Pinellas Personal Injury Lawyer

DePuy ASR hip implant patients in most states who do not file lawsuits before August 23, 2012 may lose their rights to compensation or to file a lawsuit. Every state has a law called the statute of limitations that sets a limited time period in which a lawsuit for compensation can be filed. If a person with a legal claim or legal case fails to have a lawsuit filed on their behalf within this time period their claim can be forever barred. In summary, people who do not assert their rights in court within a limited time lose those rights and can never thereafter bring that claim.

Why is the Statute of Limitations for Most ASR Hip Implant Patients This August?

Every state has its own time limit for filing lawsuits called the Statute of Limitations. DePuy and Johnson and Johnson, the manufacturers of the ASR Hip Implant, have a right to have lawsuits dismissed or decided in their favor regardless of the injuries if the lawsuit is not filed in time to comply with the statute of limitations.

Most states in the United States use a two year time period for the statute of limitations. Other states may have a 1 year up to a six year time period for the statute of limitations. Different states use different rules to calculate when these time periods start running and when it is too late to bring a lawsuit. These calculations can be difficult to make and there have been many lawsuits over the running of the statutes of limitations in different types of cases. Each person’s case should be carefully evaluated individually by an experienced lawyer because individual circumstances can affect calculating this time period. This blog is for general information and awareness and you should not use this information to make your own calculation to rely on for your case for the statutes of limitations.

This two year statute of limitations will run for many DePuy ASR hip implant cases because the official DePuy Recall Notice that received widespread publicity was issued on August 24, 2010. The two year period from that Recall Notice will expire on August 23, 2012. Thus, lawsuits for injured ASR patients must be filed in those states with a two year statute of limitations or it may be too late for those patients to make a claim.

Which States Have a Two Year Statute of Limitations

Arizona, Alabama, Alaska, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, and West Virginia are the states with a two year statute of limitations for injury cases.

However, the calculations used to measure the two year time periods are different in different states and it is important to have each case calculated by an experience attorney to be sure that the time period does not run out before the lawsuit is filed.

For example, the two year statute of limitations in Virginia is unusual in that the two year time period in that state runs from when the person first has pain or is aware of an injury even if that was before the recall of before they had any idea that DePuy might be responsible. So in Virginia it is likely that the statute of limitations may have already run on some cases where the person had pain from their hip implant before the recall date. It is possible that someone reading this blog could have a statute of limitations that will run tomorrow or next week!

Immediate individual legal advice is critical to making sure that the Statute of Limitation is not missed.

There are many states other than those listed above that have a statute of limitations of two years from the date of death if the implant caused a death. Some states have longer statutes of limitations for injury cases than for death cases.

Are There Exceptions to the Statute of Limitations?

There are few exceptions to the Statute of Limitations. One of the clearest is the Sailors and Soldiers Relief Act which can toll the statute of limitations for some active members of the military while they are in the service of our country. Tolling of the Statute of Limitations means that the time period is stopped from running. That means that some active military people could wait many years before having to file their cases. Our firm has had other types of cases where the statute of limitations has been tolled for decades while a military person is in active service.

Many states have what is called a “Discovery Rule” which means that the Statute of Limitations does not start until a person would reasonably know that they might have a liability claim. I believe many judges would rule that the widespread public dissemination of the DePuy Recall Notice of August 24, 2010 would start the clock running on the statute of limitations even if an individual person did not hear about it or know about it because the test is usually an objective test about what a reasonably informed person would know.

There is another highly complex legal rule called the “American Pipe Rule” that may be applied in some states if a class action is pending to toll the time period for an individual lawsuit for a person who would be a member of that class action. This theory should not be relied on for DePuy ASR cases because there is no viable class action that I know of. The ASR cases are coordinated for pretrial purposes in a federal multidistrict proceeding called an MDL but this is not a class action and will not toll or stop the statute of limitations from running in an individual case unless an individual case is filed for that person.

Mental incompetence can be an exception in some states that could extend the statute of limitations. For example, someone with severe Alzheimers disease might qualify in some states for an extension to the statute of limitations.

Final Advice on the Statute of Limitations for ASR Lawsuits

Every person with a DePuy ASR Hip Implant should have a detailed review of the statute of limitations done by an attorney experienced in medical product liability cases. This review should be done immediately because once the statute of limitations has run there is no way to reopen or restart it. Once the statute of limitations has run it is too late to ever bring a lawsuit for harms and injuries from the defective ASR metal on metal hip implants.

Do Not Rely on this blog as a substitute for an individual legal review of your individual case facts. This blog is to increase general knowledge and awareness of these issues and not to give any legal opinion on any individual case.

