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  • Dow Corning Breast Implant Litigation Lawyers: Breast Implant Lawyers Accepting Dow Corning Breast Implant ClaimsOur Breat Implant lawyers are reviewing Dow Corning Breast Implant Claims for women implanted with Dow Corning implants prior to June ...

Stories and Sharing

  • Dow Corning Breast Implant Litigation Resources: The Claimants’ Advisory Committee (CAC) is the official committee appointed by the U.S. District Court in the Eastern District of Michigian to represent the interests of women in the Dow Corning Bankr...

Breast Implant News

  • Dow Corning Breast Implant Litigation Resources: The Claimants’ Advisory Committee (CAC) is the official committee appointed by the U.S. District Court in the Eastern District of Michigian to represent the interests of women in the Dow Corning Bankr...

Dow Corning Breast Implant Litigation Lawyers

Written by lisaspitzer on . Posted in Breast Implant Blog, Breast Implant News, Dow Corning Breast Implant Stories and Sharing, Silicone Poisoning and Silicone Breast Implants

Breast Implant Lawyers Accepting Dow Corning Breast Implant ClaimsOur Breat Implant lawyers are reviewing Dow Corning Breast Implant Claims for women implanted with Dow Corning implants prior to June 1, 1993 and who are registered with the SF-DCT.

We are here to help with your Dow Corning silicone breast implant claims and will connect you with  a female silicone breast Implant lawyer who has been  helping women for 2 decades.  Our lawyers have  helped women obtain settlements for breast implant diseases such as Lupus, Scleroderma and General Connective Tissue Diseases.

DECEMBER 3, 2015

The District Court issued an Order approving the Consent Order To Establish Guidelines for Distributions From The Class 7 Silicone Material Claimants’ Fund. This means that the Court has authorized approved disease claims in Class 7 to be paid and has approved the parties’ agreed interpretation of “marshaling.” The order will become final once the 30-day time period for appeals has expired and no appeals have been filed. Payments can begin once the Order is final. This means that payments will not begin until sometime in January 2016 or thereafter.

 

DECEMBER 1, 2015

Copy of the SFDCT letter sent to claimaints with an approved Disease Option 2 claim regarding Increased Severity – Please note the deadline date of June 2, 2019 is incorrect. The correct deadline date is June 3, 2019. To read the response, click here.

SEPTEMBER 15, 2015

Omnibus Response to Objections & Submissions Responding to Consent Order to Establish Guidelines for Distribution From Class 7 Silicone Materials Claimants Fund. To read the response, click here.

JULY 29, 2015

Scheduling Order Regarding Consent Order to Establish Guidelines for Distributions from Class 7 Silicone Material Claimants’ Fund. To read the order, click here.

JULY 17, 2015ATTORNEYS:

Wells Fargo, the paying agent for the SF-DCT, requires law firms to provide an updated w-9 before payment can be issued. You can download a copy of the updated w-9 form here. Please complete and return the w-9 to the SF-DCT.

JUNE 12, 2015

Copy of the Notice to Class 7 Claimants Establishing Guidelines mailed by the SFDCT. To read the notice, click here.

JUNE 2, 2015

Judge Hood as issued an Order Authorizing Distribution of the Notice in reference to the Class 7 Consent Order. To read the order, click here.

MAY 26, 2015

CAC FILES MOTION ASKING FOR APPROVAL TO PAY CLASS 7 CLAIMS AND TO RESOLVE THE DISPUTE CONCERNING PREVIOUSLY DENIED “MARSHALING” CLAIMS

On Friday, May 22, 2015, the CAC filed a proposed Consent Order asking the Court to authorize payment of disease claims for Class 7 claimants. Most claimants in Class 7 have been previously paid a $600 Expedited Release Payment, a Foreign Gel Claimant Payment, or a $3,000 Cash-Out Offer. Claimants that rejected the Cash-Out Offer and elected for a full disease review have been waiting for payment on their approved disease claim. With the filing of the motion, the CAC hopes that these claimants can now be paid once the Consent Order is entered by the Court.

In addition, the CAC has reached an agreement with Dow Corning regarding thousands of Class 7 claims that were previously denied by the SF-DCT on the grounds that the claimant allegedly had not “marshaled” their recoveries from their primary manufacturer (Bristol, Baxter). Under this agreement, claims will be reviewed to determine if the claimant was eligible to apply for disease compensation from the Revised Settlement Program. If so, then that claimant cannot apply for the same disease in Class 7. However, if a claimant was not eligible to receive benefits for a particular disease in the RSP, then that claimant may seek compensation from Class 7.

For example, if a claimant was an Other Registrant in the RSP, the only disease option she was eligible for was Disease Option 2 (called Long Term Benefits). Other Registrants were not eligible for Disease Option 1 (Fixed Benefits) and diseases like ACTD. These claimants may now seek compensation for Disease Option 1 from Class 7.

The SF-DCT will re-review the claims that were previously denied and will send eligible claimants either a $600 Expedited Release Payment or $3,000 Cash-Out Payment. The Cash-Out Payment is available only to those claimants who submitted a disease claim in 2006. Claimants may reject the Cash-Out Payment and instead elect for a full disease review; however, if the claim is not approved, they will not be eligible for the Cash-Out Offer again.

 

MAY 4, 2015

The MDL Common Benefit Trust fund has announced that it will offer women who were not compensated for Explantation in either the MDL or Dow Corning Settlement a chance to apply for $5,000 explant payment. For more information about this program, please click here. Please note that this program is not affiliated with either the RSP or Dow Corning Settlement Plan.

If you are having difficulty getting your medical insurance to cover the cost of the explant surgery, there is a new resource for women. The Insurance Coverage Assistance Program will be available to provide advice and assistance on how to assess this Medicare, Medicaid, and health care coverage for issues related to breast implants. This program is to be operated by the National Center for Health Research, a consumer-oriented non-profit group in Washington, D.C., that has helped women seek insurance coverage for breast implant removal. The National Center currently operates the breastimplantinfo.org website. You may email them at info@breastimplantinfo.org with your name and email address for more information, including their toll-free number. If you do not have access to email, you can call them at 202-223-4000.

FEBRUARY 10, 2015

On January 27, 2015, the Court of Appeals reversed the District Court’s authorization to make 50% partial Premium Payments. Fortunately, the SF-DCT has already made 98% of the partial Premium Payments to eligible, approved claimants. This money does not need to be repaid. Claimants can keep the partial Premium Payment checks that were issued to them. Unfortunately, the remaining 2% of claimants who did not receive their partial Premium Payment check (or returned it for reissuance, or who had lost checks) are on hold pending either a consensual resolution to pay their claims or a court order. A copy of the ruling is under the tab “Court Orders.”

February 10, 2015,

CAC filed a petition for rehearing on this ruling, asking the Court of Appeals to reconsider or rehear the issue based on what the CAC believes are two serious legal errors. A copy of the petition is under the tab “Appeals to the 6th Circuit” and then under the sub-tab “Premium Payments.”

IF YOU NEED HELP WITH YOUR DOW CORNING BREAST IMPLANT CLAIM CONTACT US TODAY

 

Silicone Breast Implants, Leakage and Blood Level Tests

Written by lisaspitzer on . Posted in Breast Implant Blog, Silicone Poisoning and Silicone Breast Implants

If you have a silicone breast implant that has ruptured or is leaking you may have unusual silicone levels in your blood. Leaking or ruptured silicone breast implants and result in very serious diseases due to silicone poisoning.

