Was the FDA Advisory Panel on Avandia Tainted by Conflict?

It's been an eventful summer for GlaxoSmithKline (GSK) and its diabetes drug, Avandia.  First, the New York Times dropped its bombshell that secret company testing in 1999 indicated the increased risk of heart attacks associated with Avandia.  Yet, the company may have hidden its own test results, while reaping billions of dollars in revenue continuing to market the drug.

Then, this month, an FDA Advisory Panel met to discuss the future of the drug.  When the panel voted, 29 of the 32 members voted either to remove Avandia from the market or change its warning label in light of the medical issues.  Only 3 members voted to do nothing and 1 member abstained.  Now, we hear that one of the 3 members who defended Avandia and voted to do nothing may have a significant conflict of interest.  In fact, the FDA has even referred this serious issue to the Inspector General of the Department of Health and Human Services for further investigation. 

The investigation into this potential conflict of interest is still ongoing and the facts are not yet clear.  However, it now appears that the panel member under investigation may have received more than $14,000 as a paid speaker for another GSK drug.  It is unclear as to whether the panel member disclosed his advocacy of a different GSK drug to the FDA before serving on the panel.  If he did, then the FDA may not consider that issue to present a conflict since it did not involve Avandia.  While the FDA may not consider such advocacy of a different drug by the same manufacturer to be a conflict if disclosed, it still does not sit well with me.

However, the issue goes beyond the panel member advocating one of GSK's other drugs and whether he properly disclosed his relationship to the pharmaceutical giant.  More troubling, GlaxoSmithKline has now revealed that the same panelist may have actually received money for sitting on an Avandia advisory board.  Did this person have a prior relationship with the company concerning the very drug that he was considering as an FDA panel member?  If true, this undisclosed conflict would certainly present a troubling picture.

The government agencies that protect consumers and the public at large have important roles.  It is essential that the difficult investigations and decisions of these agencies be free from conflict.  In the recent few months we have clearly seen the results of a system where the same people responsible for our safety are tainted by money and relationships to the very companies they are regulating.

Interpreting the FDA Advisory Panel Vote on Avandia

Three days ago, I wrote about the diabetes drug Avandia and the allegations in The New York Times that its manufacturer GlaxoSmithKline (GSK) hid test results indicating the increased risk of heart attacks from using the drug.  At the time of that post, a Food and Drug Administration (FDA) advisory panel was scheduled to meet and discuss Avandia.

Well, the advisory panel has met.  The results of that meeting can be "spun" by both sides of the debate.  What is clear is that a significant majority of the panel voted that Avandia does increase heart risks.  Yet, the panel did not vote to remove the product from the market.  How can the results be interpreted concerning Avandia's future? 

Harlan Krumholz is a physician who is also a Professor of Medicine and Epidemiology at Yale.  Yesterday, he wrote a column in Forbes providing his interpretation of the panel's vote.  In his column, he aptly stated:  "This is a drug with a cloud hanging over it."  Although the panel did not vote to remove the product from the market, a clear majority voted either to remove the product or restrict its marketing.  His article provides some excellent opinion concerning how to interpret the panel's vote.  Interestingly, on the same day as the panel meeting, GSK apparently agreed to settle a large majority of the lawsuits currently pending against it as a result of Avandia, for the sum of $460 million.

Did Diabetes Drug Maker Hide Its Own Test Results Which Revealed Health Risks?

Explosive!  That's the bombshell dropped by The New York Times yesterday.  The article involves the drug Avandia, manufactured by GlaxoSmithKline (introduced to the market by its predecessor SmithKline Beecham).  Avandia entered the market in 1999 as a drug to treat diabetes.  Since then, GlaxoSmithKline has reaped enormous revenue from the sale of this drug.  To put these sales in perspective, it appears that in 2006, the company received $2.2 Billion in revenue from marketing Avandia.

In 2007 (after approximately 8 years of selling this drug), a Food and Drug Administration (FDA) panel issued a black box warning saying that this diabetes treatment was linked to potential increased risks of heart attack.  GlaxoSmithKline continued to market Avandia after this additional warning.

