Paragard IUD MDL Created in North District of Georgia

Paragard IUD MDL Created in North District of Georgia

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It’s an emerging tort that has potential to amass a number of cases.

Paragard is an IUD (intrauterine device) used to prevent pregnancy. It was approved by the U.S. Food and Drug Administration (FDA) in 1984.

Paragard is owned by Cooper Surgical, maker of surgical and laparoscopic instruments primarily for women’s surgical needs including devices for hysterectomy, pelvic surgery, and C-section procedures.

Because of the large number of reported complications, multidistrict litigation has recently formed in the North District of Georgia. Currently there are 95 cases filed.

Adverse events reported include the device breakage during explant (removal) surgery causing complications and injuries and the need for follow-up surgery to remove the pieces, infertility, and pain.

Other complications include:

  • Organ perforation
  • IUD arms embed in uterine wall
  • Migration outside of the uterus
  • Pieces difficult to locate
  • Ectopic pregnancy
  • Possible hysterectomy

Copper IUD

IUDs are an increasingly popular form of birth control. There are two types – hormonal and copper.

Paragard is a copper contraceptive that is advertised as “100% hormone free.” Made of flexible polyethylene plastic wrapped with a thin layer of copper coil around the arms and stem, Paragard blocks the sperm from reaching an egg and may also prevent implantation. The copper is emitted and incites an inflammatory reaction toxic to sperm and egg.

Paragard is the only copper emitting IUD used in the U.S. Three other IUDs on the market emit hormones – Mirena, Skyla and Liletta.

About the size of a pack of sugar, the user is not expected to feel Paragard. Periods are expected to be heavier and longer with spotting in between. Pregnancy with an IUD in place is associated with an increased risk of miscarriage, premature labor and delivery, and sepsis. There is even a 27% rate of miscarriage when the IUD is removed from a pregnant woman.

Long-term studies on animals to assess the potential of cancer with a copper-containing IUD have not been performed.

 

FDA and Paragard

The FDA has warned that Paragard removal may be difficult because of “partial penetration or embedment of Paragard in the myometrium” (middle layer of the uterine wall).

Since it was approved, the FDA has received more than 40,000 reports of complications associated with Paragard including 15 deaths, however, Paragard remains on the market.

In an FDA letter to CooperSurgical Regulatory Affairs, dated July 2019, the agency warns the direct-to-consumer (DTC) advertising with the dancing Paragard users, makes false or misleading representations about the risks associated with Paragard.

IUDs have long been associated with an increase in pelvic inflammatory disease (PID), infertility and death.

The use of an IUD as a reliable form of birth control has been around for decades but IUDs gained a bad reputation from the complications associated with use of the Dalkon Shield of the 1970s. Hundreds of thousands of women reported problems with pelvic inflammatory disease, infertility, spontaneous abortions, and death.  The Dalkon Shield incident encouraged the passage of the Medical Device Amendments of 1976, that, for the first time, gave the FDA some control over medical devices.

In another case of IUD complications, Bayer offered a $12.2 million settlement in 2018 to thousands of claimants over complications associated with Mirena IUD.


ParaGard MDL

On December 16, 2020, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order creating the Paragard MDL. So far, 95 cases have been filed in MDL 2974 in the Northern District of Georgia before U.S. District Judge Leigh Martin May. At the time, there were 80 actions pending in 36 districts.

The defective product action will include manufacturing defect, defective design, marketing, promotion, labeling, packaging, and distribution, and a failure-to-warn, gross negligence, and consumer protection law fraud. The plaintiffs seek punitive damages.

The defendants are alleged to have understood the risks from clinical trials and post-marketing complaints but failed to warn and instead concealed and suppressed the dangers, one complaint reads. (Plendl v Teva et al)

CooperSurgical opposed the centralization of cases but the JPLM rejected claims that the creation of an MDL would generate the filing of voluminous claims without due diligence by lawyers for the plaintiffs. Instead, it found the Northern District of Georgia serviced the convenience of the parties involved.  Six of the actions were already filed in the Northern District of Georgia. None of the cases has been resolved.

The new drug application (NDA) for Paragard was previously held by Teva Women’s Health, Inc. from November 10, 1995 to August 11, 2017. Most of the actions filed so far name Teva Pharmaceuticals USA, Inc. et al.

Previously, Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals Inc. DBA Teva Women’s Health Inc., acquired FEI (Finishing Enterprises Inc.) Women’s Health in 2005. The deal included the Paragard IUD.

