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Medical Device Liability Bill: Undoing Injustice

Don Greiwe — Tue, 19 May 2009 10:25:09 GMT

Last week, the new Medical Device Liability Bill was up for debate within Congress’ House and Energy Subcommittee. This new legislation is intended to undo the U.S. Supreme Court’s decision in Riegel v. Medtronic, Inc. In Riegel, the Supreme Court immunized certain manufacturers of medical devices by protecting them from state law product liability claims. This precludes approximately 10 million patients from claims against the manufacturer of their implanted devices when the devices were approved by the FDA.

Expectedly, pro tort reform associations such as American Tort Reform Association (ATRA) have begun marketing against passage of the new bill. In their latest press release, ATRA makes several bold claims, including: (1) the legislation’s intent is to only further trial lawyer fees; (2) this bill will allow claims that could bankrupt reputable companies; and (3) the bill would undo “longstanding law”. As a proponent of the bill, it’s clear to me that these claims are without merit.

First, the argument that pro-consumer legislation is really just pro-trial lawyer legislation is incredulous. This is nothing more than ARTA’s attempt to play to the stereotype of a trial attorney as reason to prevent victims from being made whole. Trial lawyers have, directly and indirectly, brought about increased safety measures and forced manufactures to be more conscientious of consumer safety.

Second, ATRA claims that the bill could allow excessive claims that would bankrupt the industry. The intention of product liability lawsuits, like most all other forms of personal injury litigation, is to make the injured victim whole again. Often people will hear of lawsuits with huge punitive damage awards. These punitive damages are sometimes greater than the compensatory damages themselves, and are intended to do as its name implies – punish the defendant. However, they are only available in extreme cases. In other words, the vast majority of product liability cases results in compensating the plaintiff for their injury, and are not intended to “bankrupt” any company (or for that matter, actually do bankrupt such a company).

Third, to call the decision of Riegel “longstanding” is beyond a stretch of the imagination. Riegel was decided February 20, 2008. In the decision, the Medical Device Amendments of 1976 was construed to spare medical device manufactures from claims of flawed design or labeling. While the decision has already precluded at least 1,400 lawsuits against manufacturers, the decision has created law that is far from longstanding.

The intent of this legislation is to undo the Supreme Court’s overreach into product liability lawsuits. Riegel has precluded otherwise legitimate claims, a preclusion not consistent with any other tort law. In the more recent decision of Wyeth v. Levine, the Supreme Court held that manufacturers could be held liable for mislabeled or defective drugs regardless of FDA approval.

In contrasting these two decisions, the current state of American law is this: If someone were to be seriously hurt or killed because of an FDA-approved drug was mislabeled, they are allowed to seek compensation. But if this person were injured by a mislabeled FDA-approved medical device, they would be precluded from bringing suit. Where is the consistency, or for that matter, the justice in that?

Originally posted at InjuryBoard by Don Greiwe

BPA Free Bottles Gain Popularity

Shannon Weidemann — Mon, 30 Jun 2008 15:53:24 GMT

For a long time now bisphenol-A (BPA) has been used in plastic to make it hard and clear. New studies are now making people question its safety especially when used in baby bottles, sippy cups, and the lining of formula cans. Retailers such as Babies R Us and Toys R Us are offering a BPA bottle exchange.

The National Toxicology Program, part of the U.S. Department of Health and Human Services' National Institutes of Health, released a draft report in April that concluded there may be some health concerns associated with products containing BPA, which is also present in the lining of canned foods and drinks.

The possibility that BPA may alter human development could not be dismissed, researchers said.

Canada has banned the sale of items containing BPA. Exposure has been linked to breast cancer, testicular cancer, early onset of puberty, autism, and hyperactivity. For now parents are following the old adage of better safe than sorry and exchanging their bottles for BPA-free ones. Glass bottles are making a comeback as well.

