Richmond Virginia Personal Injury Lawyer - Preemption

Medtronic Reveals Massive Payments to Doctor Accused of Falsifying Medical Research

Michael Phelan — Thu, 18 Jun 2009 16:02:51 GMT

A former military surgeon accused by the Army of falsifying a medical journal study involving one of Medtronic's products received approximately $800,000.00 from Medtronic between 2001 and 2009, according to information released on Wednesday by the company. Medtronic said the payments to Dr. Timothy R. Kuklo were reimbursement for travel expenses, speaking engagements, training other doctors or other consulting services. The Justice Department is currently investigating whether Medtronic paid doctors like Dr. Kuklo to help market medical devices for unnaproved uses.

The surgeon, Dr. Timothy R. Kuklo, claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq. The British medical journal that published the article retracted it this year after an internal Army investigation found that Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records. Other doctors at Walter Reed Army Medical Center, where Dr. Kuklo worked until August 2006, said that he had also overstated the benefits of the Medtronic product.

Medtronics is under investigation by the Justice Department and Senator Charles Grassley, Republican of Iowa, in connection with possibly illegally marketing of Infuse through outside physicians like Dr. Kuklo who work for it as consultants. The company has denied doing so. Last month, it suspended Dr. Kuklo’s consulting contract. In information released on Wednesday, Medtronic said that it made about $788,280 in direct payments to Dr. Kuklo between 2001 and 2009. It described those funds as either reimbursement for travel expenses, or payments for speaking or training other doctors on Medtronic’s behalf, or for consulting. The company said that those consulting services included working on the design of new or existing orthopedic products and surgical instruments.

It is legal for military doctors to receive payments from medical products companies, but they are supposed to seek permission from officials. Army officials have said they have not found records to indicate that Dr. Kuklo sought or received such clearance.

Those who still support the concept of preemption for medical device manufacturers need to explain to the rest of us how the FDA is supposed to protect patients from this ubiquitous greed. Studies and clinical trials used by the manufacturers to gain approval of devices and drugs are sometimes rigged and the medical literature is sometimes ghost-written by industry insiders. The FDA is under-staffed and underqualified to root out this corruption. The primary examples of this type of corruption being exposed are private lawsuits.

Originally posted at InjuryBoard by Michael Phelan

"All-Hands Meeting" Called At FDA To Discuss Lax Medical Device Oversight

Michael Phelan — Tue, 28 Apr 2009 11:20:27 GMT

Nine scientists signed letters to President Obama charging that Food and Drug Administration officials had acted illegally and that patients were routinely put at risk by unsafe medical devices approved by the FDA for sale despite significant and often unanimous objections from scientific reviewers at FDA. These scientists sent many e-mails to the FDA's prinicpal deputy commissioner, seeking his intervention, but the deputy commissioner, Joshua Sharfstein, M.D., replied that he was "already burning the candle at both ends to keep up with his job." The nine dissident scientists sent an extensive memorandum to Dr. Sharfstein charging that the "regulatory review process for medical devices has been severely distorted" and that those who raised concerns about unsafe devices had been retaliated against by agency managers.

Amond the devices alleged to have been approved inappropriately are imaging equipment for detecting breast cancer and an orthopedic knee device. The FDA also allowed hospitals to wash and reuse sterile surgical devices intended for just one use. Sounds like a great idea in this era of MRSA and other deadly bacteria and viruses. Undue influence from the device manufacturers is no-doubt a cause for some of these inappropriate approvals. The other reason is captured in Dr. Sharfstein's above-cited quote- the agency is too understaffed to do its job; hence it relies too much on safety and efficacy information provided by the drug and device manufacturers. The fox has been allowed to guard the chicken house. This is why preemption arguments are such a joke. When Newt Gingrich introduce the Contract With America, it contained a provision to turn the FDA over completely to the drug and device industry and let them regulate themselves. Thank God that did not happen.

There are signs that the FDA may take steps to kick the fox out of the chicken house. On April 10, Donna-Bea Tillman, director of the FDA's office of device evaluation, announced an "all-hands meeting" of all scientists within the office to discuss the strategic direction of the device center. This would be the first meeting of its kind in years. Under the previous administration, meeting time was awarded to industry lobbyists rather than the scientists charged with evaluating safety.

