Nevada

Meningitus Outbreak Due To Steroid Medication, Meningitus Lawyers Ready as 26 States Effected

A menigitus outbreak is now expanding to 26 states. The outbreak is linked to a contaminated shipment of steroid medication from a Massachusetts compounding pharmacy. Product liability lawyers are looking at injuries and potential deaths increasing. According to the product liabilities lawyers of Free Legal Shield there may be a huge number of pharmaceutical liability lawsuits filed against the manufacturer of thi s product. A manufacturer can be held liable for injury and death due to contamination of it's products. The hardest hit has been a clinic in Nashville Tennessee.


By

Michelle Castillo /
CBS News/ October 4, 2012, 3:22 PM
Meningitis outbreak may affect more than 23 states

The Centers for Disease and Control and Prevention (CDC) and Food and Drug Administration (FDA) announced today they are advising medical professionals not to use any products manufactured by the New England Compounding Center in Framingham, Mass., due to an outbreak of fungal meningitis tied to some medications made by the company.

Three lots of the company's preservative-free methylprednisolone acetate that go back to July 2012 have been recalled and are believed to be the cause of the recent outbreak. Thirty-five cases of fungal meningtitis in six states have been identified, with five deaths. The majority of the cases, 25 in total, have been discovered in Tennessee.

"Given the severity of illness, we believe these precautionary measures are warranted to protect public health," Ilisa Bernstein, director of the FDA office of compliance, said to reporters during a conference call today.

    Meningitis outbreak sickens 35 in 6 states, kills 5
    Tenn. meningitis outbreak tied to steroid shots

Dr. Benjamin Park, medical epidemiologist with the Centers for Disease Control and Prevention, told reporters that 23 states may have received shipments of the tainted product. These states include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia. A total of 75 facilities may have received product from one of these three recalled lots.


Deadly meningitis outbreak in U.S.

However, because the New England Compounding Center is licensed in all 50 states, there is a possibility contaminated products may be in other areas, Bernstein said.

"We don't know the scope of this," she admitted.

The initial three-lot recall by the New England Compounding Center involved 17,676 vials, the CBS News Investigative Team reported. There were two complaints filed against the company — one in 2002, one in 2003 — that were investigated and as a result the company entered into an agreement in 2006 with the Massachusetts Department of Health to correct any deficiencies. That same year, the FDA warned the company against compounding topical anesthetic creams for general distribution.

In March 2012, a complaint unrelated to the meningitis case was filed against the company regarding the potency of its eye medication. That complaint is still open and pending, according to the investigative team.

Play Video
Meningitis outbreak linked to Mass. pharmacy

Fungal meningitis is a non-contagious form of the disease. It is often caused by fungus normally found in leaf mold. Authorities said some people were experiencing mild stroke-like symptoms, including slurred speech, and difficulty walking and urinating. Other fungal meningitis symptoms include worsening and severe headache, nausea, dizziness and fever.

It can be treated with high-dose antifungal medications, usually given intravenously in a hospital. The earlier the disease is diagnosed and treated, the better the chances of survival are.

"We think that early antifungal treatment can improve the outcome of these patients," Park said.

Park said that the CDC was notified of a patient with an onset of meningitis 19 days after receiving an epidural steroid injection on Sept. 21 in Tennessee. Although all initial cultures were negative, fungus was isolated from the patient's cerebral spinal fluid. On Sep. 28, the CDC was notified of cases outside of Tennessee.

In total, one case in North Carolina, two cases in Florida, four cases in Virginia, two cases in Maryland and one case in Indiana have been discovered in addition to the 25 cases in Tennessee. Three people have died in Tennessee, as well as one person from Virginia and one person from Maryland.

The victims tend to be elderly because of the nature of patients who receive spinal epidural injections because of lower back pain. Overall, many of the patients were somewhat healthy until infection.

Play Video
Woman may have been exposed to meningitis

On Oct. 1, the New England Compounding Center voluntarily shut down their manufacturing center. During a FDA investigation of the plant, the investigators discovered contaminants in an unopened vial.

"Materials from an unopened vials was looked at under the microscope at an FDA lab and what was looked at under the microscope looked like a fungal matter," an FDA spokesperson confirmed.