Originally posted at InjuryBoard by Shannon Weidemann

Hydroxycut: The Latest Gun in DSHEA’s Wild West

Don Greiwe — Mon, 11 May 2009 09:32:22 GMT

As you probably have heard, hydroxycut has been taken off the market. On April 30^th the FDA warned consumers to immediately stop using all 14 Hydroxycut products. This comes after the FDA compiled a report detailing 23 complaints of serious liver problems ranging from jaundice to liver failure requiring transplant. In one case, a 19-year-old died as a result of the associated liver damage. The manufacturers of Hydroxycut (Iovate Health Sciences) has since recalled all Hydroxycut products from retailers nationwide.

The Dietary Supplement Health and Education Act, or DSHEA, was brought into law the in 1990s under the Clinton administration. Most dangerously, it allows dietary supplements to enter the over-the-counter market without any formal review by the FDA. It even limits the FDA’s power to ensure honest advertising; that duty is delegated the Federal Trade Commission. So despite that 8 pt font statement that “these claims have not been evaluated by the FDA” that’s onscreen when a dietary drug claims it’s a panacea, the FDA doesn’t even yield the power to sue the manufacturers who mislead a gullible consumer base via their the supplement's advertising. Many Americans would be shocked to know of how little regulatory power the FDA has over the dietary supplement market.

Without formal testing of these products, the dangerous propensity of certain dietary ingredients is usually not found until after enough deaths or injuries have occurred to make such a causal link. This could take years, as is the case with Hydroxycut and Ephedrine (now only legal for limited uses).

Some call it a cycle, and would expect another product in the near future to take Hydroxycut’s place in the market. Without change, this product will be untested and unproven. Now is the time for Congress to take action to amend the DSHEA. In the least, the FDA must be given the authority to more closely monitor and regulate the dietary supplement industry.

For more information, see this article. It gives more frightening details into how this latest recall is unfolding. As George Blackburn, M.D., Ph.D. states, "Every time we put a lid on it, as we did when we got rid of ephedra, now comes another round of adulterated products," he said. "Now with Hydroxycut, we have the same type of organ injury and illness, if not mortality, that comes from some unknown ingredient."

Patients should always tell their doctors of any supplements they are taking even if it is not known to be dangerous, because known injury may occur when combined with certain prescription medicines.

Originally posted at InjuryBoard by Don Greiwe

Baseball's Maple Bat Controversy - Does Someone Have to Die?

Matthew Leeth — Tue, 21 Jul 2009 15:18:53 GMT

Maples bats are a clearly dangerous hazard that MLB will continue to ignore until someone is killed or seriously injured. Strong language, I know, but MLB’s actions thus far can only be summarized as a grossly negligent policy only lacking a significant injury.

First, some history. MLB bats were historically made out of ash wood. Maple bats were officially sanctioned in 1997, but it was Barry Bonds hitting 73 home-runs with a maple bat in 2001 which put it on the map. From there on, most players were convinced that maple bats provide greater hitting power. In 2005, MLB had a man named Jim Sherwood test this theory. Mr. Sherwood reported that there was no advantage to using maple bats.

Undeterred, maple bats have become increasingly popular and are the bat of choice with almost every major league player. Baseball players are often described as a superstitious bunch, and while there is no actual benefit to maple bats, players often report that it just “feels” harder.

Even with no real benefit (I’m not sure if I’ve stressed that enough); there is a significantly dangerous drawback. While ash bats crack when broken, maple bats will either splinter or shatter into pieces. Sometimes a shard breaks off at the barrel, sending it flying into the stands. Sometimes, it breaks at the handle.

The MLB says they are “looking into it.” Yeah, right. The reality is that the players union has a negotiated agreement with the MLB as to the composition of their bats. And since players are convinced the maple bats will give them a competitive edge, they (as a whole) demand it. MLB PR seems to stall the media by saying they are investigating, but really they appear to just be avoiding the situation. But they won’t be able to avoid explaining to a victim’s family that an unproven alternative to ash was more important than fan safety.

Words can only say so much, though. Here’s more than enough proof that it’s time for the MLB to make the right decision by banning maple bats.

Here's Nick Green almost getting impaled at the short stop (sorry, can’t embed this). Nick Green said after the game “I don’t use maple… they say they’ve fixed it or whatever but that obviously didn’t fix [it]”)

And there are thousands of more of these images on the net. But rather than create a 15 page blog post filled with pictures, I suggest those interested read into this issue some more. This probably isn't the first time you've heard about maple bat controversy, especially if you follow baseball. But I can garauntee you it won't be your last time, either.

