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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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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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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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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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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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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In serious injury and death cases our attorneys consistently face challenges from the defense to the testimony of our highly qualified expert witnesses. These challenges are based upon the rule of evidence known as the Daubert standard.

The Daubert standard is a legal precedent set in 1993 by the United States Supreme Court regarding the admissibility of expert scientific testimony during legal proceedings. In Daubert, the Supreme Court ordered federal trial judges to become the “gatekeepers” of scientific evidence. Trial judges were instructed to evaluate expert witnesses to determine whether their testimony is both “relevant” and “reliable”.

A two-prong test of admissibility was established. The relevancy prong refers to whether or not the expert’s evidence fits the facts of the case. The relevancy requirement has always existed in the law.

The reliability prong was new. The Supreme Court explained that in order for expert testimony to be considered reliable, the expert must derive his or her conclusions from the scientific method. The court then offered general observations of whether proffered evidence was based on scientific method including such things as empirical testing, peer review, the potential error rate, and whether the theory or technique is generally accepted by a relevant scientific community.

In practice, this standard has been burdensome, and grossly unfair to claimants in courtrooms. Trial judges are simply in no better position than juries to serve as “gatekeepers” to scientific evidence. In fact, many of these judges bring their own biases to their determinations. One example given is that under this standard, if Christopher Columbus were required to appear in a courtroom during his lifetime using the Daubert standard, his opinion that the world is round would have been inadmissible.

As part of the so-called Governor’s tort reform of 2005, the Daubert standard was adopted by the state legislature for use in Georgia. However, bowing to pressure from the Prosecuting Attorney’s of the state, who realized how gross unfairness of the Daubert standard, the governor and legislature exempted criminal cases from the Daubert standard. However, catering to the demands of the insurance industry and large corporations, the legislature adopted the Daubert standard for civil cases.

Currently pending before the Georgia Supreme Court is a case in which the Daubert standard is being challenged on constitutional grounds. An argument is being made that it denies equal protection to adopt the standard in civil cases and not in criminal cases. It will be very interesting to see how the Georgia Supreme Court handles this challenge, especially in light of the fact that in recent years, large insurance companies and corporations have thrown millions of dollars into the judicial races in attempts to elect candidates who will follow their agenda.

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Posted In: Automobile Accidents , Brain Injury , Civil Procedure , Dangerous Drugs , Medical Malpractice , Pharmaceutical Manufacturer Liability , Police Chases , Products Liability , Torts , Truck and Tractor Trailer Accidents , Wrongful Death

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On June 15 of this year, we wrote an article on this blog about how pharmacy errors were causing serious injuries and wrongful deaths at an alarming rate on a nationwide basis. The problem about which we wrote unfortunately was the topic of a headline article in the news today concerning the death of a 3-year old child in Gainesville, Florida. This child died from a medication overdose. Instead of receiving the prescribed dose of a medication ordered by the doctor, the pharmacy gave him more than 10 times the amount ordered. The boy died because of this mistake.

According to the news article, a moratorium has been instituted at this facility until a quality assessment and new patient safety measures are implemented. Thus, we have one more statistic in this national problem, this time affecting a very small and innocent child and his family.

When receiving medication from a pharmacy, patients should always carefully review the label to make sure that the dosage appears to be correct. If they have any questions at all about this, they should confer either with their doctor or pharmacist. Because mistakes are made which can cause serious medical problems and/or death, not only must pharmacies be more careful but patients must also act to protect themselves. While a settlement was reached with the parents for the wrongful death of this child, obviously, no compensation can address the loss of a 3-year old child. While we hope that this problem can be effectively addressed by the pharmacy industry, until remedial steps are taken on a nationwide basis, more headlines of a similar nature are likely to be seen.

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Posted In: Dangerous Drugs , Medical Malpractice , Pharmaceutical Manufacturer Liability , Torts , Wrongful Death

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As a Georgia injury lawyer, I am always reading about dangerous drugs. One such drug is Zelnorm ® , a drug used in the treatment of Irritable Bowel Syndrom (“IBS”) and chronic constipation in individuals under 65 years of age.

On March 30, 2007, the FDA requested that Novartis Pharmaceuticals Corporation (“Novartis”), the manufacturer of Zelnorm, voluntarily remove the drug from the market. The recall is based on findings of an increased risk of heart attacks and strokes associated with the drug from clinical trials recently reported by Novartis.

Novartis reported to the FDA the results of a new analysis of 29 short term randomized, controlled clinical trials of Zelnorm. The analysis included more than 11, 000 patients treated with Zelnorm and over 700 patients treated with Placebo. The data showed the serious risk of cardiovascular adverse events associated with Zelnorm to be higher than the Placebo treatment. Thirteen patients treated with Zelnorm had confirmed cardiovascular ischemic events and only 1 Placebo treated patient experienced a cardiovascular event.

The FDA has advised patients using Zelnorm to seek immediate medical care if they experienced severe chest pain, shortness of breath, dizziness or other symptoms of heart attack or stroke. Zelnorm has also been linked to serious cases of diarrhea, ischemic colitis and death. This prompted Novartis to amend its label in March 2004 to warn against these serious risks.

Posted by Finch McCranie, LLP | Permalink | Email This Post

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

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As the Georgia Injury Lawyer Blog's Atlanta attorneys have writtten about before, prescription drug manufacturers can cause serious personal injuries and death by failure to warn of a prescription drug's hazardous side effects. A new law requires prescription drug companies to take steps to ensure drug safety and eliminate the risks of needless serious personal injury or death.

In late September, 2007, President Bush signed into law the Prescription Drug User Fee Reauthorization Act, "PDUFA." This Act creates new federal safety requirements for drug companies, and Congress made it clear that the bill does not change the burden on drug companies to warn of a drug’s hazards. That duty remains where it belongs, on the pharmaceutical company, which is in the best position to warn about problems associated with the drug.

Posted by Finch McCranie, LLP | Permalink | Email This Post

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

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