The FDA added that they are working with the firm to get more information about their products. The

GranuFlo Lawyers, NaturaLyte Lawsuits

 

Fresenius Medical is the manufacturer of  GranuFlo and NaturaLyte acid concentrate. These are drugs used in  dialysis treatment. There has been a recall of these dialysis drugs and  lawsuits are being filed.

Injury and death has resulted from these drugs:

  •  GranuFlo cardiovascular death,
  •  GranuFlo sudden cardiac death,
  •  GranuFlo cardiopulmonary arrest,
  •  GranuFlo heart attack,
  •  GranuFlo catastrophic cardiovascular injuries

 

Fresenius manufactures GranuFlo and NaturaLyte used in dialysis. These drugs cause alkalosis, a condition associated with an increase in cardiovascular fatalities.

 

The FDA received complaints describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

 

This can contribute to metabolic alkalosis, which is a significant risk factor associated with :

 

Low blood pressure

Cardiopulmonary arrest

Cardiac arrhythmia

Sudden heart attack

Stroke

Hemodialysis cardiopulmonary arrest

 

A study which was conducted between January and December of 2010 found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were 4.7 times more likely to suffer a cardiac arrest. The study also discovered that patients with pre-dialysis potassium lower than 4 mEq/L had a 6.3 times higher risk of cardiac arrest.

 

In May 2012 the FDA notified health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription.

There is a GranuFlo and NaturaLyte Class 1 Recall

 

Serial numbers for recalled Naturalyte Liquid Acid Concentrate range from:

 

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-

 

Serial numbers for recalled Naturalyte GranuFlo (powder) Acid Concentrate range from:

 

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

GranuFlo & NaturaLyte is one of the most widely prescribed dry acid products used for dialysis  at Fresenius'  clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius.  It is estimated that 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Dilaysis Patient Alert

If you, a loved one or someone you care for has been injured by these products contact us for a GranuFlo and NaturaLyte lawsuit.

Bladder Sling Lawyers, Vaginal Mesh Lawsuits

The bladder mesh is a vaginal mesh product primarily used for urinary incontinence. This mesh sling has caused severe complications and bladder mesh lawyers are filing lawsuits. Many women with a bladder mesh do not realize they are eligible to file a vaginal mesh lawsuit.

What is a Bladder Sling?

Urethral sling or bladder sling  is used  to treat urinary incontinence by placing a sling around the urethra to lift it back into a normal position and to exert pressure on the urethra to aid urine retention. The sling is attached to the abdominal wall. A bladder sling is a mesh device and is part of the vaginal mesh litigation. The complications of a failed bladder sling is increased incontinence or trouble voiding. Many women have needed to self catherize.

 Bladder Sling Complications?

According to the July 2011 FDA news release, the most common complications associated with surgical mesh bladder slings is erosion thru the vaginal wall or into the bladder, pain during sexual intercourse, bleeding, infection, perforation of various pelvic organs (bladder, colon, vaginal walls), and urinary incontinence or problems voiding as well as; neuromuscular problems, emotional problems, mesh contraction/shrinkage, and even a reoccurrence of POP and/or SUI.

Bladder sling lawsuits are being filed on a contingency fee basis against the mnaufacturers of the bladder sling:

        Bard Avaulta Support System
        AMS Elevate Prolapse Repair System
        AMS Apogee Vault Suspension System
        AMS Perigee System
        AMS Monarc Sling System
        AMS Sparc Sling System
        Ethicon Gynecare Gynemesh
        Ethicon Gynecare Prolene Soft Mesh
        Ethicon Gynecare Prolift Pelvic Floor Repair System
        Ethicon Gynecare TVT Transvaginal Sling
        Boston Scientific Pinnacle Pelvic Floor Repair Kit
        Boston Scientific Uphold Vaginal Support System
        UGYTEX Dual Knit Mesh
        Coviden IVS Tunneler Sling

Contact us today.