Duramed was acquired by Teva USA in 2008. Cooper Companies, a Delaware Corporation with headquarters in Pleasanton, California, purchased assets of Paragard IUD in September 2017 for $1.1 billion. CooperSurgical is a subsidiary of Cooper Companies. Under Georgia law, successors-in-interest are liable.

 

Sources:

Pending mdl  https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-January-15-2021.pdf

FDA letter
https://www.fda.gov/media/129526/download

Big Pharma’s Vaccine Immunity

Big Pharma’s Vaccine Immunity

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While the emerging COVID-19 vaccines promise to provide at least 90 percent effectiveness against the virus, vaccine makers are making sure they too enjoy immunity.

Even though taxpayers gladly shoveled $2.5 billion to develop the Moderna vaccine, and the federal government is spending $27 billion of your tax dollars to fund the Biomedical Advanced Research and Development Authority, BARDA, as drug makers rush a COVID-19 vaccine to market don’t expect your financial contribution to the effort to buy you any goodwill.

Pfizer and Moderna have made sure you cannot sue if you suffer severe Covid vaccine side effects.

AstraZeneca has also reportedly sought and received immunity from civil liability in the European Union. The Intercept reports that the trade group, Vaccines Europe is seeking an “exemption from civil liability” due to the “unprecedented public health and economic crisis.”

Under the federal PREP Act, lawyers have secured total immunity from liability for Big Pharma just in case something goes terribly wrong with the vaccine. Big Pharma “cannot be sued for money damages in court” over any efforts to fight the novel virus, whether a vaccine, a therapeutic, or any respiratory device.

We’ve already heard of side effects. People with a history of allergic reactions to vaccines are warned not to take the COVID shot after there have been several reports of anaphylaxis in the U.S. and UK that required an immediate injection by an Epi Pen.

With an estimated 120 vaccines in some stage of development, the potential downsides are magnified exponentially. The PREP Act effectively bars anyone who believes they have been harmed by a COVID-19 fighting vaccine.

PREP

PREP (the Public Readiness and Emergency Preparedness Act) was updated in April after being invoked by HHS in February when it was clear that COVID-19 was here to stay. The Act empowered director, Alex Azar to provide legal immunity to the companies making the vaccine or anything considered critical to the public during a pandemic, unless there is “willful misconduct” by the company.  That is a high standard sought by defendants because it is so difficult to meet.

The drug giants will enjoy that protection until 2024.

For the last decade, the Countermeasures Injury Compensation Program (CICP) was intended to provide compensation for any serious injury resulting from countermeasures the government may take during a health emergency whether vaccine, medication, device, or a public health emergency.

Zika, Ebola, Anthrax and now COVID-19 are all considered covered countermeasure threats. The injured or their survivors are supposed to be covered.

With a death benefit capped at $370,000 for the surviving family members, and up to $50,000 a year for unreimbursed lost wages and medical expenses, the program sounds good. But it is more talk than action. Of the 499 filed claims, only 29 have been paid.

Blanket immunity is rarely granted pharmaceutical companies, with some exceptions. In 1976, the swine flu makers had immunity from civil litigation. Mutual Pharmaceuticals was granted immunity from liability in 2013 when the U.S. Supreme Court decided federal preemption offered protection to Big Pharma since it was an FDA-approved drug.

And if you were told as a condition of employment you have to be immunized, your employer is off the hook as well.  The U.S. Food and Drug Administration, as do most states, enjoys sovereign immunity. “You can’t sue the king” is a remnant of British law before the American Revolution.

What could go wrong?

The Pfizer and Moderna vaccines were developed four to five times faster than vaccines are usually created due to the threat by COVID-19. That means the lengthy and expensive clinical trials were cut short during the eight-month development time.

Pfizer’s CEO Dr. Albert Bourla told CNBC that “This is a vaccine that was developed without cutting corners” and that it was approved by authorities around the world.  CNBC reports that the shortest time to develop a vaccine previously was for mumps and that took four years back in 1967.

Because it requires an ultra-cold temperature during handling and transport (-100 °F (-73 °C) Pfizer makes a point of saying its vaccine is free of thimerosal, the controversial mercury-based preservative thought to be linked to childhood autism. Thimerosol is being phased out of all vaccines even though the Centers for Disease Control and Prevention (CDC) insists it’s safe.

