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Mirena: An Overview

Mirena is one form of a long-acting birth control called an intrauterine device (IUD). The IUD is globally the most popular form of birth control with an estimated 150 million users. Manufactured by Bayer Pharmaceuticals, Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only two IUD’s approved for use in the United States. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD.

Mirena must be inserted by a medical provider. The system includes a T-shaped body made from plastic and a cylinder-shaped steroid reservoir. Mirena works by slowly releasing levonorgestrel, the progestin hormone, into the uterus each day. Because Mirena thins the lining of the uterus, it also decreases menstrual bleeding.

Clinical trials have proven that Mirena is extremely effective in preventing pregnancy. In the studies, 1,169 women 18-35 years of age used Mirena for up to 5 years. The pregnancy rate over the 5 years was 0.7 per 100 women, or 0.7 percent. After Mirena was removed, 80 percent of women who wanted to become pregnant were able to do so within a year after removing Mirena.

Unfortunately, the drug does not come without a fair share of serious side effects and problems. Some of the most serious health issues associated with Mirena include migration of the device from the uterus, device expulsion, pregnancy complications if a woman becomes pregnant while the IUD is inserted, ectopic pregnancy (an egg becomes fertilized outside the uterus) and pelvic inflammatory disease (PID). PID can cause infertility. Other less-severe, but still inhibiting side effects, are: acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

Several lawsuits have been filed against Bayer for the serious medical, physical and emotional problems resulting from use of Mirena. The lawsuits also specify Bayer knew of the risks and failed to disclose the dangers associated with using the IUD. Bayer is also accused of using deceptive marketing practices in advertising Mirena to the public. The FDA did issue a warning to Bayer for deceiving advertising practices; however, Mirena is still on the market today and available for use.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

ANATOMY OF A LAWSUIT

Pre-trial
• Litigation is the act of bringing a lawsuit against a person or company for a perceived wrong. A civil lawsuit can be settled out of court, or it can follow the steps of the litigation process. Before starting the litigation process, the wronged party, or plaintiff, usually tries to come to an agreement to resolve the conflict and avoid litigation. If no settlement can be agreed upon, the plaintiff files a complaint with the court and a copy is sent to the other party, or defendant, in the form of a summons. The defendant is given time to respond to the complaint. Once on notice, the defendant may choose to settle the case. A judge may order the suit into arbitration, in which a third party attempts to help the parties come to a compromise, or the case moves on to the next step.
Representation
• The hired attorney spends time reviewing the merits of the case, researching other legal precedents, interviewing witnesses and gathering facts. Discovery takes place between the representatives of both parties. They share information formally through written requests. Each attorney may choose to interview the other party’s witnesses in a deposition. During a deposition, the witnesses are under oath and the proceedings are recorded by a court reporter. Expert witnesses are found to testify for both sides about technical issues or bring their expertise to bear on the argument of either side by explaining what happened from their perspective. Both sides typically file motions to clarify procedures and resolve disputes prior to the trial. Sometimes evidence is asked to be held back or an attorney requests a summary judgment, asking the court to dismiss the case before it continues any further based on evidence that’s been gathered.
Trial
• A trial may be held in front of a jury or a judge. During the trial, both sides present their evidence. The plaintiff’s side goes first, and witnesses are called to testify, then cross-examined by the opposing counsel. After both sides present their evidence and witnesses, the attorneys speak to the jury in closing arguments that summarize their cases. The jury then leaves the room and enters a private place where they discuss the case and decide on a verdict. Once a decision has been reached, the losing party may ask for the decision to be changed by the judge. The losing party also may appeal the decision and request another court to review the case. An appeal can prolong the litigation process for up to a year or more.

U.S. Outbreak death toll has reached 24

The U.S. death toll fungal meningitis outbreak due to injections of tainted steroid medication has reached 24. Indiana is now reporting a third death, the Centers for Disease Control and Prevention said on Wednesday, Oct. 25th.

