los Angeles Times reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."

"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," theMinneapolis Star Tribune reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."

Millions "may be at risk." According to the AP, an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"

Modern Healthcare quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."

From the American Association for Justice news release.