Christmas is the time for toys. Parents expect that toys have been designed and manufactured with safety in mind. That is not a safe assumption. Ninety five percent (95%) of the toys sold in the United States are now manufactured overseas, mainly in China. In the last 10 years, the number of toy-related injures has increased 54%. In 2008, more than 235,000 children were treated at U.S. emergency rooms for toy-related injuries, and at least 19 children died. The causes of these injuries and deaths have included choking hazards from small detachable or easily broken parts; lead and cadmium contamination, particularly in children's jewelry; toxic chemicals in candy; and a variety of additional dangers such as igniting batteries, broken straps, and exploding parts. Small, powerful magnets swallowed by young children present a particularly insidious danger. If multiple magnets are swallowed, they can attract each other through the intestinal walls pinching, blocking or eroding the intestinal wall resulting in infections, blood poisoning, and even death. The undermanned Consumer Products Safety Commission is only able to check a tiny fraction of the toys imported into this country every year. Many of the dangers in modern toys are either latent or intentionally concealed. Even careful parents need to know that profits, and not necessarily safety, are the first priority for a number of toy manufacturers.
The public is often clueless about the true malice some corporations demonstrate in their willingness to put people's lives in jeopardy for the sake of profit. The anti-plaintiff rhetoric of recent years has reached a fevered pitch with little understanding that to give into it undermines one's constitutional right to a jury trial and the ability of a single person to use the courts to stop corporate wrongdoing when the government has failed to act. And the news tells us each day how ineffective government can be in this regard--because it is slothful, because it has been bought off with lobbyists, or because it is unwilling to challenge the prevailing political prediliections of the party in power at the moment.
We see corporate deceit in many of the cases we handle, so we get hardened to it. Sometimes we see a story, however, that amazes even us. This is one of them. A St. Petersburg, Florida company, Youth Research, had been hired to perform child safety tests on cigarette lighters. It has now been found to have falsified the tests and to have submitted fraudulent reports to federal regulators. The discovery of the fraud has prompted the Consumer Product Safety Commission to order 12 lighters off the market until they have been retested.
The CPSC implemented lighter safety standards after research showed that children under the age of 5 had inadvertently started 5,900 residential fires resulting in 170 deaths and 1,150 injuries in a two-year period. The standards require that panels of 100 children be given dummy lighters to see if they can activate the lighters. A lighter would pass only if 85% of the children could not activate it. In creating the fraudulent test results, the company altered birth dates and identity records and eliminated data that showed that a child could ignite the lighters.
The woman at the center of the fraud, Karen Forcade, has now pleaded guilty to fraud in federal court.
United States of America v. Karen Forcade, U.S. District Court, Middle District of Florida, Case No. 8:09-CR-544-T-27TBM.
Neil O'Donnell of the Alaska Personal Injury Law Group has been selected for inclusion in the 2010 edition of The Best Lawyers in America. Mr. O'Donnell was selected for inclusion in Best Lawyers in the area of product liability litigation. Selection to Best Lawyers is based on rigorous peer-review surveys. Mr. O'Donnell has now been listed in Best Lawyers for several years. Mr. O'Donnell practices in the area of product liability and personal injury litigation, business tort litigation, and professional liability litigation.
The Alaska Personal Injury Law Group recently posted an article about how the FDA and other federal agencies have systematically attempted to use preemption to make manufacturers immune from suit for injuries caused by their defective products. One point of discussion was how the FDA has weakened regulatory protection of consumers from dangerous, defective drugs. Now, just a few days later, an independent group of objective scientists has issued a new report chastising the FDA for its approval of bisphenol A, commonly referred to as BPA.
The new report was issued by the Science Board, a group of independent scientists that provides advice to the Commissioner of the FDA. The Science Board provided peer review of the FDA’s draft assessment of use of BPA in food contact applications. The Science Board concluded that the FDA position was seriously flawed.
BPA is an industrial chemical used to make polycarbonate plastic and an epoxy resin used in many consumer products. The FDA approved it for use in baby bottles and as a liner in food containers like baby formula cans. It is also used extensively in other food containers, in sport bottles such as Nalgene bottles, and as a liner in soda cans. In mid-2008, the National Toxicology Center issued an extensive report addressing the health risks resulting from exposure to BPA, including effects on brain and behavioral development in infants and small children, and the potential to cause cancer. In response, the FDA steadfastly maintained its position that BPA was safe.
The Science Board has now found multiple flaws in the FDA assessment. First and foremost, the FDA assessment failed to provide ``reasonable and appropriate scientific support'' for its finding that the public wasn't at risk from BPA. Second, the FDA ignored many peer reviewed studies that found BPA presents serious health hazards. Instead, the FDA relied upon two studies funded by the chemical manufacturers’ association, only one of which was peer reviewed. The studies ignored by FDA show multiple risks, including impaired neural development, developmental changes in children, impaired reproductive tract development and diabetes. Third, the FDA assessment improperly analyzed the margin of safety (MOS) provided by the FDA standard for BPA exposure. The Science Board found extensive evidence that the FDA standard for allowable exposure levels was at least an order of magnitude too high, particularly for children.
