Preemption and The Current President

Source: Tresa Baldas who writes for National Law Journal, a Fulton Daily Report affiliate.


The clock is ticking for lawyers specializing in consumer safety litigation as they wait to see what "midnight regulations" the Bush administration squeaks through before leaving office in January.


There are dozens of rules now under review by the administration that affect everything from prescription drug labeling to water quality to auto roof safety, according to the Office of the Federal Register, the government's official daily publication for rules, proposed rules and notices of federal agencies.

Midnight regulations are last-minute federal rules and regulations that a president issues before leaving office, usually in the last three months of his term.



Defense counsel are counting on the Bush administration to leave behind regulations that offer greater liability protection to manufacturers and less regulation. The plaintiffs' bar fears just that, warning that as many as 21 possible regulations could be a "nightmare" for consumer safety and the environment.



"Let's say all 21 pass - that's a worst-case scenario. You will be looking at thousands of consumers who will be left with no recourse and manufacturers who have the ability to walk away with complete immunity," said attorney Gerie Voss, director of regulatory affairs for the American Association for Justice (AAJ), the voice of the plaintiffs' bar, which is tracking the 21 pending consumer safety regulations.



Pre-emption front and center

But corporate defense counsel Matthew Neumeier of the Chicago office of Washington-based Howrey said that the "Bush administration is continuing to generate regulations consistent with its philosophy - that the regulation of business should be minimal.



"And if there is regulation, the regulation should attempt to protect businesses from liability under other state law theories if they're compliant [with federal rules]," he said. "The pre-emption issues are really front and center."

And it's the pre-emption language within the proposed rules that have the plaintiffs' bar particularly concerned. These rules include



• A proposed regulation that would require auto manufacturers - for the first time in 35 years - to increase the strength of vehicle roofs. Plaintiffs' lawyers say the roof strength standards are still too low, and that automakers that meet that rule will be granted complete immunity from all lawsuits, according to the AAJ.



• A proposed rule by the U.S. Food and Drug Administration (FDA) to revise warning labels regarding the use of prescription drugs during pregnancy and breast-feeding, and to update them with more detailed information, including clinical trial results.

This rule includes a pre-emption clause, which the AAJ fears will offer drug makers blanket immunity and give injured women no recourse.



• A proposed FDA rule that would shield companies from liability for potentially harmful over-the-counter drug ingredients. The proposed rule changes the status of some ingredients used in over-the-counter drugs, making them subject to additional FDA approval. Once they were approved, manufacturers no longer could be held accountable should the ingredients cause harm, according to the AAJ.


Some lawyers believe the Obama administration will eventually reverse what might slip through before Inauguration Day.


Defense counsel say that Corporate America isn't taking advantage of any regulatory favors, or behaving irresponsibly. Instead, they argue, businesses should be required to follow only one set of rules, and if they do so, they should be immune from state lawsuits.



Read more about this doctrine here.

State Budget Crisis Threatens Access to Civil Justice System

Budget shortfalls in Georgia have forced superior courts statewide to eliminate the use of senior judges, burdening already overloaded court dockets. Injured plaintiffs that rely on the civil justice system are likely to be victims of these cuts.

Senior judges are retired superior court judges who serve as needed to resolve backlogs of cases and preside over trials. They have been used with increasing frequency as caseloads around the state have increased.

Fulton County Superior Court Judge Melvin Westmoreland criticized the cuts: “It’s unfortunate the State’s mismanagement of funds has brought to a halt the most fiscally responsible way to deal with the shortage of full-time judges available to handle increased civil filings and criminal prosecutions. As a result the county jails will become even more crowded and cases will move slower through the system.”

While criminal litigants can often take advantage of speedy trial demands to move their cases through the court system, civil litigants have no such rights and cases can drag on for years before reaching trial. At least one judicial district has temporarily suspended all civil trials because of crowded dockets.

Injured plaintiffs are placed in a particularly difficult position when they are unable to have their day in court, especially when their injuries have prevented them from working. The insurance companies that are ultimately responsible for paying the plaintiff's damages, on the other hand, are likely to benefit from increasingly desperate injured parties who are willing to settle for less than the true value of their case because they cannot afford to face financial ruin while waiting years to present their case to a jury.