Stryker Hip Replacement Lawyers, Stryker Hip Replacement Helpline

Adding to the Zimmer and DePuy metal on metal hip replacement Stryker has recalled it's latest metal component hip replacement implant.  Stryker has voluntarily recalled the  Rejuvenate metal component hip replacement implant and ABG II modular- neck stems
Stryker has voluntarily  stopped  market distribution of these hip replacements due to  increased risk of injury. The hip replacement implants have been shown to fret or corrode, harming body tissue and causing pain and  swelling. Other injuries include:

  •     Severe inflammatory reactions
  •     Pain in the groin
  •     metal toxicity ort poisoning
  •     high metal levels in the blood
  •     need for additional surgery
  •     Breakdown of muscles, tendons and other soft tissues in and around the hip joint
  •     Loss of surrounding bone
  •     Loss of mobility

While other types of hip implants such as those made by Johnson & Johnson and DePuy Orthopaedics Inc. involve a metal ball rubbing against a metal socket, the Stryker Rejuvenate products involve a metal neck inside a metal stem. The Stryker Hip replacement Helpline and  hip replacement lawyers are reaching out to all victims of the failed device for a potential multi district litigation.

The products have metal components and although they are not metal on metal run the same risks of chromium and cobalt toxicity poisoning. If you have been injured you are advised to contact your doctor immediately and contact the Stryker Hip Replacement Helpline for a Stryker lawyer

NuvaRing Potential for Blood Clots and Pulmonary Embolism

NuvaRing lawyers are Reviewing cases for Blood Clots From the NuvaRing Birth Control Device.

Yaz and Yasmin have similiar lawsuits pending.

The NuvaRing birth control device was first approved by the FDA in 2001. In October 2011, the FDA released a drug safety study report indicating the NuvaRing was associated with a significantly higher risk of developing deep vein thrombosis and pulmonary embolisms than standard low-dose estrogen birth control pills. Now, according to new results published this month in the British Medical Journal, women using the vaginal ring are at a significantly higher risk for venous thrombosis  compared to those taking earlier generation oral contraceptive birth control.

All hormonal contraceptions come with some risk of blood clots, which can lead to other complications like deep vein thrombosis and even life-threatening pulmonary embolism and stroke. Danish researchers, however, studied pregnant women ages 15-49 who were free of any prior thrombotic disease, between 2001 and 2010, and discovered that women who use vaginal rings like the NuvaRing for contraception have a 6.5 times increased risk of confirmed venous thrombosis compared with non-users of hormonal contraception.

The researchers further noted that “the vaginal ring conferred a 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation progestogens”—such as Yaz and Yasmin. The researchers concluded that, "women are generally advised to use combined oral contraceptives with levonorgestrel or norgestimate, rather than to use transdermal patches or vaginal rings."

NuvaRing Lawyers blodd clot lawsuits  for NuvaRing.

NuvaRing lawsuits were consolidated  on August 22, 2008 in  the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri under  Judge Rodney Sippel, and in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti. The first NuvaRing MDL trial  is expected to take place in January 2014.

If you or a loved one has had a blood clot related medical condition from Nuvaring contact us immediately to discuss the Nuvaring consolidated lawsuits.

Attention DePuy Hip Replacement Lawsuit Filing Ending August 2012

Breaking news; If you were injured by the DePuy hip Recall You must file your lawsuit now. Filing deadline August 2012

Most DePuy ASR Lawsuits Must Be Filed Before August 2012

Posted May 18, 2012 4:57 PM

 
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.

Pradaxa Breaking News, Pradaxa lawyers, Pradaxa Lawsuits, Pradaxa Bleeding

Pradaxa has warnings for excessive bleeding. Pradaxa Helpline is concerned about Pradaxa and the elderly

The Pradaxa Helpline Has Pradaxa Lawyers to Help You

   LONDON | Fri May 25, 2012 6:07am EDT

(Reuters) – Doctors and patients should be given clearer guidance on how to avoid bleeding risks when using Boehringer Ingelheim's new stroke prevention pill Pradaxa, European regulators said on Friday.

The European Medicines Agency said data continued to confirm the positive benefit-risk balance of the anticoagulant medicine, despite cases of fatal bleeding, but advice on the risks should be strengthened.

Pradaxa is the first in a new class of medicines aimed at replacing the old and problematic drug warfarin. It is designed for use after hip and knee surgery and to prevent strokes in patients with atrial fibrillation, a form of irregular heartbeat common among the elderly.

Rival drugs include Xarelto, from Bayer and Johnson & Johnson, and Eliquis, from Bristol-Myers Squibb and Pfizer.

       Pradaxa is an anticoagulant. Anticoagulants effect the clotting time of the blood. Pradaxa is described as  a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. Pradaxa lowers the chance of blood clots forming in your body. There is a chnce of excessive bleeding on Pradaxa that can be fatal.

