Alabama Litigation Review : North Alabama Personal Injury Lawyer & Attorney : Jeff Blackwell : Hornsby, Watson, Hornsby, Blackwell & McKown Law Firm : Commercial Litigation, Workers' Compensation : Huntsville, Decatur, Athens

Last week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) met in Miami.  Among the issues set for hearing were requests to consolidate pending Federal Court cases alleging product defect claims due to transvaginal surgical mesh products against American Medical Systems, Ethicon (Johnson & Johnson) and Boston Scientific.  I have already filed one of these cases against Boston Scientific and am investigating several others.  So, naturally I am very interested in the decision as to where these cases will ultimately be consolidated.

As for the Boston Scientific cases, it is likely that they will be consolidated either before a Federal Judge in West Virginia (as generally sought by plaintiffs' counsel) or a Federal Judge in Oklahoma (as requested by Boston Scientific).  I believe the Federal Court in West Virginia is the best choice.  That Court is already handling similar claims against another mesh manufacturer, C.R. Bard, Inc.. As a result, that Court is familiar with these mesh products in general  as well as many of the medical issues.

The injuries suffered by women who have had these products implanted are very serious and debilitating.  These injuries include serious infections, erosion of the mesh into the tissue, urinary problems, injury to nearby organs, inflammation and severe pain.  Often, additional surgery is necessary to try and correct some of the damage.  In July 2011, the FDA issued a safety update detailing the dangers of transvaginal mesh products.  An article last year on MSNBC also detailed the troubling history of how this product was placed on the market and the tremendous injuries which may result from its use.

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The Federal Judicial Panel on Multidistrict Litigation has issued its Order consolidating all pending Actos cases in Federal Court. The cases have been consolidated before U.S. District Judge Rebecca Doherty in the U.S. District Court for the Western District of Louisiana. This means that Judge Doherty will preside over all the pretrial proceedings in these cases. Bloomberg has a good article concerning this decision and its impact on Actos litigation against Takeda Pharmaceutical.

I have written previously on the issues surrounding Actos:

1. Takeda May Face Thousands of Lawsuits over Actos - overview of the potential claims facing Takeda due to its diabetes drug.
2. Type 2 Diabetes, Actos, and Bladder Cancer - the use of Actos to treat diabetes.

This litigation is only in its early stages. I expect that the court will face a huge number of claims to manage.

The purpose of the multidistrict litigation (MDL) process is to consolidate cases before one court that can handle the various discovery and pretrial proceedings. The idea is that having one court handle the various pretrial issues will conserve resources, save costs, and prevent numerous courts issuing rulings that may be inconsistent. Cases are returned back to the Federal Court where they were originally filed for the trial.

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I wrote a few days ago about the health issues being associated with the diabetes drug Actos.  Now, the headline yesterday from Bloomberg says it all:

TAKEDA MAY FACE 10,000 U.S. SUITS OVER ACTOS CANCER CLAIMS

Regulators in France and Germany have already pulled the drug from their markets.  In the U.S., the typically slow to act FDA has begun to take steps as a result of the research.

The main issue surrounding Actos involves research into its relationship to bladder cancer.  Unlike many other cancers, there are fewer potential causes of this cancer.  Thus, it will likely be more difficult for Takeda to blame cases of bladder cancer on causes outside the long-term consumption of its drug, Actos.  I believe there will be claims alleging that Actos caused other problems such as strokes and heart attacks as well.  Other prior drugs in the same class as Actos have had similar issues.

A number of suits are already pending around the country over Actos and bladder cancer.  The United States Judicial Panel on Multidistrict Litigation is currently considering where to consolidate the numerous existing and expected cases for pretrial procedures.  Yesterday, the panel held a hearing on the current Actos litigation.

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Many adults are impacted by Type 2 diabetes (sometimes referred to as adult-onset diabetes or non insulin-dependent diabetes).  Type 2 diabetes is a chronic condition that affects the way your body metabolizes sugar.  Left untreated it can be life-threatening.  However, the condition can be managed.  Often, it can be managed through diet and exercise.  Unfortunately, sometimes medications are necessary.

The Mayo Clinic website has an excellent chart that lists various medications used to treat Type 2 diabetes.  These medications fall into several different categories of drugs.  Each category works to manage the condition through a different process.

Actos is in the category known as glitazones, that were designed to increase the cell's sensitivity to insulin.  What other medications were in this same category?  One medication in this category was Rezulin which was withdrawn from the market in 2000 due to issues with liver toxicity.  Another was Avandia which has been severely restricted as a result of heart issues.  I have written on prior occasions about the problems with Avandia.  Since my last post on Avandia, there have been new developments concerning the potential harm of that drug.

After these other two drugs were removed or severely restricted in use, the number of Actos prescriptions grew substantially.  How much money did Actos generate for Takeda, the Japanese company producing the drug?  A 2011 article on pharmaceutical sales revealed that Actos recorded $3.58 billion in sales over just the first 9 months of 2010. 

Now, we learn that Actos may also present considerable health risks. In September 2010, the FDA issued a safety announcement about the potential risk of bladder cancer after extended consumption of Actos.  At that time, the FDA said it was reviewing data to determine the association between Actos and bladder cancer.  According to the FDA safety announcement

An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as those exposed to the highest cumulative dose of Actos.

In June 2011, both French and German regulators suspended the sale of Actos in their countries citing studies linking the drug to an increased risk of bladder cancer.  Also, in June 2011, the FDA issued a new safety announcement about Actos.  In this announcement the FDA specifically warned consumers that

use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.

Since Takeda introduced Actos, millions of prescriptions have been issued.  The physicians prescribing the medication were not aware of these risks until the FDA recently issued its safety announcements.  This does not appear to be true for the manufacturer Takeda.  In fact, evidence suggests that Takeda knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical studies, which showed an increase in drug-induced tumors in the bladders of rats.  Yet, Takeda sold Actos without any warning of this increased risk until the FDA's recent actions requiring additional warnings.  And yet, bladder cancer may not be the only problem associated with Actos.  The latest studies indicate that bladder cancer is only one of Actos' potentially life-threatening side effects.

It is very difficult to hear the story of a patient who now suffers cancer after taking Actos for an extended period of time.  Then, on top of that, you consider the evidence that the company may have known of problems and yet sold billions of dollars of pills without a warning.  I think much more information will be revealed in the coming months about the impact of this drug on patients.

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Yesterday, I read a blog post by Mobile, Alabama attorney Edwin Lamberth.  Edwin's blog is always a great source of commentary.  Edwin's recent post discusses an important issue - foreign companies not being held accountable for the injuries and deaths caused by their defective and dangerous products.

This is a subject I've previously addressed as well.  In my prior posts, I discussed the need for Congress to pass legislation protecting the public from needless injuries by holding these manufacturers accountable.  Last year, such legislation was introduced before Congress.  That proposed legislation would not only protect consumers but would also level the playing field for manufacturers in the U.S. who are going the extra mile to try and produce safe products.

Now, the U.S. Supreme Court has weighed into the issue - but with two bad decisions that deny justice to the victims of defective and dangerous products produced by foreign companies for distribution in the United States.  Edwin's post presents a great analysis and commentary on these new decisions.  Since his post captures my thoughts on the issue as well, I would just urge others to read it.  I am very troubled by these recent Court decisions further closing the doors of justice to families dealing with a severe personal injury or the death of a loved one due to a dangerous and defective product.  I certainly hope this is not the end of this issue.  Perhaps now Congress will finally act in the interests of the public and business by passing legislation to hold those accountable who ship defective products to us.

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Atrial fibrillation is a huge health issue affecting many individuals.  It is estimated that this condition affects 2.3 million Americans.  At present, the FDA has approved a variety of treatments.

In 2009, the drug company Sanofi-Aventis began to market dronedarone under the brand name Multaq as an additional medication for atrial fibrillation.  Although the FDA approved the marketing of Multaq in July 2009, a petition several years earlier had been denied due to patient safety concerns.  According to medical data, in just over a year on the market, around 147,000 patients filled prescriptions for the medication.  At the time of approval in 2009, the company estimated that sales would eventually reach $1 Billion a year.

However, medical research now indicates that Multaq may not be the blockbuster medication for atrial fibrillation as marketed by its manufacturer.  Researchers at Cedars-Sinai Medical Center are now reporting that the medication is only half as effective as a different generic medication.  However, it is not just the effectiveness of the medication that is now being called into question.  Patient safety is also an issue.

On January 14, 2001, the Food & Drug Administration (FDA) issued a safety announcement warning health care professionals about the possibility of severe liver damage associated with the medication.  Then, on January 28, 2011, the FDA issued a warning letter directly to Sanofi-Aventis.  This warning letter follows an FDA inspection in which it was revealed that the drug maker had failed to timely report possible adverse consequences of its medication Multaq.  At present, it has been reported that several patients on the medication have suffered liver injury, including two who even suffered acute liver failure requiring them to undergo liver transplants.

This is a potential health issue that has already received some coverage from news outlets in Alabama.  In light of the significant number of people suffering from atrial fibrillation and the numerous other treatments available, it is important to continue monitoring developments with Multaq and whether this drug poses a danger of acute liver failure to patients.

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This morning I saw a post from Consumer Report's Safety Blog that contained an old Saturday Night Live skit that while hilarious, is an all too true reminder that many toys are clearly unsafe for our children.  While giving full credit to the Safety Blog, I have to re-post the skit.

In its post, the Safety Blog also provides some good, general advice concerning toys.  Their advice:

1.      Give your children only age-appropriate toys. Toys with small parts pose a choking risk and should be labeled as not for children younger than 3 years of age. The age grading that you may also find on toys not only relates to play value, but also to safety. No matter how developmentally advanced you think your child is, don’t give him or her a toy that’s intended for an older child.

2.      Be particularly cautious of toys bought from dollar stores. Our market surveillance has found that you’re much more likely to find substandard and unsafe toys at dollar stores than at major retailers.

3.      The toy’s packaging can be hazardous. Although the toy itself should have been tested for safety, its packaging likely hasn’t been.  Discard all toy packaging or at least keep it out of the reach of children.

All too often toys are manufactured without adequate safety standards or precautions.  Many of these dangerous toys are imported from countries that lack our safety rules.  The Safety Blog offers some valuable advice to avoid the potential for injury.  In addition, the U. S. Consumer Product Safety Commission lists on their website toy recalls.  The toys we give our children should be both fun and safe.  Hopefully, this Christmas they will be.

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Yesterday, the United States Department of Justice announced that it had recovered $3 Billion in fiscal year 2010 against those companies and individuals who had defrauded our government.  These recoveries involved claims for all types of fraud against our government, including military contracts, non-military contracts, federally-insured mortgages, and mineral leases, among others.  It is a welcome relief to see our government act to pursue those who steal from all of us.  In addition to the record amount recovered, it is also interesting to note that the largest single area of fraud against our government involves the health care industry.  According to the government's announcement and an NPR article involving this issue, $2.5 Billion of the $3 Billion recovered, involves the actions of big pharmaceutical companies.

I have written previously about the long FDA saga with Avandia as well as the manufacturer's apparent concealment of adverse studies involving the health risks of that drug.  I have also written about the deceptive marketing practices involving the use of shoulder pain pumps. 

We are now in the middle of discovering the extent of damage caused by DePuy's defective hip replacements.  DePuy, a Johnson & Johnson subsidiary, sold over 90,000 of these implants, including a large number here in North Alabama.  As the full extent of damage from DePuy's defective implant comes to light, it is important to remember that DePuy has previously been the subject of probes involving the practice of paying kickbacks to physicians in an effort to implant its products into patients.

According to the government's report, this year's false claims actions involved companies such as Pfizer over its promotion of the painkiller Bextra, Astra Zeneca over the anti-psychotic drug Seroquel, and Novartis.  I applaud the efforts of the Department of Justice to pursue issues of fraud against our government, including fraud and abuse concerning drugs and medical devices.  However, the government needs to act during the approval and review process so that the interest of the public is protected, from the beginning.  While recovering taxpayer funds is great, it is too late at that point for the people actually harmed by dangerous and defective products.

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Last month I discussed the recent recall of the ASR hip replacement products manufactured by Depuy Orthopedics.  With over 90,000 of these medical implants sold, this is a tremendous issue that will affect many people.  These defective implants can result in significant injuries and damages to the individuals using them. 

How will Depuy treat the patients who underwent these transplants and now face some difficult decisions?  Depuy's past conduct should provide much cause for concern.  In May, a former Depuy executive pled guilty to providing some $7 Million in bribes to doctors in Greece in an effort to persuade them to use the company's products.  In 2007, Depuy paid $84.7 Million to settle civil and criminal probes by the U.S. Department of Justice involving allegations of kickbacks to surgeons in an effort to get them to use the company's orthopedic devices.  Medical device manufacturers, like Depuy, can exercise significant financial influence without simply paying physicians directly.  The industry routinely provides fellowships, sponsors seminar trips, and utilizes means of indirect financial incentives to hospitals and surgeons.

Most physicians care deeply about their patients.  If you receive a recall letter and have a supportive physician, your physician should discuss the issues with you and conduct any needed tests.  Some supportive physicians are actually encouraging their patients to seek legal representation.  If you don't have a supportive physician, seek one immediately.

Should you sign the documents Depuy may have provided your physician?  Definitely not.  It appears there may be different versions of these documents.  However, they will allow Depuy to gather all your medical records and, perhaps, the hip device itself.  This would serve simply to help Depuy prepare its defense at your expense.

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It's been a long time since I last posted.  Between then and now, I had several significant cases set for trial that required almost all my time.  One of these cases ended in a week-long trial before getting a good result for my client who suffered catastrophic injuries.  After any long trial, one of the greatest challenges is simply catching up on the things you missed.  So, I hope to return to regular posting here.

In August, DePuy Orthopedics, Inc. (a Johnson & Johnson company), issued a recall notice for its ASR hip replacement products.  These products are the ASR XL Acetabular System and the ASR Hip Resurfacing System.  According to The Wall Street Journal, the company sold approximately 93,000 of these devices before phasing out their production last year.  The ASR Hip Resurfacing System was only available outside the United States.  However, the ASR XL Acetabular System was implanted in patients throughout the United States.

The Food & Drug Administration (FDA) approved the ASR XL Acetabular System for implantation in the U.S. in 2005.  Unfortunately, the FDA apparently approved the device without requiring clinical trials.  Now, we learn that the device has a much higher failure rate than other similar products.  This is a fact that DePuy admits in its recall notice.  The device can generate metallic debris as it wears.  Patients can suffer pain, difficulty walking, fractures, infection, and damage to surrounding tissue.  Because of these problems, additional surgery can be required.

Again, we see the results of a system that rushes products to the market without adequate information or testing.  It is unfortunate that the unsuspecting patients who underwent these implants may suffer problems and require additional surgeries that could have been avoided through earlier clinical trials.  The companies who manufacture these products and our regulatory system, should be focused on bringing the safest products possible to the physicians and patients using them.

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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.

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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.

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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.

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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.

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A study by The American Association for Justice shows that eighty-three percent (83%) of the recalls announced by The Consumer Product Safety Commission (CPSC) in 2009 were from foreign manufacturers.  The results for 2008 were similar.  What happens when one of these defective foreign-made products injures someone?

The recent litigation concerning defective Chinese drywall highlights the problems with holding foreign manufacturers accountable for the injuries their products inflict upon the public.  Millions of tons of defective Chinese drywall were imported into the United States for use in the construction of homes.  After these homes were built, owners began complaining that the drywall emitted corrosive and irritating fumes.  In November 2009 the CPSC issued a press statement,  after studying the issue, finding "a strong association between homes with the problem drywall and the levels of hydrogen sulfide in those homes and corrosion of metals in those homes."  The defective drywall was emitting hydrogen sulfide gas which not only created an irritating smell, but also, caused parts of the home to corrode.  The CPSC is continuing to study the health issues which may also be associated with the defective drywall.

Last week, a Federal Judge in Louisiana assessed $2.6 million in damages against a Chinese state-owned manufacturer of this defective drywall on behalf of seven Virginia families.  These damages relate only to the costs necessary to remediate the problem and fix the damaged homes of these plaintiffs, not the potential health risks.  Many other damaged homeowners have also filed claims which remain pending.

The problem arises in the enforcement of the Court's judgment.  Will the foreign manufacturer truly be held accountable or is this a judgment that will never be collected?  The Wall Street Journal published a great article discussing the case and its history.  In this litigation, the Chinese manufacturer never even answered the lawsuit.  While the Court's ruling on the initial drywall claim is a positive step, it remains unclear as to whether the foreign drywall manufacturer that caused this harm will ultimately pay for the damages it created.

Foreign manufacturers are often able to avoid their liability because of difficulties obtaining legal service of the claim on the company in its home country, issues related to whether the U.S. Court has jurisdiction over the manufacturer, and then problems collecting any eventual judgment.  It is important to remember that the damages caused by a defective product will be borne by someone.  If the foreign manufacturer avoids its responsibility, then the innocent consumer, our government, or a domestic company that distributed the product, will ultimately (and unfortunately) bear the loss.

In February, several members of the U.S. House of Representatives introduced legislation that would make it easier to hold foreign manufacturers accountable for their defective products.  The American Association for Justice issued a press release detailing some of the problems under current law as well as solutions presented by the proposed legislation.  Among other things, the proposed legislation would require foreign corporations to have an "agent" in the United States to accept service of process for civil and regulatory claims.  It would also require the manufacturer to consent to jurisdiction in our courts.  This is much needed legislation that will hopefully protect consumers in the future. 

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Arthroscopic surgery to treat or repair a variety of conditions in injured joints has become routine.  In our law practice, we frequently have clients who have undergone these procedures to joints such as the knee, shoulder, or hip.  Arthroscopic surgery has several potential advantages over open surgical procedures.  It is minimally invasive.  It typically involves little or no hospital stay.  It often allows a quicker recovery time.  Although typically less painful than open surgery, some patients do suffer significant pain.

Along with the advances in surgical procedures, the medical community has created many options to treat pain.  One of these modern options is the pain pump.  What is a post-surgical pain pump?  It is a device that can be implanted during surgery to deliver pain-relieving medication via a catheter to the surgical site.  The pump is typically used for short-term pain relief in the days immediately following surgery.  It is then removed and discarded.

How are the pumps implanted in a shoulder surgery?  They can easily be placed by the anesthesiologist so that they deliver pain relieving medication at the site of the anesthetic block in the tissue around the shoulder.  When used properly, pain pumps appear to be an effective and convenient alternative for temporary pain relief in the days immediately following the shoulder surgery.  So, what is the problem?  Apparently, the pump manufacturers sought approval from the FDA to implant the devices not just in the soft tissue of the shoulder, but instead, to allow implantation that would deliver medication via catheter directly into the shoulder joint itself.  The FDA said no.  According to information now being revealed, it appears the FDA said no on more than one occasion.

Instead of informing surgeons that the FDA had rejected intra-articular use of their pain pumps, the manufacturers acted in an opposite manner.  According to a recent publication by the American Academy of Orthopedic Surgeons:

sales representatives either directly told surgeons to use the pump intra-articularly or simply left it up to the doctor to figure out what "intra-operative site," as listed in the general Instructions for Use for the pain pumps, meant.

As surgeons began placing the pumps intra-articularly, patients began developing a disabling condition called post-arthroscopic glenohumeral chondrolysis (PAGCL).  Basically, this is a devastating condition where the cartilage in the shoulder joint is badly damaged or destroyed.

Recently, the FDA took the additional step of issuing a specific warning that these devices should not be used as previously marketed for placement intra-articularly.  The FDA also required the device manufacturers to update their product labels to reflect this serious warning.  According to an FDA study, almost all reported cases of chondrolysis (97%) occurred after these shoulder procedures.  Thankfully, the FDA has begun to warn the physicians and public about this dangerous use of pain pumps.  Unfortunately, it is too late for some patients.  The damages caused by the previously defective warning and subsequent mis-use of this product have resulted in several claims against the manufacturers.  This is a story of companies placing sales over safety.  I suspect much more information about this practice will come to light in the near future.

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