Thanks to Billy @ Clubhouse Cancer for compiling the pictures.

Originally posted at InjuryBoard by Matthew Leeth

New Bill Proposes to End Foreign Manufacturer Tort Liability Loopholes

Don Greiwe — Wed, 09 Sep 2009 14:34:18 GMT

Each year, many people in the United States are injured by defective foreign products imported into the United States. Loopholes in the law give foreign manufacturers ways of delaying lawsuits against them in the United States – but that may be about to change. Currently, when a foreign manufacturer’s product injures someone in the U.S. because of a defect, and the victim files suit against that manufacturer, serving the foreign defendant can take months or even years. As just one example, the recent Chinese-made drywall fiasco is faced with this sort of issue. Foreign manufacturers often seek to avoid judicial consideration of their actions by asserting that United States courts lack personal jurisdiction over their companies. New legislation, however, seeks to make it easier for plaintiffs to establish service and get the lawsuit moving.

In many cases today, serving process on foreign defendants is complicated and time consuming, thanks to international law ratified in the 1960s. Plaintiffs must translate the papers into the manufacturer’s native language, sent to a “central authority” (someone appointed by that country), then serviced per the laws of the country. This can cause huge delays, from a few months to over a year. Newly proposed legislation sponsored in early August by Senators Sheldon Whitehouse, (D-RI), Jeff Sessions, (R-Ala), and Richard Durbin, (D-Ill) called the Foreign Manufacturers Legal Accountability Act of 2009 addresses this problem with a two-pronged solution:

Foreign manufacturers will be required to have an “agent” in at least one state, which is designated to accept service on the company’s behalf.
Foreign companies consent to state or federal jurisdiction where their registered agent is located upon receiving service.

Obviously, this bill will not affect whether the manufacturer is liability for an injury or make the legal burdens on foreign manufacturers any greater than those imposed on domestic manufacturers. It simply makes service of process work as though the manufacturer were American.

Despite bipartisan support, though, the bill has not passed yet. But it is important that this important legislation get passed to finally end the loopholes which have allowed foreign manufacturers to delay lawsuits. Foreign companies that import products into the U.S. should not be able to avoid liability simply because of difficulties relating to serving process upon the company.

Originally posted at InjuryBoard by Don Greiwe

Taser Back in the News

Joe Saunders — Sat, 07 Feb 2009 11:24:02 GMT

A few weeks ago, Taser International was ordered to pay $1,423,000 in attorney fees as a result of a product's liability verdict in California. On June 7, 2008, the jury in the case of Heston v. City of Salinas, et al., N.D. Cal. Case No. C 05-03658 JW (United States District Court for the Northern District of California (San Jose)) found in favor of the family of Robert C. Heston. Specifically, the jury found that Taser International failed to warn of the risks of prolonged deployment of the stun gun. Heston suffered cardiac arrest and later died as a result of the Taser deployment.

The attorney fees decision was based on California Private Attorneys General Statute California Code of Civil Procedure §1021.5. According to the statute, in order to obtain attorney fees in such a case, the lawyers had to prove four things: 1) a plaintiff must be a successful party in an action resulting in the enforcement of an important right affecting the public interests, 2) a significant benefit, whether pecuniary or non-pecuniary, must have been conferred on the general public or a broad class of persons, 3) the necessity and financial burden of private enforcement must transcend the litigant's personal interest in the controversy, and 4) such fees should not, in the interest of justice, be paid out of the recovery.

The federal judge in the case, James Ware found "notoriety of Plaintiff's first-of-its-kind verdict, in some circumstances, has prompted a number of TASER customers and prospective customers to consider the risk of repeated and prolonged Taser electrical charges on individuals in an excited or delirious state.” This satisfied the significant benefit clause according to the Judge.

Originally posted at InjuryBoard by Joe Saunders

Jalepeno Now Salmonella Focus, Florida Tomato Growers Lose Millions

Shannon Weidemann — Thu, 24 Jul 2008 16:02:06 GMT

FDA investigator finally found salmonella in one of the thousands of samples it had tested following a huge nationwide outbreak. It was not found on a tomato however, the initial focus of the investigation. Instead it was found on a jalepeno pepper that was processed in a Texas plant and came from Mexico. Florida's tomato growers have suffered a huge loss to this growing season as their tomatoes were under the heaviest suspicion.