We can locate a Pradaxa lawyer to help you:

Silicone Breast Implant Claims Lawyers, Silicone Breast Implant Class Action

Breast implant Class Action lawyers Helping women with Dow Corning, Mentor and other Silicone breast implant claims.

Silicone breast implants caused silicone toxicity and Immune deficiency diseases with symptoms of:

  • Muscle Pain -Upper arms, neck, chest, upper back, thighs, buttocks
  • Joint Pain -hands, feet, toes, elbows
  • Pressure headaches
  • Ringing in ears
  • Sun sensitivity & rash; face, neck & upper chest
  • Hives
  • Intermittent tingling in legs, feet, arms, fingers, right upper back, neck and face
  • Many urinary tract and yeast infections
  • Burning lips, mouth, tongue
  • Dry eyes, nose, mouth, and vagina
  • Nausea, heartburn, constipation, diarrhea
  • Insomnia
  • Anxiety

And:

  •     Breast Pain
  •     Upper and Lower Back Pain
  •     dry eyes
  •     joint pain and swelling
  •     myalgias
  •     chronic fatigue
  •     Lupus
  •     numbness and tingling in extremities
  •     photosensitivity
  •     Chemical Sensitivities
  •     Muscle Pain, Stiffness, Unusual Fatigue
  •     Excessive Hair Loss
  •     Achy or Swollen Joints
  •     Extreme fatigue
  •     Skin Rashes
  •     Rheumatoid Arthritis
  •     Polymyositis-Dermatomyositis
  •     Mixed Connective Tissue Disease
  •     Scleroderma
  •     Sjogren's syndrome
  •     Anemia
  •     Sensitivity to Sunlight
  •     Kidney Problems
  •     Fever
  •     Difficulty Swallowing or Breathing

Women are still suffering today and settlements are still pending for the Silicone Breast Implant Clas Action. If you currently are registered fo r one of the breast implant settlement manufacturers and need help with your claim call 1 877 522-2123

 

Women Filing nationwide Vaginal mesh lawsuits, vaginal Mesh lawyers

The vaginal mesh has been wrecking havoc on womens lives and the numbers are just starting to reveal themselves. Wome have stories about their vaginal mesh and are ready to file vaginal mesh lawsuits. one of the women below:

Texarkana woman files personal injury lawsuit over vaginal mesh implant
5/21/2012 10:22 PM By Michelle Keahey, East Texas Bureau
 

TEXARKANA – After suffering several complications allegedly stemming from transvaginal mesh implantation, a Texarkana woman has filed a personal injury lawsuit against the medical device manufacturer.

Peggy Green filed suit against Boston Scientific Corp., doing business as Mansfield Scientific Inc. & Microvasive Inc. on May 14 in the Eastern District of Texas, Texarkana Division.

Due to stress urinary incontinence, Green was surgically implanted with the Uphold Vaginal Support System, manufactured by the defendant, on May 14, 2010.

After her surgery, she began to experience complications such as vaginal pressure and pain, vaginal bleeding and/or dyspareunia. She states that these complications are the result of the implanted medical device.

The defendant is accused of breach of warranty, negligence, and failure to warn.

The plaintiff is seeking an award of compensatory damages, punitive damages, exemplary damages, incidental damages, consequential damages, attorney's fees, and court costs.

Green is represented by Erin K. Copeland of Fibich, Hampton, Leebron, Briggs & Josephson in Houston. A jury trial is requested.

U.S. District Judge Michael H. Schneider is assigned to the case.

This is just one of many vaginal mesh lawsuits. If you have been injured and your life destroyed by a defective vaginal mesh do not delay. There are statue of limitation issues. contact our vaginal mesh free legal department today.

History of Breast Implants, Breast Implant Lawyers, Dow Corning breast Implant Claims

Breast Implant lawyers are still to this date helpling women resolve their Dow Corning Breast Implant Claims of the Breast Implant Class action of years ago. In light of this it is interesting to look at the history of Breast Implants, FDA has approved a New silicone breast Implant and despite the horrors women are still going for that well endowed look.

 

1940s
Japanese prostitutes have their breasts injected with substances such as paraffin, sponges and non-medical grade silicone to enlarge their breasts, believing that American servicemen favor women with large breasts.

1960s
The first silicone breast implants are developed by two plastic surgeons from Texas: Frank Gerow and Thomas Cronin.