The Pfizer vaccine contains no other preservative, according to the company (there are no microchips either).

Newly emerging are variations of COVID-19, as the virus mutates in order to survive, adding a layer of complexity to the immunity question.

Employers may be asking whether they can be sued for requiring employees to be immunized. Yes, requiring a vaccine can be a requirement of employers. Under the Americans with Disabilities Act, workers may be exempted from taking a vaccine if there is a medical reason or a sincerely held religious belief.

Any injuries may have to be addressed by workers’ compensation as an on-the-job injury.

If you are seeking compensation, don’t count on the Countermeasures Injury Compensation Program (CICP), a last-ditch government program managed under HHS. It provides benefits to employees who suffered work-related injuries.

Providing up to $50,000 a year for lost wages and medical expenses, it is capped at $370,376 if a COVID vaccine is fatal. In the last 10 years, of 499 claims, only 29 have been paid, providing more than $6 million. There is a one-year statute of limitations.

Individuals typically injured by vaccines have, in the past, been routed through the National Vaccine Injury Compensation Program (VICP), also known as vaccine court. Its record shows it pays about 70% of claims from 16 routine vaccines over the last decade totaling about $4.4 billion since it began in 1988. The statute of limitations there is three years.

So far, the COVID-19 vaccine is not on its list of covered vaccines.

 

Sources:
Cdc   https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html

CIPC  https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf

CNBC: You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either.
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.htm

Bloomberg on Pfizer
https://www.bloomberg.com/news/articles/2020-11-09/pfizer-vaccine-s-funding-came-from-berlin-not-washington

Allergic reactions –https://www.reuters.com/article/health-coronavirus-britain-vaccine/uk-warns-people-with-serious-allergies-to-avoid-pfizer-vaccine-idUSKBN28J1D1,

SARS outbreak reaction – https://childrenshealthdefense.org/news/heres-why-bill-gates-wants-indemnity-are-you-willing-to-take-the-risk/;

Thimerosol – https://childrenshealthdefense.org/about-us/mercury-vaccines-cdcs-worst-nightmare/

Covid ingredients – https://www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/

EU liability – https://www.documentcloud.org/documents/7046985-European-vaccine-memo.html

Big Pharma immunity – https://www.publicjustice.net/contentsupreme-court-grants-big-pharma-co-immunity-defectively-designed-drug/

What Legal Options Do I Have if I Get Sick from the COVID-19 Vaccine?

What Legal Options Do I Have if I Get Sick from the COVID-19 Vaccine?

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The recent emergency authorization by the FDA for two vaccines, Pfizer-BioNTech and Moderna, means this could be the beginning of the end for this devastating pandemic that has spread all over the world. Since the first vaccine got its approval, we are witnessing an intensive and focused effort to vaccinate and protect everyone across the country as soon as possible.

Vaccine Could Bring Relief to Lockdown Restrictions

There is a widespread belief that a rapid vaccination drive could help ease the severe lockdown restrictions in certain states and restart an acutely distressed economy. As the provisions of the CARES Act lapse soon, about 12 million people are at risk of losing unemployment benefits. Outstanding student loans and federal protection for renters face a similar fate because of the delay of this relief package.

The Viewpoint of the Anti-Vaxxers

Over the past few months as the race for the vaccine was heating up, there has been a lot of debate on whether the vaccine should be mandatory. For every voice in favor of the vaccine, there have been voices of people who want to exercise their free will and an option to say no to it.

The CDC says there is a substantial number of naysayers – people with apprehensions about vaccine safety. According to a recent Pew Research Center survey, almost 40 percent of the people are either completely against or unsure about getting vaccinated.

Is Getting Vaccinated Going to be Mandatory?

Setting a legal precedent with its 2009 pandemic preparedness guidelines, the Equal Employment Opportunity Commission (EEOC) said that employers can mandate their employees to get vaccinations against the flu. However, US law has provisions for certain exceptions where an employee can refuse vaccination without the fear of losing their job.

The Americans with Disabilities Act (ADA) grants the first exception under which an employer needs to provide acceptable accommodations to employees if they are not able to take the vaccine because of certain medical conditions.

Title VII of the Civil Rights Act of 1964 covers one more exception. According to Title VII, employees can refuse a vaccination based on their sincerely held religious beliefs.

Can I File a Personal Injury Claim Because of Injury from a Mandatory Vaccine?

