Charlottesville Personal Injury Lawyer - Product

Runaway Toyota Vehicles Take Lives

Paul Thomson — Fri, 23 Oct 2009 14:35:50 GMT

Recent reports of fatal crashes involving Toyota and Toyota-made Lexus vehicles are frightening! The crashes involve the cars accelerating uncontrollably, reaching speeds of 120 MPH, and leaving drivers with no ability to brake! The company's apologies seem sincere, however they are blaming the acceleration problem on the floor mat causing the accelerator to get stuck. This explanation fails to acknowledge life-threatening defects in the cars' overall designs, described in this article.

Toyota's designs have become increasingly computerized, making them more complicated. Many of the high-tech features designed for convenience have proven to be unsafe in emergency situations. The push-button start system is confusing and makes it difficult to turn the car off if it is accelerating out of control. The way the gear selections are arranged is also confusing and makes putting a runaway car into neutral challenging, especially in a high-stress emergency situation. The power-assisted braking system also fails to operate effectively when the car is traveling at full speed.

While removing floor mats is not a bad for a quick fix, Toyota needs to rethink their designs and include foolproof methods to stop an our of control car. The current design is clearly defective and life-threatening to anyone on the road! Aren't five fatal crashes more than enough to cause Toyota to acknowledge that their product is dangerous?

Originally posted at InjuryBoard by Paul Thomson

Toys ‘R’ Us to Keep Things Safe with "The Great Trade-In Program"

Greg Webb — Fri, 28 Aug 2009 15:25:10 GMT

In the August 26, 2009 Charlottesville section of Craigslist.com, there were 71 new posts in the "Baby+Kids" subsection of "For Sale." Going solely off of the post titles (admittedly, I disregarded a thorough analysis of each post’s contents for the sake of search-brevity), out of those 71 posts, 3 were for strollers (4%), 2 were for car seats (3%), 2 were for highchairs (3%), 8 were for swing sets/play sets (12%), 5 were for cribs/beds/bassinets (7%), 12 were for clothes (17%), 2 were for food (3%), 5 were for bikes/scooters/walkers (7%), 10 were for miscellaneous toys (14%), and 2 were for child backpacks/harnesses (for carrying children) (3%). That comes to 73%. In addition, there were three posts for "Want to Buy" items, including a "Kelty Convertible Backpack/stroller," a "dresser and booster seat" and an "infant car seat" (4%). The remaining posts were for nondescript items or general mass toy/baby item sales.

Now this is not intended to pass judgment on those posters, nor is it to discredit the helpfulness of the Craigslist service; but those figures demonstrate the fact that, beyond the traditional familial "passing down of the crib," people – strangers, rather – are selling and buying used children’s items to and from one another daily. And that is just in Charlottesville, a small city. Compared to New York City, which had a whopping 769 listings on Wednesday the 26^th, Charlottesville’s 71 posts are, relatively speaking, small potatoes.

From this limited yet telling research, it is safe to surmise that between the 71 posts in Charlottesville and the 769 posts in New York City, there is at least some risk involved in these exchanges based on the volume and frequency in which they are made. This goes said under the full understanding that in any Craigslist transaction there is an implied "risk" involved.

However, the point remains that the acquisition or requesting of used children’s items is a less than surefire way to ensure the safety of one’s child. In an attempt to prevent such exchanges, Toys ‘R’ Us and Babies ‘R’ Us will be offering a trade-in program for parents looking to unload old or used children’s items in exchange for a 20% discount toward the purchase of new items in the same categories.

Jerry Storch, chairman and chief executive of the Wayne, N.J. company, was quoted in The Wall Street Journal, saying, "We feel it's critical to get these older products out of the chain of commerce."

This exchange program is at least partially influenced by the constant updating of the quality control standards imposed on the industry. Requirements and regulations are always being changed, and older products that may not have been held to the same standards as products currently on the market are not only potentially more dangerous, but they’re also more susceptible to being traded and/or resold by previous owners who don’t need them anymore. The Wall Street Journal reports that the Consumer Product Safety Commission (CPSC) and safety advocacy groups seem to agree, urging people to be aware of the potential dangers in buying and selling old and used items. Their concerns are only reinforced by the dramatic increase in recalls over the years, with 563 product recalls having been issued in 2008, an increase of 162 from 2005.