I am happy to give individual case opinions at no charge if I can review the specific facts of your case and compare them to the laws of the statute of limitations applicable to your specific case. If you have retained a lawyer to represent you then you should contact that lawyer for an opinion on the statute of limitations.

Every person who has not already filed a lawsuit should obtain a legal opinion on the statute of limitations from me or any other experienced medical device product liability attorney as soon as possible to protect their legal rights .

Every six years Florida Supreme Court Justices appear on voters' ballots for what is called a merit retention vote. This provision of Florida law has served for decades as a check to allow the removal of corrupt or incompetent judges. It was not designed or intended to be used as a political tool to remove judges based upon disagreement with a judges legal conclusions in specific cases.

Nevertheless, this year Florida Supreme Justices Fred Lewis, Barbara Pariente and Peggy Quince are the target of a Tea Party activist group named Restore Justice 2012. This Tea Party group is organizing a campaign to remove these qualified and experienced judges through the retention process. The group does not even contend that the justices are unqualified. Restore Justice 2012 simply wants a Supreme Court that will agree with their ideological ideas. This tea party campaign is not about restoring justice it is about subverting justice. The citizens of Florida should not be fooled by this extreme group into questioning the proven integrety of our Supreme Court Justices.

All judges in Florida including Supreme Court Justices are limited by law in their ability to campaign and discuss issues that might come before them as judges. As a result the Justices, in many respects, have their hands tied in trying to respond to this retention challenge.

Therefore, as a Florida lawyer for over 30 years I write this article to support our Supreme Court Justices and to urge that all voters this election vote to retain Justices Lewis, Pariente, and Quince.

In 2009 after the U.S. Food and Drug Administration raised questions about the safety of the DePuy ASR Hip Implants Johnson & Johnson decided to sell all the hip implants in its inventories before discontinuing the product.

An article to be published in tormorrow's New York Times details the factual proof that Johnson & Johnson put its own corporate profits ahead of the safety of hip implant patients. Journalist Barry Meier, who has been conducting a detailed investigation for several years sets forth these facts:

1. The 2009 data from the Austrailian Registry showed high failure rates of the ASR after just a few years rather than the expected 15 years.

2. In 2009 the U.S. FDA confidentially notified DePuy Orthopedics that it would not approve a new ASR Resurfacing System.

3. A 2009 letter from the FDA expressed concerns about high metal levels in ASR traditional hip implant patients.

4. DePuy employees discussed selling out the inventories during 2009 and 2010 until the inventories were almost depleted and then recalled the product in August of 2011.

Legally, this conduct by Johnson & Johnson and DePuy Orthopedics could be considered gross negligence, or wanton and willful conduct. Such conduct can be the basis for punitive damages to punish the company in the lawsuits that are pending.

In a legal punitive damages case a jury is entitled to consider the wealth of the corporation in order to evaluate how large a monetary damage award would really punish the corporate defendant. Such damages could be many millions of dollars for such a large company as Johnson & Johnson. These damages would be in addition to the damages for medical expenses, lost wages and pain and suffering of an implant patient whose ASR failed shortly after implant.

I believe that these lawsuits will be settled in the next year or so. I do not think that Johnson & Johnson wants to see what a jury thinks of their irresponsible and selfish conduct.

Today Saunders & Walker participated in the filing of a lawsuit in Phoenix Arizona involving the Wright ProFemur Total Hip System. This is a different type of hip implant lawsuit than most in the media lately. Most of the recent discussion and litigation concerning hip implant failures has involved metal on metal hip implants where the implants slowly failed as a result of elevated chromium and cobalt levels causing damage to the tissue.

The failure of the Wright ProFemur implant in the case of Dale Parcell which was filed today in Phoenix was a sudden break of the neck of the implant that connects the femoral stem with the femoral head. This failure caused Mr. Parcell to collapse to the ground in extreme pain and undergo emergency surgery.

The lawsuit alleges and the medical literature provides evidence that Wright Medical had been aware for years that the titanium modular necks were corroding and fracturing, In fact, in 2009 Wright Medical changed the composition of the modular necks from titanium to cobalt chromium. However, there was never a recall announced of the titanium stems.

U.S. Food and Drug Administration (FDA) regulations require that a manufacturer of a medical device such as the ProFemur hip make a determination as to whether the product change is a change that is intended to reduce harm. If so, the manufacturer is required to report that to the FDA. Such a report likely would have triggered a recall notice. It appears that Wright Medical did not make such a report to the FDA.

It is only when a recall is instituted that medical device manufacturer such as Wright Medical is required to disclose how many people have been implanted with these products. Prior to recall product sales and implantation numbers are proprietary company information and can be kept secret.

This lawsuit should provide a way to find out what happened here and how many patients have this hip implant and could be at risk of sudden and painful failure.

Products liability lawsuits against three different manufacturers of transvaginal surgical mesh devices were assigned to a single federal judge in a multidistrict litigation proceeding this week. The February 7, 2012 Order by the Panel on Multidistrict Litigation assigned lawsuits from all over the United States to the federal Court in Charleston West Virginia. A prior multidistrict litigation proceeding involving the C.R. Bard Avaulta vaginal surgical mesh has been pending in the Charleston Court for several years.

The panel of judges making this assignment reasoned that the reported defects in all of these mesh products were similar and that Judge Godwin in Charleston who has been handling the C.R. Bard Avaulta pelvic mesh litigation could use his experience to expedite the litigation involving the other manufacturers.

A multidistrict litigation is not a class action. Each woman will continue to have her own individual case and if the case does not get settled the case will be remanded to her home town for an individual trial. Each woman will have the right to make her own individual decision on whether to settle or take her case to trial.

Multidistrict litigation is frequently used in mass disasters such as an aircraft crash or a major hotel fire or collapse. It is expected that there will be thousands of women who will eventually file lawsuits. The widespread marketing of transvaginal surgical mesh to women in the United States is, in my opinion, a mass health disaster.

The lawsuits allege that the manufacturers of these products recklessly and negligently marketed these mesh products for surgical treatment of pelvic organ prolapse and stress urinary incontinence and put the companies’ interest in making profits ahead of the safety of women. Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can be treated surgically in most cases using a women’s native tissue without implantation of surgical mesh. The risks of complications are much lower if the mesh is not used.

In many cases with mesh implantation the mesh causes inflammation and infection. The implanted mesh also can shrink and cause chronic pain. Frequently, the mesh will start to extrude through the vaginal wall causing bleeding and pain. Many women have had multiple surgeries to try to trim the extruding mesh or cut deeper to try to remove parts of the mesh. It is practically impossible to remove the mesh because it is implanted deeply through the pelvis with strips or arms extending deep into the pelvis and towards the abdomen. Consequently, there may be no cure for some of these women. I have one client that has had 8 surgeries and is still in pain every day.

It appears that the manufacturers mislead the womens’ doctors by promoting the mesh kits and being safe and effective for treating POP and SUI. The medical studies that the manufacturers used to promote these products describe the anatomical benefits of using the mesh to restore the vaginal vault but the studies did not look at the outcomes on the women who had the implants in the months and years after implant. The U.S. Food and Drug Administration has recently become concerned about the high rate of adverse outcomes after these implants and is conducting data collection to decide whether to order a recall to prevent future implant surgeries on such a broad scale. Many medical specialists believe that is a few limited cases a mesh implant might be warranted if the woman is fully and properly advised of the risks of bad side effects but that the wholesale promotion of these mesh products to all women with POP or SUI is dangerous and wrong.

These mesh kits probably cost less than $100 to manufacture but they are sold to hospitals for over $2,000. This high profit margin provides an inventive for the manufacturers to sell as many of these kits as they can. It will be interesting to see what juries think of this motive to oversell these devices. Many of the lawsuits ask for punitive damages against the manufacturers on this basis.

The three new manufacturers added to the multidistrict proceeding procedure are American Medical Systems, Inc., (AMS); Boston Scientific Corp.; and Ethicon, Inc. which is a Johnson & Johnson company. Each of these manufacturers makes a number of different transvaginal surgical mesh products in different sizes and designs but it appears that they all have unacceptably high rate of side effects and complications.

The coordination of these cases for pretrial management will help to define the scope of this national health disaster and provide a forum for the women and their lawyers to find out the truth about what these companies knew and why they chose to expose women to these horrible health complications.

In anticipation of a wave of lawsuits, the federal courts have issued an order coordinating the Actos bladder cancer lawsuits before one judge in the United States District Court for the Western District of Louisiana. Actos is a diabetes medication that is promoted to decrease insulin resistance but has been linked to bladder cancer.

Actos is the single ingredient product containing pioglitazone. The medication is also sold in combination with metformin under the names Actosplus Met and Actosplus Met XR. Metformin is another diabetes medication that has a different mechanism of action. Pioglitazone is also sold in combination with glimepiride, a third diabetes medication, in a product called Duetact.

Actos is a blockbuster profit maker for pharmaceutical manufacturer Takeda Pharmaceutical Industries Limited with sales of over $2.5 half billion in 2010. Sales appear to be beginning to decline in the face of concerns about the risks of bladder cancer. In September 2010, The U. S. Food and Drug Administration (FDA) began reviewing data from an ongoing Takeda ten year epidemiological study of the relationship between Actos and bladder cancer.

In the spring of 2011 the European Medicines Agency (EMA) began a review of the risks of bladder cancer from Actos. In June of 2011, France’s drug safety agency suspended the use of Actos followed by Germany and Luxembourg. In June of 2011 the FDA required a new safety label indicating that: “The use of Actos for more than one year may increase a person’s chance of bladder cancer”.

Takeda is one of the oldest pharmaceutical companies in Japan. It has created a subsidiary in the United States entitled Takeda Pharmaceuticals North America, Inc. that is based in Deerfield, Illinois. There are a number of lawsuits that have been filed in Cook County, Illinois, the home of the American subsidiary, and many more cases are expected to be filed there.

Symptoms of bladder cancer may include blood in the urine. Actos, Actosplus Met, or Duetact should not be discontinued without consultation with the treating doctor because the benefits of the drugs for treatment of the diabetes need to be weighed against the risk of cancer in each individual.

The diabetes drug Actos has been associated with bladder cancer and the FDA has now required the manufacturer to provide warnings of this risk. Prior to 2011 Actos manufacturer Takeda Pharmaceutical Company did not warn consumers or physicians of this risk. Takeda never did any medical studies of people before marketing Actos. However, in the rat studies that were done in 1999 there was evidence that Actos caused bladder cancer in the rats. Takeda ignored this evidence from the rat study and marketed the drug to the public anyway.

It appears that Takeda put its own desire for profits ahead of the safety of diabetes patients by selling Actos without proper testing and without a proper warning on the product. This bad conduct on the part of Takeda is the basis for the lawsuits that are now being filed against Takeda on behalf of Actos users who have been diagnosed with bladder cancer.

Bladder cancer is very rare and is treatable if diagnosed early. Early signs of bladder cancer are red tinged urine or blood in the urine. Other causes of bladder cancer are certain dyes used in beauty salons and chemicals sometimes used in leather shops and machine shops.

Actos is a sales name for Pioglitazone. Actos is also sold in combination with metformin under the trade names Actosplus Met and Actosplus Met XR. It is also sold in a combination drug called Duetact.

Actos is in a family diabetes drugs called Thiazolidinediones which are referred to as TZDs. Other diabetes drugs in this class are Rezulin and Avandia. Rezulin was recalled for causing liver damage and Avandia is severely restricted because of its risk of causing heart attacks. I think the FDA may be reluctant to force a recall of Actos because it is the only TZD that can realistically be used anymore. It remains to be seen whether the benefit of Actos can justify the risk of bladder cancer. However, Actos users and their physicians should have been warned of this risk by Takeda.

Diabetes patients should not discontinue Actos or any other drug without consulting their physician. Any diabetes patient who has developed bladder cancer while taking Actos should get legal counsel to advise them of their legal rights because there are is a limited time to bring a lawsuit or it could be barred by the statute of limitations.

Penn State football coach Joe Paterno was fired by the University Board of Trustees tonight for failing to report the rape of a 10 year old boy in the showers at the Penn State locker room over ten years ago. Jerry Sandusky, Paterno's asistant football coach was caught in the act of raping the boy by another Penn State employee who made the report to Joe Paterno at the time.

Pennsylvania state law requires that anyone who is aware of the abuse of a child make a report to law enforcement authorities. Decent moral judgement also requires taking action to protect children and bring the child molester to justice.

The Penn State Board of Trusteees should be commended for taking prompt action. It would be a travesty for Paterno to appear on the football field this weekend as a representative of Penn State.

The Penn State scandal is similar to the Catholic Church priest child sex abuse scandal. In both situations revered and powerful individuals put their own prestige ahead of protecting children from sex abuse. In both sitiations if is difficult for those abused to come forward against such powerful institutions. It is difficult to speak truth to power. I have seen the courage of young men who are struggling with the difficulties of confronting powerful institutions in the lawsuits that I have brought against the Catholic Chuch and other powerful institutions.

I am sure that there will be lawsuits brought against Penn State for its negligence in not taking action to protect children. While monetary compensation cannot restore the innocence of childhood to these boys it may bring some measure of justice for the wrongdoing of Coach Sandusky. Joe Paterno, and Penn State.

Pharmaceutical drug manufacturer GlaxoSmithKline will pay $3 Billion to settle for civil and criminal illegal marketing schemes that were the subject of a U.S. Government investigation. The investigation of the drug company included inquiry into Glaxo's promotion of Avandia, a diabetes drug that has likely resulted in many deaths due to heart attacks. Medical advisory panels at the FDA had concluded that the very limited benefit of taking the diabetes medication likely did not justify the increased heart attack risk of taking the drug for most patients.

In my opinion, GlaxoSmithKline put their own financial profits ahead of patient safety and officers and employees of the company involved in this crime should have faced criminal convictions rather than simply paying shareholder funds to avoid responsibility for the harm that they have done to diabetes patients.

This is the largest legal settlement by the U.S government with a drug company. The next biggest settlement was a settlement with Pfizer pharmaceutical company for $2.3 billion a few years ago. That settlement also involved illegal marketing of drugs.

GlaxoSmithKline has also settled many private civil lawsuits and class actions by patients who had taken Avandia and suffered heart attacks. Many civil cases are still pending against the company but none have gone to jury trial yet as far as I know.

Unfortunately, it has become commonplace for our major drug manufacturers to over promote drugs to increase sales even it kills or injures members of the public. Drug companies have apparently decided that it is more profitable to develop new promotions to sell more drugs they already make rather than to develop new drugs that could really help people. This profit scheme involves promoting drugs based upon their ability to sell them rather than whether the drugs actually provide a benefit to the patients.

The medical device industry appears to be following the same dangerous marketing practices as the pharmaceutical companies. The recent medical disaster involving the promotion of metal on metal hip implants that are failing should prompt a similiar federal investigation. The DePuy ASR metal on metal hip implants and the Zimmer Durom Cup hip implants are no longer on the market as a result of high failure rates. Our firm is also seeing increasing failures of the Biomet and Smith & Nephew metal on metal hip implants as a result of metallosis.

It will be interested to see if the U.S. government investigates the marketing of these metal on metal hip failures. This epidemic of hip implant failures is costing the taxpayer millions of dollars in medicare expense in addition to the pain and suffering of the hip implant patients. The FDA is currently conducting a long term study to develop better data on these metal on metal hip implant failures. I hope that this data will supply the foundation for an investigation of the marketing practices in the medical device industry for the all out promotion of metal on metal hip implants.

It has been widely reported that metal on metal hip implants such as the DePuy ASR are failing at an alarmingly high rate. An article in today's New York Times newspaper provides a scientific explaination for how the metal debris from these hips interacts with the body to cause these failures.

The process of injury to the tissue of the hip compartment starts when metal debris from the friction of the metal ball on the femur moves on the metal liner in the acetabular cup in the hip. These metal fragments are released into the body and then scavenger cells arrive to attack these foreign substances. The scavenger cells ingest and partially digest the metal fragments. During this process the metal fragments are broken down into ions which are positively electrically charged. These charged ions then react with human tissue. Positively charged ions are known to cause chemical changes in human tissue which can damage the tissue and cause necrosis of death of the human cells. It can also trigger an immune response called metallosis which can cause a loosening of the acetabular cup.

Positively charged ions are known to be travel to different locations in the body through a process caledl electrolysis or electro-osmosis. In short, if there are parts of the body where the ph levels have a gradient change in electrical charge this can cause the charged ions to travel. This scientific theory has not been the subject of any studies that I have seen involving hips and was not discussed in the New York Times article but it could provide an explaination for some of the extensive damage that continues to be found in metal on metal hip implant patients.

It has been known for over a decade that metal on metal hip implants can release metallic ions into the hip compartment but it appears that the hip implant manufacturers ignored this risk in a rush to compete with each other to gain market share and increase profits.

Our law firm is seeing cases involving all of the manufacturers including DePuy, Biomet, Wright, and Smith and Nephew. The DePuy ASR litigation is the most advanced with the DePuy Pinnacle litigation following close behind. Few Bioment cases have been filed but we expect those to increase and we are seeing significant numbers of Biomet hip failures. Smith and Nephew makes the Birmingham Hip Replacement known as the BHR. These have the best success rate so far but there are still failures of the BHR that are clearly caused by the metal ion debris exposure.

The U.S. Food and Drug Administration (FDA) is conducting a study across all manufacturers whoich should shed more light on the differences among manufacturers but it appears that they all suffer from this unacceptable risk of failure posed by the metal on metal articulation. Many surgeons that I have spoken with will not use and metal on metal hip implant because they believe the risk of failure from the metallosis does not justify the purported benefit of longer implant life.