A mandatory vaccination, if it causes any adverse effects, increases the risk of personal injury claims against employers. However, the conventional legal procedures make it difficult to seek claims if there is no foreseeable harm from the vaccine and no clear evidence of negligence.

The chances of a personal injury claim being successful are low if the employer did not administer the vaccine, even if they mandated it for the employee. And this is especially true if the employer does not make the vaccination mandatory for those workers who have qualified exemptions. An employer must have justifiable grounds to refuse requests for exemptions and must make sure to document them fully.

Protection Against Personal Injury Claims for Vaccine Makers

In a 2018 decision, the United States Supreme Court provided protection to vaccine makers from legal claims seeking compensation against them for injuries or fatalities. The court’s decision further reiterates that the National Vaccine Program and the FDA, and not juries, are better judges of the safety and efficacy of vaccine design.

 Will a COVID-19 Vaccine Be Treated Differently?

The laws currently in place deal with employers involved in direct patient care if the risk to patients is substantial. However, the United States Equal Employment Opportunity Commission (EEOC) believes the COVID-19 virus to be a ‘direct threat’ as per the standards laid down by the ADA. This allows for more stringent controls and medical screening than generally permitted under the ADA.

Federal agencies like the CDC and Occupational Safety and Health Administration (OSHA) seemingly approve of employer-mandated vaccination policies, particularly for critical sectors of the economy. The CDC has a document regarding this, titled ‘Roadmap to Implementing Pandemic Influenza Vaccination of Critical Workforce’, and OSHA has been advocating its inspectors to get the COVID-19 vaccine as soon as it becomes available.

The Latest EEOC Guidance for COVID-19 Vaccine

 On December 16th, 2020, the Equal Employment Opportunity Commission (EEOC) issued its guidance for employers concerning the interplay between the COVID-19 vaccine policy and federal equal employment opportunity laws.

The EEOC’s guidance reinforces that employers have the authority to carry out mandatory vaccinations. However, employers must provide accommodation and engage with certain categories of employees.

These include, firstly, the employees who cannot get the vaccine because of disabilities. The second category of employees that can refuse the mandatory vaccine are the ones with genuinely held religious beliefs that preclude any type of vaccination.

In both exceptions, employers cannot exclude the workers from the workplace without sufficient proof that they pose a ‘direct threat’. Also, the employers must engage with the employees to find out if a way to mitigate the risks to others is available without terminating or excluding the exempted employees from work.

Be Prepared for the New Normal

 The introduction of guidance promulgating mandatory COVID-19 vaccines is likely to result in plenty of requests for accommodations on various grounds such as medical, ethical, and religious.

Employers may enforce mandatory vaccination policies but must keep in mind the limited exemptions. As we are approaching a new normal, we must be ready to change our perceptions regarding health and work, and employers may have to make some unprecedented decisions.

Is Law School Worth It?

Is Law School Worth It?

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It is well-known that law school requires a major commitment both in terms of time and money. If you go full-time, you will be giving up three years of your life to study law and do little else besides eating and sleeping. In fact, most law schools do not allow full-time students to work more than 20 hours a week.

As far as the financial commitment goes, the average private law school tuition in 2019 was $49,312, while the average public law school tuition was $28,186. If you are one of those exceptional students who has excellent grades and a high LSAT score, you might be fortunate enough to get most or all of your tuition paid through scholarships. But for most, the high tuition combined with the limited ability to earn an outside income means you will probably run up well over six figures in student loan debt.

In recent years, the high cost of going to law school has prompted many aspiring attorneys to question whether or not it is worth it. After a steady climb that began in the early 1970s, law school enrollment peaked in 2010 at 147,525 students. But since then, JD enrollment has steadily declined. In 2019, there were 112,878 students enrolled in law school, down 23.5% from the 2010 peak.

Is Law School Still Worth the Price of Admission?

Clearly, many students who were considering a legal career have concluded that the answer to this question is “no”. Much of this sentiment was brought on by what has become known as the “Great Recession”, which began in 2008. Many students who graduated from law school between the years of 2009 and 2017 have had a very hard time finding work, unless they graduated from an elite institution like Harvard or Yale.

Only 44% of those in this group who were surveyed said that they had a “good job” waiting for them after they graduated, and 26% said that it took them more than a year to find one. These are definitely not good numbers for a postgraduate program that requires three years of your life and can leave you six figures in debt.