Now, we learn additional information.  Apparently, the company did its own secret internal testing, back in 1999.  What did it reveal?  According to the New York Times, the secret 1999 study results indicated the increased risk of heart attacks associated with Avandia.  Did the company stop marketing Avandia?  No.  Did the company publish the results?  Apparently not.  In fact, the Times article indicates that internal corporate emails specifically stated that the results should be hidden.

Is this the first time that this drug maker has been caught concealing important health and safety information?  Again, the answer is no.  Several years ago, the company was found to have hidden data linking its anti-depressant Paxil to suicidal thoughts in children and teenagers.

The drug maker is not alone in receiving blame in this situation.  In past years, the FDA has failed in its duty to protect us and allowed many unsafe products to be marketed.  Hopefully, the FDA will now "step up to the plate" and do its job.  This week an FDA advisory committee is meeting to discuss the developments concerning Avandia.  Hopefully, the complete nature of this drug will be revealed so that an honest decision can be made concerning its continued use.

50 Years After 'To Kill A Mockingbird'

Today, July 11, marks the 50th anniversary of the publication of To Kill a Mockingbird.  This weekend, The USA Today published a story discussing this literary milestone.

The author, Harper Lee, has published no other novels.  Yet, her one and only major novel has had such a profound impact.  Is this book the great American novel?  Perhaps I'm biased.  However, growing up in Alabama and now practicing law here, I think so.  While my question as to the great American novel could spark a lengthy debate, this book would certainly be one of the finalists.  Periodically, I will re-read the book or re-watch the excellent movie adaptation.

As I read several articles about this anniversary, I was genuinely surprised that there have been a few recent critics of the novel.  In my opinion, these few contemporary criticisms are mis-placed.  In making their criticisms, these few critics have largely removed and separated the story from its actual setting, both geographically and historically.  A Birmingham News article this morning addressed the few criticisms of the story.

If you have never read To Kill A Mockingbird, then I would strongly urge you to do so.  If you read the book long ago, perhaps back in high school, I would urge you to read it again.  It is certainly a story that will inspire you again and again.

Congress Holds Hearings On The "Foreign Manufacturers Legal Accountability Act"

Previously, I wrote about legislation introduced into the U.S. House of Representatives to protect American consumers from dangerous and defective imported products.  The statistics are very troubling.  In 2009, 83% of the recalls announced by The Consumer Product Safety Commission (CPSC) were from foreign manufacturers.  Statistics from recent prior years are similar.

Last week, a Congressional subcommittee held hearings on the proposed bill.  The hearing brief prepared by the subcommittee staff summarizes the current problems with dangerous imported products.  According to the subcommittee brief: 

 

The import of consumer products into the United States more than doubled in the decade between 1998 and 2007.  This sharp rise in imported consumer products has been accompanied by an overall increase in product recalls and a disproportionate increase in the share of product recalls involving imported products – particularly products from China.

In 2007, the Consumer Product Safety Commission (CPSC) announced 473 recalls.  This was the highest level of recalls in ten years.3 Of those 473 recalls, 389 (82%) involved imported products.  Of the 389 recalls involving imported products, 288 (74%) involved products from China.  Among the defective imported products grabbing national attention in the past several years were: a children’s craft kit containing beads coated with a chemical similar to a date rape drug; toy trains coated with lead paint; a contaminated blood thinning drug; and drywall emitting sulfurous gases.

While the CPSC has been working to bolster its surveillance of imported products and working with foreign governments to improve compliance with U.S. safety standards, holding foreign manufacturers accountable for injuries caused by defective products that make it into the hands of American consumers remains a problem. Victims trying to sue foreign manufacturers for injuries caused by defective products face significant obstacles with respect to providing service of process (notice about the litigation required to be given to the defendant) and establishing jurisdiction over foreign manufacturers in U.S. courts.

 

According to a CPSC representative at the hearing, by 2008 almost 80% of the toys purchased in the United States were imported from China or Hong Kong.  The fact that the vast majority of toys we place in the hands of our children are imported certainly makes this an important issue

Currently, injured victims trying to sue a foreign manufacturer face substantial hurdles simply providing the required service of process to the foreign defendant.  The Hague Convention on Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters, provides a very time consuming method requiring all legal documents to first be translated into the foreign manufacturer's native language and then provided to a governmental authority for actual attempts at service.  Even if the injured victim eventually has the foreign manufacturer served, the manufacturer will often challenge the suit by claiming the U.S. Court does not have personal jurisdiction over it due to its lack of actual contacts in the United States.  The current rules work to greatly increase the time and expense on the innocent victims of the defective product and the judicial system as a whole.  In addition, they often serve as a means for the manufacturer to escape ultimate liability for the damages caused by its defective product.

