Charlottesville Personal Injury Lawyer - manufacturers

New Legislation May Aid Consumers Harmed By Foreign Manufacturers

Greg Webb — Mon, 14 Sep 2009 02:00:00 GMT

Many products consumed these days, from children’s toys to medicines, are made in countries where, often, manufacturing standards are almost nonexistent. Therefore, when products have defects, it is extremely difficult to hold these foreign companies responsible in the United States’ Court System. The consumer would have to travel to the country and rely on that country’s government to serve processes on the manufacturer and translate all documents into that language.

When Congress returns from its break in September, lawmakers will consider legislation called the Foreign Manufacturers Legal Accountability Act ("FMLAA"), which would even the legal playing field. The act would cover “consumer products regulated by the Consumer Product Safety Commission ("CPSC"); drugs, devices and cosmetics that are regulated by the Food and Drug Administration; biological products as defined by the Public Health Service Act; as well as chemical substances that are defined by the Toxic Substances Control Act.” It would also require foreign companies have representatives in the United States where legal papers can be served. Surprisingly few legislators have expressed opposition to this legislation so far.

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

FDA Commissioner Supports Direction of Food Safety Bill

Greg Webb — Mon, 15 Jun 2009 08:00:00 GMT

The new commissioner of the Food and Drug Administration, Dr. Margaret A. Hamburg, entered the debate over how to fix the nation’s food safety system in her first appearance before Congress as commissioner recently. Dr. Hamburg told the House Energy and Commerce Subcommittee on Health that the safety legislation sponsored by several Democrats was moving in the right direction, but that the FDA would need more money to make it happen. Republicans complained about specific aspects of the measure that may go to a vote as soon as next week, highlighting the loss of the bipartisan consensus that had existed during earlier hearings.

The legislation blends provisions from bills offered by several Democrats, requiring that food manufacturers write and enact safety plans, pay an annual fee of $1,000 to the FDA, and track the distribution of all food products. In turn, the agency would be required to inspect all food facilities at least once every four years, inspecting high-risk facilities every year and a half. Dr. Hamburg noted that the registration fees will not provide enough funding to implement the legislation’s targets when evaluated realistically.

Texas Representative Joe Barton, the senior Republican on the full committee, said in March that he and the chairman of the committee, Democrat California Representative Henry Waxman, were in agreement on the subject of food safety. During the hearing, however, Mr. Barton said that the registration fees were too high and that a provision requiring food labels indicating country of origin was burdensome. He also objected to provisions that will expand the FDA’s powers, giving it the power to compel manufacturers to recall their products and subpoena manufacturing records. Mr. Waxman defended the fees as asking the industry to chip in to fund measures necessary to help avoid expensive recalls.

Pamela Bailey, president of the Grocery Manufacturers Association, told the committee that the industry was concerned about the size of the fees and their effect on the FDA’s credibility. Ms. Bailey issued a statement saying that while the industry is responsible for the safety of its products, securing the safety of the food supply is a government function which should be financed with government resources.

Dr. Hamburg also addressed the agency’s new safety review of bisphenol-A, a chemical used to harden plastics that is also known as BPA. Studies have suggested that BPA may accelerate puberty, but the agency concluded during the Bush administration that it wasn’t harmful at levels found in the American market. The FDA’s science advisory panel rejected that conclusion in October, and the new review is expected by the end of the summer.

Before the hearing, activists passed out fliers protesting increased levels of antibiotic-resistant bacteria due to the routine use of antibiotics in livestock. Dr. Hamburg said that the growing problem of antibiotic resistance was also a concern of hers. No decisions were made in this regard, however.

Originally posted at InjuryBoard by Greg Webb

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

Medical Device Bill To Be Introduced Following Recent Supreme Court Decision

Greg Webb — Tue, 31 Mar 2009 17:37:06 GMT

Democrats in Congress are moving to overturn a Supreme Court decision that allowed medical device manufacturers to be shielded from lawsuits after the Supreme Court Justices recently decided drug makers should not receive the same protection. Last Wednesday, the Court ruled against Wyeth’s contention that it should not be subject to lawsuits in state courts for Phenergan, its anti-nausea drug, because the Food and Drug Administration (FDA)approved the medication. This ruling upheld a $6.7 million award to a Vermont woman who lost her arm when she was improperly injected with Phenergan.