Eight new cases of meningitis were reported, pushing the total nationally to 312 cases in 17 states, the CDC said. Five joint infections caused by injections also have been reported, bringing the total number of infections to 317.

The number of cases has continued to climb despite the recall of the product by the New England Compounding Center (NECC). New cases were reported in Michigan, New Jersey and Virginia in addition to the death reported in Indiana.

If you suspect you have received contaminated steroid injections, symptoms may include fever, headache, stiff neck, nausea, vomiting, photophobia, altered mental status. People often feel like they have a severe case of the flu.

http://nolan-law.com/nlg2014/pdf/necc-preliminary-report-10-23-2012.pdf

The Contaminated Steroid Shot is Methylprenisolone

Methylprednisolone (Brand name: Depo-Medro) is a corticosteroid hormone. It is used to treat pain and swelling that occurs with arthritis and other joint disorders. It is recommended usually be outpatient clinic physicians to be given as a shot in the arthritic joint and pain is supposed to subside within days of receiving the shot.

This medicaion may also be used to treat various conditions such as blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/intestinal/kidney /lung diseases, and immune system disorders. It decreases your immune system’s response to these conditions and reduces symptoms such as swelling, pain, and allergic-type reactions. Methylprednisolone may also be used with other medications in hormone disorders.

This medication is usually injected into a joint as directed by your doctor. Methylprednisolone may also be injected into a muscle or into abnormal skin tissue. The dosage is based on your medical condition and response to treatment

This medication should appear milky white. Before using, check this product visually for particles or discoloration.
.
If this medication is injected into a joint, be careful how much pressure you put on that joint, even if it is feeling better.

Normal side effects include: weakness, weight loss, nausea, muscle pain, headache, tiredness,and dizziness when this drug is suddenly stopped. To prevent these withdrawal symptoms when stopping methylprednisolone, your doctor may reduce your dose gradually

Birth Control Pill Injury Report

Suit alleges Baxter’s heparin killed wife

Baxter International Inc. faces a growing number of lawsuits from families who blame the company’s blood-thinning drug heparin for deaths of loved ones. Heparin was used by millions of people to prevent blood clots during dialysis and other medical procedures.

The latest wrongful death suit was filed Wednesday in Cook County Circuit Court by the widower of an Iowa woman who died at home during kidney dialysis Nov. 30. Mark Scott of Davenport accuses Baxter of selling defective heparin that caused her death.His wife, Melissa Scott, 53, began experiencing nausea and vomiting after treatment began in August, said Tom Ellis, a spokesman of the Nolan Law Group in Chicago

Chicago, which brought the suit on behalf of Mark Scott. On Nov. 30, Ellis said, an allergic reaction to the heparin caused Scott to fall and as a result disconnect from the machine. Mark Scott found his wife on the floor after she called out to him during a treatment. The death certificate said death was caused by an air embolism in the heart, Ellis said. An autopsy was not performed.”Mark wants to know for sure what happened to his wife,” Ellis said. “His wife was well trained on the dialysis machine.”

A Baxter spokeswoman said the company had not yet seen the Scott suit and declined to comment on its specific allegations. But she said the company is aware of at least four other wrongful death suits in the

U.S.
U.S.

“No patient deaths have been confirmed by medical or epidemiological evaluation by Baxter or [the U.S. Food and Drug Administration] to have been caused by the allergic-type reactions associated with the current heparin recall,” said Baxter spokeswoman Erin Gardiner. “None of these suits includes any credible medical information to allow the company to medically evaluate these claims.”The Deerfield-based company also is defending at least five suits brought by patients who allege they were harmed by tainted heparin.

The FDA is investigating whether heparin is connected to as many as 19 deaths and more than 700 serious illnesses since

Jan. 1, 2007
. Baxter insists that four deaths so far may be connected to adverse reactions to heparin.Baxter recalled the drug in February after a spike in severe allergic reactions in patients. Further investigation revealed a significant amount of an unidentified foreign substance contaminated batches of heparin.

The suspect active ingredient originated at a

Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.
Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.

