Friday, January 25, 2013

Judge Appoints Trustee To Oversee NECC’s Bankruptcy

A steroid produced by the Framingham-based New England Compounding Center has been linked to a fungal meningitis outbreak that’s killed 44. The company filed for Chapter 11 bankruptcy in December, saying the purpose of the filing was to establish a compensation fund for victims.

The company at first opposed an independent trustee, saying it would delay progress toward establishing the fund. Lawyers on Thursday dropped objections, saying the company did not want a battle with creditor.

Here is the Order:


Thursday, January 24, 2013

Energy drinks brace for caffeine crash

Could an FDA investigation mean the beginning of the end for energy drink makers, whose products are full of caffeine but lack regulation? An FDA letter written to Sen. Dick Durbin (D-IL) confirmed that the agency is taking "science-based actions" in order to determine the possible risks associated with energy drinks, which are often consumed by teenagers and young adults. 

The letter, a late-November response to Durbin's expressed concern over energy drinks, says the FDA will consider requiring product labels to advertise caffeine content as well as warnings about possible effects. Federal laws do not currently require labels to carry actual caffeine content or warnings about possible negative effects.

Read more:

C & H Meats recalls marinated pork and chicken products

C & H Meat Company of Vernon, CA, is recalling approximately 79,400 pounds of marinated pork and chicken products because they are misbranded in that they contain monosodium glutamate (MSG), which is not declared on the label.
The products subject to recall include:
  • 10-oz. packages and bulk packages of Korean Brand BBQ Flavored Spicy Pork Butt
  • 10-oz packages and bulk packages of Marinated Spicy Pork Butt
  • 10-oz. packages and bulk packages of Korean Brand BBQ Flavored Spicy Boneless Chicken Leg Meat
The products subject to recall may bear the establishment number "EST. 4831" or "P-4831" inside the USDA mark of inspection. These products were produced on various dates through Jan. 16, 2013, and distributed to retail establishments and restaurants in California.

Wednesday, January 23, 2013

Abogados-Philadephia Site Debuts

My good friend Steve Wigrizer and I are working on several cases together in the Pennsylvania area. One of those cases involves a young woman's death we allege was caused by DMAA.

Well, his office has a new website that is hispanic only for his area. Well done, clean, good information.

Worth a look:

Bugaboo Recalls Strollers Due to Fall and Choking Hazards

The U.S. Consumer Product Safety Commission and Health Canada,  announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Bugaboo Cameleon and Bugaboo Donkey Model Strollers

Units: About 46,300 in the U.S. and 4,440 in Canada

Importer: Bugaboo Americas, of El Segundo, Calif.

Manufacturer: Bugaboo International B.V., of Amsterdam, The Netherlands

Hazard: A button on the stroller's carrycot/seat carry handle can become disengaged and cause the handle to detach, posing fall and choking hazards to young children.

Incidents/Injuries: Bugaboo has received 58 reports of carry handles detaching. No injuries have been reported.

Description: This recall involves the carry handles on Bugaboo Cameleon and Bugaboo Donkey model strollers with detachable carrycots/seats. The strollers were sold with a base, sun canopy and other accessories in various colors. A fabric tag on the side of the sun canopy has Bugaboo and the model name. Strollers included in the recall have a serial number that falls within the range listed below. Serial numbers are printed on the stroller's chassis, located under the carrycot/seat.
Bugaboo Cameleon
Serial Number 04011090900001 to 04031101009999
Serial Number 08011090900001 to 08021100800386
Serial Number 140100093600531 to 140103123350418

Bugaboo Donkey
Serial Number 170101105300001 to 170104130900500
Sold at: Buy Buy Baby, Neiman Marcus, Nordstrom, Toys R Us and other baby product stores nationwide, online at and other online retailers. The Bugaboo Cameleon was sold between September 2009 and June 2012 for about $980. The Bugaboo Donkey was sold from January 2011 through December 2012 for between $1,200 and $1,600.

Tuesday, January 22, 2013

Gainesville Company Recalls Gluten-Free Chicken Nuggets

King’s Delight, a Gainesville, Ga. establishment, is recalling approximately 1,572 pounds of frozen chicken nuggets labeled as gluten-free because they contain wheat, a known allergen that is not declared on the label, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. 

