P.I.S.S.D. -- Personal Injury, Social Security Disability. Dallas Texas Lawyers

Studies On Chemical In Plastics Questioned - FDA

The Washington Post has an article today that illustrates the fallacy in the current trend of the Bush administration and the U.S. Supreme Court to push the doctrine of "preemption." This is the legal theory that basically states if a federal agency approves a product, then consumers are forbidden to file any claims for damages caused by that product. The argument against premption is that the government is starving the federal agencies by reducing their budgets, thereby reducing their abilities to adequately test products. The story is about safety concerns with the chemical compound bisphenol A (BPA). Here are excerpts.

Despite more than 100 published studies by government scientists and university laboratories that have raised health concerns about a chemical compound that is central to the multibillion-dollar plastics industry, the Food and Drug Administration has deemed it safe largely because of two studies, both funded by an industry trade group.

The agency says it has relied on research backed by the American Plastics Council because it had input on its design, monitored its progress and reviewed the raw data.

The compound, bisphenol A (BPA), has been linked to breast and prostate cancer, behavioral disorders and reproductive health problems in laboratory animals.

As evidence mounts about the risks of using BPA in baby bottles and other products, some experts and industry critics contend that chemical manufacturers have exerted influence over federal regulators to keep a possibly unsafe product on the market.

Congressional Democrats have begun investigating any industry influence in regulating BPA.

"Tobacco figured this out, and essentially it's the same model," said David Michaels, who was a federal regulator in the Clinton administration. "If you fight the science, you're able to postpone regulation and victim compensation, as well. As in this case, eventually the science becomes overwhelming. But if you can get five or 10 years of avoiding pollution control or production of chemicals, you've greatly increased your product.

Scientists first flagged possible health risks of BPA more than a decade ago. From 1997 to 2005, 116 studies of the compound were published, many of them focused on its effects in low doses. Of those funded by government, 90 percent showed a health effect linked to BPA. None of the industry-funded studies found an effect; all of them said BPA is safe.

Drug Makers Near Old Goal: A Legal Shield

I wrote recently about the legal doctrine of pre-emption that is threatening to steal legal rights from American consumers. Now the New York Times has published a lengthy but excellent article on the subject of the legal shield sought by drug manufacturers. Here are excerpts, but I encourage you to read the article.

The Supreme Court appears to be on the verge of endorsing a doctrine that the F.D.A. should not be second-guessed by courts.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines.

Consumers Beware - Pre-emption By Preamble Steals Your Legal Rights

Recent actions by federal regulatory agencies, combined with a U.S. Supreme Court decision are extremely troubling to consumer advocates. The gist of the problem is that federal agencies under the Bush administration are taking the stance that their rules trump state court verdicts.For example, if a federal agency said a prescription drug was safe, then a state jury verdict finding the drug to be unsafe would be void.

Aside from the overarching argument that federal agencies have no constitutional right to exert control over state courts, the problem with this approach is that political considerations can decide whether the agencies find certain products to be safe. If a giant pharmaceutical company makes a large contribution to a presidential candidate, there will be a natural tendency for the president to influence the federal agency to protect the financial interests of the pharmaceutical company. Some consumer advocates think that's exactly what's happening now.

Who gets hurt by this process? Consumers who have legitimate legal claims against manufacturers, but are prevented from filing those claims.

The Dallas Morning News ran an interesting story about this Pre-emption by Preamble." Here are excerpts.

If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can't sue the maker for injury if it met agency standards.

The Consumer Product Safety Commission says you can't sue a mattress maker if your mattress bursts into flame despite meeting commission standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration proposals for stronger roofs.

Plaintiffs' attorneys call it "silent tort reform." But it's part of tension existing since the nation's founding: conflict between state and federal law.

If they clash, state laws give way. That's in Article Six of the Constitution. But in areas where there is no federal law, federal courts must defer to laws of the state where a lawsuit is heard. That includes product liability.

A developing body of judicial opinion could place new limits on the rights of those who buy or use products, consumer advocates say. It also could mean the savings of billions of dollars by companies insulated from lawsuits.

What's riling plaintiffs' lawyers, consumer groups and some regulators is agencies' assertions their rules override state product liability laws. Most such claims are rooted in statements in the introductions to their rules, not the rules themselves.

"These pre-emption preambles may be only the beginning," New York University law professor Catherine Sharkey wrote in the DePaul Law Review. She projected preambles may "displace competing or conflicting state regulations or common law as a matter of course."

The practice varies by agency but is spreading. "It's absolutely a trend," said Deepak Gupta, staff lawyer for Ralph Nader's public citizen Litigation Group.

One example of what this means to the average person is found in NHTSA proposals for new SUV rollover rules.         