A recent study by the Texas Public Policy Foundation seeks to quantify the perils of attending law school. The report applies the debt-to-earnings test known as the Gainful Employment Equivalent (GEE) to 168 law schools and reaches this very harsh conclusion:

Among the riskiest of the largest academic fields is law. Seventy-three percent of law schools fail these debt-to earnings tests, and 68% of law school graduates attended a program that fails. Students should think twice about enrolling in one of these failing programs, and policymakers should stop providing taxpayer subsidies for them.

We should point out that this was an analysis of students who actually finished their JD program. But because of the difficulty of the program and the time commitment involved, a significant percentage of students who start law school never even make it to the finish line. This is also something that should be factored in when determining whether or not law school is worth it.

Does Law School have Any Upside at All?

If you have read this far, you are probably thinking that going to law school is a bad idea for you and perhaps for most others as well. But like every legal argument you hear in a courtroom, the first side to argue their case always seems right – until you hear the opposing viewpoint.

Is law school worth it? Well, one thing we can say with certainty is that law school is clearly not for everyone, and not even for many of those who can get accepted. Furthermore, if you are looking at pursuing a legal career just for the money, prestige, or maybe because people in your family think it is a good idea, you should probably reconsider.

If you do not have a passion for the law and the drive and determination to establish a successful career no matter what obstacles get in the way, then this might not be the field for you. If, on the other hand, you do have that passion and drive along with the desire to serve legal consumers, then you should not necessarily let the cost of going to law school scare you away.

There are plenty of upsides to pursuing a legal career. Here are some of the reasons that this career path could be a great choice for you:

Emerging Fields of Law

We live in an increasingly complex society, and every area of society has a legal aspect to it. What this means for law students is more specialty opportunities than ever before. In addition to standard practice areas like personal injury, family law, criminal defense, and estate planning, there are numerous emerging fields that law school graduates can go into. Here are just a few of them:

  • Elder Law
  • Healthcare Law
  • Technology and Cyber Law
  • Intellectual Property (IP) Law
  • Data Protection and Privacy Law
  • Environmental Law
  • Media and Entertainment Law

Opportunity to Make a Real Difference

Being a lawyer gives you the chance to change the lives of countless individuals for the better. When you represent a client, you give voice and advocacy to someone who needs your help and may have a difficult time standing up for their own legal rights. In addition, lawyers are often part of litigation that changes society in positive ways. Many of our local, state, and federal officeholders began their careers as attorneys and are now in positions where they can shape help shape better public policy.

Being a lawyer is challenging work. But it is also extremely fulfilling and rewarding when you are able to make the kind of impact attorneys can make. And along the way, you will have the opportunity to grow in numerous ways and make a true and lasting difference.

Less Competition

The declining law school enrollment in recent years means fewer new attorneys coming out of law school. At the same time, many Baby Boomer attorneys are entering retirement at a time when we have more legal specialties than ever before. So, for those who decide to go forward with law school, there is a greater potential for a lucrative and fulfilling career.

There may have been a glut of new lawyers during the Great Recession years, but this is not likely to be the case in the future. If you go to law school now, you may be bucking the advice of organizations like the Texas Public Policy Foundation; but sometimes, taking a contrarian approach (e.g., zigging when everyone else is zagging) provides some of the greatest rewards.

When it comes to law school itself, it is important to note that there are ways to significantly mitigate the costs of this field of study. As we touched on to earlier, a higher LSAT score means the chance at getting scholarships. And you can often obtain a better score by taking an LSAT prep course and/or investing several hours into a self-study program.

It is also wise to consider attending a public law school instead of a private one in order to save money on tuition. On average, it will cost you 40% to 50% less to attend a public law school. And keep in mind that many of the higher ranked law schools are public institutions, so you do not necessarily have to sacrifice a quality education to save money.

Better Ways to Market your Practice

Whether you end up starting your own practice or working for another firm after law school, one of the most important strategies to get yourself established is building your personal brand. If you do this effectively, you can establish authority in your area of practice, increase your earning potential, and open up more career opportunities.

The good news is that building a personal brand and standing out from your competition is easier than ever in today’s digital age. It still requires an effective strategy and consistent work, but the internet levels the playing field and gives every attorney the opportunity to establish themselves more quickly. By using the right personal branding approach, you will be well on your way to realizing your dream of becoming a successful attorney.

What Are Your Thoughts?

If you are a law student or you are thinking about going to law school, what are your greatest concerns? After everything you have learned so far, do you think a legal career will be worth it for you?

