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Aluminum Bat Manufacturer Found Liable For Player’s Death

Greg Webb — Mon, 16 Nov 2009 14:58:24 GMT

After twelve hours of deliberation, a jury in Lewis and Clark County, Montana recently sided with the parents of former Miles City American Legion baseball pitcher Brandon Patch, who died after being struck in the temple by a batted ball in a 2003 baseball game against the Helena Senators. Hillerich & Bradsby Co., an aluminum bat manufacturer best known for their Louisville Slugger bats, was found liable for Patch’s death because it failed to provide adequate warning as to the dangers of the bat used by a Helena Senators batter. Hillerich & Bradsby Co.’s attorneys argued any other bat would not have hit the ball any differently; in fact, they claimed most bats on the market would have stuck the ball even harder and that Patch’s death was a tragic accident. The Patch family’s attorneys, however, argued Brandon only had 378 milliseconds to respond to the batted ball, whereas most bats on average give 400 milliseconds to respond. The bat manufacturer was ordered to pay $792,000 to Patch’s estate. The funds were allocated to cover the earnings Patch would have made had he lived, and the pain he suffered for four hours after the injury before ultimately dying. Another $58,000 was awarded to Patch’s parents for funeral expenses and their mental grief.

Aluminum bats have faced a lot of scrutiny due to their internal wall structure and because their weight is more evenly distributed than wooden ones, making them easier to swing harder and faster. A third decision made in the suit was that the bat was not defective, therefore making it more dangerous like the Patch family attorneys claimed. The Patch family said the suit was never about the money but was to get adequate warning about the dangers of these bats so something like this will not happen again. They have also started to advocate for the use of wooden bats. Brandon Patch’s baseball team reverted to wooden bats after his death.

Originally posted at InjuryBoard by Greg Webb

DOJ Indicts Stryker Biotech On Charge Of Fraud

Greg Webb — Mon, 16 Nov 2009 14:45:31 GMT

The Justice Department has reported that Stryker Biotech LLC, the medical device manufacturing division of Stryker Corp., and its top management have been indicted on federal charges of fraud due to a marketing scheme for bone-growth products OP-1 implant and OP-1 putty. These two products were promoted for use in a manner different from the use approved by the Food and Drug Administration (FDA). Although Stryker did have a federal exemption that authorized it to sell the products for "humanitarian" reasons to treat a rare condition, it instead promoted a combination of the devices with a bone void filler called Calstrux and provided "recipes" on how to combine Calstrux with OP-1 in ways never approved by the FDA.

The indictment charged Stryker Biotech, its former president, and three current sales managers with a scheme that involved devices used during invasive long bone and spinal surgeries; the former president and the company were also charged with making false statement to the FDA. If the company is convicted, it could face serious fines and possible exclusion from participating in federal and state healthcare programs. The former president and the three sales managers could also face jail time if convicted of wire fraud conspiracy and misbranding charges.

Because of the potentially negative ramifications of a conviction, Stryker is expected to aggressively pursue a settlement.

Originally posted at InjuryBoard by Greg Webb

Misleading Toyota Recall Sparks Criticism From NHTSA

Greg Webb — Sun, 22 Nov 2009 08:33:15 GMT

Federal safety regulators have reprimanded Toyota Motor Corp. for issuing misleading and inaccurate statements that no defect exists in the 3.8 million automobiles it voluntarily recalled on September 29 after a 2009 Lexus ES 350 sedan accelerated out of control in San Diego County, California, killing four people. The National Highway Traffic Safety Administration (NHTSA) released a statement that the Lexus and Toyota vehicles do, in fact, have an “underlying defect” that involves the design of the accelerator pedal and the driver's foot well. Toyota officials, however, blame the accident and other uncontrolled acceleration incidents nationwide on the gas pedal becoming entrapped by an improperly installed floor mat.

In its recall, Toyota claims there is no problem with the accelerator itself but asks consumers to instead remove driver’s-side mats if the mat is incompatible with the vehicle and not properly secured; the automaker also posted a video statement which disputed news reports that the "unintended acceleration" could be linked to other factors, such as the electronic throttle control systems. NHTSA officials were thus prompted to issue a clarification and stated the matter will not be closed until Toyota addresses the defect and suggests a solution.