Attorneys general from 26 states asked the organization in 2005 to drop lawsuit protection from the rules, which could go into effect as early as July 1.

"State governments and the federal government will have to cover millions of dollars in health care costs which they will pass along to taxpayers, costs that, by all rights, should be the responsibility of manufacturers," the attorneys general wrote.

Sen. Patrick Leahy, D-Vt., at hearings last fall, said agencies have issued at least a dozen rules to shield drug and other product manufacturers from liability.   

Indeed, plaintiffs lawyers say "pre-emption by preamble" has been coming in waves during the Bush administration.

             

Honda To Recall 40,000 ATVs

From the U.S. Consumer Product Safety Commission comes this announcement of a recall of Honda all-terrain vehicles:

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Model Year 2007 Honda TRX 500 ATVs

Units: About 40,000

Manufacturer: American Honda Motor Co., Inc. of Torrance, Calif.

Hazard: Water can enter the throttle position sensor and freeze, causing permanent damage if the rider forces the throttle lever. This could cause the throttle to stick open, posing a risk of injury or death to riders.

Incidents/Injuries: Honda has received two reported incidents of the throttle sticking, no injuries have been reported.

Description: This recall involves Model Year 2007 Honda TRX 500 ATVs, also known as the Honda Foreman and Foreman Rubicon. The adult-size ATVs are designed for use by riders age 16 and older. The 2007 model year ATVs are available in red, black, blue, olive, and camouflage. The Honda name and wing logo are printed on the fuel tank and the model name is printed on the side panel just below the seat.

Sold by: Honda ATV dealers nationwide from June 2006 through December 2007 for between $6,500 and $7,600.

Manufactured in: USA

Remedy: Consumers should immediately stop using these recalled ATVs and contact any Honda ATV dealer to schedule a free repair. Registered owners of the recalled ATVs have been sent direct notice.

Consumer Contact: : For additional information, consumers can contact Honda (866) 784-1870 between 8:30 a.m. and 5 p.m. PT Monday through Friday, or visit the firm's Web site at www.powersports.honda.com

Anti-Consumer Preemption Case Nears Completion

A case currently before the U.S. Supreme Court has the potential of stripping consumer rights established over long years of legislative and judicial processes. The case involves the doctrine of preemption, and specifically relates to a medical device approved for sale by the U.S. Food & Drug Administration.

Preemption is a doctrine pushed hard by big business, Republican legislators, and conservative judicial activists. The gist is that if a product is approved by a federal agency, and then is found to be defective, consumers are prohibited from suing the manufacturer. An unspoken but necessary component of preemption is the emasculation of federal agencies through the budget process. In other words, starve the agencies so they can no longer subject new products to adequate testing, then when the unsafe products are approved, declare them to be beyond the scope of personal injury lawsuits. It's a beautiful thing if you happen to be a manufacturer. It's raw politics at its ugliest if you happen to be an injured consumer.

The Web site LawyersAndSettlements.com has a good article on the current preemption case, involving a Medtronic balloon catheter.

DOT Finally Adopts Tougher Standards In Side-Impact Crashes

After many years of lawsuits by plaintiff lawyers against auto manufacturers for improper and inadequate side-impact protection, the Department of Transportation has finally taken steps to mandate higher passenger safety. Better late than never. Here is the DOT statement:

U.S. Transportation Secretary Mary E. Peters today announced new side impact safety requirements for all passenger vehicles. It is expected that the upgrade, developed by DOT’s National Highway Traffic Safety Administration (NHTSA), will save hundreds of lives every year. The new standard requires auto manufacturers – for the first time ever – to provide head protection in side-impact crashes. It also would enhance other protections for passengers involved in such crashes.

"This new standard will spare hundreds of families from losing a loved one in a side- impact accident, and will forever raise the bar on safety for drivers and passengers across America,” Secretary Peters said.

Side-impact passenger vehicle crashes are a serious – and frequently severe – safety problem on the nation’s roadways. Side impact crashes account for 28 percent of all fatalities, the majority of which involve a brain injury. NHTSA estimates that the new requirements will save over 300 lives and prevent nearly 400 serious injuries per year.

For the first time, a dummy representing a small adult female will be used in side-impact performance testing. A new and more technically advanced dummy representing an adult male of average height will also be used in crash testing.

"With these rigorous new requirements, we are building on the strength of innovative and life-saving side impact technologies that are already available to many new car buyers,” NHTSA Administrator Nicole R. Nason said.

While NHTSA does not require specific technologies to meet its new performance requirements, manufacturers likely would meet this upgraded rule with various types of innovative head, chest and pelvis protection systems, such as side curtain air bags and thorax air bags.