Contributed by John D. Hadden
Turkheimer & Hadden, LLC

GTLA - In Practice: Micah Gravley

Micah Gravley is the Statewide Grassroots Director for GTLA.

In this podcast, Jamie and Micah discuss general issues related to GTLA and the importance of member participation.

GTLA: In Practice - Jay Sadd

In addition to serving as former editor of Calendar Call, the official publication of the General Practice and Trial Section of the Georgia State Bar, Jay has also served as Chairman of the Legal Education Committee for the Young Lawyers Section of the Georgia Bar; board member of Initiative 2000, which commemorated the 10th anniversary of the Americans with Disabilities Act; member of the Communications and Outreach Committee of The Public Justice Foundation; and Chairperson of the Education Committee for the Georgia Trial Lawyers Association. Currently Jay serves as Vice-Chairman of the Board of Director for the American Association of Adapted Sports Programs, Inc., and as an instructor for the Trial Techniques Program, Emory University School of Law.

In this podcast Jay Sadd and Jamie discuss how he came to be involved in GTLA and the impact it has had on his career.

The Holiday Season is here

I received my first holiday card over the Thanksgiving day weekend and thought how thankful I am for lawyers. After I opened the card, I checked my email and saw a blurb from my good friend and world renowned Trial Lawyer, Don Keenan. Aside from his exploits as a Trial Lawyer, Don sends out a yearly email noting the top 10 dangerous toys.
I can't speak for Don, but I presume that he would rather you did not give those toys to your children thereby running Mr. Keenan out of his business, too. You see, Don sues manufacturers and doctors that harm children.
Many of my trial lawyer friends do the same. Big business doesn't voluntarily do the right thing and remove dangerous toys and products from the shelves. So trial lawyers sue them, put the manufacturers under the spotlight, and force them to remove the hazardous products by hitting them in their pocket books; the only thing they cherish.
We have seen time and time again where government has failed to regulate big business, too. Yet trial lawyers never fail their cause- the promotion of safety.

That's why I am thankful for lawyers this holiday season.

A thought or two about branding

What is a lawyer's brand? Many of us resort to consultants or marketing professionals to help us address this basic question. In some ways it is an annual problem when it comes time to update a website or renew an ad in the Yellow Pages.

According to this article, it takes more than just frustration with your current situation or a bucket of money to throw at the problem.

"You see it in professional spin-offs all the time… Two or three key architects in an established firm leave with a few clients, just knowing they can do it better on their own. But then they go out and start a company that’s cut from the exact same cloth as the last place they worked. They use the same accounting software, the same processes, the same fee structure, and even the same spiel in their pitches. The only thing that’s changed is the location and the letterhead."

Author Michael Gerber, in his book "The E-Myth," tackles this problem head on.

If you are looking for a holiday gift for a lawyer with a branding issue, consider this easy to read, but thought provoking book.

Receive Levi's Calls by Text

News from Keep Georgia Safe shows how technology helps with alerts like a Levi's call:

What is a Levi's Call? - Georgia's AMBER Alert

A Levi's Call is an emergency bulletin that is issued whenever a child has been abducted and is in imminent danger of harm or death. The goal is simple: To locate the child and the abductor expeditiously before any harm comes to the child. In Georgia, this alert is known as "Levi's Call" in memory of 11 year old Levi Frady.

Get a real-time text of alerts:

To receive real-time notification of Levi's Call, Georgia's AMBER alert, Mattie's Call, elderly or disabled missing person alert, and Kimberly's Call, dangerous fugitive alert, via text on your cell phone, go to their site and enroll. You can read more about the other types of alerts on their site.

With your help, you can become a part of the Keep Georgia Safe wireless network.

Recall Alert: Infant Gas Relief Eye Drops

Johnson & Johnson and Merck Consumer Pharmaceuticals Company announce the voluntarily recall of approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide.

The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). The recall was announced as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

Lot numbers are: SMF007 and SMF008.

Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Source.

Recall Alert: ReliOn Syringe Recall

The FDA reports this week that ReliOn syringes have been recalled. Here is the report from the FDA site:

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Caps on Damages Case Settles

For Immediate Release
October 31, 2008
rdehart@gtla.org

Caps on Damages Case Settles in Favor of Mr. Park

Atlanta, Georgia—Yesterday afternoon, the case of Park v WellStar Hospital settled for an undisclosed amount. The case was on appeal to the Georgia Supreme Court following a Fulton Superior Court ruling that Georgia’s statutory limit on damages in a medical malpractice case was unconstitutional. The defendants’ appeal was scheduled for oral argument before the Georgia Supreme Court next Monday.

“We are pleased that the Park family has received justice,” said Rob Roll, an attorney for Park. “This case truly represented the uphill battle facing Georgia’s families since SB 3 became law. While this case was closely watched, we have never lost sight of the paramount importance of the best interest of our clients. It is clear that the defendants did not want the caps provision to be scrutinized by the Georgia Supreme Court. And the Parks deserved and received justice.”

The case was filed by Plaintiff Cheon Park, 59, who fell from a ladder at his home in late 2006. He was taken to WellStar Douglas Hospital by ambulance with complaints of pain in his neck, shoulder, arm and pelvis. Once at the hospital, doctors treated Park for a dislocated shoulder and then released him that same evening. Upon his discharge, Park could not stand on his own and had to be lifted by hospital staffers and his loved ones into his car. Just a few days later Park, still in pain, was taken to Grady Hospital where X-Rays revealed he had a severely damaged spine. Park is a now a C4 quadriplegic and confined to a wheelchair.

The Parks filed suit in Fulton County Superior Court against the Hospital. During that tumultuous time, the Parks learned of SB 3. In 2005, the Georgia Legislature passed a sweeping, so-called “tort reform” measure. Claims of “jack-pot-justice” and “frivolous lawsuits” flooded the halls of the Gold Dome. In one fell swoop, SB 3 drastically compromised the Constitutional Rights of all Georgians. In some aspects SB 3 attempted to limit Georgia citizens’ Constitutional Rights and in other aspects those Rights were completely eradicated.

After receiving the news that a chance for a financial recovery had been destroyed just one year before, the Park family asked the judge for a ruling on the two main components of SB 3— the application of a gross negligence standard in emergency rooms and the cap on ‘non-economic,’ or ‘quality of life,’ damages. Last May, Judge Marvin Arrington ruled that Georgia’s medical malpractice cap on non-economic damages was indeed unconstitutional. He had yet to release his decision on the gross negligence standard.

“Judge Arrington’s decision addressed several aspects of caps on damages that could not pass Constitutional muster,” said Trent Speckhals, an attorney for the Park family. “His ruling addresses this state’s—and this nation’s—fundamental value of a citizen’s right to trial by jury. His commonsense ruling balances the rights of all Georgians, young and old, rich and poor, and restores the guarantees set forth in our Constitution.”

Judge Arrington’s decision may still be used as a persuasive decision in future civil suits.

“This conversation about the unconstitutionality of SB 3 is not over. But what is most important now is that the Park family can try to piece their lives back together,” said GTLA President, Fred Orr. “Trial lawyers are an impressive bunch of people. And this latest case proves that. Our profession knows that there is nothing more important than the client you were hired to obtain justice for. The Park family may have struggled for the next several years while their case played out in court. Instead, now they can put this behind them and start rebuilding their future. I commend the attorneys who represented this deserving family.”

Rob Roll and the attorneys at Watkins, Lourie, Roll & Chance, PC, Trent Speckhals of Speckhals and Cora, Michael Terry and Frank Lowry of Bondurant, Mixson & Elmore, and Ned Miltenberg of the Center for Constitutional Litigation, PC were all instrumental in the representation of the Parks in this case.

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The Georgia Trial Lawyers Association
Protecting the Constitutional Promise of Justice for all by
Guaranteeing the Right to Trial by Jury,
Preserving an Independent Judiciary, and
Providing Access to the Courts for all Georgians

www.gtla.org