This incident may affect Toyota’s credibility because the automaker was alleging it had a clean record with the NHTSA when it actually did not. Toyota claims it never intentionally mislead the American public and is still developing vehicle-based remedies to ensure unintended acceleration events do not happen again; these remedies may include changes in the placement of pedals, or a change to the engine control software in the vehicles' onboard computers. Since 2003, the NHTSA has investigated eight cases of unwanted acceleration in Toyota vehicles; two of these probes led to small recalls while the other six were closed by the agency due to no finding of a defect. In all of these investigations, the NHTSA did find that the Toyota braking system could lose most of its efficiency and power when the throttle is fully opened and that other aspects of vehicle design, such as using push-button ignitions, could add risk in sudden-acceleration events. In the San Diego County incident, officials found the pedal’s design may have had an enhanced risk of being obstructed by the floor mat.

The recall affects the 2007-2010 model year Toyota Camry, the 2004-2009 Toyota Prius, the 2005-2010 Toyota Avalon, the 2005-2010 Tacoma, the 2007-2010 Toyota Tundra, the 2007-2010 Lexus ES 350 and the 2006-2010 Lexus IS 250 and IS 350.

Originally posted at InjuryBoard by Greg Webb

Fire on Ice – More Maytag Fridges Recalled

Greg Webb — Tue, 01 Sep 2009 18:01:11 GMT

Due to an electrical failure, Maytag has expanded its initial March recall of 1.6 million refrigerators to an additional 42,000, now including refrigerators under the Maytag, Magic Chef and Performa by Maytag and Crosley umbrellas. The failure is being cited as a potential fire hazard which causes the compressor to kick on at random and may lead to overheating.

The recall in March was issued after Maytag, now owned by Whirlpool Corp., received 41 reports of refrigerators catching fire, 16 of which lead to property damage. Since then, Maytag has received an additional 23 reports of fridges catching fire, 4 of which have lead to property or smoke damage.

The AP reports that, "The refrigerators in question are side-by-side and top freezer refrigerators made in black, bisque, white and stainless steel. They cost between $350 and $1,600 and were sold from September 2000 to May 2004." Maytag says that bottom-freezer models are safe to continue using.

Maytag has issued a statement imploring consumers to call (866) 533-9817 to schedule a free in-home repair rather than returning their defective appliances and purchasing new ones.

All damages and injuries resulting from a fire related to a Maytag refrigerator can be reported at the CPSC’s website: www.cpsc.gov/cgibin/incident.aspx

Originally posted at InjuryBoard by Greg Webb

Validity of Pfizer Neurontin Drug Study Questioned

Paul Thomson — Wed, 18 Nov 2009 00:01:00 GMT

Studies on the Pfizer Inc. drug Neurontin may have been skewed in order to have favorable results, reports Bloomberg. The drug is intended to treat epilepsy, however the studies focused on uses for Neurontin that had not yet been approved by the FDA. Researchers found that data from the studies on Neurontin that made its way into medical journals was inconsistent with the actual findings from the trials. Unfortunately, medical professionals assume these publications contain accurate information. What this points to is that Pfizer may have attempted to mislead the medical community about the effectiveness of Neurontin for certain off label uses. Pfizer denies this.

"Physicians are allowed to prescribe drugs for uses not approved by the FDA, and drugmakers are allowed to provide publications about off-label uses," the article states. When they are prescribing drugs for uses not approved by the FDA, studies such as the Neurontin study are doctors only source of information. Drugmakers need to provide accurate information in order to promote the best interests of doctors and patients. Our health depends on drugmakers' reliability!

Originally posted at InjuryBoard by Paul Thomson

Corruption in Psychiatric Healthcare

Paul Thomson — Mon, 16 Nov 2009 01:00:00 GMT

The Chicago Tribune reported startling ties between psychiatrist Dr. Michael Reinstein and pharmaceutical company AstraZeneca. The doctor, worth about a half million dollars to the drug maker, did research on the antipsychotic drug, Seroquel. Dr. Reinstein claimed his research found the best-selling drug had the pleasant side effect of decreased appetite, resulting in patient weight loss, despite the fact that Seroquel and similar drugs have been linked to weight gain and diabetes.