If you are an attorney, what would you say about your experience with law school? Was it worth it? Are you happy with the field you have chosen?

Please leave us your feedback. We would love to know your perspective and opinion on this controversial topic.

Elmiron Bladder Pain Drug Warning Added by J&J

Elmiron Bladder Pain Drug Warning Added by J&J

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Made by Janssen Pharmaceuticals, a division of Johnson & Johnson, Elmiron (pentosan polysulfate sodium), was approved by the U.S. Food and Drug Administration (FDA) to protect the bladder wall from irritants in urine, which causes interstitial cystitis or painful bladder syndrome.

Elmiron actually works like heparin and is a weak anticoagulant, acting like a blood thinner.

It is not a cure, but Elmiron promised to provide some relief to the painful symptoms for the three to eight million women affected from the pain associated with the inflammation or irritation of the bladder. It’s estimated up to four million men may also suffer from interstitial cystitis, which may be due to a defect in the protective lining of the bladder.

Symptoms include a burning sensation and urinary urgency, a feeling of discomfort of pressure in the bladder or lower abdomen, pain during intercourse, and pelvic floor muscle pain.

Now, 24 years after its approval, Elmiron is linked to maculopathy, the most common cause of blindness.

Janssen Pharmaceuticals, a division of Johnson & Johnson, added a warning in June concerning a potential life-altering retinal disorder – pigmentary maculopathy. This was added to the side effects already appearing on the instructions for use (IFU) including abnormal liver function, nausea, diarrhea, and hair loss.

Sufferers usually experience vision loss after at least two years. The vision problems must have onset within a year of stopping the drug or during its use. Damage may stop if caught in the early stages of drug use.

Scientific Studies

Three ophthalmologists conducting a review of patients at Kaiser Permanente in Northern California found about one-quarter of users of Elmiron displayed signs of eye damage. Taking a closer look at 91 patients who had taken an average of 5,000 pills found 22 patients with signs of drug toxicity.

Emory Eye Center in Atlanta, Georgia also noted six patients who were long-term users of Elmiron developed changes to their macula, the part of the eye which allows us to see with detail and clarity.

Lawsuits alleging a failure to warn the public and doctors about the risk of vision problems are now being filed. Tens of thousands of patients may be affected.  Patients who have filed report they are experiencing blurred vision and vision impairment including retinopathy and maculopathy.

Patients with liver issues should consult with their doctor before using the drug.

WARNINGS

Retinal Pigmentary Changes

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.”

Symptoms of Elmiron use may include:

* Dimming vision

* Difficulty reading

* Difficulty adjusting to the light

* Loss in a field of vision

* Loss of night vision

* Difficulty seeing objects that are close

* Blindness

* Halo vision

* a diagnosis of pigmentary maculopathy

*A diagnosis of macular degeneration

* A diagnosis of Macular Retinopathy

* A diagnosis of Retinal Deterioration

* A diagnosis of Pattern dystrophy

LEARN MORE:

American Academy of Ophthalmology news release

FDA Prescribing Information for Elmiron

May 2018, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium

Multi-District Litigation Formed for Allergan’s Textured Breast Implants

Multi-District Litigation Formed for Allergan’s Textured Breast Implants

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Litigation is proceeding in New Jersey federal court concerning Allergan’s Biocell Textured Breast Implants. The multidistrict litigation (MDL 2921) was formed in December before The Honorable Judge Brian R. Martinotti and Judge Joseph Dickson.

Back in 2017 and earlier in 2011, the FDA warned about a rare form of cancer – anaplastic large-cell lymphoma, a cancer in the lymphatic system.  This rare form of Non-Hodgkin’s lymphoma can develop after a breast implant procedure, specifically textured breast implants, according to the FDA.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) may be the result of the texture on the implant, created to keep it in place. The increased surface caused by the texturing may retain more bacteria than a smooth implant. One theory is that biofilms form creating chronic inflammation.

So far, 393 defective product complaints have been filed with 375 actions still pending. In August, a federal judge decided plaintiffs can not withhold their names from Allergen. Plaintiffs filed pleadings asking to use a pseudonym or initials to avoid disclosing personal medical information.

Common Facts

The MDL is addressing some common facts – when did Allergan know or should have known about the risks of textured breast implants and their connection to a rare form of cancer and whether the company provided adequate warnings, testing and manufacturing of the implants.