Seizing the opportunity introduced by the Court’s decision, Democrats reintroduced the Medical Device Safety Act, which would allow similar lawsuits against companies that manufacture heart devices, replacement hips, catheters and other apparatuses. The medical device lobbying group quickly criticized the act, claiming it would impede medical innovation, create more lawsuits and result in higher health care costs for all Americans. However, many interest groups, including the AARP, trial lawyers and consumer advocates, support the bill. Many analysts believe this measure will soon become a law.

Let there be no mistake, this is a good bill and it needs to be passed. No one, absolutely no one, including corporations, should be immune from being held accountable for wrongful conduct, including negligence. For years the medical device manufacturers and pharmaceutical companies, among many other large business industries, have been seeking immunity from lawsuits. Some of them achieved partial victories during the last presidential administration through back-door preemption regulations via federal agencies. It looks as if the Obama Administration (and Congress) is proceeding on a more consumer-oriented track, looking out for the little guy. Hopefully, this philosophy will continue.

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

Peanut Recall Needed Company Approval – FDA Has No Teeth

Greg Webb — Tue, 24 Feb 2009 08:00:00 GMT

Although a criminal investigation has begun regarding whether or not the Peanut Corporation of America deliberately sold contaminated products, the federal government still needed the company’s permission prior to announcing a huge recall of its products. Current rules require the wording of the recall statement to be approved by the corporation before the Food and Drug Administration (FDA) can publish it. Presently, the FDA relies on cooperation from food manufacturers even if they are undergoing criminal investigation. Some Democrats in Congress, however, are trying to get this changed by giving the agency more power to declare mandatory recalls without companies’ consent. Legislation is in the works that will split the agency’s food oversight into a separate entity, which will have mandatory recall authority and other powers.

President Obama has also promised to completely review FDA operations because he does not believe the agency has caught problems as quickly as they should. Obama will soon announce a new FDA commissioner and other officials who will institute a “stricter regulatory structure” in order to prevent failure in food-safety inspections. Part of this review will determine whether the requirement for the peanut company’s approval caused delays in warning the American public, which created safety hazards.

Public health officials pinpointed the contamination as originating from the Blakely plant January 9. The peanut company announced a limited recall on January 13 and expanded it on January 16. However, the company waited until January 28 to recall all of its products made in 2007 and 2008 even though it had known since 2007 that tests of products showed traces of salmonella. The dangers were well known to health officials, but nothing could be done about removing the products until the Peanut Corporation of America decided on the recall. More than five hundred people have become sick after the salmonella poisoning outbreak and eight have died. More than 340 peanut product brands have been recalled.

The fact that the FDA cannot compel a recall under these circumstances is astounding. The system is broken and it needs to be fixed. Let's hope that the new Congress and President will give the FDA some teeth in these types of life and death situations.

Originally posted at InjuryBoard by Greg Webb

W.A.T.C.H.’s 2008 “10 Worst Toys” List

Greg Webb — Mon, 08 Dec 2008 21:12:17 GMT

World Against Toys Causing Harm, Inc. (W.A.T.C.H.) held it’s 36th Annual “10 Worst Toys” Conference in Boston this past November after seeing at least 66 toy recalls resulting in more than 7,890,000 units of toys recalled for various dangers in the past year.

W.A.T.C.H., a Massachusetts charitable non-profit corporation, called for toy manufacturers to provide accurate and complete language on packaging when it comes to warning consumers about hazards. The 2008 “10 Worst Toy” list includes examples of packaging and labeling which fail to give consumers fair warnings of known dangers. The high number of recalls proves that manufacturers put profits before child safety. At least 26 recalls were the result of toys with excessive lead content, and many other recalls involved small parts violations. Choking is the cause of 44 percent of toy-related deaths, and the Consumer Product Safety Commission (CPSC) has issued recalls for at least 25 toys with choking ingesting or aspiration risks.