The product subject to recall include: [Labels]
8-oz. cartons of “APPLEGATE® Naturals Gluten-Free Chicken Nuggets.”

The establishment number “P-2617” can be found printed on the side of each carton. The products were packaged on Sept. 19, 2012. The lot number “210864” and the best before date “08/28/13” are printed on each carton’s side panel. The UPC code “25317-00556” is printed on the back of each carton. The products were distributed to retail stores in Indiana, Maryland, Oregon and Washington. Consumers who purchased these products should return them to the store for a full refund.

Siemens Recalls Temperature, Humidity Sensors on Fire Hazard

Seimens has recalled 57,000 temperature and humidity sensors after receiving four reports from schools and hospitals that the sensors overheated and caused a fire, the U.S. Product Safety Commission said.

The four reported fires caused minor damage, and no injuries were reported.
Siemens Industry Inc.'s wall-mounted Q-series sensors are designed to control heat, air conditioning and humidity in commercial buildings, hospitals and schools.

The sensors were sold by Siemens sales offices, partners, resellers and installers from June 2007 through Aug. 2012 for $200 to $400. The white or beige sensors come in three designs, with a blank cover, a digital display screen, or a digital display and door.

Idaho firm recalls fully cooked meat and poultry products

 LJD Holdings, Inc., doing business as B and D Foods, a Boise, Idaho establishment, is recalling approximately 33,500 pounds of fully cooked meat and poultry products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The problem was discovered by the company through microbiological testing and the products are being recalled due to concerns of cross-contamination. FSIS and the company have not received reports of illnesses due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

The products subject to recall bear the establishment number "EST. 6266" or "Est. P-6266" inside the USDA mark of inspection, as well as an identifying case code of "110622." The products were produced on Dec. 6, 2012, and distributed to foodservice and institutional customers, as well as an industrial customer in the distribution areas noted above.

Friday, January 18, 2013

Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients

Amgen todayannounced the top line results of a large phase 3 heart failure trial of the drug and said  the trial had failed to meet its primary endpoint.
The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, which started in 2006, had randomized 2,278 patients with heart failure and anemia to receive either Aranesp or placebo. Patients in the trial started with hemoglobin levels between 9 and 12 g/dL. Physicians then sought to achieve hemoglobin concentrations between 13 and 14.5 g/dL. The company said the trial did not meet the primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, CI 0.90 – 1.13).

Hospital Reuses Insulin Pens After Being Told Not to do S

Amazing. Amazingly stupid?

The Food and Drug Administration warned hospitals nationwide against reusing insulin pens on multiple patients in March 2009, 19 months before the Buffalo VA Medical Center began a practice that could have prompted its nurses to do that very thing.

What’s more, the hospital continued running the risk of spreading deadly viruses through those insulin pens for more than two years until last Nov. 1, despite a January 2012 alert from the Centers for Disease Control and Prevention reiterating the FDA’s earlier warning.

News of the government warnings – and the Buffalo VA’s apparent ignorance of them – only further infuriated members of Congress who are concerned that the faulty nursing practice could have exposed upwards of 716 patients at the local hospital to HIV, hepatitis B or hepatitis C.

Thursday, January 17, 2013

Study shows ER visits tied to energy drinks have doubled since 2007

From AP and the MS blog:

From 2007 to 2011, the government estimates the number of emergency room visits involving the neon-labeled beverages shot up from about 10,000 to more than 20,000. Most of the cases involved teens or young adults, according to the survey of the nation's hospitals released late last week by the Substance Abuse and Mental Health Services Administration.
More than half of the patients considered in the survey told doctors they had consumed only energy drinks. In 2011, about 42 percent of the cases involved energy drinks in combination with alcohol or drugs, such as the stimulants Adderall or Ritalin.

The beverage industry says energy drinks are safe and there is no proof linking the products to adverse reactions.

Here is a partial from the DAWN network:

Energy drinks are flavored beverages containing high amounts of caffeine and typically other additives, such as vitamins, taurine, herbal supplements, creatine, sugars, and guarana, a plant product containing concentrated caffeine. These drinks are sold in cans and bottles and are readily available in grocery stores, vending machines, convenience stores, and bars and other venues where alcohol is sold. These beverages provide high doses of caffeine that act as a stimulant upon the central nervous system and cardiovascular system. The total amount of caffeine in a can or bottle of an energy drink varies from about 80 to more than 500 milligrams (mg) of caffeine, compared with about 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce cola.1 Research suggests that certain additives may compound the stimulant effects of caffeine. Some types of energy drinks may also contain alcohol, producing a hazardous combination; however, this report focuses only on the dangerous effects of energy drinks that do not have alcohol.