While the Allergan products were supposed to have been removed from the market last year, not all of the implants have been accounted for.

Because of that, the FDA on September 12, 2019 – FDA announces Class I global recall of Allergan Natrelle BIOCELL textured products, saline and silicone breast implants plus tissue expander. Class 1 is the most serious recall.

At that time, the agency found there were 573 BIA-ALCL cases involving 481 Allergan breast implants. This includes 33 deaths, frightening news for the more than 300,000 woman who have breast augmentation annually in the U.S.

The reason for the additional is incomplete device tracking data on about 52,000 BIOCELL breast implants. Patients were told to reach out to Allergan to determine if the company has their implant information or to contact the surgeon or hospital to retrieve their medical records.

Allergan also makes Biocell textured implants for other names including Natrelle, Inamed, and McGhan.

Initially, in July 2019, Allergan announced a worldwide voluntary recall of BIOCALL textured breast implants and tissue expanders, both saline and silicone filled. Allergan also makes Natrelle smooth and Microcell breast implants and tissue expanders which are not named in the recalls.

AbbVie (ABBV) a global pharmaceutical company based in Chicago, purchased Irish-based Allergan plc in May 2020 for $63 billion. Allergan is best known for its Botox and Juvéderm brands in the aesthetics division. This was one of the biggest deals in pharmaceutical industry.

Not Breast Cancer

In a new analysis, the FDA calls its findings a spike in cases. Among the 160 cases seen from July 2019 through January 5, 2020, the total of unique cases of BIA-ALCL came to 733. Three deaths were included. Of those cases reported to the FDA, 85 percent were Allergan implants.

A 2016 paper published in Aesthetic Surgery Journal found chronic inflammation from scar tissue may be the body’s way of responding to a foreign body, triggering an immune response and cancer. The lymphoma is always found in the scar tissue capsule.

Not only are the breast implants the subject of a recall but so are the tissue expanders, used in breast reconstruction following a mastectomy. An expander is intended to be a temporary implant.

The problem- a risk of anaplastic large cell lymphoma (BIA-ALCL), which is a cancer of the immune system. The FDA finds that the Allergen textured breast implant represents six times the risk of BIA-ALCL. The real-life consequences find that among 573 cases, 481 of those patients had the textured implants at the time of diagnosis.  Among the 573, there were 13 deaths.

The BIA-ALCL is usually successfully treated by removing the scar tissue and the implant. Additional radiation and chemotherapy may not be needed.

Chronic Inflammation

Why use a textured breasts implant?

Some surgeons have chosen a textured implant because they are reported to hold their position better and may be ideal for patients who have had mastectomy. Included in the recall is the Allergan Natrelle 133 and 133 Plus tissue expanders. To date they have not been associated with the cancer even though they have the same proprietary texture.

This recall is for the unused stock of BIOCELL implants and tissue expanders from doctor’s offices and hospitals. Patients with the troubling implants were told they did not need to have them removed.

Patients worried do not have to have the implants removed. Allergan had sent an urgent warning to U.S. customers, primarily surgeons, instructing them to return all unused implants.

As of early 2020, cases of ALCL associated with textured implants are blamed on 36 deaths and 733 cases of ALCL.

The cancer is identified in the scar tissue and fluid surrounding the implant. BIA-ALCL can spread throughout the body. Symptoms of this type of cancer are pain or swelling near the breast implant. Other symptoms of this type of cancer are:

  • Lumps in the breast or armpit
  • Breast hardening
  • Changes in the appearance of the breast
  • Redness or rashes
  • Weight loss
  • Fatigue

The BIOCELL textured implants represent less than 5% of the market of all breast implants in the U.S. and 10% of ALL breast implants sold in the U.S. Look at the FDA to determine if your particular textured breast implant is included.

LEARN MORE:

See NIH https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908488/
https://trofire.com/2020/08/24/fda-announces-new-analysis-of-breast-implant-related-cancer-and-illness/

 October 2020 Medpage today
https://www.medpagetoday.com/hematologyoncology/breastcancer/88999

https://news.abbvie.com/news/press-releases/abbvie-completes-transformative-acquisition-allergan.htm

https://www.theguardian.com/business/2019/jun/25/botox-maker-allergan-bought-by-us-drug-giant-abbvie-for-63bn

July 2019
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders

June 2020
https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue

In June of 2020, Allergan launched a multi-pronged campaign to contact patients who may not be aware of the year-long campaign.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders