Arsenault, who holds a spot on the Plaintiffs’ Steering Committee (PSC) for the DePuy ASR Hip litigation, is a veteran of class actions and complex litigation.  He will present “Multidistrict Status Update” along with David R. Cohen, a Federal Special Master from Cleveland, OH; and Lawrence L. Jones, II, of Jones Ward PLC in Louisville, KY.

Arsenault’s firm is actively investigating claims against DePuy Orthopaedics and its parent company, Johnson & Johnson, for potentially faulty hip implants.   He and his partners are  frequent speakers and chairs of litigation conferences throughout the United States and Canada.  Additionally, Arsenault is  a recognized author, is frequently quoted by national news media, and will being teaching Advanced Litigation courses at LSU’s Paul M. Herbert Law Center this fall.

The medical device lawyers at Neblett, Beard & Arsenault are investigating claims against the makers of the recalled ASR Hip Resurfacing System and the ASR XL Acetabular.  Nearly 100,000 of these hip replacement products have been recalled worldwide.  Neblett, Beard & Arsenault has experience in handling medical device litigation, including our representation of victims of failed Sulzer Orthopedics hip implants.  If you have any questions regarding the Johnson & Johnson hip replacement recall, defective Zimmer Durom Hip Cups or any other medical device litigation, please call 1-800-256-1050 today.

There are an estimated two million infusion pumps currently being used in hospitals and clinics across the country. The Obama administration has stepped up its efforts to reinvigorate the FDA after years of criticism that the agency was a rubber stamp for the medical device industry. The FDA’s Center for Devices and Radiological Health oversees numerous critical medical device products including heart implants, imaging equipment and the infusion pumps which have all come under particular scrutiny. The Center’s director said last week that the FDA had concluded the pumps could be made far safer. He also indicated the new, more vigorous approach pre-approval might be extended to other types of medical devices as well. The FDA says it intends to ratchet up the expectations for medical device manufacturers noting there have been 79 recalls involving infusion pumps alone in the past five years. That’s certainly good news to the innocent victims of defective medical devices they have entrusted their health to.

Under current FDA rules, life-sustaining medical devices like heart defibrillators must typically undergo clinical trials before they are approved for sale. Until now, the FDA has cleared other critical devices like the infusion pumps without clinical testing based solely on the manufacturer’s claim that the new device is “similar to a product that is already approved and on the market”. That will no longer be the case.

This FDA action is welcome, if not somewhat late, news for the safety of the general public who use these medical products.

There have been over 1,000 reports of radiation overdose errors in the past 10 years. Most of the reported problems involve computer-controlled machines that generate high-powered beams of radiation to target cancer cells. Problems with the computer software led to most of the errors. Faulty design and use errors have also led to overdosing.

This FDA action comes after a series of New York Times articles which highlighted the crippling effects of radiation overdoses and accusations by some in the medical community that new medical devices were not being aggressively reviewed before being allowed on the market. The articles pointed out the apparent inability of regulators and the medical community to keep pace with the rapid technological advances in the medical device industry.

Reaction to the FDA action was generally favorable although Dr. Howard Amols of Memorial Sloan-Kettering Cancer Center in New York said the FDA did not address the serious, systemic problems of inadequate staffing, personnel competency and hospital quality assurance programs.

The biggest business lobbying group in the nation is the U.S. Chamber of Commerce which spent $47 million on advertising in 2009 to defeat health care reform in addition to $144 million for lobbying. The Chamber plans to spend $50 million in this mid-term election year on candidate-focused ads alone. The proposed legislation forces disclosure of who is funding the ads which will allow voters to better understand who may benefit from the issue. The Court’s decision also invalidated the 2002 campaign finance laws which had the support of only four Republicans. Any new legislation would need the support of 60 Senators to shut off an expected Republican filibuster.

Why should we care? Because the ordinary citizen’s rights may be eroded or eliminated through heavily-funded, corporate-influenced political advertising who can now hide behind their veil of secrecy to promote legislation to their advantage. Pharmaceutical and medical device manufacturers will be able to fund legislation to shield themselves from liability for their defective products. Liability insurance companies can support candidates who will push so-called “tort reform” to limit damages in everything from medical malpractice to punitive damages. Political campaign funding should be transparent so the American public knows who is contributing to a particular campaign and the reasons why they are doing so.