1962
Timmie Jean Lindsey becomes the first woman to receive silicone breast implants.

1976
The Food and Drug Administration enacts the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. FDA now has the authority to review and approve the safety and effectiveness data of new medical devices. But since silicone breast implants have been on the market for almost 15 years, they are "grandfathered." Manufacturers of the implants, when called to do so by the FDA, will be required to provide safety and effectiveness data.

1977
Richard Mithoff, a Houston attorney, wins the first lawsuit for a Cleveland woman who claims that her ruptured implants and subsequent operations had caused pain and suffering. She receives a $170,000 settlement from Dow Corning. Case receives little publicity.

1980s
Ralph Nader's Public Citizen Health Research Group, Washington, D.C. sends out warning signals that silicone breast implants cause cancer.

January 1982
FDA proposes to classify silicone breast implants into a Class III category which would require manufacturers to prove their safety in order to keep them on the market.

1984
Stern vs Dow Corning, San Francisco. Case wins on many internal Dow Corning documents that had been discovered in a Dow storage area by attorney Dan Bolton . Maria Stern's systemic autoimmune disease is found by a jury to be caused by her silicone breast implants. Bolton introduces the silicone-induced problems for the first time in court, with "experts" that theorize the silicone-immune system connection. After a monthlong trial, the jury awards Maria Stern $211,000 in compensatory damages and $1.5 million in punitive damages. The evidence is sealed by a court order.

June 1988
Six years after the 1982 proposal, FDA classifies the implants into Class III. Premarket Approval Applications from silicone breast implant manufacturers are due by July 1991. The PMA's must prove affirmatively, with valid scientific data evaluated by the FDA, that their devices are safe and effective. After the PMA's are submitted by the manufacturers, the FDA has 180 days to evaluate the safety data.

December 1990
Program on the dangers of silicone breast implants airs on "Face to Face with Connie Chung."

December 1990
Congressional hearing headed by Representative Ted Weiss deals with the safety of silicone breast implants. This hearing also discusses the fact that not all the information that the manufacturers have are available for public scrutiny due to a court order from the Stern verdict.

July 1991
Dow Corning releases 329 studies to FDA.

July 1991
Toole vs Baxter, Alabama. Jury decides against Baxter/Heyer-Shulte and awards the largest settlement so far, $5.4 million, to Brenda Toole. Toole, who shows only preliminary symptoms of systemic autoimmune problems, nevertheless had silicone in her lymphatic system according to plaintiffs' witnesses and thus an increased risk of developing an autoimmune disease.

September 1991
FDA concludes that the silicone breast implant manufacturers' safety data does not prove the devices are safe–or harmful. Manufacturers are told to submit further data.

November 1991
The FDA brings together its General and Plastic Surgery Devices Panel to review all of the safety data from the manufacturers' PMA's. The purpose of the panel is to advise FDA as to what they could tell the public about the safety and effectiveness of the silicone breast implants based on the PMA's. The panel is composed of a broad range of experts, including representatives from the fields of plastic surgery, oncology, epidemiology, internal medicine, immunology, radiology, pathology, gynecology, toxicology, sociology, biomaterials and psychology, as well as industry and consumer groups. The panel hearing rejects the data from Dow Corning, Mentor, McGhan, and Bioplasty, concluding there is not sufficient data about the risks and benefits of the devices. The panel recommends the devices stay on the market temporarily and with limited access. The need for more safety data is stressed.

December 1991
Hopkins vs Dow Corning, San Francisco. The largest award yet, $7.3 million, is given to Mariann Hopkins whose mixed connective- tissue disease is linked to her ruptured silicone breast implants. The lawyer for the case, Dan Bolton, wins the suit with the help of internal memos and studies from the Stern lawsuit,     in addition to new studies he recently obtained from Dow. Mr. Bolton gives several of the internal documents to the FDA which has never seen the documents before.

December 1991
To date, 137 individual lawsuits have been filed against Dow Corning.

January 1992
FDA Commissioner, David Kessler, calls for a voluntary moratorium on the distribution or implantation of silicone breast implants until the FDA and the advisory panel have an opportunity to consider newly available information. The manufacturers agree.

February 1992
The class action lawsuit is filed in Cincinnati by Stan Chesley. The hope is to compensate women at a faster rate than filing individual lawsuits.