While the CPSC issues recalls for some dangerous toys, many still remain on store shelves. Hazards that reappear every year include choking, strangulation, impact injuries, burns, impalement, puncture wounds, and lacerations. In 2006, the CPSC reported nine deaths of children when they choked on or aspirated a toy, 22 toy-related deaths of children under 15 years old, and about 220,500 toy-related injuries treated in U.S. emergency rooms.

The Consumer Product Safety Improvement Act of 2008, signed into law on August 14, expands the authority of the CPSC and places stricter restrictions on toy-makers and the entire distribution chain. W.A.T.C.H. notes, however, that policing such a large industry will remain a challenge, and that toy manufacturers must put safety before profits. The toy industry makes $30 billion a year, and more than three billion toys are sold each year in the United States.

Nominees for the 2008 “10 Worst Toys” are:

Sportsman Shotgun

Hazard: Potential for eye injuries. This realistic looking weapon is sold online as a “toy”, and uses rubber bullets, which are loaded into the shotgun’s magazine and then pushed into the gun’s chamber. “You are now ready to shoot,” boasts the advertising. This weapon is not a toy and should not be sold for use by children.

Go Go Minis Pullback Vehicle

Hazard: Potential for choking injuries. The rear tires of these miniature fire trucks, garbage trucks and school buses are removable, presenting a serious choking injury hazard. Though there is a “choking hazard” warning, it only appears on the display box and not on the individual toys.

Inflatable Giga Ball

Hazard: Potential for impact and other serious injuries. Children 4 years and older are encouraged to crawl inside this inflatable ball. The box warns against use on hills and in water, and that parent supervision is “required,” however the toy itself indicates that adult supervision is only “recommended.”

Animal Alley Purse Set

Hazard: Potential for ingestion/aspiration injuries. These soft toys are sold for infants. The ponies have long, fiber-like hair that is not adequately rooted and is easily removable. This presents the potential for ingestion or aspiration, but these hazards are not referenced anywhere on the product or product tags.

Spider-Man Adjustable Toy Skates

Hazard: Potential for wrist and other impact injuries. The skates, recommended for “Ages 3 To 6”, have warnings on the packaging, including a requirement that children wear helmets, wrist guards, knee pads, and elbow pads while skating, but only include knee and elbow pads.

Pucci Puppies – My Own Puppy House Golden Retriever

Hazard: Potential for choking injuries. Children ages “2 years +” are encouraged to play with this golden retriever puppy, dog house, and accessories including a bone, cookie, chew toy and food bowl. The accessories are easily ingestible small parts.

Walk’n Sounds Digger The Dog

Hazard: Potential for strangulation/entanglement injuries. The toy industry has voluntary standards requiring strings on playpen or crib toys to be less than 12 inches in length. This pull-toy’s cord measures 26 inches. This toy is intended for “infants” and recommended for children “over 12 months,” and is a prime candidate for cribs and playpens.

Meadow Mystery Play-A-Sound Book With A Cuddly Pooh

Hazard: Potential for choking injuries. A soft Winnie-the-Pooh doll sold, sold with a book, has a cloth mask which, once removed, poses a potential choking hazard. The package states that the toy has been safety tested for children “18 months+,” but the tag attached to Pooh states that it is “[r]ecommended for all age groups.”

Extreme Spiral Copters

Hazard: Potential for eye injuries. Children “Ages 5 and Up” are encouraged to launch the copter projectile into the air with an elastic band, in a fashion similar to a slingshot. Cautions include “DO NOT SUBSTITTUE THE SUPPLIED COPTER WITH ANY OTHER PROJECTILE” and “DO NOT AIM AT EYES OR FACE”.

Ninja Battle Gear – Michelangelo

Hazard: Potential for blunt impact injuries. This line of toys encourages children to wield weapons while pretending to be a ninja. Michelangelo’s “Nunchaku”, recommended for children 4 years and older, consists of two long plastic handles connected by a plastic chain. The manufacturer describes the toy as a “Kick-butt signature weapon.” There are no cautions or warnings relating to potential impact injuries.

Originally posted at InjuryBoard by Greg Webb