The event, called "The Great Trade-In," will run from August 28 until September 20. Products eligible will include strollers, bassinets, travel systems, play yards and high chairs – 29% of August 26^’s Craigslist listings in Charlottesville.

Originally posted at InjuryBoard by Greg Webb

Bill Will Hold Foreign Companies Accountable For Defective Products

Greg Webb — Fri, 14 Aug 2009 08:00:00 GMT

The Foreign Manufacturers Legal Accountability Act of 2009, a bipartisan bill that was recently introduced in the U.S. Senate, aims to help victims of tainted Chinese drywall hold foreign manufacturers more accountable for their defective products. The act would cut down the red tape faced by American consumers who try to sue foreign companies.

The legislation arose from a May Senate subcommittee meeting that asked how to hold foreign manufacturers accountable for their products. During the hearing, an Alabama-based home building company, Mitchell Co., described how difficult it was to get a response from a Chinese manufacturer after the manufacturer’s drywall was found to be defective. The flawed drywall gives off a sulfuric odor that some homeowners have blamed for health problems. Because Mitchell Co. was unable to formally serve notice to the Chinese manufacturer, the company was not able to get the compensation it desired.

Among its stipulations, the act calls for the manufacturer to have a representative in each state that the company does business, who could be served in any claims. It also aims to make foreign companies agree to be accountable to U.S. courts if sued. Sponsors and supporters of the bill claim this is the best way for Americans to receive justice for any defective products since foreign manufacturers typically use technical legal defenses to avoid compensation. They claim that with the profit and benefits of the American market should come accountability for defective products.

Originally posted at InjuryBoard by Greg Webb

Nine Companies Pay Penalty For Lead In Toys

Greg Webb — Tue, 21 Jul 2009 08:00:00 GMT

As punishment for violating the federal lead paint ban, the United States Consumer Product Safety Commission (CPSC) announced nine children’s product manufacturers, importers and sellers, including Dollar General and Michael’s, have agreed to pay more than $500,000 in civil penalties. These penalties settle the allegations that the companies knowingly manufactured, imported, or sold toys and/or other children’s products with paint or surface coatings that contained high levels of lead. The high levels of lead found in the affected toys violated federal law due to the health risks lead poses in children.

In 1978, a federal ban was passed that prohibited children’s products from having more than .06 percent lead (by weight) in paints or surface coatings. The products involved in the settlement were recalled in 2007 and 2008, and include such items as pencil pouches, sunglasses, children’s metal jewelry, and Halloween baskets. Tests showed that the paint or surface coatings on these items contained lead in excess of .06 percent by weight. One firm even found products that contained surface coatings of nearly 60 percent lead.

It is unfortunate that these penalties are not higher. They amount to less than a slap on the wrist for these companies, whose conduct is unacceptable. Hopefully, most of the conduct was just grossly negligent, and not a true, wilfull violation of the law.

Originally posted at InjuryBoard by Greg Webb

New GM Accepts New Product Liability Claims

Greg Webb — Mon, 20 Jul 2009 08:00:00 GMT

In a bid to win court approval for a quick sale from bankruptcy, General Motors Corp. (GM) has agreed to accept liability for future product defects. Additionally, GM stated that it would change the terms of its proposed asset sale to address the objections raised by twenty suppliers and was working to create a “consensual” agreement regarding the future of a joint-venture plant with Toyota. These statements by GM demonstrate how the auto manufacturer and Obama administration officials have worked to counter some of the more controversial issues raised by the company’s bankruptcy filing. A group of nine state attorney generals, for example, voiced opposition to GM’s reorganization because it would have robbed consumers of protection against product defects under state legislation.

By August, under the GM reorganization plan, a new company would be created to buy the company’s best assets out of bankruptcy. This new company would be 60 percent owned by the federal government, 17.5 percent by the United Auto Workers union and 11.7 percent by the Canadian government and the province of Ontario. The consumers who have lawsuits pending against GM have objected to the reorganization plan since those injury and wrongful-death claims would have to be paid from the sale of GM’s most worthless assets. They further claim the automaker’s insurance would only cover product liability claims of up to $35 million per claim. This amount would not cover the claims of almost any of the lawsuits since many of the cases involved “devastating injuries” from alleged automobile defects.