We suggest you get your blood levels tested if you have any symptoms of silicone toxicity or just to play it safe.

Symptoms

  • Muscle inflammation
  • Chemical sensitivity and sensitivities to perfume, smoke and other inhalants
  • Joint pain
  • Fatigue
  • Weakness
  • Anxiety and depression
  • Hair loss
  • Memory loss
  • Foggy thinking
  • Night sweats
  • Tingling in the hands and feet
  • Heacaches
  • Abdominal pain
  • Chest pain
  • Other autoimmune disorders, including rheumatoid arthritis and Sjogren’s syndrome, scleroderma, fibromayalgia, and multiple sclerosis

Dow Corning Breast Implants Silicone Poisoning Alert

Silicone Poisoning Is Serious

Many Women With Dow Corning Breast Implants Have Developed Auto Immune Disorders

DOW Corning Claimant’s Should Get Silicone Medical Testing

There are two medical tests for silicone in the body.

 

1.) Silicone Antibodies – UNILAB Test #8099 Cpt 86318

 

Regular 4ml Serum at room temperature = Analytic time 7-10 days

 

2.) Silicon Levels – UNILAB Test# 9025 CPT84285

 

Minimum 2ml to 4ml Serum Analytic time 7-10 days

 

These tests are available through your  physician or a laboratory or walk in testing center. You may have to pay cash for these tests. You may have to call your local medical laboratory and ask for the code numbers. The tests  were developed by a rheumatologist at the University of California at Los Angeles.

You can try a local testing laboratory. There are testing labs that will do tests without a prescription. You can get the codes from a UNILAB in your area.

 

 

 

Helping Mothers With Young Boys With Breast Enlargement From Risperdal

Written by lisaspitzer on . Posted in Breast Implant Blog

 Lawyers for Risperdal Breast Growth in Young  Boys

Breast Implant Helpline has expanded their drugs and devices department to reach mothers with young boys that have had unusual breast development from Risperdal.

If your son has developed breasts from Risperdal our attorneys are filing  lawsuits on behalf of boys who developed breasts after Risperdal use, The medical term for this is gynecomastia.

 Johnson and Johnson Fails To Warn And Lawsuits Are Being Filed

We are available to help you if your son  has been  diagnosed with gynecomastia or male breasts after using Risperdal.

Breast Growth
Puffy Nipples or Enlarged Nipples
Painful Breasts or Nipple Discharge
Mastectomy or Gynecomastia Surgery to Remove Male Breasts

Children With These Side Effects Have Severe Emotional Problems

Many are having suicidal ideation due to this deformity

Risperdal (risperidone) is an atypical antipsychotic which is approved by the FDA for treatment of  schizophrenia. Since it was introduced, Risperdal has been widely used by children for bi-polar disorders, autism, irritability, aggression and behavior disorders.

Risperdal Injury Lawyers Are Looking At Serious Side Effects

Male children on Risperdal are being diagnosed with gynecomastia or the abnormal development of large mammary glands. This unusual development  deformity in  boys and adolescents is causing severe physical and emotional issues.

What Is Causing This?

An increase in the amount of the hormone prolactin in the blood caused by the drug. Prolactin is what increases  lactation in women following childbirth, and may cause boys to develop gynecomastia from Risperdal. Imagine how frightening it is for your son to have lactating breasts at an age when they are dealing with adolesence and   peers that  can be very cruel. Very often surgery is necessary to remove the breasts caused by the Risperdal gynecomastia.  The physical pain and suffering and  emotional trauma for boys and young adult males,  who already are emotional fragile, can result in outbursts, depression and potential risk of suicide. Coming off thos medication suddenly can create  a sever imbalance and mood swings as well as psychosis.

Risperdal Settlements Offered

Settlements for Risperdal breast growth have been reached by Johnson & Johnson in  “bellwether” trials.  The terms of these  Risperdal settlements have not been reported.

Medical Psychiatric Social Worker Available To Speak To You

Call our Risperdal Helpline today

Young Men On Risperdal

September of 2012,  Johnson and Johnson settled an individual Risperdal lawsuit filed for  a young man who developed female type breasts after being treated with the Risperdal for a period of five years. This  gynecomastia lawsuit filed on behalf of 21-year-old,  was settled for an undisclosed amount.

How Much Can a Dow Corning Breast Implant Lawyer Charge

Written by lisaspitzer on . Posted in Breast Implant Blog

Breast Implant Helpline is helping women with their SFDCT claims. Do you need a Dow Corning SFDCT lawyer? Call us now.

How much can my attorney charge?

Pursuant to Section 5.10 of the Amended Joint Plan of Reorganization, the fees and expenses of an attorney representing any claimant who receives payment from the Settlement Facility are limited to the following:

The fees shall not exceed the sum of:
    (a) 10% of the first $10,000 paid to the claimant
    (b) 22.5% of the next $40,000 paid to the claimant
    (c) 30% of the amount in excess of $50,000 paid to the claimant

Your attorney is allowed to charge actual expenses incurred in representing you. For more information on allowed attorney fees and expenses, refer to the Amended Joint Plan of Reorganization, The Claimant Information Guide, section 9.01 of Annex A To Settlement Facility and Fund Distribution Agreement and the Agreed Order Adopting Q&As Regarding Article IX of Annex A, The Claims Resolution Procedures.

Breast Implant Stories, Breast Implant Lawyers, Class Action

Written by lisaspitzer on . Posted in Breast Implant Blog

Anatomy of a Crisis: One Perspective on the Silicone Implant Story

Clinics in Plastic Surgery, Volume 26, Number 1, January 1999
Note: Long after Dow Corning went bankrupt, the National Academy of Sciences stated there is no proven link between silicone implants and systemic disease.

Since 1977 our law firm has represented a national plastic surgery organization, the largest state plastic surgery association, and the largest physician-owned medical malpractice company in the country. We believed ourselves fairly well-informed on plastic surgery and its practitioners. By 1991, silicone had been in medical use for many years, and the utilization of silicone breast implants in augmentation and reconstructive surgery was both widespread and unquestioned. Surgeons were regularly assured by the manufacturers that the product was efficacious and safe. Between 1974 and 1989, only 99 breast implant-related cases were filed against Dow Corning, the largest manufacturer of these implants.1

It is estimated that between one million and two million women had silicone breast implants between 1964 and 1992.2 Questions regarding safety, for example, whether implants increased the risk of cancer to recipients, were addressed in reassuring studies, including the Deapen survey in 1986.3 This study found no increase in the risk of cancer among approximately 3,000 Los Angeles women with gel-filled implants. Doctors were advised that continuing manufacturer research had turned up nothing of concern. Patients were satisfied with results. In 1990, the American Society of Plastic and Reconstructive Surgery evaluated 600 detailed questionnaire responses and announced that 92 percent of breast implant recipients were well satisfied with the product and 82 percent would have the procedure performed again.4

A few contradictory signs, however, appeared. In March 1991, a New York jury awarded a plaintiff $4.4 million on her claim that her polyurethane implants caused cancer.5 The verdict was reduced to $1.5 million, but the case caused an awakening in the plaintiffs' bar. (Unlike silicone, polyurethane was regarded with skepticism by the medical community, and the polyurethane-coated implants were later taken off the market.)

