The Law Chat

Drug Company Wrote the Reports the FDA Relied on in Approving Vioxx

The current issue of the Journal of the American Medical Association has an article about the fact that the drug company Merck used ghostwriters to publish studies about its drug Vioxx without revealing the involvement of the ghostwriters or the fact that some of the academics involved with the research were paid.  The article can be found here.  The article reviewed over 250 documents and found that Merck frequently had studies and research performed by Merck scientists, but when the results were published, an academic researcher would be listed as the primary author.  In many cases, the fact that academic researcher received payment from Merck was not revealed in the study.  These actions undoubtedly had an impact on the FDA in reaching its decision to approve Vioxx for sale to the public.  The FDA does not employ independent scientists to perform studies and its review process is therefore limited to a review of the science that is provided to it by the drug company that is seeking approval of the drug.  A study known to be performed by Merck or that has an academic affiliation which has been purchased would be looked at more skeptically by the FDA in its approval process than a study which appears to be the work of independent, unpaid researchers.  Merck sought to bolster the credibility of its own research by making it appear that outside, independent academics had been involved in the research.  This behavior by Merck was not uncovered by the FDA, but was uncovered by civil justice lawyers who sifted through millions of documents provided to them by Merck to get at the truth of the science upon which the FDA based its approval of Vioxx.  This deceptive practice by Merck shows the need for a stronger more independent FDA approval process and the need for strong civil justice attorneys to reveal these practices when the FDA fails to prevent them.   

FDA Underfunded According to Senators On Both Sides

The New York Times has reported today that Democratic and Republican Senators who have reviewed the issue believe that next year's proposed funding for the FDA is inadequate.  Read the article here.  The current proposal by the Bush administration is a 3% budget increase which according to the article is not enough to cover increased costs of running the administration.  Given the importance of the role of the FDA and the recent revelations that it is unable to fulfill its mission, it is time for the FDA to receive sufficient funding so that it can fulfill its function and protect Americans from potentially harmful products. 

Written By: Attorney Chris Booberg

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Supreme Court Set to Rule On Pre-Emption

The Supreme Court is set to rule sometime early next year on the idea of pre-emption as it relates to the FDA's approval of a drug.  If the Supreme Court rules in favor of the drug companies, it could mean that FDA approval of a drug prevents people from suing in their state court or it could prevent them from being able to sue at all.  It has been recently reported and noted previously in this blog, that the FDA does not perform any testing of its own before approving a drug.  The FDA is forced to rely on whatever testing is done by the drug company and relies on the drug company to report the results of its testing.  The case that is coming before the Supreme Court next year involves a situation where a drug company performed a test, but did not submit the results to the FDA until after the drug had received FDA approval.  You can read more about the case here.  In the case going before the Supreme Court, the FDA waited six years before it released results of Johnson and Johnson internal testing that showed that the Ortho Evra birth control patch released much higher than expected amounts of estrogen.  This situation points out the need for the plaintiffs to have access to the Courts in cases where the FDA is unable to protect the public from a potentially harmful drug.  A wide ranging ruling pre-empting plaintiff's lawsuits will possibly leave people who a hurt by drugs in the future without any recourse because the drug companies can point to the FDA approval and argue that it grants them immunity from suit.

Written By: Attorney Chris Booberg

Visit Our Website: JoelBieber.com  

A Possible Explanation for the Social Security Disability Backlog

The New York Times has an article today that provides some insight into a possible reason for the incredible backlog of Social Security Disability cases.  Many private disability insurers require their policy holders to file claims with Social Security Disability when they file for disability under the private insurance policy.  This is because most private disability policies allow the insurer to reduce the amount of benefits paid by the amount that the individual receives from Social Security Disability.  The effect of this requirement has been to clog the Social Security Disability system with claims from people who meet the disability requirements for their private disability insurance, but do not meet the more stringent standards for Social Security Disability.  You can read the article here.  This information came to light as a result of a whistle blower lawsuit that was filed by former employees of disability insurance carriers. 

 

FDA Relaxing Oversight of Drug Companies?

Drug companies have sales representatives who make calls on doctors to meet with them about the drugs that their company makes and give them information about the benefits of the drugs in order to increase sales.  Currently, the law requires that the drug representative only discuss uses of the drugs that have been approved by the FDA.  The FDA has now announced that it is considering relaxing this law.  The FDA is considering allowing the drug companies to distribute marketing about drugs directly to doctors relating to uses for which the drugs have not received FDA approval.   To read an opinion article by a professor and department head from Duke University click here.  This idea sounds like having the fox guard the hen house.  The reason for the FDA approval process, as weak as it is, is that the FDA reviews the available science and research and approves a drug for certain uses.  This proposal would allow the drug company to determine what was an appropriate "off-label" use and market that use directly to doctors without any FDA involvement.  This is a step too far and hopefully the FDA will receive enough negative comments during the public comment period that it will see the error of this misguided plan. 