Issued today by NHTSA, the new rule will require that manufacturers begin equipping all vehicles with improved side-impact protection that meets the federal standard, beginning with a phase-in schedule that starts in 2009.

Link of the Day - Auto Lemon Meter

A Connecticut law firm has a cool "Lemon Meter" on their Web site, enter a few facts about your vehicle purchase, and you'll find out whether your car is covered by your state's lemon laws.

Nissan Recalls Altimas and Sentras

From the Associated Press today:

Nissan is recalling 686,500 Altima and Sentra passenger cars to fix problems with a sensor that could lead to engine stalling.

Nissan Motor Co. spokeswoman Jeannine Ginivan said Monday there have been no reports of crashes or injuries tied to the issue. More than 650,000 of the recalled vehicles are in the United States, with the remainder in Mexico and Canada.

Merck Agrees To Settlement Of Some Vioxx Claims

Announcement was made today of a proposed settlement agreement between Merck, the manufacturer of Vioxx pain medication, and attorneys representing certain plaintiffs in lawsuits claiming that heart attacks or strokes were caused by the intake of Vioxx.

The settlement proposal is quite complex, and is not a "done deal" yet. Here is the official press release from Merck:

Merck Agreement to Resolve U.S. VIOXX® Product Liability Lawsuits

Agreement Provides for $4.85 Billion Payment

WHITEHOUSE STATION, N.J., Nov.  9, 2007 - Merck & Co., Inc. today announced that it has entered into an agreement with the law firms that comprise the executive committee of the Plaintiffs' Steering Committee of the federal multidistrict VIOXX litigation as well as representatives of plaintiffs' counsel in state coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against the Company in the United States.  The agreement, which also applies to tolled claims, was signed by the parties this morning after they met with three of the four judges overseeing the coordination of more than 95 percent of the current claims in the VIOXX litigation. If certain conditions under the agreement are met, the Company will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter into the resolution process.  This is not a class-action settlement.  Claims will be evaluated on an individual basis. "This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines," said Richard T. Clark, chairman, president and chief executive officer of Merck.  "The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount." The conditions in the agreement, which is open only to those cases filed or tolled on or before Nov. 8, 2007, include: To qualify, claimants will have to pass three gates: an injury gate requiring objective, medical proof of MI or ischemic stroke (as defined in the agreement), a duration gate based on documented receipt of at least 30 VIOXX pills, and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury; Individual cases will be examined by administrators of the resolution process to determine qualification based on objective, documented facts provided by claimants, including records sufficient for a scientific evaluation of independent risk factors; The agreement provides that Merck does not admit causation or fault; Neither stroke claims that are hemorrhagic in nature nor transient ischemic attacks will qualify; Law firms on the federal and state Plaintiffs' Steering Committees and firms that have tried cases in the coordinated proceedings must recommend enrollment in the program to 100 percent of their clients who allege either MI or ischemic stroke; The parties agree to seek court orders from the four coordination judges requiring plaintiffs' attorneys to promptly register all of their VIOXX claims, whether filed or tolled, and to identify the alleged injury - in order to establish the universe of all existing claims in the United States; Participation conditions: payment obligations under the agreement will be triggered only if, by March 1, 2008 (subject to extension by Merck), plaintiffs enroll in the settlement process: (a) 85 percent or more of all currently pending and tolled MI claims, (b) 85 percent or more of all currently pending and tolled ischemic stroke claims; (c) 85 percent or more of all eligible claims involving a death; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use; and This agreement applies only to U.S. legal residents and those who allege that their MI or ischemic stroke occurred in the United States. Under the agreement, separate funds will be created by the Company in the amount of $4 billion for MI claims and $850 million for ischemic stroke claims.  Once triggered, Merck's total payment for both funds of $4.85 billion is a fixed amount to be allocated among qualifying claimants based on their individual evaluation.  While at this time the exact number of claimants covered by this agreement is unknown, the total dollar amount is fixed.  Payments to individual qualifying claimants could begin as early as August 2008 and then will be paid over a period of time.  Merck retains its right to terminate this process without any payment to any claimant, and to defend each claim individually at trial if any of the participation conditions in the agreement are not met. The Company expects to record a fourth-quarter 2007 pre-tax charge in the amount of $4.85 billion to cover the cost of the agreement. "This agreement is the product of our defense strategy in the United States during the past three years and is consistent with our commitment to defend each claim individually through rigorous scientific scrutiny.  Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine if they qualify for payment," said Bruce N. Kuhlik, senior vice president and general counsel of Merck. "This agreement also makes sense for the Company because since 2004, we have reserved approximately $1.9 billion for defending VIOXX litigation and, absent this agreement, could anticipate that the litigation might stretch on for years." "Creating a process to look at individual claims is the fairest way to efficiently and quickly provide payment to qualified claimants," said Russ Herman, Liaison Counsel in the federal multidistrict VIOXX litigation and Chair of the Plaintiffs' Negotiating Committee.  "Specific causation has been a very difficult issue.  This is an opportunity to end a long and difficult litigation that has stretched on for more than three years.  A fair resolution is in everybody's best interest.  This agreement would only apply to claims already filed or tolled." "This is the right time for an agreement," said Mr. Kuhlik.  "Recent court rulings confirmed that the window has closed for filing suits in a number of states, consistent with our view that statutes of limitations have expired in almost every state.  Additionally, three of the coordination judges have issued orders that require non-eligible and non-participating plaintiffs to provide documentation of the factual basis for their claims early in the litigation process.  Merck reserves the right under this agreement to terminate our involvement unless the vast majority of eligible claimants elect to participate." Forty-two states, Puerto Rico and the District of Columbia have statutes of limitations of three years or less.  Already, New Jersey Superior Court Judge Carol Higbee and Federal District Court Judge Eldon Fallon have issued orders in cases from New Jersey and eight other jurisdictions ruling that the statutory period for making VIOXX personal injury claims has passed.  Merck voluntarily withdrew VIOXX from the marketplace on Sept. 30, 2004. The discussions between Merck and the plaintiffs were originally requested by Judge Fallon, Judge Higbee, California Superior Court Judge Victoria Chaney, and Texas County Court Judge Randy Wilson.  Judges Fallon, Higbee and Chaney, who met with the parties prior to the agreement being signed, issued case management orders that will require plaintiffs seeking to pursue VIOXX claims outside this resolution process to provide in a timely fashion certified copies of their medical and pharmacy records, as well as expert causation opinions. Merck has submitted a similar order to Judge Wilson. The Company will continue to defend all claims that are not included in the resolution process. Plaintiffs requesting additional information should contact the Chair of the Plaintiffs' Negotiating Committee for further information: Russ Herman of Herman, Herman, Katz & Cotlar, LLP at (504) 581-4892. Status of Litigation Juries have now decided in favor of the Company 12 times and in plaintiffs' favor five times.  One Merck verdict was set aside by the court and has not been retried.  Another Merck verdict was set aside and retried, leading to one of the five plaintiff verdicts.  There have been two unresolved mistrials. As of Oct. 9, 2007, in the United States, the Company had been served or was aware that it had been named as a defendant in approximately 26,600 lawsuits, filed on or before Sept. 30, 2007, which include approximately 47,000 plaintiff groups, alleging personal injuries resulting from the use of VIOXX, and in approximately 264 putative class actions alleging personal injuries and/or economic loss. Merck has entered into a tolling agreement with the multidistrict litigation Plaintiffs' Steering Committee that establishes a procedure to halt the running of the statute of limitations for certain categories of claims allegedly arising from the use of VIOXX by non-New Jersey citizens.  The Tolling Agreement requires any tolled claims to be filed in federal court.  As of Sept. 30, 2007, approximately 14,100 claimants had entered into Tolling Agreements.  The parties agreed that April 9, 2007, was the deadline for filing Tolling Agreements and no additional Tolling Agreements are being accepted. The claims of over 5,550 plaintiff groups had been dismissed as of Sept. 30, 2007.  In addition, about 20 cases scheduled for trial were either dismissed or withdrawn from the trial calendar by plaintiffs before a jury could be selected.

Bizarre -- Aqua Dots Toys Recalled, Linked To 'Date-Rape' Drug

Can the news from China get any stranger than this? In Mattel's latest toy recall (Mattel is up to at least 21,000,000 recalled toys just in the past few months), the popular Aqua Dots beads have been found to contain a chemical that acts as a date-rape drug when ingested by children. Here are excerpts from a story in the Dallas Morning News:

Aqua Dots, which features small beads that bond with water, contain chemical 1,4-butanediol, an industrial solvent that the body converts to drug gamma-hydroxy butyrate, according to the U.S. Food and Drug Administration's Web site.

Two children in the U.S. who swallowed the beads were hospitalized after they became comatose and later recovered, the U.S. Consumer Product Safety Commission said in a statement. The toys were manufactured in China and distributed by Toronto-based Spin Master, it said.

The recall comes as consumer concern grows about Chinese-made products amid revelations this year of toxic pet food, contaminated vitamins, lead paint on toys and deadly cribs. President George W. Bush earlier this week called for increased penalties for companies that sell dangerous products and establishing a certification program for producers that meet safety standards.

China, which produces four-fifths of the toys sold in the U.S., has been the focus of several recalls this year, including at least 21 million items recalled by the world's largest toymaker, Mattel Inc.