GM has agreed, however, to continue paying “lemon law” claims so consumers would be entitled to a refund or replacement for defective vehicles. GM has also stated that the reorganized company, which will be nationalized with a $50 billion investment from the United States Treasury, will assume liability for future product defect claims as well.

While it is a good thing that GM will be back in business as (the New GM), it is a tragedy that there are thousands of product liability claims, including those for asbestos-related illnesses, that will effectively be kicked to the curb. All claims that existed before the "reorganization" are likely never going to be paid anything close to acual value. All of those that fall into this latter group probably feel as if the justice system has failed them. I am not sure how I could argue differently at the present time.

Originally posted at InjuryBoard by Greg Webb

FDA’s Lax Investigation Leads to Shipment of Contaminated Syringes

Greg Webb — Wed, 01 Jul 2009 08:00:00 GMT

Natalie Fullerton’s parents were thrilled to see their year-old daughter recover from a double-lung transplant. Her father dutifully used fluid-filled syringes to clean a tube that doctors had implanted in her chest to deliver intravenous medication. Despite his fear, bacteria infected the toddler’s blood and she was rushed to the hospital. Four months later, Natalie died in her mother’s arms.

The syringes Mr. Fullerton had been using were part of a contaminated lot made in a factory owned by Lake Zurich businessman Dushyant Patel. That batch and another have since been linked to 4 deaths and 162 illnesses across the country. Inspection reports and other documents show that the U.S. Food and Drug Administration missed several opportunities to prevent the tainted syringes from being used.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector investigated reports of red, brown, and black particles floating in syringes. She reported that the North Carolina plant managers had a plan to deal with rust, but did not note that the plant had switched to an unreliable sterilization tactic. When the FDA learned a week later that a distributor had recalled 1.3 million syringes, it should have conducted a thorough inspection of the plant, according to its operations manual. An FDA spokeswoman reports that this didn’t happen because the agency is so understaffed that it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or death.

Federal prosecutors zeroed in on AM2PAT President Patel. An indictment on fraud, conspiracy, and other charges alleges that his firm produced syringes laced with bacteria and lied about performing sterility tests. Two employees, one a plant manager, were sentenced in February to 4 ½ years in prison for fraud and allowing tainted drugs into the marketplace. Authorities believe that Patel fled to India and are seeking to extradite him.

Patel bought a share of the North Carolina business and took over as president in 2001. Prosecutors allege that the operation was a fraud from the start, and that the firm’s application to make syringes incorporated fake data for a test to establish shelf life of the syringes. Unaware, the FDA gave Patel permission to start production in 2003.

The firm bought empty syringes and filled them with saline or heparin, solutions designed to prevent blood clots from forming in catheters. AM2PAT then sold the syringes to distributors who marketed them to hospitals and pharmacies, earnings nearly $7 million in profits in its last two years. In March 2005, a pharmacist reported finding orange sediment floating in one syringe and spotting an inch-long hair in another. An FDA inspector spent six days in the Raleigh plant three months later, noting nine significant violations, some of which could have an adverse effect on product quality. Shortly after, the FDA sent a warning letter, but it reported in January 2006 that Patel had either fixed or promised to address the major problems. New complaints were lodged in the spring and summer of 2007, including an AM2PAT employee who claimed that management was not adhering to appropriate clean-room temperatures during manufacturing.

The FDA’s Atlanta branch scheduled an inspection for June 26, 2007, but the plant was shuttered when the inspector arrived in Raleigh. By the time an inspector located the new plant, B. Braun Medical had recalled more than 1 million syringes following reports of particles floating in the saline. Six weeks after the inspection, the FDA issued a news release on the B. Braun recall’s finding that the particles were medical-grade silicone, which is capable of causing brain damage or a deadly clot. The FDA now admits that, until reports of injuries mounted, its Philadelphia office did not communicate information about the recall to its Atlanta office.