Communication between the two parties is even shadier than the unusual research conclusions. Dr. Reinstein, who also did promotional tours for AstraZeneca, is said to have made demands for his expenses to be covered and to have made threats to prescribe his patients to a competitor if his wishes were not fulfilled. AstraZeneca officials who were skeptical of Reinstein's research findings were hushed by others in power due to the doctor's importance as a customer. Both Reinstein and the company have denied making such statements, however, records of spending reveal that AstraZeneca paid the doctor $490,000 over ten years. While it is not uncommon for companies to pay researchers, this amount is excessive and also should be disclosed to the public.

AstraZeneca and Reinstein broke ties in 2008 for unknown reasons, but regardless, patients' lives were changed. Several individuals are quoted in the article who have gained excessive weight and been diagnosed with diabetes since taking Seroquel prescribed by Dr. Reinstein. It is unacceptable for doctors and drug companies to disregard their patients' well-being in order to make a profit. Corporate and individual greed does not have a place in our healthcare system!

Originally posted at InjuryBoard by Paul Thomson

FDA To Review Cosmetic Face Fillers

Greg Webb — Wed, 26 Nov 2008 08:00:00 GMT

Plastic surgeons have vowed to aid the government in tracking one of the most popular new beauty treatments, face fillers. This procedure involves facial injections, which use various kinds of gels to smooth away wrinkles, as opposed to Botox, which uses a toxin to act on facial muscles. This minimally invasive new procedure, used by both men and women, promises youthful good looks at a cheaper price and requires less recovery time than a facelift. However, unfortunately for some patients, the result can be blotchy skin, bumps on the face or worse.

The Food and Drug Administration (FDA) is worried these fillers are being used on areas not approved by the organization, such as lips. There has also not been enough research on darker skinned patients, who seem to be susceptible to complications from fillers. The FDA asked independent advisers for the best ways to monitor the long-term safety of face fillers and for guidance on improving testing and warning to potential patients about risks. The advisers will be shown data from 823 patients who suffered reactions after being treated by fillers between 2003 and this September; the overwhelming majority were women. Some of these reactions included facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions. Although no deaths have been reported, some of the complications were problematic enough to cause follow-up treatment. The American Society of Plastic Surgeons has agreed to encourage doctors to report problems, improve training for doctors and their assistants, and advise consumers.

In this writer's opinion, it seems as if one appropriate course to take before having such "work" done to oneself is to thorougly check your doctor's credentialing, check any references you may know, thoroughly investigate the "fillers" being used, thoroughly question your doctor about the "fillers" being proposed, ask about alternative treatment available, and think about whether or not the treatment is actually necessary.

Originally posted at InjuryBoard by Greg Webb

Maclaren Failed to Report Finger-Chopping Danger

Paul Thomson — Fri, 20 Nov 2009 09:00:00 GMT

Maclaren recently recalled strollers made as far back as 1999 because the stroller hinge can cause a child's finger to be amputated when placed in the hinge upon opening or closing the stroller. Twelve children have had their fingers amputated! The New York Post reported that Maclaren knew about the defect as early as 2004, when the first finger amputation was reported.

Maclaren now faces fines up to one million dollars for failing to report the problem to the Consumer Product Safety Commission. Companies are required to report dangers to the CPSC immediately. The fact that Maclaren failed to do so is absurd! Twelve children have lost their fingers--that's ridiculous! Customers are encouraged to take advantage of the recall and Maclaren needs to be held accountable for their lack of responsibility!

Originally posted at InjuryBoard by Paul Thomson

AstraZeneca’s Seroquel Subject of $520 Million Settlement

Greg Webb — Wed, 04 Nov 2009 17:58:05 GMT

AstraZeneca, a pharmaceutical company, has reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its best-selling psychiatric drug Seroquel. According to research firm IMS Health, Seroquel was the top selling anti-psychotic medication in 2004 with about $17 billion in sales. AstraZeneca joins a list of drug manufacturers forced to pay billions of dollars to settle inquiries filed by former company insiders.

