Georgia Injury Lawyer Blog

Victims of the wrongful death of their loved ones testified this week before Congress concerning adulterated supplies of Heparin. One of the largest suppliers of this drug, which is used in kidney dialysis and various other surgeries to prevent dangerous blood clots, is Baxter International, Inc. Not only did the victims of families who have been damaged by this product testify before Congress, representatives from Baxter were also subpoenaed by the Energy and Commerce Committee which is reviewing the Food and Drug Administration’s response to this scandal.

While the evidence is still unclear, it appears that the Heparin product manufactured by Baxter International, Inc. was derived from factories in China that had not been properly audited and inspected. There is also evidence that a particular sulfate product used in the manufacture of Heparin was deliberately substituted because it was less expensive to use than a safer sulfate ingredient. Regardless of the final results of Congress’ investigation, it was clear from victim testimony that the lack of oversight by Baxter relative to the activities of its foreign operations has lead to a tremendous amount of suffering for the victims’ families.

To date, 81 people have died from using contaminated Heparin. One gentleman who testified before Congress not only lost his wife but also his son who were undergoing kidney dialysis in Ohio. This man’s wife and son died within one month of each other. Thus, the wrongful deaths caused by this dangerous product clearly are deserving of congressional scrutiny so that other unwitting victims of products imported from abroad will be spared similar fates.

We have written before on this blog about dangerous products that harm the American public. This seems to be yet another example of where the U. S. Food and Drug Administration has failed the American public in failing to insure that medical supplies are safe for public use and consumption. Not only may Baxter International have failed the American public, the government itself in its oversight role, may have also contributed to these tragedies. Even though Baxter, which had supplied about half of the U. S. Heparin market recalled most of its products in February of this year, the fact remains that 81 deaths have occurred and tremendous suffering which could have been avoided has been experienced as a result of the failure of proper oversight for these dangerous products.

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Posted In: Dangerous Drugs , Products Liability , Torts , Wrongful Death

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Wal-Mart announced this week that it will soon stop selling baby bottles made with the chemical bisphenol A (BPA). The retailer said that it was immediately stopping sales of baby bottles, sippy cups, pacifiers, food containers and water bottles made with BPA in its Canadian stores. There has been speculation that Canada’s health department would soon declare the chemical unsafe.

On Monday the U.S. National Toxicology Program released a draft report that expressed concern that BPA, which is used to make plastic, could cause behavioral changes in infants and children and trigger the early onset of puberty in females.

Wal-Mart has sold BPA-free baby bottles for several years alongside bottles with the chemical. But yesterday was the first time the retailer indicated it would convert its entire U.S. stock.

Other retailers are also stocking products made without the chemical. A spokeswoman for Target said the chain began testing glass baby bottles in its stores in January. Babies R Us said its sales of glass bottles have increased fivefold since last spring.

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Posted In: Products Liability

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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 (CPSC) says you can't sue a mattress maker if your mattress bursts into flame despite meeting CPSC 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 (NHTSA) proposals for stronger roofs.

Consumer advocates call this "silent tort reform." It is part of the tension between state and federal law that has existed since the nation's founding. If there is a conflict, state laws must yield under Article 6 of the Constitution. But where there is no federal law, federal courts must defer to laws of the state where a lawsuit is heard. Big business and insurance companies are now using this to avoid responsibility for negligent actions and omissions at the expense of innocent consumers.

Under the Bush administration, a developing body of judicial opinion could place new limits on the rights of those who buy or use products. It also could mean the savings of billions of dollars by companies insulated from lawsuits.

Federal agencies are increasingly promulgating rules favorable to big business and insurance companies at the expense of ordinary citizens. They then assert their rules override state tort and product-liability laws. In a novel approach, these agencies are claiming that the preemptive effect is based on statements in the introductions to their rules, not the rules themselves.

The practice varies by agency but is spreading. It delights corporate defense lawyers. The argument is that federal agencies are the absolute rule-makers.