Although consumed by a range of age groups, energy drinks are marketed to appeal to youth and are consumed by 30 to 50 percent of children, adolescents, and young adults.2 Of the several hundred brands of energy drinks on the market, the most popular brands of energy drinks that account for the majority of the market share are Red Bull, Monster, Rockstar, Full Throttle, and Amp. Marketing for energy drinks often targets young people, suggesting benefits such as increased energy and stamina, weight loss, and enhanced physical and/or mental performance.2 Emphasizing thrill seeking with names such as "Cocaine" and "Venom," energy drink companies use innovative media to reach their audiences, such as advertisements in video games and at sports events, and solicit market research feedback from consumers via social media to help identify new packaging designs.3 The popularity of these drinks has increased markedly in recent years, with energy drink sales increasing 240 percent from 2004 to 2009.4

Mirena IUD News for January 2013

The Mirena Intrauterine Device (IUD) is  a form of birth control and is inserted by a healthcare provider during an office visit.  It was approved by the Food and Drug Administration (FDA) in December 2000 and is currently used by more than 2 million women in the United States.  The product is manufactured by Bayer, Inc.

The Mirena IUD consists of a T-shaped polyethylene frame with a steroid reservoir around a vertical stem.  The T-body is 32 mm by 32 mm (vertical and horizontal).  The reservoir contains 52mg of levonorgestrel (a type of hormone) and small amounts are released daily.

While the package inserts and literature do warn about complications associated with the Mirena IUD, the patient is not warned that after the IUD is inserted it can perforate or pass through the uterus into other body parts such as the abdomen.  If this occurs, it is necessary to remove the IUD through a surgical procedure such as a laparotomy.

In 2009, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for making false and unsubstantiated claims about Mirena® in their “Simple Style” program. 

Here is a partial list of warnings:

  • Intrauterine Pregnancy
    • Long-term effects and congenital anomalies
  • Embedment
  • Perforation
  • Expulsion
  • Ovarian Cysts
  • Breast Cancer
  • Patient Counseling Information
  • Patient Evaluation and Clinical Considerations
    • A physical examination should include...
    • Irregular bleeding may mask symptoms and signs of endometrial polys or cancer...
    • ...If involution is substantially delayed, consider waiting 12 weeks postpartum...
    • Mirena should be used with caution in patients who have:
      • migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
      • exceptionally severe headache
      • marked increase of blood pressure
      • severe arterial disease such as stroke or myocardial infarction
  • Insertion Precautions
    • Observe strict asepsis during insertion...
    • Fundal positioning of Mirena is important to prevent expulsion...
    • If the patient develops decreased pulse, perspiration, or pallor, have her remain supine until these signs resolve. Insertion may be associated with some pain and/or bleeding...
  • Continuation and Removal
    • Re-examine and evaluate patients 4 to 12 weeks after insertion and once a year thereafter...
    • If the threads are not visible, they may have retracted into the uterus or broken, or Mirena may have broken...
    • Promptly examine users with complaints of pain, odorous discharge...
    • Consider the possibility of ectopic pregnancy...
    • Removal may be associated with pain and/or bleeding or neurovascular episodes.
  • ...Very common adverse reactions (>1/10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts...
  • Who should not use Mirena?
    • Do not use Mirena if you...
    • have or suspect you might have cancer of the uterus or cervix
    • have breast cancer now or in the past or suspect you have breast cancer
  • Tell your healthcare provider if you
    • have high blood pressure
  • How is Mirena placed?
  • Should I check that Mirena is in the proper position?
  • How soon after placement of Mirena should I return to my healthcare provider?
  • What are the possible side effects of using Mirena?

Granuflo Update for January 2013

The litigation involving a recalled dialysis drug continues, and here is our update for January. 