A review of past headlines illustrate the vast number of defective products that have caused a multitude of injuries and cost Americans dearly: Bridgestone and Firestone tires, prescription drugs Vioxx, Baycol and Halcion, dietary supplement ephedra, medical devices like Guidant defibrillators, Medtronic pacemaker leads,and  Dalkon Shield; silicon breast implants, asbestos, and tobacco products just to name a few. Litigation has resulted in recalls of numerous products including Ford Pinto and Explorer, Chrysler minivans, baby cribs and strollers and infant car seats, children’s Tylenol, flammable clothing, birth control medication and devices, tainted food products, and the most recent Toyota vehicles causing unintended acceleration just to name a few.

Aviation litigation has resulted in a drastic drop in the number of crashes and deaths involving aircraft. According to the Consumer Federation of America, there has been a dramatic change in the rate of accidental deaths and injuries since the enactment of products liability laws and stiffer regulation. As a result they estimate that approximately 6,000 deaths and millions of injuries have been prevented on an annual basis.

People are powerless to protect themselves against defective products and the harm they cause without these laws and regulation, as well as the courageous attorneys willing to take on the manufacturers. Beware of the political hue and cry for so-called “tort reform” by business interests and insurance companies trying to gut these important safeguards. Those who support such disingenuous political initiatives just may end up being the victim of a dangerous product without legal recourse to compensate them for the resulting injuries.

Why should we be concerned? Because when the FDA fails to act promptly, convicted researchers are allowed to continue work on important testing of drugs that eventually become available to the average consumer. The FDA must be held to the highest standards in the development of drugs and medical devices that can be a threat to patient safety.

Even the senior Republican on the House Commerce Committee, Rep. Joe Barton, criticized the ineptness of the Bush administration FDA. The current administration says it has improved the process of vetting researchers with increased staffing and centralized coordination. As Rep. Barton said, “The problems at FDA are daunting but with a little common sense and modest legislation the American public can be ensured of their safety when consuming FDA-approved drugs and devices.

Last year a consumer survey found that 68% supported legislation requiring public disclosure of financial relationships between physicians and industry. 78% believed that doctors who accepted gifts from the pharmaceutical industry were influenced to prescribe certain drugs. The problem is that everyone wants to trust his/her doctor and only 34% said they would be likely to ask their doctors about the troubling financial ties. Patients feel awkward about questioning their doctor and are not likely to create negativity or alienate them.

To address the ever-increasing reach of the giant companies, Sens. Herb Kohl (D-MN) and Chuck Grassley (R-IA) have introduced the Physician Payments Sunshine Act which would require all payments more than $100 made by a drug or medical device company to a doctor be reported. These payments have been characterized as “research” or “gifts” in the past.

You can bet the big pharma/medical lobbyists will fight passage of this proposed legislation. They will cloak their opposition to this change by trying to hide behind their standard mantras of doctor/patient confidentiality and interference with medical research. This bill would eliminate the transparency problem and benefit patients who are unlikely to challenge their doctors for the greater public good. We should urge our elected representatives to support the Sunshine Act.

As injury attorneys who have represented thousands of clients injured by defective medical devices and pharmaceuticals, we know the importance of our court system in holding negligent manufacturers responsible. Our regulatory system alone cannot do the work of protecting consumers. The tort system is an important complement to any federal oversight. We call on Congress to pass, and President Obama to sign, the Medical Device Safety Act and to restore the rights of injured patients.

Synthes ran over 200 unauthorized human trials of their bone filler involving patients who underwent one of two spinal procedures, vertebroplasty or kyphoplasty. In these procedures, the cement-like bone filler is injected into spinal fractures. Three patients died during the procedures. The four Synthes executives are now facing criminal charges and possible prison sentences.

Prosecutors allege Synthes knowingly approached doctors to perform the procedures despite a 2002 FDA warning of the risk of generating large blood clots. Even after learning of the deaths, Synthes continued to hold seminars teaching doctors how to perform the procedures and callously chose not to report the deaths to the FDA.

The federal prosecutors should be applauded for taking the unusual step of criminal indictments against these greedy corporate executives who put profit over concern for patient safety. Usually executives only face civil fines and go their merry way with their ill-gotten gains. Perhaps after a few executives are sent to prison there will be a clear message that the safety of medical devices being sold to the public must remain the paramount concern of medical device manufacturers.

The legislation would give the FDA the authority to regulate cigarettes and other tobacco products.  Say what?  An agency that is already underfunded and understaffed is getting more responsibility?