Silicone implants had been in use before the Food and Drug Administration (FDA) was given authority to classify medical products; as part of the regulatory catch-up process, the FDA classified breast implants as a Class III device in 1988.6 This classification required pre-market approvals (PMAs) and also entailed safety testing for certain risk factors identified by the FDA. The manufacturers were given 30 months to provide safety data for PMAs, which they submitted in July 1991. This lengthy process was considered routine both in the FDA and in the medical world.

In November 1991, as part of the PMA process, the FDA convened a scientific advisory panel to study the safety and efficacy of silicone breast implants. The panel concluded that more research was needed but noted a lack of evidence of substantial risks. It recommended that implants remain on the market as a public health necessity because of their known benefits.7 The FDA set January 6, 1992, as the date for its decision on the approval and continued marketing of implants. No change was anticipated, and approval was considered routine. There was, however, an abrupt change in the projected scenario. As a result of media uproar, on January 6, 1992, the date on which the FDA was supposed to announce its decision on the approval and continued marketing of implants, Commissioner David Kessler announced a moratorium on the sale and use of silicone implants.8

What had happened? During the period in which the FDA had convened its scientific advisory panel to evaluate implants, noted television personality Connie Chung aired her famous "green gunk" segment with an intentionally ruptured polyurethane-coated implant. Her evaluation, intoned in the style of the witches' warning in MacBeth, over national television on November 8, 1991, predicted disaster for women with implants. No distinction was made between the polyurethane product and the silicone implant.

By itself, the Chung show would probably have been just another of the sensational TV "exposés" regularly presented for our edification. But on December 13, 1991, a San Francisco federal jury awarded Marianne Hopkins $7.5 million in her breast implant lawsuit against Dow Corning. Of this amount, $6.5 million represented punitive damages. The award was based on a jury finding that Dow Corning had "falsely and maliciously" failed to warn of the potential dangers of its silicone breast implants.9 The verdict made the front page of newspapers nationwide. The effect was immediate: Across the country, attorneys started drafting complaints.

On December 30, 1991, Dan Bolton, Ms. Hopkins' attorney, wrote a letter to FDA Commissioner Kessler describing certain documents and information gathered from the Dow Corning files pursuant to discovery orders and revealed during the Hopkins trial, which the FDA believed had been withheld from its November 1991 panel hearing. None of this information contradicted the basic finding of the FDA advisory panel. But it did encourage a number of television talk-show hosts to take up the subject enthusiastically. Almost every such show featured a silicone "victim" or a silicone "expert" who criticized implants. Sidney Wolfe, MD, head of the Public Citizen's Health Research Group, wrote to Kessler advising him to ban the silicone implants immediately rather than leave them on the market while safety studies were completed. Newspapers across the country reported these developments and the concerns about the implants.

On January 24, 1992, the first breast implant class action against both doctors and manufacturers was filed in Ohio.10 In February 1992 the FDA convened a second panel of experts to review new information, particularly the Dow Corning internal memoranda that brought about the Hopkins verdict. The FDA heard from a variety of medical practitioners, manufacturers, a number of plaintiffs and their legal advocates, and assorted "consumer" groups.

On a key point, the panel found that "there was not enough evidence to establish a cause and effect relationship between gel-filled breast implants and immune-related or connective tissue disorders—that is, it is not known whether women with breast implants are more likely to have those conditions than women without implants." The FDA concluded that more research was needed to prove the long-term safety of the product, although it recommended that silicone gel implants used after mastectomy and other limited uses constituted a public health need and that implants should remain on the market for these purposes.11

To help create a groundswell of support for litigation, plaintiffs' attorneys set up educational "seminars" in all kinds of meeting places. Not only could they create a tent meeting-like atmosphere to recruit plaintiffs, they were also able to recruit instant "expert" witnesses in connective tissue disease and a host of vague afflictions. Every such meeting meant a real increase in filed cases.

Just as the fascination of the media with the breast implant crisis fed the litigation mill, the glazed look in corporate eyes revealed manufacturers totally overtaken by events. In March 1992 a widely experienced and respected senior legal advisor to Dow Corning was quoted as stating: "Given the rapidity with which this has come on, I just have not formulated a good plan yet." As it turned out, Dow Corning never did. More significantly as a harbinger of the future, the CEO of that company said that implants accounted for only 1 percent of Dow Corning's $1.7 billion in revenues, but estimates of total liability claims ranged up to $2 billion.12

On the regulatory front, FDA Commissioner Kessler had convened two scientific panels, and on April 16, 1992, the FDA announced that breast implants with silicone gel would be available only through controlled clinical studies.13

Before the Hopkins case and the Chung show, a review of manufacturers' product complaint records submitted to the FDA as part of the PMAs had shown few, if any, complaints of autoimmune or connective tissue disorders from breast implants. Now there was a mushrooming epidemic. In January 1992 there were approximately 15 active silicone breast implant cases in California. By March 1993 approximately 700 implant cases had been filed in California. By October 1993 there were 2,300 cases filed in California.14

In Texas, just before Christmas 1992, Santa Claus appeared. A jury in Harris County, the most rewarding place in the country for plaintiffs' attorneys, awarded Pamela Johnson $23 million in her case against Bristol Meyers—$5 million for actual damages and $20 million for punitive damages. Following this verdict the Harris County clerk's office was swamped with new filings. During the week following the verdict 150 new cases were filed, and by the first week of January 1993 over 1,400 cases had been filed in Harris County.15

Plaintiffs' firms borrowed large amounts of money to increase their litigation attorney roster. Experts in attributing memory loss, aches and pains, and general malaise to connective tissue disease caused by silicone were retained.

Hardly a daily television chat show aired without a segment on this growing crisis. In June 1992 the CBS program "48 Hours" had one entitled "The Fear Within" featuring women with silicone breast implants complaining of their injuries and fears. It reported that one-third of the women who had their implants removed felt better afterwards. In the same month, a woman on "Larry King Live" on CNN told how she had attempted to remove her silicone implants with a razor blade because her insurance would not pay for the procedure. Jenny Jones, on her TV program, announced that she, too, was a silicone breast implant "victim."

Women's support groups, not previously considered sources of scientific information, were now widely quoted on breast implant horror stories and became a news source for interested media. The "Silicone Sisters," the "East Coast Connection of Breast Implant Survivors," and the "Command Trust Network" all distributed information on the dangers of silicone breast implants.

And the court filings mounted, in California and Texas particularly, but generally across the nation. In 1993, the manufacturers announced a $4.7 billion settlement offer, which was later revised. By early 1996, an estimated 450,000 women had received official court notice of the revised breast implant settlement offer. The total from the state court cases cannot be accurately tallied, but every indication is that there were thousands of such cases. By the end of 1994, more than 20,000 individual lawsuits had been filed against Dow Corning alone. In many of these cases the doctor was a codefendant. 16

There is no doubt that silicone triggers a hyperallergenic reaction in some women, and some women become very sick. But a true accounting of how many became sick before they had implants, how many attributed to the implants the pain, memory loss, and the general debilitation that comes with growing older, and how many were seriously affected by their implants, became lost in a sea of litigation. Thousands of cases were filed alleging horrible illnesses. Plaintiffs argued that the medical literature, chiefly Japanese, supported the allegation that silicone gel causes autoimmune disease. Our search of the journals reached a contrary conclusion. But why weren't cases filed earlier? Did everyone suddenly get sick at the same time?