The current legislation in the House of Representative solves these initial problems by requiring that foreign manufacturers importing products into the United States designate a registered agent in this country who is authorized to accept service of legal papers.  Registering an agent would also constitute a link establishing personal jurisdiction in the United States where the agent was located.  Similar legislation has also been introduced in the U.S. Senate.

The current legislation does not cure the problem of defective products flooding our market.  We certainly need to take steps that will enforce important safety standards for all products, including those imported to the United States.  Enforcing safety standards protects our citizens from needless injury and damage.  However, this legislation will prevent foreign manufacturers from escaping accountability simply based on service of process and jurisdictional issues.  As a result, it is a much needed step.

 

Proposed Legislation Would Impact Medicare Reimbursement in Personal Injury Claims

As I have previously written, it is essential that an attorney handling personal injury claims have a sound knowledge of reimbursement and subrogation issues.  Otherwise, the attorney will be ill-equipped to protect his injured client and maximize any recovery for that client.  Many issues and facts impact the rules applicable to each specific case.  For instance, does the injured party have health coverage through a private plan?  Is that private plan provided through an employer?  If the injured party does not have private coverage, do they have coverage through Medicare or Medicaid?  Is the coverage through some other public source, such as the Veterans' Administration?  Each of these presents unique issues and rules.

I could write exhaustively concerning the various aspects of dealing with each type of coverage and its unique issues.  However, I truly believe that most attorneys who handle personal injury claims would agree that dealing with Medicare is the most frustrating of any of these.  Imagine a system that requires (with the full force of Federal law) the injured party and his legal counsel to reimburse it from a settlement or judgment, then will not communicate effectively or timely so that those parties can fulfill their legal obligations.  That is Medicare.  Attorneys for personal injury claimants often wait months (or longer) for Medicare to respond to efforts at repayment.  A reporter at The Miami-Herald did an excellent job documenting the frustrations of lawyers attempting to comply with Medicare laws on behalf of their injured clients.  At our office we have experienced that frustration first-hand.  In addition, just imagine how much money is actually available to our government in attorney trust accounts throughout our country.

Finally, those knowledgeable and involved in the Medicare reimbursement process are beginning to discuss methods that would force Medicare to act in a just and timely manner.  In March, legislation was introduced into the U.S. House of Representatives on this issue.  The proposed legislation has support from varied groups, including groups often at odds in personal injury claims.  Despite their differing opinions on many issues, these varied groups all seek changes in Medicare reimbursement procedures that would make the process quicker and more efficient.  What does the proposed legislation do?  The bill itself is fairly short.  It simply provides time limits for Medicare to respond when parties seek to reimburse prior payments for medical treatment.  That is a much needed change that should certainly be discussed and considered.  While I do have some initial concerns with the bill, including whether a potential defendant in a claim could use the provisions to its benefit in litigating that claim, it is a much needed start to resolving a frustrating issue for injured parties.  It is also my hope that Medicare will act to comply with any enacted time requirements so that health care costs are not unnecessarily shifted from private insurers to our government.

 

 

OSHA Proposes New Standards to Prevent Injuries From Falls

On May 24, 2010, the Occupational Health and Safety Administration (OSHA) announced proposed revisions to the rules governing fall protection standards.  Falls are one of the most common work-related hazards.  According to OSHA, falls are the most common cause of fatalities at construction sites and account for one of every three construction-related deaths.

I have seen first-hand the life-changing injuries that can be caused by easily preventable falls.  They include a worker who suffered a disabling brain injury when he was required by his company to climb on stacked materials that shifted, causing him to fall to the concrete floor.  They include two workers knocked from their elevated work platform by a moving crane.  They include a worker who was required to move a scissors lift while extended despite an uneven surface below, resulting in the entire lift toppling to the ground.  These disabling injuries (and many of the deaths and injuries from falls) could easily be prevented through either the provision of proper equipment or proper job planning.  Instead, the employers in each of these falls neglected to provide the proper equipment or to plan for potential hazards.  In fact, if employers would simply conduct an activity hazard analysis before performing a specific job for the first time, most hazards could easily be identified and prevented.