$27.1 Million Punitive Damages Verdict in Arkansas Prempro Suit

Bloomberg has reported on the $27.1 million dollar punitive damages verdict in an Arkansas Prempro case in which the compensatory damages of $2.75 million were decided last week.  You can read the article here.  This is a strong message from the jury to Wyeth, the manufacturer of Prempro.  This verdict comes on the heels of a new AMA study regarding the use of Prempro which was detailed in a previous blog. 

Study Finds New Heath Risks from Prempro

Our firm represents a number of women who have sued Wyeth Pharmaceuticals after being diagnosed with breast cancer which we believe was caused by use of the medicine Prempro.  In a study released today, The American Medical Association has revealed that a study of the drug Prempro causes an increased cancer risk in women who take it.  This result took the leaders of the study by surprise.  In an article in Medicalnewstoday.com, the lead investigator of the study stated, "This latest study reinforces the original finding that combined hormone therapy of estrogen plus progestin should not be taken for the purpose of reducing disease in post-menopausal women," Chlebowski said. "These findings also reinforce the need for monitoring for cancer in women who have taken the combination of estrogen plus progestin."  This is strong support for the thousands of women who developed breast cancer after taking Prempro in an effort to avoid bone loss or for cardiovascular benefits.  This study demonstrates that any potential benefit of disease prevention is outweighed by Prempro's potential to cause breast cancer.  The full study can be found here.

FDA Inspection Leads To Stryker Hip Implant Recall

Although the FDA is under fire now for being unable to perform its mission, the efforts of the FDA have lead to a hip implant recall.  The Stryker medical device company has instituted a voluntary recall of some of its hip implants as a result of inspections by the FDA.  Read more here.  If you have had a recent hip implant involving a device made by Stryker, you should consider a visit to your surgeon to ensure that it is operating properly and is not subject to recall.

Heparin Recall

The New York Times has an article this morning indicating that the maker of the drug Heparin has instituted a recall.  In the article, it is revealed that the Food and Drug Administration has admitted that it failed to follow its own guidelines by failing to inspect the Chinese plant where a critical ingredient of heparin is made from pig intestines.  This is an interesting development given that the Supreme Court of the United States ruled last week that approval by the FDA of a medical device precludes injured plaintiffs from suing manufacturers under state law.  Read more about that case here.  Hopefully, the Heparin case will prompt our legislators to turn a critical eye toward the FDA and its oversight and approval process.  It appears that this may already be happening.   According to the FDA itself, it is almost incapable of carrying out it's wide ranging mission.  Governmentexecutive.com reports that a soon to be released report of the FDA finds that "The Food and Drug Administration faces shortfalls in staffing and information technology, which have resulted "in a plethora of inadequacies that threaten our society," according to a report by the agency's Science Board."  Given the FDA's admission of its shortcomings and it's failure in the Heparin case, the confidence placed in it by the Supreme Court of the United States is misplaced.

Does the Chief Justice Understand Punitive Damages?

preToday, the United States Supreme Court heard arguments in a case involving the damage caused in Alaska when the Exxon oil tanker Valdez spilled 11,000,000 gallons of oil.  Area fishermen sued and won a judgment of $2.5 billion in punitive damages against Exxon.  Punitive damages are damages which are granted in addition to the damages in the case to punish a defendant for bad conduct.  The case was covered in the Washington Post and you can read the article here.  In this case, the Chief Justice of the Supreme Court and the attorney for the fishermen had the following exchange:

So what can a corporation do to protect itself against punitive-damages awards such as this?" [Chief Justice] Roberts asked in court.

The lawyer arguing for the Alaska fishermen affected by the spill, Jeffrey Fisher, had an idea. "Well," he said, "it can hire fit and competent people."

According to the article, this response resulted in laughter from the audience at the argument and a disaproving look from the Chief Justice. 

Although the Chief Justice of the United States Supreme Court seems primarily concerned with protecting corporations, the attorney for the Alaskan fisherman had it right.  If corporations and the individuals they employ didn't act irresponsibly at times to the detriment of the lives of individuals, we would not need the ability to seek punitive damages.  However, coporations and their employees don't always take appropriate actions and the law needs a mechanism to punish them when they do not.  That mechanism is punitive damages which punishes Defendants in the pocketbook where it hurts the most.  The $2.5 billion in damages, which so concerned the Chief Justice of the Supreme Court of the United States, represented three weeks profit for Exxon.      

Written By: Attorney Chris Booberg