Toward the end of October 2007, the plant shipped the contaminated heparin-filled syringes. Authorities now link four deaths to the contamination. After the CDC linked the syringes, two investigators and a microbiologist interviewed workers, dug through records, examined equipment, and studied quality control in the factory. Patel had apparently concluded that the white particles that spurred the recall were caused by the failure of a standard sterilization process involving radiation. He adopted “UV light” sterilization, which the FDA says is a non-traditional technique. An employee also told investigators that the company kept two sets of records: one revealing rushed shipments of syringes that hadn’t completed sterilization tests and another fraudulently indicating that the plant was holding syringes on-site for two weeks while chemists conducted sterility tests. Patel responded that someone was sabotaging his records.

Gordon Harnack, a consultant who helps companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant and concluded that inspectors didn’t look deep enough, even as contamination problems became apparent. Although the syringe case has not received the attention that followed deaths from salmonella-laden peanut paste, consumer advocates say that both breakdowns are the result of a shift from aggressive enforcement to FDA partnership with the industries it is meant to oversee.

In response, FDA Commissioner Margaret Hamburg has pledged to make product safety a top priority. She said that she believes that it is critical for the FDA to take an aggressive approach to inspections and to maintain vigilance in ensuring that manufacturers comply with regulatory, legal, and moral obligation to provide safe products. FDA spokeswoman Siobhan DeLancey had previously defended the agency’s actions, saying that they had inspected the plant multiple times on a relatively low number of complaints and that the agency worked hard to prosecute the plant managers once reports of infections came in. This prosecution came too late for the Fullerton family, however, and many affected individuals have filed lawsuits in Cook County.

Originally posted at InjuryBoard by Greg Webb

Report Says Children’s Products Contain Dangerous Chemicals

Greg Webb — Mon, 08 Jun 2009 08:00:00 GMT

A March publication from the Campaign for Safe Cosmetics reported finding formaldehyde and 1,4-dioxane, a trace contaminant of chemicals used in cosmetic products, in 55 children’s personal-care products. The Environmental Protection Agency lists these chemicals as probable human carcinogens. Seventeen of the products contained both chemicals, including Johnson & Johnson’s Baby Shampoo.

The same month, New York Senator Kirsten Gillibrand announced the “Safe Baby Products Act,” which asks the FDA to investigate chemicals used in children’s toiletries. She expressed concerns as a mother because many of the products listed in the report were products that she kept in her bathroom.

The editor of Stats.org, Trevor Butterworth, conveyed reservations about the implications of the report. Butterworth said that people are exposed to similarly low levels of these chemicals every day in food, air, and shower water, and that studies linking them to cancer are based on ingesting or inhaling large quantities of the chemicals in industrial or lab settings.

A statement from Johnson & Johnson said that all of their products meet or exceed requirements in every country in which they are sold.

Originally posted at InjuryBoard by Greg Webb

Federal Investigation Leads to Criticism of Company Conducting Medical and Drug Trials

Greg Webb — Thu, 09 Apr 2009 08:00:00 GMT

Coast Independent Review Board, a Colorado company that drug and medical device manufacturers pay to oversee patient safety during clinical trials, has come under criticism at a Congressional hearing regarding whether the company performed its duties adequately. Undercover federal investigators created a fake medical trial of a bogus surgical product called Adhesiabloc in order to see how closely companies like Coast monitored the studies they were paid to review. Two of Coast’s competitors refused to approve the study’s design, while Coast approved the trial.

Coast’s chief executive officer, Daniel Dueber, accused the government of "extensive fraud" against his company and remained combative throughout the hearing. He said he cannot imagine why the government would create a fake trial and also cannot believe the American government would do something like this to his company.

The hearing was initiated after incidents in recent years involving patients dying during clinical trials or companies submitting fraudulent information to the Food and Drug Administration (FDA) in order to get new medical products approved. During this period of time, the oversight of clinical trials has shifted from academic medical institutions to companies like Coast. There is a growing concern that these commercial review boards may be too heavily influenced by the drug and device companies that pay for their services. Critics also say that manufacturers will shop around for a board that will accommodate them after other reviewers reject their research plans. Over a period of five years, Coast reviewed 356 studies and only rejected one. Meanwhile, the company has more than doubled its revenue since 2004. A separate FDA inspection last year led to Coast receiving a warning letter after officials discovered an unqualified person was used to approve an advertisement to recruit trial subjects.