According to OSHA chief Dr. David Michaels:

This proposal addresses workplace hazards that are a leading cause of work related injuries and deaths.

I plan to review the new proposal carefully.  Hopefully, it will provide some of the clear and simple safeguards needed to protect workers from fall hazards in the workplace.

Alabama Courts Continue to Limit Retaliatory Discharge Claims

The old saying "bad facts make bad results" is certainly true in the case of M&J Materials, Inc. v. Isbell, just released by The Alabama Court of Civil Appeals.  These bad facts simply provided our appellate courts another opportunity to express their general distaste for retaliatory discharge suits.

First, a little background is important.  As many people know, Alabama is generally an "at will" employment state.  That means your boss can fire you for a good reason, bad reason, or even no reason at all.  Of course, the "at will" doctrine is subject to Federal discrimination laws and collective bargaining agreements by unions.  Federal laws and unions aside, state law exceptions to the "at will" doctrine in Alabama are few and far between.  Or, is it closer to "slim and none" when exceptions are considered under Alabama law?

Alabama's Workers' Compensation Act does provide one exception to the "at will" doctrine.  The Act says:

No employee shall be terminated by an employer solely because the employee has instituted or maintained any action against the employer to recover workers' compensation benefits under this chapter or solely because the employee has filed a written notice of violation of a safety rule pursuant to subdivision (c)(4) of Section 25-5-11.

Ala. Code §25-5-11.1.  In looking at this statue, our Courts have focused their attention largely on the word "solely."

Now, back to the recently released case of M&J Materials.  In this case, the employee injured his wrist at work.  He made a claim for workers' compensation benefits.  Then, he was fired.  What was the reason provided for his termination?  Apparently, the employee decided to bring his handgun to work.  In an effort to argue the offered reason for the termination was simply a pretext to fire him for his workers' compensation claim, the employee claimed that his co-workers were also bringing their guns to work.  Whether this was a common practice or not, the company had a clear written rule against bringing guns to work and there was no evidence that the management personnel who fired the injured worker knew anything about other co-workers also bringing their guns to the plant.

All in all, these bad facts gave our appellate courts another opportunity both to deny a retaliatory discharge claim and express just how difficult it will be to even present these claims to a jury.  Employers don't simply admit firing employees because they have been hurt on the job.  Of course, they typically offer some other rationale for terminating the employee.  If you are an injured worker, how do you prove the employer's stated reason for firing you was simply an excuse to terminate you because you had sought workers' compensation benefits?  It is clearly not enough to present some facts simply calling the stated reason into question.

Here is the tremendous hurdle an injured worker faces simply to get his claim to the jury:

An employer's stated basis for a discharge is sufficient as a matter of law when the underlying facts surrounding the stated basis for the discharge are undisputed and there is no substantial evidence indicating

(a) that the stated basis has been applied in a discriminatory manner to employees who have filed workers' compensation claims;

(b) that the stated basis conflicts with express company policy on grounds for discharge, OR,

(c) that the employer has disavowed the stated reason or has otherwise acknowledged its pretextual status.

These cases are very difficult legally.  From the very beginning, it is essential that any attorney considering such a claim carefully screen the case, thoroughly investigate all the facts and diligently gather all the evidence in order to meet the high legal burden placed upon these claims in Alabama.

 

A Novel Approach to the Punitive Nature of Wrongful Death Damages in Alabama

My partner Bud Watson is frequently asked to speak at seminars to share his years of observation and experience as both a former judge and current litigator.  I have asked him to share some of his strategies on this blog from time to time.  With that in mind, Bud provided this entry concerning an area of the law unique to Alabama -- The availability of only punitive damages in wrongful death actions.  Bud's observations on this issue are especially timely since I recently wrote about the interaction of Alabama's survival statute with its unique approach to wrongful death claims.  I have copied Bud's observations on this issue and posted them below:

 

By Bud Watson:

Here is a strategy that legal counsel might find helpful in wrongful death cases in Alabama.  Again, in Alabama (the only such state), there are no compensatory damages in wrongful death cases.  That means no recovery for medical expenses; no recovery for pain and suffering; no recovery for the huge financial impact to a family when a father or mother is killed.