FDA finds unidentified substance in Baxter’s blood-thinning drug heparin

A significant amount of an un-identified foreign substance contaminated Baxter International Inc.’s blood-thinning drug heparin, the U.S. Food and Drug Administration said Wednesday, raising the possibility of intentional tampering in a supply chain that begins with pig farms in China
.The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December.

The FDA on Wednesday said heparin is connected to as many as 19 deaths and 785 serious illnesses since

Jan. 1, 2007
Jan. 1, 2007

. But the FDA timeline extends well beyond the period from September to November, when Baxter’s Cherry Hill, N.J., plant produced the heparin connected to the recent rash of serious allergic reactions. The suspect active ingredient in heparin originated at a Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis.
“We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
At least one former top FDA official who helped lead the fight against counterfeit drugs indicated that some Chinese suppliers in the past have introduced foreign substances to boost production when supplies are tight. That’s what happened in the early 1990s with an antibiotic known as gentamicin sulphate, which produced adverse reactions and some deaths in the U.S.
“The obvious question is, ‘Are these plants back-dooring their supply in order to supplement their capacity?'” asked Benjamin England, who chaired the FDA’s Counterfeit Drug Working Group before leaving for a private law practice in

Washington, D.C.
, in 2003.Epidemic in

China
China

Heparin is produced from an enzyme in the mucous lining of pig intestines. The suspect lots of heparin were made beginning in September, just after the peak in an epidemic of an often-fatal disease known as “blue ear” that afflicted more than 250,000 pigs throughout

China
. More than half those pigs died or were exterminated.An FDA official at the press conference said it is possible supplies of the adulterated ingredient came from pig intestines. But FDA officials emphasized they have not pinpointed the source.

Conventional quality and safety testing typically does not discover a foreign substance,

England
England

added, because the tests are not designed for that purpose.The FDA in its press conference Wednesday said conventional tests performed by Baxter and Scientific Protein did not show any variation because the contaminant is so similar to heparin.

“It acts like heparin in this test, so it looks like everything is fine in the test,” Woodcock said.

Only after further testing, using nuclear magnetic resonance spectroscopy, did the differences in chemical makeup become apparent, the FDA said.
Scientific Protein’s plant obtains heparin from bulk providers of raw material. From its plant in

Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill
Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill

plant for final processing, packaging and shipping.Pointing fingers

Baxter, in its own press conference, sought to point the investigative spotlight back to

China
China

. Baxter executives said the active pharmaceutical ingredient sourced from its China-based supplier is the focus of the company’s investigation.”Either the problem lies further back in the supply chain, somewhere before the material gets to the processing plant, or there’s something in the processing before it comes to Baxter,” said Peter Arduini, president of Baxter’s medication delivery business.

Arduini said the company’s

Cherry Hill
Cherry Hill

manufacturing plant, where multidose vials of heparin are finished and filled before shipment to hospitals and dialysis centers, recently passed an FDA inspection.Arduini said Baxter’s investigation centers further into the “supply stream” in

China
China

. There could be “process issues” associated with Scientific Protein’s Chinese manufacturing plant, he said.Baxter also took issue with the numbers provided by the FDA, which said heparin has played a role in 19 patient deaths since

Jan. 1, 2007
Jan. 1, 2007

. Baxter insists that four deaths so far may be connected to adverse reactions to the suspect heparin.For its part, Scientific Protein disagreed with the FDA’s interpretation of test results that seems to focus the investigation on a possible adulterated material being added during Scientific Protein’s production process.