The wholesaler that processed the contaminated pepper, Agricola Zaragoza in McAllen, Texas, has recalled all its pepper shipments as a result of the FDA's findings. And restaurants, grocery stores and other food services have been notified of the FDA's stepped-up warning against the fresh peppers as well as fresh salsa or sauces that use jalapenos as ingredients.

The FDA has issued an advisory against eating raw jalepenos. Those that have been cooked or pickled should be fine. The rare Saintpaul stain of salmonella has sickened more than 1,000 people around the country. Many people that fell ill at the beginning reported that they had eaten something with raw tomatoes.

Originally posted at InjuryBoard by Shannon Weidemann

Ford Recalls Pickup Trucks

Shannon Weidemann — Thu, 15 May 2008 11:29:14 GMT

A brake hose problem is forcing the recall of Ford F-150 pickup trucks as well as the Lincoln Mark LT truck. The truck recall involves 650,000 2005 and 2006 trucks.

Ford trucks covered by the recall are equipped with 5.4-liter engines. The brake hose on those trucks can detach from an intake manifold, causing the driver to lose the "assist" function that provides additional power to the brakes, according to the safety notice.

The trucks could still be stopped with remaining braking power but it would require drivers to apply "more force to the pedal," Ford spokesman Wes Sherwood said.

Ford will contact owners of the recalled trucks to schedule a repair o the brake hose. No injuries have been reported due to the faulty component. There have been 11 minor accidents reported though. Ford can be contacted for more information at 1-800-392-3673. The recall also affects around 50,000 trucks in Canada.

Originally posted at InjuryBoard by Shannon Weidemann

Children's Necklace Recalled for Lead Poisoning

Christina Cole — Fri, 04 May 2007 02:01:41 GMT

The Oriental Trading Company, in cooperation with the Consumer Product Safety Commission, is volunarily recalling 132,000 Children's Religious Fish Necklaces because they contain high levels of lead. Lead is toxic if ingested by small children and can cause serious health effects.

The recalled necklaces hang from a black cord and have a silver fish pendant. The necklaces were sold through Oriental Trading Company Inc.'s website and catalog from January 2005 to January 2007.

If your child has one of these necklaces you should take it away immediately and discard it. You can also contact Oriental Trading Company for a refund.

Consumer Contact Information: Oriental Trading Company Inc. at (800) 723-6155 anytime or visit the firm's Web site at www.orientaltrading.com.

Originally posted at InjuryBoard by Christina Cole

Indoor Tanning Can Give You More Than You Bargain For

Bob Carroll — Mon, 14 Aug 2006 17:37:08 GMT

You may want to think more than twice before you head to the tanning salon. The New York Times reports: In the last two years, the World Health Organization, the American Medical Association and the American Academy of Dermatology have labeled tanning beds as the health-peril equivalent of cigarettes.

Skin Cancer Is Up; Tanning Industry a Target

"If adults want to make the decision to use tanning beds, fine," said Dr. James M. Spencer, clinical professor of dermatology at the Mt. Sinai School of Medicine and a co-author of a 2004 paper published by the Academy of Dermatology proposing regulations to bar minors in tanning salons. "But we don't sell cigarettes to minors, and indoor tanning is similar -- we know it will cause cancer. Not maybe. Not might. It's going to cause cancer. No one under 18 should be allowed to use those things."
Melanoma, the most lethal form of skin cancer, claims an estimated 8,000 lives annually in the United States. It is the most common cancer in young women aged 25 to 29, according to recent dermatological studies.
Despite the lack of indisputable evidence of the cause, however, dermatologists have taken a hard line against tanning. They point to three intersecting reasons for concern -- the rising number of melanomas being diagnosed, studies indicating possible links between melanomas and sunburning in early life, and the popularity of tanning among teenage girls -- to support their proposal to bar those under 18 from indoor tanning parlors.

Originally posted at InjuryBoard by Bob Carroll