AstraZeneca disclosed one of the investigations related to physicians who participated in clinical trials involving Seroquel and another related to off-label promotion of the drug. However, a company spokesman refused to give more specifics about the physicians or clinical trials under investigation. He also said the company was in final negotiations to settle the whistle-blower lawsuits and reach a corporate integrity agreement with the U.S. Justice Department.

As a result to the company’s aggressive marketing campaign, Seroquel has been used for children and elderly patients for indications not approved by the Food and Drug Administration (FDA); doctors are allowed to prescribe any approved medication for off-label uses. AstraZeneca has also said that as of October 9, it has been served with 14,444 civil lawsuits over Seroquel’s misleading marketing because many of the patients using the drug have developed diabetes and other health problems.

Originally posted at InjuryBoard by Greg Webb

Additional Crib Dangers May Not be Addressed by Recent Recalls

Greg Webb — Sun, 30 Nov 2008 20:23:36 GMT

In October, the Consumer Product Safety Commission (CPSC) issued a recall on 1.6 million Delta Enterprise Corp. cribs, but those cribs that had been fixed by the recall may not be safe after all. The Chicago Tribune reviewed government documents and found another 19 instances of hazards on the Delta cribs, all of which were different from those affected by the recall.

Cribs have turned out to be one of the most deadly nursery products, though they are designed for a baby to be left unattended for hours at a time. One small missing or broken part could lead to injury or death. In the 1970s and 80s, two fixes helped reduce the number of deaths from cribs: lessening the distance between side slats, and removing corner posts that could snag babies’ clothing, leading to strangulation. The problems with cribs today come from both the complexity of cribs and the shift to manufacturing cribs abroad. Many cribs make the transition from cribs to toddler beds to adult beds, which may add convenience but also involves more moving parts which can become worn down or lost. In addition, manufacturing cribs overseas has resulted in low or no quality control at those facilities.

A major problem with crib assembly is inadequate instructions and designs that allow parents to inadvertently assemble the product in dangerous ways. CPSC engineer Patty Hackett said “Some of the instructions are worthless. I’ve seen cribs mis-assembled and still operate. That’s what scares me.” One example is the Delta Athens crib, which allows parents to install the stabilizer bar upside down but still function. The stabilizer bar holds the crib together and supports the mattress platform. The Myhra family experienced a frightening incident with their Delta Athens crib when nine-month old Sabrina began crying from her crib, and mother Cari walked in to find one end of the crib mattress had fallen to the floor and Sabrina clinging to the crib sheet to avoid getting trapped between the mattress and the crib frame. Their crib’s stabilizer bar had been installed upside down, but the crib looked normal with the bar that way.

The mattress problem is not an isolated incident. Delta is aware of complaints about its mattress supports and is working with the CPSC on the issue. Their company position is that “when properly assembled, the cribs are absolutely safe,” said spokesman Jack Gutt. However, commission records show that the mattress problem is not solely caused by incorrect assembly. In 2002, the bottom of a one-year-old boy’s Delta Luv crib collapsed, which was caused by a wood joint that failed “possibly caused by the lack of sufficient glue.” In 2004, a two-year-old girl was trapped after a rivet on the mattress support failed. Luckily both children survived. These are just a few of many incidents, according to CPSC reports.

The CPSC staff has challenged the regulatory system instituted under President Reagan, which forces them to defer to voluntary standards that are controlled by manufacturers. They urged commissioners to bypass the process and move toward federally mandated safety regulations because the current standards “are inadequate to prevent entrapment deaths and injuries of young children.” Earlier this month, commissioners agreed.

Consumer demand for convenience and low prices have prompted companies to look to overseas factories for cheaper materials and labor. However, this choice may sacrifice quality and safety. Rachel Weintraub, director of product safety at the Consumer Federation of America, asked, “Is the quest to produce lower-cost cribs leading to a sacrifice on the quality of the wood and other parts? They are making their product overseas, so they’re getting the benefit, but they’re not taking additional measures to deal with increased risk.”

Originally posted at InjuryBoard by Greg Webb