For the past several years, the Bush administration has pursued a covert campaign to steal the rights of victims of dangerous drugs and other defective products. Contrary to the conservative Republican mantra of "personal responsibility," federal agencies have been giving "Get Out of Jail Free” cards to irresponsible corporate wrongdoers. The goal is to deprive the injured victims of defective products of their rights to fair compensation under state law.
An in depth study just released by the American Association for Justice has documented how federal agencies have used "preemption" to try to allow corporate wrongdoers to escape justice. What is preemption? Rightly used, preemption means a federal law preempts all contrary state laws where Congress has expressed its intent to totally occupy a specific area of law.
What is the result of such language? If it is effective, consumers can be prevented from filing lawsuits in state court when the product that injured them complied with federal standards, no matter how inadequate those regulations may be. No suit may be maintained even though the product might be considered defective under state law. By this means, the federal law trumps the state law, and the corporate wrongdoer is immune from liability for the injuries its product caused.
Political appointees of the Bush administration have gutted many of the regulations that are supposed to protect us all. Compounding the wrong, they then inserted into those ineffective regulations language that purports to preempt lawsuits by victims of dangerously defective drugs, defective automobiles, and other harmful products. Since 2005, seven agencies of the United States government have issued more than 60 rules with preemption language in the preamble to the rule. These preemption provisions generally were inserted at the last minute, without notice to interested state governments, consumers or other affected groups. Often, the proposed rule stated that no preemption was intended, but the Bush bureaucrats inserted a preemption provision into the final rule after public comment had ended.
"Why," you may ask, "would the government want to keep people injured by dangerous drugs or other defective products from asserting their legal rights?" Why, indeed. Protection of the public is the mission of many of the agencies that have tried to cheat these victims and help the corporations that harmed them. Contrary to their true mission, under the Bush administration the agencies have taken up the cause of protecting corporations at the expense of public safety. A bigger perversion of the role of federal regulators would be hard to find.
Once a medical device is on the market, doctors can use them for other, unapproved purposes. Given this running room, Medtronic allegedly touted to doctors the use of its Infuse Bone Graft for use in cervical spine surgeries. Three whistleblower suits have been filed by former Medronic employees asserting that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic has paid $40 million to settle two of the suits, and the third remains pending. It alleges that the doctors working with Medtronic received inflated royalty payments and inappropriate consulting fees. (We have previously reported on other odious industry practices, here and here.)
In July, the FDA sent out a warning letter to doctors warning of life-threatening complications when the device is used in the cervical spine. The complications arose from use of recombinant morphogenic proteins, which caused swelling of the neck and throat tissue and led to compression of the airway and the neurological structures of the neck. Patients suffered difficulties swallowing, breathing, or speaking, and required emergency medical care including intubation and tracheotomies.
If a surgeon were going to operate on your neck, would you want to know if a medical device manufacturer was paying him to use the product on you, money paid in addition to the surgical fees you are already paying?
If you can't trust the folks wearing the white coats, who can you trust?
With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.
Now that's a fact you would want to know before the doctor operated, isn't it?
The Bush Administration has consistently sought to undermine consumer-oriented regulatory practices in favor of corporate interests. If it could also take a shot at plaintiffs and their demon trial lawyers, all the better. One of its more spectacular successes was the Supreme Court's recent decision in a medical devices case, Riegel v. Medtronic, which stands for the proposition that the FDA's approval of a medical device should preempt any litigation against the manufacturer in state claims by someone the product injures. As expected, every defendant with any conceivable preemption argument is now injecting that defense into products liability and negligence claims all across the country. FDA and Mercury Regulation;FAA Regulation. The Alaska Personal Injury Law Group just defeated a similar move by a defendant arguing that the FAA's regulation of aircraft should preempt state claims against an air carrier.
The Supreme Court will next consider the application of the preemption doctrine in an injury claim against Wyeth by a Vermont guitarist who lost her arm below the elbow after she was injected with Phenergan, a nausea medicine. Wyeth v. Levine, Docket No. 06-1249. At issue is Wyeth's claim that it should be immune from suit because of the FDA's approval of Phenergan's label. It reasons that the FDA's regulatory approval should be enough to preempt the plaintiff's claim that the manufacturer failed to warn about the dangers of IV injection of the drug. Remarkably, The New England Journal of Medicine has joined 47 state attorneys general and two past FDA commissioners in submitting amicus briefs to the Supreme Court warning that the FDA lacks the ability to serve "as the sole guarantor of product safety".
It is well known that the FDA simply cannot know all the risks of a product or warning label it approves. This is especially true when the manufacturer intentionally skews clinical trial results, Newsday, Annals of Internal Medicine or otherwise keeps product risks from the FDA to achieve the lucrative benefits that come with the approval of a new drug or device, NEJM, Synthes Story. The FDA is not constituted to truly regulate this industry, and it cannot get to bedrock truth the way litigation can. Often, the FDA does not act until litigation proves the product's dangers and makes public the evidence the manufacturer kept from the FDA when the drug or device was approved. Talbert v. E'ola Products, Inc.. If Big Pharma succeeds in the Wyeth matter, millions of Americans will be at risk from dangerous drugs. Without the protections of the legal system, their claims will be unrepresented, and corporate interests will run roughshod over the FDA. At this juncture, Congress will likely have to act to restore the balance of regulatory and legal interests the courts previously forged in protecting the rights of individuals to pursue state claims when injured by dangerous products approved by the FDA.