In a recent report, officials at the Government Accountability Office (GAO), a research arm of Congress, said they found the commercial review system to be extremely susceptible to manipulation. It was the GAO who set up the sting mission at Coast. According to the FDA, Coast has since submitted a plan to improve its procedures following GAO’s investigation. The hearing also focused on whether the FDA and Department of Health did their job in overseeing clinical trials to protect the patients.

Originally posted at InjuryBoard by Greg Webb

Congressmen Push To Nullify Supreme Court’s Medical Device Decision

Greg Webb — Tue, 03 Mar 2009 08:00:00 GMT

Some members of Congress are attempting to remove a 2008 Supreme Court decision that stands as a barrier against suing medical device manufacturers. This ruling has barred patients, or their survivors, from suing manufactures of complex medical devices if the Food and Drug Administration (FDA) has approved the products sale. Since this ruling, judges from around the country have cited it in dismissing cases against a wide range of manufacturers. For example, situations in which a woman was burned internally by a device that was meant to reduce menstrual bleeding, and numerous patients who claim they were injured by faulty heart implants or joints.

Recently, however, some members of Congress have decided they want to give potential plaintiffs a chance at legal action. Two House Democrats plan to reintroduce legislation that will nullify the Supreme Court Decision. A similar bill introduced in the Senate last year is also expected to be reintroduced. The legislators, as well as patient advocates, say the Supreme Court’s decision has left patients legally powerless against “spotty oversight of products” by the FDA. With the Supreme Court ruling, patients are facing a dangerous situation in which the FDA is incapable of keeping dangerous products off the market and patients cannot sue companies for restitution.

The House Energy and Commerce Committee is expected to hold hearings this session to determine whether the FDA’s process for device approval is adequate after numerous claims that it does not have the necessary resources to asses all risks that a device poses once it gets on the market. Opposition to the legislation claims the FDA is the appropriate body to set national safety standards and allowing juries to undermine its decisions will hinder product innovation.

Many believe the Supreme Court’s decision does not reflect the unpredictability of the FDA review process. Recently, for example, when doctors extracted a faulty electronic cable from a patient’s heart, a vessel was punctured causing excessive bleeding. The patient died two days later and a lawsuit against Medtronic, the manufacturer of the faulty device, was thrown out. This cable, called a lead, was never tested in humans before it went on the market and before Medtronic could recall the product, it was implanted in more than 235,000 patients; five of these patients may have died due to the problem.

The Supreme Court is currently deciding whether it should give the same type of legal protections to drug manufacturers in the case of Wyeth v. Levine. Hopefully, the Court will not grant such broad-reaching immunity for drug manufacturers. Drug companies, like all persons and entities in our country, should be held responsible for wrongful conduct, especially when such conduct sacrifices safety in the name of profits.

Originally posted at InjuryBoard by Greg Webb

Banned Chemical in Toys Still in Marketplace

Greg Webb — Wed, 03 Dec 2008 08:00:00 GMT

Children’s products containing the recently banned chemical phthalate already in stores and warehouses will be allowed to remain in the marketplace, the Consumer Product Safety Commission said in a decision issued November 18.

The ban, passed in August, is supposed to remain in effect until a scientific review is complete. However, the decision issued by CPSC’s general counsel Cheryl Falvey, means it will be illegal to sell products made after the ban is in place February 10, 2009 that contain types of phthalates, chemicals used in soft plastic linked to reproductive problems. Products made before February 10 will be legal to sell, even after the ban takes effect.

“That’s obviously not what was intended,” said Diana Zuckerman, president of the National Research Center for Women & Families. However, the way the law is written, the ban must be prospective, said Julie Vallese, CPSC spokeswoman. To find out whether a product was made before or after the ban, consumers can call the manufacturer, said Vallese.

Manufacturers believe the CPSC made the right decision. They would have had to spend thousands of dollars on testing for the chemicals. Kathleen McHugh, president of the American Specialty Toy Retailing Association, which also represents small toymakers, was pleased “because there is dispute about whether those phthalates are harmful, and what are they going to replace them with.”

The new law contains other requirements such as new limits on lead and mandatory testing and certification that are leaving companies in the dark. Though there was a series of public forums hosted by the CPSC, businesses are still asking for more specific guidance.

Originally posted at InjuryBoard by Greg Webb