Currently there are several requests to consolidate cases involving Granuflo/Naturalyte before one Court. Parties have asked the Joint Panel on Multidistrict Litigation to centralize cases in either Massachusetts, or Mississippi, or California. The JPML hearing will be in California in March.   

 What Is GranuFlo?

Fresenius Medical Care’s dialysis product GranuFlo is a “dialysate,” i.e., a substance that physicians can use to treat acute and chronic renal (kidney) failure.
The kidneys clean the blood of waste chemicals and help maintain the body’s pH level. When they fail, the body’s pH level become more acidic than is should be. Dialysates used to treat kidney failure include chemicals that the body can convert into the alkaline substance bicarbonate, which neutralizes some of the acid buildup in the blood stream.

GranuFlo: Heart Attack Side Effects

GranuFlo contains more bicarbonate than other dialysates, and a June 2012 New York Times article describes Fresenius’s knowledge of the risks posed by its product’s high bicarbonate level. According to the article, Fresenius sent a memo to its clinics warning that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own, however, until March 29, 2012, when the FDA consequently began investigating Fresenius for possible violations of federal regulations, the Times reports.
The most difficult part of our investigations? Patients don't go for dialysis treatment and ask for this product.   

Wednesday, January 16, 2013

Lap Band Facility gets a Warning Letter

An FDA Warning Letter says that oBand Centers in Marina Del Rey, CA, is making misleading claims in its promotional materials for the Lap-Band, a device indicated for weight reduction in certain severely obese adults.
According to the letter, the company's website fails to reveal material facts about Lap-Band risks. The letter also says that a web video that is intended to convey indications for tse, contraindications, warnings and adverse events is not accessible to viewers, due to the brief appearance of the information and tiny, blurry print that renders the content illegible.

Fake Botox Warning

According to the U.S. Food and Drug Administration, Canadian medical supplier Canada Drugs has been linked to the sale and distribution of fake Botox.

Read more:

Here is the letter:

The U.S. Food and Drug Administration (FDA) has alerted more than 350 medical practices that they may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier. These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment.  
To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA requests that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.  Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses.
Medications not approved by FDA may also lack the necessary and required labels that ensure their appropriate and safe use. For example, unapproved botulinum toxin products may not contain the boxed warning or Medication Guide required in FDA-approved botulinum products. As a result, health care practitioners and patients may not be fully informed of the potential serious risk of harm or death from the use of these products.
The text of the letter FDA sent to the physicians or medical practices on November 30, 2012 is below, along with a list of the doctors and clinics to which the letter was sent.


Dear Dr.:
The U.S. Food and Drug Administration (FDA) has received information indicating that your medical practice has received medications from a foreign supplier owned and operated by Canada Drugs, known as Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. Most, if not all, of the products sold and distributed by these suppliers, including versions of Botox®, have not been approved by FDA. The manufacture and handling of these products may not be of suitable quality to ensure safety or efficacy, and the products have not been proven to be safe and effective pursuant to FDA standards. FDA is very concerned that products distributed by these suppliers may cause harm to patients, because they may be unsafe or ineffective.
Medications obtained from Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Clinical Care, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards. Such products put patients at risk of exposure to ineffective or dangerous products. In virtually all cases, importing or causing the importation of unapproved prescription medications from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal. FDA has previously warned about unapproved and counterfeit oncology products obtained from some of these same foreign suppliers.[1]
Medications that are not approved by FDA may lack necessary and required labeling to assure their appropriate and safe use. For example, FDA has determined that a prominent “boxed” warning is required in the labeling for medications that have special problems, particularly ones that may lead to death or serious injury.  A Medication Guide that contains information that can help patients avoid serious adverse events may be required instead of, or in addition to, a boxed warning. Unapproved botulinum toxin products may not contain the boxed warning or Medication Guide in its labeling as required in FDA-approved products. As a result, the healthcare provider and patient may not be fully informed of the serious risk of harm or death associated with botulinum toxin products.
FDA requests that you cease using, and retain and secure all remaining products purchased or received from Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Clinical Care, or any other foreign or unlicensed U.S. sources until further notice. Please do not return any product(s) to the place of purchase at this time. FDA is continuing to evaluate this situation. If any unapproved medications remain in your possession, please contact FDA’s Office of Criminal Investigations (OCI) to arrange for the collection of the medications.
On January 13, 2012, FDA issued a notice to Healthcare providers about the risks of purchasing unapproved medications from unlicensed sources, and included information on how to identify whether distributors or the products received are legitimate.[2]
Information regarding any criminal activity involving the importation and use of foreign unapproved medications can be reported to FDA's Office of Criminal Investigations (OCI).
Healthcare providers and patients are asked to report adverse events related to the use of suspect medications to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Heathcare providers and patients can either:
·         Complete and submit the report online or
·         Download form, or
·         Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
FDA is committed to promoting and protecting the public health by ensuring that only safe, effective, and high-quality medications are available to the American public. Please contact
Eleni Anagnostiadis at should you have any questions regarding this letter.
/S /
Thomas J. Christl
Acting Office Director
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research