After 44 years in both public law and private practice, I have concluded that frequently the search for truth in the legal process can resemble a bear peeling a grape. It takes a long time and is painful to watch. This proved to be true of the breast implant litigation.

The Doctors Company is the endorsed malpractice insurance carrier of the nation's largest plastic surgery association. While other carriers insure significant numbers of surgeons in various states, The Doctors Company has policies covering approximately 535 plastic surgeons across the country. Of this total, approximately three-quarters are in California and two-thirds of those are in southern California. Nationwide, between one and two million women had received breast implants, and informed estimates indicated 80 to 85 percent of these women had received them for cosmetic purposes.

The first cases indicated that California would be a very active litigation venue. While the early filings gave every indication of plaintiffs seeking damages from the doctor, it was difficult to predict how such issues as informed consent and closed capsulotomies might shift liability even further away from the manufacturers to the surgeon.

Even a conservative prediction of the total cost of the lawsuits, including defense costs, associated defense expert fees, potential indemnity payments, and other related expenses, would amount to a very substantial sum that could severely affect The Doctors Company. Two of the smaller manufacturers, Mentor and McGhan, had assessed their potential costs and decided to fund a settlement pool of millions of dollars to escape the expense of repeated trials. Before the Hopkins case, only a few lawsuits had been filed against Mentor. In the next year and a half, it was served with more than 1,000 cases. No one could predict what the growing number of suits against the doctors would eventually total.

Questions relating to the doctors' relationship with the manufacturers were paramount. Would the manufacturers stand by their product, which they had assured doctors was safe and effective? Would the disclosures in the Hopkins case poison defense efforts? Would there be a strong scientific response from the research community? What would objective scientific studies show? Would there be multiple state court actions against individual doctors, or state class actions, or a federal class action? What would the FDA ultimately do?

As for the largest manufacturers, it quickly became apparent that, unlike the plaintiffs who had formed steering committees to develop a common approach to the litigation, there was no shared strategy among them. Baxter made a decision to defend these actions aggressively and won most of its cases. Bristol Meyers, particularly in southern California, appeared to devote considerable resources to discovery and depositions only to settle on the courthouse steps. Dow Corning had no apparent strategy and was truly unpredictable.

Initially, we had briefly envisioned joining the manufacturers in a spirited defense of the product. That approach was quickly discarded after noting that the manufacturers' various defenses often included pointing the finger at the doctor. After surveying the early cases being tried, we made a decision to vigorously oppose any assessment of blame to the surgeons, who had not known of any doubts the manufacturers might have had regarding silicone implants. Participation in a number of meetings with respected research authorities left us dubious of the validity of the extreme claims made by the plaintiffs regarding the product.

What gradually became clear was that plaintiffs' attorneys in California wanted no part of the developing federal class action suit assigned to the very able and experienced Judge Sam Pointer. They believed that they had a much better opportunity in individual suits. If they sued the doctor together with the manufacturer, that coupling would defeat any manufacturer's efforts to claim diversity of jurisdiction and attempt to move the case to federal court, since the plaintiff and the defendant doctor both resided in California. In addition, state juries are generally more liberal in their awards than federal juries.

A second reason to push for individual suits was found in the most unfortunate June 1993 Supreme Court decision in Daubert v. Merrill DowPharmaceuticals. In that case, the Supreme Court, against the urging of six Nobel Prize winners and the New England Journal of Medicine decided not to limit the admissibility of "junk science" as expert testimony, and refused to adopt a "peer review" test. Previously, the "generally accepted" standard of admissibility articulated in Frye v. U.S. was used by many courts, including California, to determine the admissibility of "junk science." Now, each judge would act as gatekeeper on the admissibility of expert evidence under the much looser Federal Rules of Evidence. By filing individual cases, plaintiffs' attorneys obviously hoped to be able to bring in the travelling "experts" with their novel and often bizarre scientific notions.

A third reason for individual suits was to push the doctor-defendants into quick and lower settlements that could help finance the more serious legal effort against the manufacturers, which to the plaintiffs' attorneys was starting to look like the Aztec riches of Mexico as seen by Hernando Cortez.

What the plaintiffs' attorneys did not understand is that any significant malpractice settlement paid on behalf of a doctor must be reported both to a state medical board and to the National Practitioner Data Bank in Washington, both of which constitute significant blots on a physician's record.

It was clear to us at The Doctors Company that our response had to be fast and effective, and it was. With the invaluable help of The Doctors Company's medical director, Dr. Mark Gorney, a former president of the American Society of Plastic Surgeons (ASPS) who had great knowledge and insight into the issues surrounding the controversy, we were quickly able to persuade the officers and board of The Doctors Company of the need to spend a considerable sum of money on our defense efforts.

My associate, Norman Miley, who worked closely with me on this project, had sixteen years of trial experience. I had coordinated several large cases for the state of California and had once been chairman of a plaintiffs' steering committee in a significant class action. But it was clear to us that we needed someone to devote full time to the job of implementing and coordinating our defense efforts. We chose a very able trial lawyer with whom we had previously crossed legal swords. Despite having no medical malpractice experience, Marshall Cornblum was a brilliant choice. He came with no preset notions and with an analytical mind. He joined us in March 1992. We were in constant communication with him and met on a regular basis.

We decided to bring together our most experienced The Doctors Company defense counsel from the states most impacted by the litigation. These states ranged from Connecticut to Hawaii, but we expected the most activity in California. Later, we shared ideas and strategy with counsel from the other California carriers. The Doctors Company defense group first met in April 1992. A mass of journal articles and scientific studies was evaluated. A database of what was known and when it was known was established at one coordinating law firm office, Larson & Burnham in Oakland, California. A plastic surgeon, Dr. Jack Fisher, of the University of California at San Diego, and an outstanding rheumatologist, Dr. David Kneapler, were retained as consulting experts. We also engaged the services of Katherine Newman, an anthropologist from Columbia University, who is an expert on juries and jury selection. We hired an interviewer to question all the former Hopkins jurors that we could locate. Those interviews established several points. The jury had been puzzled by the voir dire conducted by Dow Corning's counsel, and they were enraged by the documents that clearly showed that Dow Corning's own employees seriously questioned its testing procedures. In addition, the jury ignored testimony from Ms. Hopkins' two treating physicians, presented by the defense, that her adverse disease symptoms were apparent before the implants were inserted.

At the first meeting of The Doctors Company defense counsel in 1992, we outlined Marshall Cornblum's role and that of Larson & Burnham. We reviewed the history of the breast implant "problem," the types of implants and changes in design, the adverse reactions that were claimed or established, capsular contraction, gel leakage, autoimmune disease, the present status of the litigation, pending individual actions, and the class actions. In this dense case review, tactical legal issues relating to filing answers to the complaints, potential cross-complaints, interrogatories, requests for the production of documents to be sent with the answers, subpoenas for hospital records and records of other known medical providers, responses to plaintiffs' discovery requests, document production by our defendant doctors and depositions were all discussed. Trial matters—jury instructions, a trial brief, motions in limine, voir dire issues and jury selection, the development of a trial theme and general litigation approach—and legal research matters—informed consent, product liability theories against physicians, statute of limitations, including the effect of the federal class action on the statute of limitations, and a host of ancillary matters—were set out in a detailed, seven-page agenda. It also provided for the development of a computerized document-management system for medical articles, FDA hearing transcripts, Dow documents, reporting and calendaring of court matters, action matters, and discovery matters.