In theory, regulating the tobacco industry sounds like a good idea.  The agency would be able to regulate the contents of tobacco products, make their ingredients public, prohibit flavoring, require much larger warning labels and strictly control or prohibit marketing campaigns, especially those geared toward children.

However, I’m not so sure the FDA is ready to take on new responsibilities.  The underfunded structure and oversight ability of the current FDA needs drastic change. There have been too many defective drugs and medical devices, tainted food and dangerous toys allowed to enter the marketplace.

After all of the tainted pistachio, peanut butter, lettuce and pepper scares, some in Congress think a separate food agency is necessary. If the FDA is given additional oversight over tobacco, their workload will only increase.  Congress needs to adequately fund and staff the FDA before dolling out new responsibilities.

Can Obama Protect Consumers?

We’ve written many previous blogs on the issue of federal preemption and its devastating effects on consumer protection from unsafe products. Entrusting the safety of medical products and our food system to an underfunded, overwhelmed, and industry-infiltrated regulatory agency is a foolish mistake that leaves us all open to injury and illness with no recourse for compensation or justice. While we’re appreciative of FDA efforts, placing the vast duty of consumer protection into the hands of this one federal agency is absurd.

Our previous presidential administration disagreed, favoring federal preemption of the state tort system for the safeguard of big business, and leaving  unsuspecting citizens to fend for themselves in the all-too-common event of foodborne illness or medical product injury. When preemption grants wayward food and drug companies’ immunity, while concurrently tying the hands of the tort system….guess who ends up on the short end of the stick?

Fortunately, times truly are changing, and the Obama administration is ushering in long overdue progress on the consumer protection front. President Obama recently issued a directive for the Heads of Executive Departments and Agencies calling for strict limitation of state law preemption. The memorandum begins by acknowledging the efficacy of state and local governmental control:

Throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national Government.

…The purpose of this memorandum is to state the general policy of my Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption.

In addition to the suppression of unwarranted preemption statements in future regulatory preambles and codified regulations, the directive also calls for the review and possible amendment of regulations issued over the past ten years that may include unjustifiable claims for preemption.

Let’s hope that this is a firm first step in the direction of recognizing the necessity of the tort system’s regulatory function in consumer protection, an issue we recently addressed in a blog post you can access here: Forbes: Tort Attorneys Recognized as Leaders in the Fight for Food Safety. The risk of liability for the sale of unsafe products is a strong motivator for food and drug companies to maintain high standards. Consumer safety depends upon the tort system, and we’re glad to see the current administration take a stand on the side of consumers.

The president’s actions not only restore long-held individual rights but also, and perhaps most importantly, reflect an end to the powerful influence big business, their political contributions and lobbyists had during the eight years of the Bush administration. Everyone should have access to the courthouse. Consumer advocates and ordinary citizens should applaud the presidential action…it was the right thing to do for the common guy.
Read the Obama Memo.

That hasn’t sat well with the hundreds of victims of Medtronic’s defective Sprint Fidelis pacemaker leads which crack and can shock the patient multiple times. There are also growing concerns over complications following cervical surgery from Medtronic’s INFUSE Bone Graft as well as inflammatory mass growths in patients using Medtronic’s Intrathecal Infusion Pump.

Legislators are being pressured by their angry constituents to even the playing field with these large pharmaceutical manufacturers. A manufacturer should be accountable for the products they make and sell, especially those that are implanted in the human body.

Current law gives the manufacturers immunity from suit and a free pass to sell a defective product if their medical device was approved by the FDA. This proposed Act will provide a powerful deterrent by returning the right of individuals to hold the manufacturer liable for their faulty products and will ensure that medical devices are actually safe to be implanted in our bodies.

This proposed bill will ensure that victims of dangerous medical products have access to the courthouse and a chance to persuade a jury that the manufacturer put profit ahead of consumer’s safety. The Bush administration pushed a preemption agenda in order to shield big corporations from the possibility of individual damage lawsuits. Naturally, the pro-big business Republicans oppose this new legislation. They and their well paid lobbyists are waging an all out propaganda campaign to defeat its passage using political buzzwords and attacks on trial lawyers to sidetrack public opinion. They want the authority on whether a medical device is defective to rest with the FDA, even though it is woefully underfunded and has a track record of too-cozy relationships with the companies it supposedly regulates.

We should all contact our legislators and urge them to support the Medical Device Safety Act. It’s in all our best interest to level the playing field for victims who have to take on corporate giants.