Originally posted at InjuryBoard by Michael Phelan

KBR Accused of Exposing Our Troops to Known Toxic Chemical

Michael Phelan — Tue, 23 Dec 2008 10:38:32 GMT

The CBS Evening News(12/22, story 8, 3:30, Smith) reported that on since the beginning of the war in Iraq, may be facing yet another scandal." CBS added, in April, 2003, James Gentry of the Indiana National Guard arrived in southern Iraq to take command of more than 600 other guardsmen. Their job: Protect KBR contractors working at a local water plant. Guardsman Gentry stated, "We didn't question what we were doing. We just knew we had to provide a security service for the KBR." Today Gentry is dying from a rare form of lung cancer which he believes was caused by months of inhaling hexavalent chromium, an orange dust which is part of a toxic chemical found all over the Iraqi plant. At least one other Indiana guardsman has already died from lung cancer and others are said to be suffering from tumors and rashes consistent with exposure to the deadly toxin. CBS "has obtained information that indicates KBR knew about the danger months before the soldiers were ever informed. ... A new internal Army investigation obtained exclusively by CBS News says the Army's medical response was prompt and effective. But even after a briefing today, Indiana Senator Evan Bayh says that KBR has a lot to answer for." KBR has been paid more than $28 billion by our government since the beginning of the war in Iraq [that's BILLION not million!]. You may recall that KBR is an offshoot of VP Cheney's old firm, Haliburton, and that the administration awarded the $28 billion to KBR on a no-bid basis. It is outrageous that KBR knowingly exposed our brave troops to a deadly toxin. This is a perfect example of why this country needs a tort system that is free of over-regulation by the government. Because, if the current administration had its way, injured citizens like Guardsman Gentry would be out of court. KBR would either be immune from liability or the federal government would be deemed to have preempted the plaintiff's right to sue for damages. I encourage everyone to read the Seventh Amendment. The framers put it in the Constitution for a very good reason.

Originally posted at InjuryBoard by Michael Phelan

FDA Rank and File Do Not Support Preemption

Michael Phelan — Thu, 30 Oct 2008 14:13:38 GMT

Yesterday the U.S. House Committee on Oversight and Government Reform issued a report saying FDA career staff objected to a change in preemption rules, even saying the central factual justifications for the agency’s new positions were false. The report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. Prior to this the FDA had asserted through a rule on drug and device labeling that manufacturers should not be held accountable for failing to update their label with additional risks, if the original label was approved by the FDA.

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:

" [M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

Prior to the rule being issued one FDA career official asserted that the rule “is not as it purports to be, consistent with the agency’s role in protecting the public health…”

A copy of the report can be found at http://oversight.house.gov/documents/20081029102934.pdf . My friend, Brooks Schuelke, has also written an important blog on this topic and has written a series of blogs on the White House's attempt to ram complete preemption down the throats of the public and the states.

The Bush Administration continues to push for federal agencies to support the concept of preemption, even in the face of dissent from agency insiders who know best how the agency functions. Contrary to the view of the White House and the FDA general counsel (an administration stooge), the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks. The concept of preemption, as it is being pushed by the administration, violates principles of states' rights and citizens' rights to trial by jury as set forth in the Seventh Amendment.

Originally posted at InjuryBoard by Michael Phelan

Documents Reveal Bush Administration Top Priority: Exempt Big Business from Civil Justice System

Michael Phelan — Thu, 16 Oct 2008 11:16:02 GMT

According to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ), the Bush Administration's attempt to shield big business and Wall Street from the free market date back long before the current bail out. Documents released by AAJ detail how helping corporations escape accountability for dangerous products by denying consumers their Seventh Amendment right to trial by jury and by abrogating the Republican party's long-standing state's rights principles has long been the administration’s top priority. People at the highest levels of the Bush administration repeatedly ordered federal agencies to usurp state law and undermine consumer protections.

The FOIA documents detail a Bush regulatory strategy called preemption. In short, the Bush administration has decided that federal rules should usurp – or preempt – the rights of states to protect their citizens with stricter safety standards. In turn, consumers can no longer use the state protections when harmed by negligence or misconduct, giving total immunity to negligent corporations.

AAJ has tracked how the administration’s first attempts to preempt states rights utilized friend-of-the-court briefs on behalf of corporations in civil justice cases. After only mixed success, the administration then shifted strategies, targeting instead regulatory agencies in charge of product safety oversight. I wrote about the Administration's use of "preambles" to regulations and policy statements in final agency rules to effect back-door tort reform in an earlier blog about preemption. Beginning in 2005, statements claiming that federal agency rules preempt state law began surfacing in the preambles of regulation issued by the federal government, and in some cases in the body of the final rules themselves. Because the courts have not yet conclusively determined whether preambles carry the full weight of law, corporations have a new legal theory on which they can argue in product liability cases.

“Unelected federal regulators are now claiming that states can’t protect their own citizens with stronger consumer protections,” according to AAJ President Les Weisbrod. In an upcoming Supreme Court case, 47 state attorneys general filed a brief arguing the FDA is breaking with historical precedent. In fact, in their brief they urge the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that state law forces a drug manufacturer to pay $6.8 million to a Diana Levine, whose arm had to be amputated after she was injected with an improperly-labeled Wyeth drug.

Since 2005, seven federal agencies have issued over 60 proposed or final rules with preemption language in the preamble. During the past year, AAJ submitted numerous FOIA requests that prove the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language. In an earlier request, OMB responded that there were no documents. However, emails recently obtained from the individual agencies prove that OMB did indeed discuss preemption with agencies, and in some instances OMB officials wrote the language.

Given this discrepancy, AAJ submitted an expanded request for OMB documents. On September 26, 2008, OMB responded it had identified 146 documents, but refused to release any of them, saying that “the disclosure of these documents would not be in the public interest.”

In piecing together the emails from the FOIAs, AAJ uncovered the sleazy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule’s release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.

AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.

Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.

Federal agencies like the FDA, the Consumer Protection Agency, the Centers for Disease Control, and the National Highway Transportation and Safety Administraion exist to protect tax paying citizens from dangerous food, drugs, vaccines, medical devices, consumer products and other products. The Bush Administration turned this regulatory scheme upside down by placing lobbyists for the industries the agencies were supposed to regulate in charge of those very agencies and then instructing its minions to write into the agencies' preambles and final rules language preempting citizens' Seventh Amendment rights to trial by jury in state courts.

It ain't right!

Link to AAJ's full report of this scandal, titled,“Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability”.

View the Wall Street Journal's article "Bush Legacy Could Be Found In Tort Reform" online.

Originally posted at InjuryBoard by Michael Phelan

Here's Why Preemption is a Joke

Michael Phelan — Thu, 01 May 2008 11:33:28 GMT

Aredia, Baycol, Bextra, Celebrex, Fen Phen, Rezulin, Vioxx, and Zyprexa. These are all drugs that were "approved" by the FDA. Does FDA approval mean that the FDA tested these drugs itself? No! The FDA does not have the resources to test the food, medical devices, and drugs it is empowered to regulate. The FDA relies upon the manufacturer seeking approval of its drug or device to test its own product. The manufacturer's clinical trials, animal studies, and other test data is submitted to FDA advisory panels for review. The FDA does not have adequate staff to look behind the data the manufacturer chooses to share with the FDA. How many times in the past 15 years has the FDA learned after approving a drug that the manufacturer withheld or hid during the drug approval process critical safety or efficacy information. Oops, we forgot to submit that offshore clinical trial that showed a strong association between our drug and strokes! To compound the problem, the FDA advisory panels are fraught with conflicts of interest. It is not uncommon for the manufacturer seeking approval of a drug to have paid consulting fees to members of the FDA advisory panel charged with regulating the drug.

The most recent example of the fallacy of treating FDA approval as some sort of gold standard is the heparin debacle. American companies like Scientific Protein Laboratories, which supplied the contaminated heparin to Baxter International, which manufactured and distributed the finished heparin, have decided to outsource supply and production for some of their products to China. In the case of heparin, the pig intestine product is coming from the bowels of rural China. The FDA has now identified Changzhou, SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin that has killed over 80 people. According to a Congressional investigator, the contaminated crap used by Chagzhou cost $9.00 a pound compared with $900.00 a pound for heparin. Once again, Americans are being killed unnecessarily because a company put profits over safety.

And get this! The FDA admits it neglected to inspect the Changzhou plant, and China is now refusing to permit the FDA to inspect the plant in the future. Does this sound like the FDA has the wherewithal to guarantee the safety of a product that gets injected into the bloodstream?

Incredibly, the argument put forth in products liability cases involving unsafe drugs by the Administration and the Supreme Court in favor of denying an injured American his or her Seventh Amendment right to a trial by jury boils down to the fact that the drug was "FDA approved." Yet, the bipartisan consensus in Congress is that the FDA needs a rapid increase in its budget to be able to ensure the safety of the nation's drugs, medical devices, and food. The Bush Administration's response was to propose a budget for the FDA that does not even cover its expected cost increases. It's time to take cronyism out of this equation. Product safety must be the goal, not appeasing the interests of the drug manufacturers. Until the FDA has the resources to ensure product safety, the concept of federal preemption of drug cases is a joke.

Originally posted at InjuryBoard by Michael Phelan