Actor Dennis Quaid and his wife are preparing to fight such a contention — this one made by the FDA — in a suit accusing Deerfield, Ill.-based Baxter Healthcare Corp. of putting vastly different doses of a blood-thinner into confusingly similar packages. The Quaids went to court in November 2007, after their infant twins were given 1,000 times more heparin than babies should get. Their suit contends Baxter should have changed the packaging after three babies died in 2006 at an Indianapolis hospital.

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Posted In: Dangerous Drugs , Insurance Company Abuse , Medical Malpractice , Pharmaceutical Manufacturer Liability , Products Liability , Torts

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A study released yesterday contained bad news for makers and buyers of portable defibrillators, devices that deliver electrical shocks meant to revive victims of sudden heart In the first major study of their use in household settings, researchers found no evidence that the devices produced significant life-saving benefits. The study, of more than 7,000 heart patients, concluded that patients in homes equipped with the gear died at the same rate as those without it.

Defibrillators were originally designed for ambulance crews. However, they have recently been marketed to consumers for use in homes.
Importantly, the study noted that the life-saving potential of the automated external defibrillators was well established in hospitals, emergency vehicles and in public settings like airports and casinos. At public locations there are typically employees close at hand who are trained to use the defibrillators.

The home study, which was sponsored by the government but partly financed by industry, followed the patients an average of three years. The death rates from all causes and from heart problems in the group that was given defibrillator kits — and training in how to use them — were lower than expected but virtually identical to the group that did not receive the equipment. It turned out that just 14 patients treated in the three-year study suffered the specific heart rhythm malfunction that the defibrillator could combat. Of that group, four survived to be released from the hospital.

But the study served mainly to spotlight the health care system’s limited options in dealing with sudden cardiac arrest — a heart malfunction that each year strikes 166,000 Americans outside the hospital.
Unlike a heart attack, which involves a restriction of blood flow to the heart’s muscle and is often not fatal, sudden cardiac arrest results from chaotic, rapid heartbeats and is invariably deadly unless normal heart rhythms are quickly restored. About 75 percent of cases occur in the home. Although many victims have had previous heart problems, others are stricken with no warning. .

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Posted In: Products Liability

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Many wrongful death lawsuits have been brought against the manufacturer of the popular police taser device but according to the manufacturer’s boasts which are in the public record, no such lawsuits have been successful. And yet, practically every week it seems, another person is killed by the use of this product.

Our wrongful death and injury lawyers read last week a news article about a teenager who was killed by the use of a taser after an altercation inside of a grocery store near Charlotte, North Carolina. Apparently, a 17-year old teenager got into an argument with one of his supervisors at a grocery store and police officers were summoned to the scene. When the officers arrived, the teenager allegedly was highly agitated and allegedly refused all verbal demands. A police officer used a taser on the teen to subdue him. The taser killed the teenager, age 17. It appears from the news accounts of this incident, the death of this teenager was not warranted by his non-violent conduct as he had not committed nor was he charged with any crime. He was merely upset and agitated and was not a threat to anyone as he apparently had no weapons on his person.

Over and over again it seems that people are killed by this device and yet the device continues to be used by the police. While every case is different, of course, in many cases we read about the use of these tasers in cases where the suspect is not known to be violent, has committed no major felony or other violent crime, and yet is intentionally stunned with this product, sometimes with fatal results.

We would encourage the law enforcement community to reconsider its use of this product. Despite the protestations of the manufacturer, there is abundant anecdotal evidence in the public domain which suggests that this product can kill healthy people including healthy teenagers. The use of such deadly force in a context where the suspect is not known to be violent nor is armed seems questionable at best thus calling upon a review by the law enforcement community of their procedures and their use of this product.

Many times, litigation is the best tool available to address products like these. Other lawyers have tried to sue the manufacturer, apparently without success. Whether a successful wrongful death lawsuit can be brought based on this most recent incident remains to be seen but clearly there needs to be further review of this potentially dangerous product. Non violent persons encountered by the police should not be subject to the “death penalty” caused by the use of an unreasonably dangerous product.

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Posted In: Products Liability , Torts , Wrongful Death

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Our personal injury lawyers read today about a serious accident case involving an overturned school bus which apparently lost control and overturned about 40 miles north of Atlanta near Canton, Georgia. It was traveling from one high school to a middle school when the accident happened. When the bus overturned, even though no students were ejected from the bus, according to initial reports, approximately 25 students were injured. Two were reported to be in critical condition.

Initial news accounts state that the bus driver apparently lost control of the bus after going around a curve. The bus overturned on its side. It is doubtful that this school bus was equipped with seatbelts. Had the seatbelts been in place, one must wonder whether the two students in critical condition would have been as seriously injured as they apparently were.

Approximately one year ago, another bus ran over the top of an exit ramp crashing off of a bridge onto its side on Interstate Highway 75. This involved the Bluffton University baseball team. There were seven (7) deaths associated with that incident. In that accident, there were no seatbelts available for the baseball team occupants and some of those killed had been ejected. In the most recent case involving the school bus, many were injured and some perhaps critically once again because of joint and concurring driver negligence and the lack of seatbelts.

One must wonder how many more accidents there will have to be before Congress will require seatbelts for school buses and other motor carriers for hire such as commercial buses that one sees almost daily in large metropolitan areas. Until and unless seatbelts are required, our lawyers and the public will regretfully and, in all likelihood, continue to read about preventable injuries to bus occupants.

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Posted In: Automobile Accidents , Products Liability , Torts

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Last Wednesday the Supreme Court of the United States made it harder for injury and wrongful death victims to sue manufacturers of federally approved medical devices. This decision will also impact cases involving dangerous drugs. The issue before the Supreme Court was whether the Estate of Charles Riegel could sue a company under state law over a medical device which had previously been cleared for sale by federal regulators. Under federal law, a company must prove the safety and effectiveness of a medical device before the United States Food and Drug Administration will approve it for the marketplace. In an 8 to 1 decision, the Court ruled against the Estate of the injured patient who suffered serious injuries when a catheter burst during a medical procedure. As a result of this Supreme Court decision, state lawsuits are barred to the extent that they might impose requirements that are different from federal requirements. In other words Federal law will prempt state law where the two are in conflict or different. Not surprisingly, the Bush Administration sided with the medical device industry, saying unfavorable state jury verdicts would force companies to alter product designs or product labels that had already gotten FDA approval. This case is bad news for people injured by defective medical devices. The fallout from last week’s Supreme Court decision in this case will no doubt be felt throughout the country. Attorneys with cases pending against device makers such as Medtronic, Stryker and Johnson & Johnson expect these companies to file Motions to Dismiss the lawsuits which are currently pending. Lawyers also are concerned that this ruling may prompt judges to dismiss product-injury lawsuits before injured plaintiffs can gain access to data that might prove that the companies used false or misleading data to get government approval to market the devices.

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Posted In: Dangerous Drugs , Pharmaceutical Manufacturer Liability , Products Liability

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In January of this year, the FDA issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendment’s Act of 2007 (FDAAA). Unlike the FDA’s proposed rule, Congress intended the duty to warn customers of a drug’s hazards rests with the drug company, who is in the best position to warn about problems associated with the drug. However, under the FDA rule, drug companies will enjoy more relaxed labeling requirements and will use the rule to claim immunity for failing to warn patients of potential drug hazards. The FDAAA requires a drug company to update its label to include drug hazard warnings as soon as there is reasonable evidence of that risk. This law allows consumers to be aware of a drug’s potential risks at the earliest possible moment and prevents injuries and deaths such as those associated with Avandia and Vioxx. However, under the new FDA rule, drug companies will only have to revise their warning label where they establish “sufficient evidence of a causal association” which could take years. This is a significantly higher standard that drug companies would have to meet before informing consumers of a potential hazard. It is imperative that Congress hold oversight hearings to curb this agency’s abuse of power because the FDA has ignored expressed Congressional intent and this proposed rule will not serve to make drugs safer. Instead the proposed rule will make it more difficult for consumers injured by prescription drugs to hold negligent drug companies accountable.

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Posted In: Dangerous Drugs , Pharmaceutical Manufacturer Liability , Products Liability

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This Wednesday the Supreme Court issued a major anti-consumer opinion, making it harder for consumers to sue manufacturers of federally approved medical devices.
In an 8-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure. The case has significant implications for the $75 billion-a-year health care technology industry, whose products range from heart valves to toothbrushes.

At issue before the Supreme Court was whether the estate of Charles Riegel could sue a company under state law over a device previously cleared for sale by federal regulators. Under federal law, a company must substantiate the safety and effectiveness of a medical device before the U.S. Food and Drug Administration will approve it for the marketplace.

Charles Riegel's family alleged that the catheter produced by Medtronic Inc. of Fridley, Minn., outside Minneapolis had a design defect and an inadequate warning label. Riegel survived the procedure to unclog an artery, though he had permanent disabilities. He died in 2004.

State lawsuits are barred to the extent they would impose requirements that are different from federal requirements, said the ruling by Justice Antonin Scalia. In dissent, Justice Ruth Bader Ginsburg said that Congress never intended "a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Not surprisingly, the Bush administration sided with industry, saying unfavorable state jury verdicts would compel companies to alter product designs or labels that had already gotten FDA approval.

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Posted In: Pharmaceutical Manufacturer Liability , Products Liability

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Last year, the Food and Drug Administration (FDA) issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), an Act which encompasses the Prescription Drug and User Fee Act. As a result, drug companies will enjoy more relaxed labeling requirements and will surely use the rule to claim immunity for failing to warn patients of potential drug hazards. When Congress passed the FDAAA it included language confirming the responsibility of the drug manufacturer to promptly update its drug label when they become aware of new safety information. Congress was clear that it intended to keep the burden squarely on the drug companies to update warning labels. Nonetheless, the FDA had promulgated this new rule against Congress’ expressed wishes. Congress explicitedly stated that it did not intend to ease the requirements on drug companies to inform consumers of potential drug hazards. It reiterated the need for drug companies to change its label if the drug company learns of reasonable evidence of that risk. In fact, the drug companies fought and lobbied hard to include language to loosen warning label obligations that the Congress specifically left out of the final Bill. But since the drug companies could not get Congress to agree to lessen their responsibilities towards consumers, they turned to the Bush Administration. Unfortunately, the FDA’s tactics are not new to Bush Administration bureaucrats. Unelected federal agencies have been ignoring congressional directives in a number of other cases. The Environmental Protection Agency (EPA), National Highway Traffic Safety Administration (NHTSA), Consumer Product Safety Commission (CPSC), and others are also engaging in this tactic of bureaucratic activism.

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Posted In: Dangerous Drugs , Pharmaceutical Manufacturer Liability , Products Liability

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Our Georgia injury lawyers are accustomed to seeing cases involving horrible injury and cases of death caused by all types of accidents but burn cases are at the top of the list. We were discussing the news accounts today in Savannah reporting that firefighters found three, and perhaps as many as six, bodies in the wreckage of a still-burning sugar refinery leveled by an explosion overnight. In addition to the death cases, dozens of employees have been injured, many critically burned. Officials suspect sugar dust, which can be volatile, as the cause of the explosion. Reportedly the explosion happened in a storage silo where refined sugar is stored until it is packaged.

Obviously all of the injured employees will immediately be entitled to workers compensation benefits, including payment of all medical bills but given the very limited disability benefits available under the workers compensation laws of Georgia, this is very little consolation to the injured. Having litigated products liability cases involving injury and death, we wonder whether there are some third parties who may be liable for this explosion. Surely, this huge sugar refinery was aware of the potential danger posed by sugar dust. Was there a system in place which failed? Was ventilation machinery defective or not properly maintained by third party entities hired by the refinery? All of these questions and more need to be explored in order to adequately protect the interests of injured workers and the families of those who died in this tragedy.

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Posted In: Premises Liability , Products Liability , Torts , Workers Compensation , Wrongful Death

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Lawyers who practice in the field of dangerous medical devices and drugs are never surprised to discover relationships between physicians and pharmaceutical and medical device companies. Recently, questionable ties between supposedly objective researchers and the maker of an artificial spinal disk have come to light. An artificial spinal disk is a device that is used in place of conventional surgery during which patients’ vertebrae are fused.

In a study of nearly 240 patients with lower back pain, physicians reported that the artificial spine disk, manufactured by Prodisc, had worked much better than conventional fusion surgeries. A well-known spine specialist and one of the study’s researchers said in a 2006 news release that “as a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily.”

Discovery in a lawsuit against the manufacturer has disclosed that the surgeon had a large financial interest in the outcome of the study. So did other doctors at about half of the 17 research centers involved in the study. Federal law requires that manufacturers inform the Food and Drug Administration of researchers’ financial interest in a product or drug before the study is used to seek approval of a device. It is unclear whether the disk’s manufacturer made this information available to the FDA.

In the study results submitted to the FDA , an unusually large number of patients were not included. Some of those patients had very poor results. As a result, some doctors are very critical of the research stating that the study may have overstated the value of Prodisc. They point out that clinical researchers with financial conflicts have incentives to overstate the value of a new product.

Dr. Richard A. Deyo, a Professor at Oregon Health and Science University, summed up the matter in this way, “The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing. More people are more interested in getting on the gravy train than on stopping the gravy train.”

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Posted In: Dangerous Drugs , Medical Malpractice , Pharmaceutical Manufacturer Liability , Products Liability

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This blog will continue in our series of providing our readers with answers to frequently asked questions in the context of a serious injury case. This blog will address FAQ number 3:

3. If a client settles his or her personal injury claim against an at fault defendant, will they have to repay their own insurance carrier under current subrogation provisions of the law?

Answer: This question often comes up in the context of serious injury cases where the injured individual has incurred substantial medical expenses. If the injured individual is covered by a self-funded ERISA plan, federal law requires that reimbursement be tendered to the self-funded health insurance plan from that portion of the settlement which constitutes reimbursement for the same expenses. This is what the doctrine of subrogation means, that being that the insurance company is subrogated against the rights of the injured individual to recover monies it had to pay as a result of the negligence of the third party. If the third party pays the medical expense money to the injured individual, the health insurance company is subrogated and therefore has a right to recover those expenses back from the at fault party since the at fault party caused those expenses to be incurred. In the context of a case where the injured individual only has insurance through a ERISA self funded plan, the bad news for injured individuals is that they may very well have to repay the healthcare plan with monies recovered from their settlements.

In cases where a healthcare plan is insured, that being the plan is not fully self funded by the employer and/or the employee contributes to the premiums or the employer’s insurance company is not completely self funded, it is an entirely different matter. Georgia follows the “made whole” doctrine which means that unless the claimant is first “made whole” for all of his or her damages, there is no right of subrogation. Because all serious injury cases are factually specific, as is the analysis of arcane ERISA documents and other federally insured plans for federal employees, it is necessary that each case be addressed on a case by case basis. As a general proposition, our firm always endeavors to provide all funds recovered from a settlement directly to the client. Whether we are successful in defeating claims for subrogation, however, is dependent upon the facts. As the old saying goes, a lawyer can’t make the facts, the best lawyer can do is work with the facts involved. Thus, this frequently asked question can only be answered on a case by case basis which obviously requires advice from an attorney experienced in these matters.

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Posted In: Automobile Accidents , Products Liability , Uninsured Motorist Coverage , Wrongful Death

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A few months ago there was a large amount of news coverage regarding the death of a woman from eating contaminated oysters at an Atlanta restaurant. Now, the Georgia Department of Agriculture is alerting consumers that norovirus has been found in some raw oysters harvested in Louisiana. Georgia Agriculture Commissioner Irvin announced that raw oysters harvested from the West Karako Bay Section of Growing Area 3 in Louisiana from Dec. 3 through Dec. 21 may possibly be contaminated with norovirus. Inspectors are looking for these oysters in Georgia retail and wholesale facilities.

The FDA has received reports of norovirus infection in seven people who ate raw oysters on Dec. 13 at a restaurant in Chattanooga, Tenn. The Tennessee Department of Health's test results from two of the ill patients were positive for norovirus. The FDA confirmed the presence of norovirus in shell oysters harvested from the West Karako Bay section of Growing Area 3 and served at the Tenn. restaurant.

The Louisiana Department of Health and Hospitals closed the affected growing area on Dec. 21. The FDA is working with the states involved to determine if any additional actions may be necessary to ensure public health protection.

The original shipper of the oysters is Prestige Oyster Company of Theriot, La. The company shipped the oysters to Bon Secour Fisheries in Bon Secour, Ala. Bon Secour Fisheries, in turn, shipped the oysters to the restaurant in Chattanooga. It is possible that oysters from the designated area are still available in other retail and food service settings.

Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus, with the illness lasting one to two days. However, the illness can become serious for the very young, the elderly and people with weakened immune systems.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

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Posted In: Products Liability , Torts

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The Food and Drug Administration has issued a warning about fentanyl pain patches. The fentanyl skin patch contains fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The FDA has received recent reports describing deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

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Posted In: Dangerous Drugs , Medical Malpractice , Pharmaceutical Manufacturer Liability , Products Liability

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Companies that produce dangerous products suffered a major defaet last week in the United States House of Representaatives. By a vote of 407 to 0, the House of Representatives passed legislation reauthorizing the Consumer Product Safety Commission (CPSC) and included statutory language specifically prohibiting the CPSC from issuing any rule or regulation that expands the scope of federal preemption of state law.

During the Bush administration, the CPSC has issued rules and regualtions which it argues preempt state laws governing dangerous products, thereby depriving innocent parties injured by these products from seeking redress in the courts. Obviously, based upon the vote, both Democratric and Republican lawmakers in the House recognized the dangers of this practice.

Seeking to end this unfair practice, the House Energy and Commerce Committee included specific language in the Committee Report, which is the official statement of congressional intent. The Committee Report language formally and specifically disapproves the CPSC’s effort to override state common law by including preemption language in preambles to its proposed rules and final rules. Specifically with regard to preemption language in the preamble to a recently issued rule on mattress flammability, the Report states “this preamble should not be accorded deference by State or Federal Courts.”

The Report specifically identifies the importance of “tort actions based on negligence” which the Committee says “are predicated on procedures and standards developed over hundreds of years of American and English jurisprudence.” And it says this about the preservation of common law remedies generally: “The preemption provisions of the statutes under the jurisdiction of the CPSC are clear, and State common law actions and standards are not preempted.”

The bill will now go th the Senate for action.

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Posted In: Products Liability , Torts

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The United States Supreme Court heard arguments yesterday in a case which may have a major impact on lawsuits against medical device makers brought by patients who have been injured by defective products. The Supreme Court will be asked to consider whether patients can bring lawsuits over defective devices which have been cleared for sale by the Food and Drug Administrations’ approval process. In this case, a federal appeals court barred a suit which claims a New York man suffered permanent injury when a Medtronic heart catheter burst during a heart procedure.

The decision of the lower court would undercut thousands of lawsuits, including cases over defibrilators made by Medtronic and Boston Scientific Corp. Guidant unit. The ruling may also shield Medtronic from suits over its recalled Fidelis defibrilator wires. In 1996, a divided Supreme Court allowed lawsuits over products approved through a separate Food and Drug Administration approval process that provided for fast-track reviews of devices. The case before the Supreme Court concerns a pre-market approval process which is a more intensive FDA review.

The Bush administration is not surprisingly backing the medical device makers in their argument that the federal pre-market system should preclude claims that companies ought to have done more to ensure safety.

The current Supreme Court has almost uniformly ruled against plaintiffs in insurance and antitrust, as well as products cases.