Bodega Clinicas

I'm of Cuban origin, and for me the 'bodega' was where my grandparents went for almost everything they needed. My parents too. Here's a read on how these clinics are catering to the spanish speaking population:

 The “bodega clinicas” that line the bustling commercial streets of immigrant neighborhoods around Los Angeles are wedged between money order kiosks and pawnshops. These storefront offices, staffed with Spanish-speaking medical providers, treat ailments for cash: a doctor’s visit is $20 to $40; a cardiology exam is $120; and at one bustling clinic, a colonoscopy is advertised on an erasable board for $700.

According to the article, little is known about the competency of the medical providers in the clinic, the manner and method of oversight/regulation,  and the responsiveness of the doctors at each clinic.

One thing is certain - these clinics are not going away. In my hometown of Atlanta, there are two new ones near my office. I saw a line out the door at one of them on a recent weekend. How the FDA or any state agency responds to the virtual explosion of these clinic bodegas remains to be seen. If it's business as usual, you may not see any real effort for oversight in the next two years, and by then it may be too late. Will there be instances of harm, unsanitary conditions, or issues regarding pill dispensation?    

Read more here:

Monday, January 14, 2013

Merck Starts Overseas Recall of Cholesterol Drug

Merck & Co said it is recalling Tredaptive, its medicine to raise "good" HDL cholesterol levels, in overseas markets where it is sold, after it failed to prevent heart problems in a large study and raised safety concerns.
The medicine is not approved in the United States but the U.S. drugmaker sells it in about 40 countries.
Merck said it would recall stocks of Tredaptive now held by wholesalers, but that pharmacies can continue to dispense their remaining supplies. Even so, the company said it plans to discourage doctors from prescribing the pill based on negative findings from the trial which were announced last month. The study followed more than 25,000 patients in Europe and China for almost four years.

Alabama Supreme Court: Pifzer Suit Involving a Generic Drug May Proceed

(Hat tip to Pharmalot, link below)

The Alabama Supreme Court ruled last week that a lawsuit against Pfizer by a man who claimed he was injured by a generic version of its Reglan heartburn medicine may proceed. The reason? The brand-name drugmaker purportedly failed to warn his physician about the risks.
In that case, Weeks took Reglan and developed tardive dyskinesia. Although he took only generics, Weeks accused Wyeth, which sold Reglan and is now owned by Pfizer as well as two generic drugmakers – Teva Pharmaceuticals and Actavis – of failing to warn of the risk of long-term use.
At issue was whether Weeks could press his lawsuit against Pfizer, a question that a federal court asked the Alabama Supreme Court to decide. In its ruling, the Alabama court wrote that “an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product.”
The issue for the Court: Under Alabama law, may a drug company be held liable for fraud or misrepresentation based on statements that it made in connection with the manufacturing of a brand name drug, by a plaintiff alleging injury from a generic drug maker, and distributed by a different company? 
We'll be digesting this opinion and commenting on it later this week. The ramifications, however, are far potentiall far reaching.  
Here's the opinion in PDF format:

Friday, January 11, 2013

January 2013 Kidney Dialysis Drug Recall: Granuflo News Update

We've been writing about a Fresinius recall of their products known as Granuflo and NatyuraLyte; there was a recall last year based on a Fresenius' internal review of patients treated at Fresenius clinics that found at least 900 instances where patients suffered some type of cardiac injury during  or just after dialysis treatment. NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate that allegedly converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints
At year's end in 2012, Plaintiffs filed Motion to Consolidate the cases into multidistrict litigation (MDL) for all federal lawsuit.  
Several Plaintiffs filed a request with the U.S. Judicial Panel on Multidistrict Litigation asking that all Naturalyte and GranuFlo lawsuits filed in U.S. District Courts throughout the country be consolidated for pretrial proceedings in the District of Massachusetts.
Early in 2013,  Fresenius said in court papers that it agreed that consolidation of the NaturaLyte and Granuflo litigation was appropriate and supported the transfer of the cases to the District of Massachusetts
In another response by interested parties filed on January 3, several Plaintiffs with pending lawsuits have objected to centralizing the cases in Massachusetts, indicating that the litigation should be consolidated in the southeast, because of the number of cases filed in that region. Their choices are the Southern District of Mississippi and the Northern District of Alabama. 

Here is the Fresenius Response:

Thursday, January 10, 2013

Settlement in suit on pregnancy drug

Four sisters who claimed in a lawsuit their breast cancer was caused by synthetic estrogen their mother took during pregnancy in the 1950s have reached a settlement with the drug company Eli Lilly and Co., a lawyer for the sisters said Wednesday.
Attorney Julie Oliver-Zhang said the settlement, for an undisclosed amount, was reached on the second day of a trial in U.S. District Court in Boston. They had not specified damages sought in the lawsuit.
Indianapolis-based Eli Lilly did not immediately respond to a message seeking comment.
The sisters' case was the first to go to trial out of scores of similar claims filed in Boston and around the country. A total of 51 women have lawsuits pending in U.S. District Court in Boston against more than a dozen companies that made or marketed the drug.

Update on the Rakofsky versus the Internet Case - Lessons

I'm not a party in the case known as Rakofsky versus many Defendants (including bloggers, the ABA, and others).

I had previously written about the case here: The Plaintiff claimed defamation as well as negligence for some reason against many many Defendants.  

In my prior post, I asked a question to a hypothetical potential client back in 2011: If someone like the Plaintiff came to my office to discuss a possible lawsuit like this, I'd ask him/her these questions: Are you prepared - as a recent law grad trying to build a practice - to spend the next 2-5 years emotionally involved in this litigation?

Well, now we know more about this case, and more than 18 months later, the case is still sitting. It looks like at the hearing on Motions to Dismiss, the Court asked pointed questions regarding the allegations in the Complaint. It went on to ask pointed questions regarding the theories. It went so far as to suggest ramifications if one set of allegations sounding in negligence were not dismissed - and they were not. 

After the hearing in the Summer of 2011, what has happened? Well, the Court intimated that it would take action if the negligence claims were not dismissed. A letter followed from Plaintiff, noting no cases in support of a negligence theory under New York law, and ending with a note to the Judge allowing the Court to have the counts dismissed if the Court was so inclined. 

So what happens next? Nothing. For months. Until recently, when a Defendant filed a Motion for Sanctions against the Plaintiff.      

What is the lesson here for law students, business people, and even lawyers? That in anger, the threats of litigation don't turn out the way law professors might teach. It's one thing to sit on a law library, office, or starbucks and claim that in theory there has been a wrong, but in reality? 

Reality is this case - A Complaint that expands by hundreds of paragraphs, many Defendants, and a river of Motions to Dismiss. A case that has been sitting not for months, but for years. A case that - presuming it survives the pending Motions - has discovery yet to start.   A case with no trial date ever being discussed, much less set. 

Stay tuned for what happens next- but it's going to be a while.  


Wednesday, January 09, 2013

Aricept Lawsuit: Public Citizen Sues FDA Over Safety Of Alzheimer's Drug

A consumer group pressing the Food and Drug Administration to remove the highest dose of an Alzheimer's disease drug from the market is suing the agency for what it calls "foot-dragging."
Public Citizen  high dose has more-dangerous, potentially deadly side effects including vomiting, which in Alzheimer's patients "can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death." Other side effects more common at the high dose are nausea, diarrhea, anorexia and confusion.
Read more here

Yoplait Greek Yogurt Fraud Lawsuit sent to FDA

A federal judge will let the U.S. Food & Drug Administration decide whether General Mills Inc. may label its Yoplait Greek yogurt with the words "Greek" and "yogurt."
U.S. District Judge dismissed a federal lawsuit by a consumer who accused General Mills of defrauding customers. She directed both sides to take their dispute to the FDA.
More here.

Here is the opinion:

FDA reviewers: Diabetes drug may pose heart risk

Johnson & Johnson's experimental diabetes drug could bring minor heart risks because it raised cholesterol levels in patient testing, or so claim to federal drug reviewers.
According to documents released this week, FDA staffers read  studies that showed J&J's canagliflozin raised levels of LDL, or bad cholesterol. 
Several  studies did not find other serious problems, such as weakening of bones, damage to the liver or kidneys, or various cancers.

FDA Investigates Another Compounding Pharmacy

Federal regulators have quiet­ly stepped in to inspect another Massachusetts pharmacy similar to New England Compounding Center, the Framingham company blamed for the national fungal meningitis outbreak that sickened more than 660 people and killed 40.
Food and Drug Administration workers recently joined state officials, who have been conducting surprise inspections of compounders, to inspect one pharmacy because regulators determined the company’s actions fell under federal jurisdiction.

Tuesday, January 08, 2013

J&J Faces First Vaginal Mesh Implant Trial in New Jersey

J and J will defend its produt in the first trial over its vaginal mesh implant in a case brought by a South Dakota woman who blames the product for constant pain and 18 subsequent operations.
The lawsuit by Linda Gross, 47, is the first of 1,800 in state court in New Jersey to go to trial  over whether J&J’s Ethicon unit adequately warned of the risks of the device.
Jury selection begins this week when more than 100 potential jurors began filling out questionnaires. 
The U.S. Food and Drug Administration told J&J, C.R. Bard Inc. and 31 other manufacturers last January to study rates of organ damage and complications linked to implants. Doctors implanted more than 70,000 mesh devices in U.S. women in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.

Fisher-Price Recalls to Inspect Rock 'N Play Infant Sleepers Due to Risk of Exposure to Mold: News today from the CPSC regarding infant sleepers:  

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should immediately inspect this product and stop using it if mold is found. Units currently in retail stores are not included in this recall to inspect.
Name of Product: Newborn Rock 'n Play Sleeper™

Units: About 800,000 units

Importer: Fisher-Price Inc., of East Aurora, N.Y

Hazard: Mold can develop between the removable seat cushion and the hard plastic frame of the sleeper when it remains wet/moist or is infrequently cleaned, posing a risk of exposure to mold to infants sleeping in the product. The CPSC advises that mold has been associated with respiratory illnesses and other infections. Although mold is not present at the time of purchase, mold growth can occur after use of the product.

Incidents/Injuries: Fisher-Price has received 600 reports of mold on the product. Sixteen consumers have reported that their infants have been treated for respiratory issues, coughs and hives after sleeping in the product.

Description: This recall to inspect includes all Fisher-Price Rock N' Play infant recliner seats called sleepers. The sleeper is designed for babies up to 25 pounds and is composed of a soft plastic seat held by a metal rocking frame. The product has a removable, fabric cover that is sold in 14 patterns and color palettes.

Sold at: Mass merchandise stores nationwide and online since September 2009 for between $50 and $85. Units currently in retail stores are not affected by this recall to inspect. Only products that show signs of mold after use by consumers are included in this announcement.

FDA: Glister-Mary Lee Recalls Brownie Mix Over Allergy Concerns

 Gilster-Mary Lee of Chester, Illinois is voluntarily recalling one lot of Chocolate Chunk Brownie Mix because it contains cartons containing undeclared walnuts. (Wrong packaging/cartons were used that do not declare walnuts). People who have an allergy or severe sensitivity to walnuts run the risk of serious or life threatening allergic reaction if they consume these products.
The only brand involved is Food Club Chocolate Chunk Brownie Mix packaged in cases of 12/21.5oz. Cartons have a Best By date of NOV 28 13 D02 (UPC# 36800-13486). This Best By date code is located on the corrugated case AND on the top flap of the carton. Consumers should return the product to the store or discard it.
The product was distributed to Abingdon, VA. Warehouse on December 5, 2012.
Gilster-Mary Lee became aware of the mis-packaging during an internal review. Investigation indicated that during this production run walnut brownie cartons were inadvertently exchanged with plain Chocolate Chunk Brownie cartons. No illnesses have been reported in connection with this recall.