February 1992
Dow Corning CEO, Lawrence Reed, is replaced by Keith McKennon.

February 1992
The General and Plastic Surgery Devices Panel reconvenes to review the new information regarding the safety of silicone breast implants. The panel recommends that the further use of implants be limited for reconstruction only and that women receiving the implants participate in scientific protocols and that epidemiologic studies be conducted to assess the risk of autoimmune disease. The panel concludes that no causal link has been established between autoimmune disease and silicone breast implants.

February 1992
Many of the Dow Corning internal memos are released to the public.

March 1992
Dow Corning leaves the silicone breast implant business as do Bristol-Myers Squibb and Bioplasty. McGhan and Mentor will still manufacture breast implants. Dow sets up a fund for further research into the safety of breast implants.

April 1992
Dr. Kessler lifts the moratorium on silicone breast implants. The only women allowed to receive implant surgery are those undergoing breast reconstruction. All of the implant recipients must become part of a scientific protocol.

May 1992
First woman gets implants under new rules.

December 1992    
Johnson vs Bristol-Myers Squibb, Houston. Pamela Jean Johnson wins $25 million, $5 million actual damages and $20 million punitive damages in a case argued by Texas attorney John O'Quinn. A jury finds Ms. Johnson's ruptured silicone implants were linked to her mixed connective tissue disease, auto-immune responses, chronic fatigue, muscle pain, joint pain, headaches, and dizziness. Expert witnesses and lawyers admit her symptoms amount to "a bad flu."

December 1992
To date 3,558 individual lawsuits have been filed against Dow Corning.

June 1993    
Dick Hazleton becomes CEO of Dow Corning.

December 1993
By year's end 12,359 individual lawsuits have been filed against Dow Corning.

March 1994
A Houston jury awards three women a total of $27.9 million against 3M, $15 million in punitive, $12 million in compensatory damages for illness. The lawyer arguing the case against 3M is John O'Quinn. The three women suffered from either atypical lupus, neurological impairment, and a "silicone induced" autoimmune problem.

March 1994
The class action suit is finalized by manufacturers with Dow Corning being the largest contributor. The other contributors include Baxter, Bristol-Myers Squibb/MEC, 3M. It is the largest class action settlement in history. Manufacturers claim there is no scientific evidence linking silicone breast implants with autoimmune diseases. There are set monetary amounts that will be awarded to women with specific medical conditions. No requirements are needed to prove implants are the cause of their ailments. Women will be allowed to drop out of the settlement. Companies can also opt out if too few women register claims.

April 1994
Preliminary approval to class action by Judge Pointer. Clears the way for women to start applying for claims in the settlement.

June 1994
The Mayo Clinic epidemiologic study is published in the New England Journal of Medicine, which finds no increased risk of connective-tissue disease and other disorders that were studied in women with silicone implants.

September 1994
Final approval of class action/global settlement from Judge Pointer.

December 1994
By this date 19,092 individual lawsuits have been filed against Dow Corning.

1995
The American College of Rheumatology issues a statement saying the evidence is "compelling" that implants did not cause systemic disease.

February 1995
Gladys Laas vs Dow Corning.

May 1995
Dow Corning files for Chapter 11 bankruptcy. Dow is facing 20,000 lawsuits, some with multiple plaintiffs and about 410,000 potential claims that have been filed in the global settlement. The bankruptcy essentially halts all litigation.

June 1995
About 440,000 women have registered in the global settlement. About 70,000 can be immediately compensated.

June 1995
The Harvard Nurses Epidemiologic Study is published in the New England Journal of Medicine. This finds no increased risk of connective-tissue disease or certain signs and symptoms     of connective-tissue disease in women with silicone implants.

October 1995
Mahlum vs Dow Chemical, Reno. This is the first case where Dow Chemical, the parent company of Dow Corning, is the sole defendant. Charlotte Mahlum is awarded $3.9 million in compensatory damages and $10 million in punitive damages. About 13,000 breast implant lawsuits are pending against Dow Chemical.

November 1995
New global settlement is devised minus Dow Corning. Bristol-Myers Squibb, Baxter and 3M are the participants. The monetary awards are less than the previous settlement.

December 1995
By now 15 individual lawsuits against Dow Corning have gone to trial involving some 19 plaintiffs. Of these, Dow Corning have had 8 trial "wins" and 6 trial "losses," with one split decision.