It is an extraordinary testament to how far off course the Bush Administration has taken American administrative agencies that a national medical journal must file an amicus brief in the highest court in the land to state the obvious. (Remember, "Well, Mr. President, torture is illegal...) Up has become down in American jurisprudence courtesy of the Bush Legacy. Hopefully, legal analysis and not political agendas will guide the Court when it decides Wyeth.
Oral argument before the Court is to be held on November 3, 2008.
When we represent clients at the Alaska Personal Injury Law Group, we do our homework. When serious injuries occur, we have to become experts ourselves in the particular medicine being used to treat our clients. We thus comb through and rely extensively on medical literature in virtually every case we handle. We use it in our work with the medical experts we engage to help our clients, and we also share it with our clients.
And whether you realize it or not, you rely on medical literature every time you see a doctor or take any medication. This is because the engine of medicine runs on the data from medical literature. That data is what the FDA uses to decide whether to allow a medication or medical device to be sold, and what your doctor relies on to decide if a treatment, medical device, or medication will help you. Extraordinary rules and guidelines are put in place to make sure that the scientific findings in a particular study are objective and scientifically verified.
So it is always shocking when we learn that a manufacturer has taken liberties with the research data to make it appear that their product works when it really doesn’t. (We saw this repeatedly in the litigation against diet supplement manufacturers: Talbert v. E'ola Products, Inc.) We know why this happens: millions and sometimes billions of dollars are made by manufacturers in these endeavors, and greed can be a powerful motivator. Every time we learn about one of these situations, it reaffirms the need to vigilantly enforce the principles that guide regulators and researchers who develop research data. Western medicine is so profoundly effective because it is "evidence-based medicine". If we allow clinical researchers to get into bed with the manufacturers, how can we trust that the research data they create for the manufacturers is valid, objective and truly "evidence-based"?
Today’s when-the-cat’s-away lesson involves Synthes, the manufacturer of an artificial spinal disc called the Prodisc. It turns out that doctors at about half of the medical facilities conducting clinical trials, i.e., performing surgeries, using the Prodisc stand to profit handsomely if the Prodisc is approved by the FDA. For example, 12 of the surgeons involved in the study had also invested in Synthes. The concern is that the study results submitted by the manufacturer to the FDA did not contain data about a large number of patients, some of whom said they had poor outcomes. Those critical of this conflict of interest suggest that the data casts the Prodisc, scientifically speaking, in “an overly flattering light.” Was it because surgeons in the study were also investors in the device? We can’t know for sure, but we do know that the research data is now tainted because of this impropriety.
This situation gives us yet another example of how conflicts of interest can distort scientific data and why the FDA and other gatekeepers should vigilantly eradicate them. The FDA should not accept data from clinical trials conducted by those who would profit from market approval of the device or medication being studied. The hospitals and universities conducting such trials should not permit their researchers and physicians to financially benefit from the studies being conducted. As professionals, the physicians themselves should recognize such conflicts of interest and refuse to participate as researchers or investors—attorneys, for example, are ethically barred from representing clients when such conflicts exist and are professionally bound to recognize when a conflict exists and refuse to represent a client when a conflict is present.
This situation with Synthes is also remarkable because these issues have actually come to light—most such conflicts of interest do not. Until the clinical data on the Prodisc is substantiated by objective researchers, surgeons and potential patients should steer clear of this device. If you can’t trust your doctor, who can you trust?
Source: N.Y. Times:
Association for Ethics in Spine Surgery:
On January 5, 2008, a Servant Air Piper Navajo Chieftain with 10 people aboard crashed shortly after take off from Kodiak, Alaska. The pilot and five passengers tragically died in the crash. Surviving passengers reported that a baggage door popped open shortly after takeoff and the pilot was attempting to return to the airport. The National Transportation Safety Bureau (NTSB) is investigating the crash. Based on recent NTSB investigations in Alaska, that may take awhile. I represented a family who lost a loved one in the crash of a PenAir Cessna Caravan 208 shortly after takeoff from the Dillingham airport on October 10, 2001. The pilot and nine passengers died in that crash. The NTSB did not release its probable cause determination until January 23, 2003 -- 15 months after the crash. I am presently representing a family who lost a loved one in the crash of a PenAir Piper Saratoga PA-32 shortly after takeoff from the Pt. Heiden airport on December 14, 2006. The NTSB recently released its "factual report" on that accident just over one year after the crash. The NTSB has yet to make its probable cause determination. This illustrates why it is important for families to promptly hire counsel to independently investigate an accident and not to wait a year or more to see what the NTSB concludes about the accident. The families who have lost a loved one will typically not know what the NTSB has been up to for a year or more. In the meantime, important evidence may be lost and important witnesses may have disappeared.