The unique nature of Alabama law is not present because of some explicit statutory language.  It is a creation of our court.  Alabama courts have concluded that life is priceless and therefore not amenable to crass valuation in dollars.  The only allowable damages are punitive.

Yet, in all cases where punitive damages are claimed, the plaintiff can expect from the defense a long list of boilerplate challenges suggesting that punitive damage rules are unconstitutionally vague.  These defenses or motions to dismiss or strike contend that punitive damages should not be allowed because there is no objective standard by which to measure such damages.  In other types of cases where compensatory damages are also allowed, the law does impose some standards by which to measure punitive damages in conjunction with the compensatory damages assessed.  However, in the wrongful death context in Alabama, these objective comparisons are not present.  The truth is that, as presently applied and in the abstract, these challenges to punitive damages in wrongful death claims are probably correct.  The pattern jury instruction on punitive damages in Alabama also provides little guidance on this issue.

With this background, what is the novel strategy that could be argued in wrongful death cases in Alabama?  It is a pre-trial offer of proof stating the following:

The defendant has contended that there is no objective standard to direct a jury with regard to punitive damages.  In analogous criminal cases (such as criminally negligent homicide cases) the Court is required by law, before setting sentence, to initiate a victim impact statement pursuant to Ala. Rules of Criminal Procedure, Rule 26.3(7), which includes the economic and psychological impact on the family members.  Therefore, the plaintiff offers to provide proof to the jury of the financial and psychological impact of the death of the victim on the victim's immediate family members.  The plaintiff will provide evidence of victim impact from the victims themselves as well as through expert testimony from professionals such as physicians, psychologists, and economists.  Additionally, pursuant to Ala. Rules of Criminal Procedure, Rule 26.8, the application of punishment requires a full evaluation of the wrong and all its consequences.

If accepted, the plaintiff could then provide testimony concerning the impact of the death upon the remaining family members.  The offered approach does not conflict with the Alabama cases holding that a dollar value cannot be placed on the victim's life.  Rather, the emphasis is on the impact of the wrong as a necessary part of reaching a reasonable decision as to the level of appropriate punishment to assess as punitive damages.

Although judges with whom this approach has been discussed and to whom this approach has been made have expressed great interest and intrigue, Alabama courts have yet to rule on such an offer of proof.  On the occasions where I have made this offer in the past, a settlement for the applicable policy limits has soon followed.  As a result, I have not yet pursued the issue to completion in Alabama's court system.  In my conversations with opposing counsel, I believe that most defendants and their counsel do not wish to test this approach at an appellate court level.

 

It's Time to Re-Think Alabama's Survival Statute

In Alabama, un-filed tort claims do not survive the death of the victim.  This is because of a special statute created by our legislature.

Why is this significant?  Consider the impact of this technicality on two different, hypothetical, tort victims.  Both victims suffer terrible injuries when struck head-on by an intoxicated driver.  Both are rushed to the hospital.  Both spend months receiving very expensive, specialized medical care.  Did I point out that months of hospital care would be very expensive!  Both lose wages.  The first victim files his case against the intoxicated driver who injured him.  Then, he dies.  The second victim dies before he can file his claim.  For the first victim (who actually filed his claim), his estate can still pursue the claims and seek to recover for the tremendous damages.  For the second victim, his estate must now pay huge expenses for medical care and other losses out of his assets, with no ability to recover these items from the person actually at fault.  Needless to say, these bills could easily consume an entire estate and leave the heirs with nothing.

Doesn't Alabama allow wrongful death claims?  Yes.  If the above victims died from their injuries (and not some separate cause), their heirs could pursue wrongful death claims.  However, under Alabama law, you cannot recover compensatory damages in a wrongful death claim.  Under Alabama's unique wrongful death procedure, only punitive damages are recoverable.  So, again, one estate can recover these huge expenses while the other cannot.

This unique aspect of Alabama law can lead to devastating consequences for families.  However, this injustice could be easily fixed by our legislature.  Alabama could adopt the Uniform Law Commissioners' Model Survival and Death Act or enact some other provision that fixes this problem.  In prior years, proposals have been introduced into our legislature.  It is certainly time for this issue to be seriously considered.