After our first few meetings, we were quite sure that while the manufacturers might have had doubts about their silicone studies, the doctors never knew of them and, in good faith, relied upon the manufacturers' repeated representations that the silicone implant was not only a good product, it was a safe product.

But we needed to know what an average juror would believe. To that end, we obtained a courtroom in the Los Angeles Superior Courthouse on a quiet Saturday, February 20, 1993. Drawing from a jury list in Orange and Los Angeles counties, we assembled 60 persons in the courtroom and presented a mock trial involving a woman suing her plastic surgeon, alleging various sicknesses from a silicone implant. Our selected trial counsel also attended. We intentionally left out a manufacturer/defendant so that attention could be focused solely on the doctor.

Most of the themes developed during the mock trial followed the concerns voiced during the meetings with defense counsel. Expert witnesses for both sides included a plastic surgeon and a rheumatologist echoing the best plaintiff and defense points.

Afterwards, the 60 jurors broke into five groups of 12, together with a social sciences facilitator, to discuss what they considered important in reaching their decisions. Videos of their deliberations and of the trial itself were made. Katherine Newman oversaw the operation and on April 1, 1993, presented us with a 26-page summary of the mock trial jury findings. While there were quite a few surprises, the findings confirmed our basic defense strategy and gave us clear indications of the kinds of jurors who would listen to us and what arguments would convince them. Armed with this reassuring knowledge, we reaffirmed our commitment to the maxim: "Millions for defense, but not one cent for tribute."17

Gazing across the legal ramparts, we thought we understood what our legal adversaries in the plaintiffs' bar were doing. What we could not understand was what Dow Corning was doing. In early 1993, as the number of breast implant cases in California reached more than 2,300, the manufacturers announced a $4.7 billion global settlement.18 Terms of the settlement offered the more seriously affected plaintiffs more substantial amounts, but, incomprehensibly, there would be some payment for everyone in the action. Suddenly, doctors' secretaries, who had been quite pleased with their implants for 10 or 15 years, informed these surgeons, whom we represented, that they meant no disrespect to them, but they had to get in on a good thing, and so they joined the "lotto for ladies."

Rather than ameliorating the situation, Dow Corning's announcement increased the filings and whetted appetites. In May 1995 Dow Corning threw its hands up and its executives out and filed for bankruptcy.

Against this background, the plaintiffs' attorneys at first did not believe us when we said we would not settle for even a dollar, but gradually they learned of our preparation and our determination. The number of claims asserted against The Doctors Company reached 1,046. It was anticipated that hundreds of additional cases would be filed by lawyers who were awaiting developments and The Doctors Company's reaction to the first cases before filing their actions.

Slowly, the tide receded. The claims that had not been filed were never filed. Cases were dismissed by the score. And, while a few remain in the court docket, chiefly outside California, we do not believe they constitute a real threat. The cost of this preparation was nearly $7 million, chiefly in payments to trial counsel to work up defenses for the accused doctors.

What is important, however, is that no judgment was ever entered against any of our insured doctors. Of more than 1,200 reported incidents, only two plastic surgeons insured by The Doctors Company have gone to trial over the breast implant crisis to date; both cases resulted in verdicts in favor of The Doctors Company insureds. I submit that our strategic response, while expensive, was very effective. The Doctors Company had put up actuarial reserves of $30 million against what was originally thought to be a dire threat to its very existence. That was based on a cold actuarial analysis.

As George Bernard Shaw wrote: it is not the experience that matters, what counts is what you learn from it. What have we learned?

Scientific studies had no impact on legal filings. As the evidence mounted and prestigious institutions, such as Harvard and Johns Hopkins, and others in the United States and Europe, reported widespread evidence that there were no data to support the silicone-sickness frenzy, the media finally stopped its anecdotal reporting of an epidemic. Their reports came too late, however, to affect the filed cases, which continue to have a life of their own. In 1992, our esteemed consultant asked in the New England Journal of Medicine "When will science prevail?"19 In the legal world, the answer would appear to be, not soon.

We know what this cost The Doctors Company. What it cost the manufacturers is undoubtedly much more. There are now very limited options for women who want silicone breast implants. Those who left the field, including the manufacturers of raw materials for jaw implants and other prostheses, are not likely to return.

Any problem in new and promising technology may be seized on as a threat to human survival. Witness the sorry spectacle of what happened with pedicle screws. Watch what is happening to the Norplant birth control device. The future for medical devices that might improve certain human physical conditions does not look bright. The trend towards mass litigation, mass recruiting of "victims," quick consolidation into class actions, and the push towards industry settlements to avoid huge legal defense costs are likely to lead to overseas manufacturing in areas less blessed with our tort system and subsequently with far less development of new products in the United States.

Unless we learn the lesson of what this legal system costs, we are bound by Santayana's dictum, "Those who cannot remember the past are condemned to repeat it."

 

References

    Anonymous (attributed to Public Citizen), 1992 Silicone Implant Clearinghouse, reprinted in Breast Implant Litigation, New York: Law Journal Seminars Press, 1992, pp 115, 159.
    House Committee on Government Operations Staff, The FDA's Regulation of Silicone Breast Implants, 102 Cong., 2nd Sess., Washington, DC: Comm Print, 1993.
    Deapen, D.M., Pike, M.C., Casagrande, J.T., et al: The relationship between breast cancer and augmentation mammoplasty: An epidemiologic study, Plast Reconstr Surg 77:361-7, 1986.See also Berkel, H., Birdsall, D., Jenkins, H., Breast augmentation: A risk factor for breast cancer?, N Engl J Med 326:1649, 1992.
    American Society of Plastic and Reconstructive Surgeons, Inc., Press release, November 19, 1990.
    Livshits v. Natural Y Surgical Specialties, 87 Civ. 2403 (S.D.N.Y.).
    53 Fed. Reg. 23, 862 (June 24, 1988).
    U.S. Department of Health and Human Services, FDA Press Office release, November 14, 1991.
    U.S. Department of Health and Human Services, FDA Press Office release, January 6, 1992.
    Breast Implant Litigation Reporter, Andrews Publications, March 1992, p 10. See also Griffin, W., Emerging issues in breast implant litigation, American Bar Association, 1993.
    Dante v. Dow Corning, Class tentatively certified by federal court in Cincinnati. Reported in Breast Implant Litigation Reporter, March, 1992, p 3.
    U.S. Department of Health and Human Services, update on silicone gel-filled breast implants, FDA news release, February 27, 1992.
    McKennon, Keith, quoted by Breast Implant Litigation Reporter, Andrews Publications, March, 1992, p 14.
    News Release Update on Silicone Gel-Filled Breast Implants, May 25, 1992.
    Medical Legal Aspects of Breast Implants, Leader Publications, October, 1993, p. 8.
    Medical Legal Aspects of Breast Implants, Leader Publications, January, 1993, p. 4.
    Hazelton, Dick, quoted in transcript of Frontline, February 27, 1996, WGBS Educational Foundation, p. 10.
    Adams, John (attr.), reply to Talleyrand in XYZ Affair concerning French seizure of American ships.
    Medical Legal Aspects of Breast Implants, Leader Publications, September, 1993, p. 1.
    Fisher, J., The silicone controversy—when will science prevail?, N Engl J Med 326:1696, 1992.

About the Author

Charles O'Brien, LLB, Board of Governors, The Doctors Company, Napa, California

Symptoms of Lupus, Silicone Breast Implant Lawyers

Written by lisaspitzer on . Posted in Breast Implant Blog

Breast Implant lawyers are helping women with silicone disease claims and proof of disease claims such as Lupus. Many women have developed immune disorders and silicone toxicity diseases from silicone entiring their bloodstream and into their body from leaking and ruptured breast implants.

Information from womenshealth.gov

    Autoimmune diseases  such as Lupus are a part of the breast implant class action disease claims.

What is lupus?

Lupus (LOO-puhss) is a chronic, autoimmune (aw-toh-ih-MYOON) disease. It can damage any part of the body (skin, joints, and/or organs inside the body). Chronic means that the signs and symptoms tend to last longer than six weeks and often for many years. In lupus, something goes wrong with your immune system, which is the part of the body that fights off viruses, bacteria, and other germs ("foreign invaders," like the flu). Normally your immune system produces proteins called antibodies that protect the body from these invaders. Autoimmune means your immune system cannot tell the difference between these invaders and your body's healthy tissues ("auto" means "self"). In lupus, your immune system creates autoantibodies (AW-toh-AN-teye-bah-deez), which sometimes attack and destroy healthy tissue. These autoantibodies contribute to inflammation, pain, and damage in various parts of the body.

When people talk about "lupus," they usually mean systemic lupus erythematosus (ur-uh-thee-muh-TOH-suhss), or SLE. This is the most common type of lupus. It is hard to guess how many people in the U.S. have lupus, because the symptoms are so different for every person. Sometimes is not diagnosed. The Lupus Foundation of America thinks that about 16,000 new cases are reported across the country each year.

Although lupus can affect almost any organ system, the disease, for most people, affects only a few parts of the body. For example, one person with lupus may have swollen knees and fever. Another person may be tired all the time or have kidney trouble. Someone else may have rashes. Over time, more symptoms can develop.

Normally, lupus develops slowly, with symptoms that come and go. Women who get lupus most often have symptoms and are diagnosed between the ages of 15 and 45. But the disease also can happen in childhood or later in life.

For some people, lupus is a mild disease. But for others, it may cause severe problems. Even if your lupus symptoms are mild, it is a serious disease that needs constant monitoring and treatment. It can harm your organs and put your life at risk if untreated.

Although the term “lupus” commonly refers to SLE, there are several kinds of lupus:

    Systemic lupus erythematosus, or SLE, makes up about 70 percent of all cases of lupus. SLE can be mild or severe and can affect various parts of the body. Common symptoms include fatigue, hair loss, sensitivity to the sun (photosensitivity), painful and swollen joints, unexplained fever, skin rashes, and kidney problems. In general the diagnosis of lupus is based off of a combination of physical symptoms and laboratory results.
    Cutaneous (kyoo-TAY-nee-uhss) lupus erythematosus can be limited to the skin or seen in those with SLE. “Cutaneous” means “skin.” Symptoms may include rashes/lesions, hair loss, vasculitis (swelling of the blood vessels), ulcers, and photosensitivity. A doctor will remove a small piece of the rash or sore and look at it under a microscope to tell if someone has skin lupus and what form it is. There are two major kinds of cutaneous lupus:
        Discoid (DISS-koid) lupus erythematosus, also called DLE, mainly affects the skin. The discoid rash usually begins as a red raised rash that becomes scaly or changes color to a dark brown. These rashes often appear on the skin on the face and scalp, but other areas may also be affected. Many people with DLE have scarring. Sometimes DLE causes sores in the mouth or nose. A doctor will remove a small piece of the rash or sore and look at it under a microscope to tell if someone has DLE. If you have DLE, there is a small chance that you will later get SLE. Currently there is no way to know if someone with DLE will get SLE.
        Subacute cutaneous lupus erythematosus makes up 10 percent of lupus cases. About 50 percent of the time, people with subacute cutaneous lupus also have SLE. Subacute cutaneous lupus causes skin lesions that appear on parts of the body exposed to sun. These lesions do not cause scars.
 

 Lupus can cause these diseases to occur earlier in life:

    Heart disease. When you have lupus you are at bigger risk of the main type of heart disease, called coronary artery disease (CAD). This is partly because people with lupus have more CAD risk factors, which may include high blood pressure, high cholesterol, and type 2 diabetes. The inflammation that accompanies lupus also increases the risk of developing CAD. Women with lupus are often less active because of fatigue, joint problems, and/or muscle pain, and this also puts them at risk. Heart disease is the number one killer of all women. But, women with lupus are 50 times more likely to have chest pain or a heart attack than other women of the same age.
    Osteoporosis (OSS-tee-oh-puh-ROH-suhss). Women with lupus have more bone loss and broken bones than other women. This might be because some medicines used to treat lupus cause bone loss. The disease itself can also cause bone loss. Also, pain and fatigue can keep women with lupus from exercising. Staying active is important for keeping bones healthy and strong.
    Kidney disease. Many symptoms of lupus come from the swelling of organs in the body. Almost half of all people with lupus develop kidney problems, called lupus nephritis. Kidney problems often begin within the first five years after lupus symptoms start to appear. This is one of the more serious complications of lupus, but there are treatments if problems are caught early. However, it is important to know that kidney inflammation is not painful and you can’t feel it. That is why it's important for people with lupus to keep up-to-date with the screenings their doctors recommend. These will include urine and blood tests.

Common signs of lupus are:

  •     Joint pain and stiffness, with or without swelling
  •     Muscle aches, pains, or weakness
  •     Fever with no known cause
  •     Feeling very tired
  •     Butterfly-shaped rash across the nose and cheeks
  •     Other skin rashes
  •     Unusual weight loss or weight gain
  •     Anemia (uh-NEE-me-uh) (too few red blood cells)
  •     Trouble thinking, memory problems, confusion
  •     Kidney problems with no known cause
  •     Chest pain when taking a deep breath
  •     Sun or light sensitivity
  •     Hair loss
  •     Purple or pale fingers or toes from cold or stress

Less common symptoms include:

  •     Blood clots
  •     Seizures
  •     Sores in the mouth or nose (usually painless)
  •     Severe headache
  •     Dizzy spells
  •     "Seeing things", not able to judge reality
  •     Feeling sad
  •     Strokes
  •     Dry or irritated eyes

If you hav a registered claim with on of the Silicone breast implant class action facilities and have Lupus contact the Breast Implant helpline to speak to a breast Implant Lawyer and find out if you have a claim.

Breast Implant Lawyers Helping with Disease Claims for Sjogren’s Disease

Written by lisaspitzer on . Posted in Breast Implant Blog

Shedding light on Sjogren’s. Many women are still suffering from Sjogren's disease from the silicone breast implant class action. Breast Implant lawyers helping with disease claims and deficiency notices.

Posted: Friday, June 1, 2012 7:35 am

By Emily May – emay@warricknews.com

Vicki Siebe won’t let a little autoimmune disease or two get her down.

In 1998, Siebe went to the doctor for headaches and itchy, burning eyes. She had a history of autoimmune disease in her family, so her doctor tested her. She came back positive for Sjogren’s Syndrome.

While it isn’t the most well-known autoimmune disease, it is one of the more prevalent. Sjogren’s (pronounced “show-grins”) is the second largest in the category, behind only rheumatoid arthritis. It is actually more common than lupus.

Sjogren’s attacks the moisture producing glands in the body — like those found in the mouth, eyes and lungs. Siebe’s first big realization of exactly what Sjogren’s can do came when her father died in 2002. She said she felt pressure in her eyes, but was unable to cry. By the end of the day, her eyes were blood-red.

“You literally don’t have any tears,” Siebe said. “It means that there’s no way to get rid of dust or wind. It can cause eye disease.”

She also produces very little saliva, which makes it hard to speak or eat.

“It assists in keeping bacteria washed out and like when you eat, the saliva, of course, aids in digestion,” Siebe said. “It affects all the way down. It affects your whole digestive system because you don’t have the breakdown in your mouth.”

There are two types of Sjogren’s diagnoses — primary and secondary. Primary means Sjogren’s is the only autoimmune diagnosis. Secondary includes more than one autoimmune diagnosis. Siebe tested positive for lupus in 2009, upgrading hers to secondary.

“That just complicates my situation,” she said. “I can’t go out in the sun and the heat, I have to keep covered up.”

Sjogren’s is also a likely factor in a lymphoma cancer diagnosis Siebe received in 2004.

She became so weak that she had to be carried into the doctor. At the time, she wasn’t aware that Sjogren’s patients are 44 times more likely to develop lymphoma than most people.

“I was stage four,” she said. “I wasn’t given very long to live. Luckily, I had two physicians — new physicians — who, at the time of this were very, very aggressive. They got me right into chemo. I had to have surgery. That’s been eight years ago. I’ve been in remission for about seven years.”

After her cancer scare, Siebe said she planned on returning to life as usual. But, she quickly found her priorities had changed.

“In the last two years, because of the lupus and the Sjogren’s, I have had a major life change,” she said. “I quit work in 2006. After my cancer, I went back to work for about a year and a half, but I couldn’t handle some of the stress. Actually, my priorities had changed and the meetings and company things just wasn’t very important to me any more.”

At the suggestion of her husband, she took a little time off work. She quickly found that her entire life had changed. The lupus made her intolerant to the sun. Activities she used to enjoy — gardening, fishing, going to auctions with her husband — were no longer possible without major consequences later. So, she did a little research on the Internet and found the Sjogren’s Syndrome Foundation. She joined the foundation and later decided to become an awareness ambassador for southern Indiana.

“I thought that was one thing I could do to use my brain,” Siebe said. “The advantage is everyone who is in the foundation has Sjogren’s. They know there are days that you can’t get out and do anything. There are no deadlines and no time lines. It’s a volunteer thing.”

Siebe said she hopes to bring a little more notoriety to Sjogren’s Syndrome.

“They all think it’s a weird disease, when actually it’s the second-largest autoimmune disease,” Siebe said.

She has already raised more than $300 by organizing a jean day at Castle North Middle School. She said she also hopes to start a support group and raise a little awareness for the disease.

“I want people to be aware that the disease is out there,” she said. “If you have symptoms, get to a doctor.”

Dow Corning Breast Implant Controversy, Dow Corning Breast Implant Lawyer

Written by lisaspitzer on . Posted in Breast Implant Blog

Dow Corning and the Silicone Breast Implant Controversy
posted by Handsome Devil on Wed, 01/04/2012 – 20:32

University of Wisconsin-Whitewater
 

1. What are some of the major factors that led to the Breast Implant Controversy?

Throughout the 1980s and 1990s, class-action lawsuits claimed that Dow Corning's silicone breast implants caused systemic health problems. The claims first centered around breast cancer, and then migrated to a range of autoimmune diseases including lupus, rheumatoid arthritis and various neurological problems. Ok
Even though Dow Corning has spotted the signs such as stakeholder complaints and various test reports in advance, they have not handled the problems ethically and have tried to manipulate information detrimental to themselves.
Here are a few issues we found in the article:

Ethically the company should have listened to the scores of questions from customers and their doctors about serious medical problems resulting from the use of its product; however, the company has not stopped producing the product or not done anything to improve the current situation for the stakeholder’s benefits – consumer health. Yes
Secondly, the company ignored the internal reports over lack of safety testing, as reported. The mammary task force raised a question that the product could cause “a bleed through” into surrounding tissue and the test result was still “inconclusive”, even in the new product tests the engineers didn’t make sure of the product safety. In spite of these facts, the company kept selling the product to the market.
Thirdly, the company has disregarded its social responsibility to lead its community. It seemed to limit its responsibility only within its legal responsibility in a case that its product breaks the rules. To make business ethics perfect in its community, it should take care about its full responsibility on its legal aspect and its moral ethics. The unbalanced ethics approach finally not only risked the stakeholder’s health but also increased social costs in its communities. Ok
Lastly, the top managers violated its fiduciary duty to its stakeholder even in facing the allegations that the company had hidden negative test results and lied to the public about the safety of its products. The board of the directors continued to manufacture and sell the product as well as to proceeded to fight customers who brought suit alleging injury. Ok
There are other key factors such as the competition etc that need to be discussed
 

2. What are the ethical issues and principals involved in this case? Who has acted the most and the least responsibility? Explain.

The main ethical issue of the article was whether or not breast implants, although potentially harmful to the body, should be on the market.
Since the 1960’s when Dow Corning used silicone to develop the first prototype of a breast implant, there have been ethical concerns that have not been resolved.
In the early 90’s, breast augmentation was the second most common cosmetic procedure performed by plastic surgeons, and the top money maker. Not only were breast implants important for reconstructive surgery, such as after an accident or cancer treatment, but the demand for the implants was growing more rapidly as an elective procedure. There is even a growing medical opinion that micromastia, known as flat-chestedness, is a disease which can result in a patient having a total lack of body image and low self esteem. Thus, the enlargement is necessary to insure an improved quality of life for the patient. Ok
However, as the number of breast implant patients increased, so did the number of complaints. There were allegations of the implants causing pain, scarring, and even debilitating autoimmune diseases in the patients. But how was a product that was clearing injuring patients allowed to be on the market? How ethical was it to allow these products to be so available, and yet, so potentially dangerous? Yes
First of all, breast implants were not governmentally regulated when first developed in the 1960’s. FDA could not require approval for safety and effectiveness before products were on the market.
Second, in accordance with “good manufacturing” practices, Dow Corning did attempt to determine safety of medical products before releasing them to the public. However, the determination of “safety” was vague and based on the company’s opinion. When tested on animals, silicone was injected into the body. There was clear evidence of chronic inflammation; however, because the silicone would not be injected into humans, the finding was ignored.
Third, the new and improved implants were brought into the market quickly without extensive medical testing. The reasoning for this was because similar substances had already been tested in other facilities. It was; however, brought to the attention of Dow Corning that “bleed throughs” were occurring. The company assigned a few employees to investigate (meanwhile still providing breast implant procedures). They found that the bleeding was “no greater than what we measure from old control gels”. However, it was stated that these tests were “inconclusive”, and were never researched again. Ok
Finally, in 1975, it was found that the reject rate at inspection was as high as 50% on some production lots. And yet, the implants were still available on the market.
Need to also integrate some theoretical perspective to assess Dow’s egoism + utilitarian principles
The responsibility for these ethical issues is a combination of both the Dow Corning company and the government. The Dow Corning company, although not held to any level of standards, was providing a potentially harmful product to the public. Yes Testing was done, but was not conclusive. The government (FDA) allowed companies, like Dow, to supply harmful products because they did not require extensive testing. It was not until 1989 when the FDA finally identified silicone implants as Class III devices, meaning riskiest. But still, after many hearings, breast implants were cited as a “public health need” and were left on the market.
Plastic surgeons and the public also hold some responsibility. Surgeons, although knowledgeable about the possible effects, still recommended and used the products on their patients. Many breast cancer advocacy organizations and satisfied recipients also supported Dow Corning and the use of breast implants. Ok
I

3. What was the role of the US Food and Drug Administration? Should they take some blame for the scandal? Should they have taken a more active role early in the controversy? Is the role government agencies can play in this respect limited?

In the early years of the product, the Food and Drug Administration (FDA) had very little oversight of silicone breast implants. The FDA did regulate products meant for ingestion (pharmaceutical drugs) since 1906 (Pure Food and Drug Act) but implants were considered medical devices and outside the FDA’s regulatory scope. The products could be removed from the market only if the manufacturer was proven to break the law. Despite the Medical Amendments Act to the Food and Drug Act (1976) the FDA didn’t label breast implants as dangerous until 1989 (after numerous lawsuits). Ok
The FDA should have taken an active role to regulate these products and can be considered somewhat responsible. Dow Corning was able to put a new product designed for internal human use into the market with little testing and no oversight. Their testing revealed health dangers that they ignored and kept from the public. If the product was regulated, the FDA would have seen the effects on laboratory animals – the Silicon causing inflammation as it sticks to various organs and lymph nodes. Despite intent to keep the silicon out of the body, ruptures or leaks would cause damage and users at least need to be aware of the risk before putting the product inside their bodies. Regulation would have revealed the numerous red flags (animal testing, plastic surgeons’ trade show) associated with Dow Corning’s implants and their FDA approval would have been delayed until the problems were solved. Yes
Dow Corning and other corporations have the goal of making profits and increasing their shareholders’ wealth. The FDA and other government agencies should realize this and put checks in place to ensure these companies offer safe products and services. Breast implants may not be a food or a drug but they are meant for internal use in the human body and they should have been added to the regulatory scope of the agency much earlier than they were. One of the roles of government is to protect its citizens (national defense, criminal justice, health care) and while it is often hesitant to regulate business (especially when that business makes significant contributions to political campaigns) when blatantly dangerous products are made available to consumers, the government does have and should use its authority to regulate and prohibit sales of these devices.
 

4. Why did Dow’s exemplary formal code of conduct fail in preventing the controversy? What can be done to make a Code of Ethics more effective?

Dow’s exemplary formal code of conduct failed because its implementation was flawed and didn’t address all ethical issues, most important being safety. With great diligence they fought to make all business transactions legit, thus denouncing scandals which was admirable, but to avoid addressing safety as an ethical issue is not above reproach. The first ethical question raised should be “is the product we are manufacturing safe to the parties we are soliciting?” If studies are performed findings should be disclosed on the label and not hidden. Safety not being on the ethics score card made the formal code of conduct vulnerable to controversy. Ok To make a product that may have safety issues without proper notification to the parties involved is highly unethical. The employee’s at Dow involved in the safety studies as well as the top level managers that made the decision to push the product were quite aware of the situation. The urge to generate profit and regain market share took precedent over any safety concerns.
In an effort to make the Code of Ethics more effective, a company such as Dow’s must address all ethical issue’s leaving nothing to chance. To the fullest extent any possible ethical dilemma the company could face should be analyzed and given a proper course of action. Yes Granted no society lives in utopia, thus no Code will be perfect, but at no point should major issues such as safety be brushed under the rug to obtain a profit. Companies must also be willing to be honest with themselves in addition to the parties that they serve. Doing so not only makes it easier to create an effective Code of Ethics but also implementing it will come with ease. In the Dow’s case they were not being honest about the product they were promoting and selling. Stemming from the early stages they knew the product had potential to be a safety hazard but elected to forgo the proper testing to ensure the product wasn’t detrimental to an individual’s health.

Breast Implant Helpline can help you with your breast implant claim
 

 

Silicone Breast Implant Lawyers, Silicone Breast Implant Class Action

Written by lisaspitzer on . Posted in Breast Implant Blog

Nationwide Breast implant helpline and Breast implant lawyers are helping women get compensation from the silicone Breast implant claims class action Recovery and compensation settlements.
Currently there are several class action lawsuits being filed by victims of defective breast implants.for Dow Corning, Mentor, Squibb, and others resulted in Lawsuits alleging such harm as cancer and autoimmune disease raked in millions of dollars throughout the 1990s, putting silicone breast implant manufacturers out of business or in danger of bankruptcy. With the assistance of “silicone doctors” who used minimal scientific evidence to support their claims, plaintiffs had stunning success. The wave of silicone breast implant lawsuits was largely a result of public opinion and aggressive pursuit of lawsuits by plaintiffs’ attorney, not medical evidence.

Dow Corning Brand Breast Implants Handled by Dow Corning Trust Facility (SF-DCT)

Settlements are currently handled for Dow Corning brand breast implants for Class 5 claimants as well as cases involving implants that contained silicone gel for Class 7 claimants. A product liability attorney will be able to explain the requirements for each of these defective breast implant lawsuits.

Funds are available for various foreign claimants and for those that received other Dow Corning manufactured products
The program offers settlement payments ranging from $2,000-$300,000 to eligible defective breast implant claimants until June 3, 2019.

The rules set up for breast implant litigation are very complex for the MDL-926, Revised Settlement Program and the Settlement Facility Trust of Dow Corning (SF-DCT). get help from a breast Implant helpline lawyer.

Speak to an experienced breast implant settlement attorney regarding defective breast implant claims or any other product liability cases for specific rules setup for product claims.

If you or a loved one are seriously injured or a death has occurred as the result of a defective breast implant or product, contact breast implant helpline and our breast implant lawyers to learn if you are entitled to legal compensation or have any questions regarding a breast implant registered claim.

Dow Settlement Lawyers, Breast Implant Lawyer, Breast Implant Helpline

Written by lisaspitzer on . Posted in Breast Implant Blog

Dow Settlement Lawyers  For Breast Implants, Breast Implant Helpline

Breast Implant Helpline Lawyers represent women across the United States who had Dow Corning breast implant or tissue expander placed in their bodies before June 1, 1993. Implant brands include Dow Corning, Silastic II, Cronin, DCW, MSI, Mueller 5 and Varifil. For those women that do have qualifing implants, there is still compensation available under the Dow Settlement until June 1, 2019.

Nationwide Sicone Claimant Helpline. Helping women with Silicone Breast Implant Claims in:
Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. 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