December 1995    
By now more than 20 (non-case report) studies and abstracts have come out in the U.S. and internationally, all failing to support a causal relationship between silicone implants and a variety of auto-immune related illnesses.

April 1996
Two Federal judges in New York appoint an impartial, expert panel to review the scientific issues involved in breast implant lawsuits. This rare move will influence judges throughout the country.

September 1996
The California Court of Appeal upholds a decision dismissing Dow Chemical and Dow Corning from 1,800 breast-implant lawsuits.

December 1996
Oregon Federal Judge Robert E. Jones, after input from a panel of impartial scientists, rules that plaintiffs' lawyers cannot present evidence that silicone implants caused disease because it is scientifically invalid. He dismisses 70 claims, shocking the litigation community.
Sam C. Pointer, the Alabama judge overseeing all federal implant cases, appoints his own panel of scientific experts who are not connected to implant litigation.

January 1997
The American Academy of Neurology reviews existing silicone implant studies and reports that "existing research shows no link between silicone breast implants and neurological disorders."

March 1997
A judge in Michigan rules that the Dow Chemical Company is not liable for the medical problems of hundreds of women in the state. Thus far, some state appellate courts have upheld Dow Chemical's liability and others have not.

August 1997
The New York Times reports that implant manufacturers have been winning 80% of cases against them. Nevertheless, a state jury in the first class-action suit finds that Dow Chemical (which owns half of Dow Corning) knowingly deceived women by hiding safety information about the silicone in their implants.

September 1997
The Journal of the National Cancer Institute publishes a review of scores of medical studies that concludes breast implants do not cause breast cancer. The researchers described the evidence for linking implants to any other disease as "borderline."

December 1997
The first class-action lawsuit in an implant case is reduced to its original eight claimants when a Louisiana judge decides the 1,800 women have cases too dissimilar to group into one lawsuit.

April 1998
Two large Scandinavian studies fail to show that silicone implants are linked to neurological disease.

July 1998
Plaintiffs agree to Dow Corning's offer of $3.2 billion to settle tens of thousands of claims of injury from silicone breast implants. The agreement will let the plaintiffs receive money within a year and also enable Dow Corning to emerge from bankruptcy proceedings.
After being asked by the British minister of health to review the safety of silicone implants, a seven-member panel of scientists report no convincing evidence that they cause disease. (The U.K. has never removed silicone implants from the market.)

November 1998
Dow Corning files for bankruptcy reorganization, which includes the $3.2 billion previously agreed-to settlement and offers claimants several payout options. Those who want to cash-out immediately and not file a disease claim will be paid $2,000. This figure can also be combined with $5,000 for implant removal surgery and $20,000 for a ruptured implant. Those who have already filed a disease claim will receive between $10,000 and $250,000 plus any compensation claimed for removal or ruptures.

December 1998
After two years and $800,000, a panel of four independent experts appointed by Judge Sam C. Pointer, overseer of implant lawsuits in the Federal courts, concludes that scientific evidence so far has failed to show that silicone breast implants cause disease.
Nevada Supreme Court upholds a compensatory damage award of $41 million against Dow Chemical to Charlotte Mahlum for her multiple-sclerosis-like symptoms. Dow Chemical was earlier found liable for helping Dow Corning conceal evidence about the harmful effects of silicone. The court, however, overturns a $10 million punitive award.

 Breast Implant Class action, Breast Implant lawyers January 1999
A jury in a Washington Federal court awards $10 million in compensatory damages against Bristol-Myers Squibb Co. to an attorney who claimed her implants caused scleroderma.

Spring 1999 Silicone-gel-filled Breast implants
Silicone-gel-filled implants remain off the market in the U.S. pending manufacturer safety studies. They are available only to women who have had or will have breast surgery for a medical condition or have other complications from existing implants, and only if they agree to be part of a scientific protocol, or study. The latest status of silicone breast implants can be found at the FDA website.

June 1999
The Institute of Medicine releases a 400-page report prepared by an independent committee of 13 scientists. They conclude that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as lupus or rheumatoid arthritis. The Institute of Medicine is part of the National Academy of Sciences, the nation's most prestigious scientific organization. Congress had asked the Institute to set up the committee. The committee did not conduct any original research; they examined past research and other materials, and conducted public hearings to hear all sides of the issue.