“During the call with the media, FDA speculated that the source of the adverse events may be a contaminant,” Scientific Protein said in a statement. “It is important to note that this theory is speculation at this point, and [Scientific Protein] is participating actively in working with the FDA to pursue this theory as well as others so that we can understand the cause of the adverse events.”
Scientific Protein’s

Changzhou
Changzhou

plant, owned in a joint venture with a Chinese partner, is preparing a response to an FDA inspection report last week that criticized the plant’s record-keeping, reporting and processes. “It is important to emphasize that the root cause of the heparin adverse events has not been tied to any of the agency’s observations,” Scientific Protein said in a statement.FDA inspections

Dr. Andrew C. von Eschenbach, commissioner of the FDA, declined to say whether the FDA physically inspects the more than 700 Chinese facilities that ship pharmaceutical ingredients and drug products to the

U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.
U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.

consumers.Von Eschenbach said the agency is beginning to reallocate resources to better address the problems presented by the huge growth in foreign-made drugs. “We recognize that the number of sites that we must pay attention to that are beyond our borders are going to require us to address this systematically,” he said.

The FDA plans to increase the number of inspectors, base inspectors in key foreign cities, and build stronger working relationships with foreign regulators, Von Eschenbach added.

test

$6.25 Million Dollar Settlement Paid By Insurers For 57 Year Old

On July 13, 2010 Cook County Judge Donald J. Suriano approved a settlement in the amount of $6,250,000.00 for the benefit of Luis and Kathy Vasquez.  Luis Vasquez was a roofer for Knickerbocker Roofing and Paving Co. and suffered severe injuries on March 8, 2004 when he fell through a roof on the premises owned and operated by Metra known as the 51st Street Coach House. Mr. Vasquez fell straight through a concrete roofing tile some twenty feet to the concrete floor below. The general contractor for the entire project including the re-roof project was Defendant Walsh Construction Company. The roofing contractor, a sub contractor to Walsh, was Knickerbocker Roofing and Paving Company. CTE, Inc., a/k/a Consoer Townsend Environdyne and Cotter Consulting were also contractors.  Plaintiffs allege the Defendants were jointly responsible for inspection of the panels and that Defendant Walsh was responsible for safety on the job.

The $6.25M was paid by all Defendants to settle all claims.  Settlement includes waiver of the $560,000.00 workers’ compensation lien.

Luis and Kathy Vasquez are represented by Donald J. Nolan, Thomas P. Routh and Paul R. Borth, of Nolan Law Group in Chicago, Illinois.

Defendant Walsh Construction Company is represented by Thomas Boylan and Bradford Burton of Cassiday Schade, LLP in Chicago, Illinois.

Defendant Metra is represented by Michael McColl of Foran Glennon Palandech Ponzi & Rudloff, PC in Chicago, Illinois.

Defendant CTE, Inc. is represented by C. Steven Tomashefsky and Jean Gallo of Stein, Ray & Harris, LLP in Chicago, Illinois.

Defendant Cotter Consulting is represented by Bruce Lyon and Angie Grove of LaBarge, Campbell & Lyon in Chicago, Illinois.

Defendant Knickerbocker is represented by John Prusik of Prusik Selby Daley & Kezelis in Chicago, Illinois.

CASE NUMBER:        04 L 011387 Vasquez v. Walsh Construction Co., of Illinois et al.

JUDGE:                       The Honorable Donald J. Suriano

Settlement Amount:       $ 6,250,000.00

Nolan Law Group is a Chicago based personal injury law firm concentrating in aviation accidents, construction accidents, brain injury litigation, medical malpractice, premises liability, product liability, and trucking accidents.

Questions should be directed to Thomas P. Routh of Nolan Law Group at 312.630.4000

$500 Million Jury Verdict Leveled Against Teva Pharmaceutical Industries and Baxter International in Propofol Lawsuit

A District Court jury in Clark County Nevada ordered Teva Pharmaceutical Industries and Baxter to pay a combined $500 million in punitive damages to a plaintiff  who contracted Hepatitis C during an endoscopy procedure after vials of the drug Propofol were allegedly reused on him. The verdict comes on top of the $5.1 million in compensatory damages awarded to the plaintiff and his wife.

Attorneys for the plaintiffs originally offered to settle the case for $1.7 million but the offer was rejected by the defendants.

The bulk of the verdict was against Teva Pharmaceutical who was ordered to pay $356 million in punitive damages, while Baxter International was ordered to pay only $144 million (Teva manufactures Propofol and Baxter distributes Propofol).  

The lawsuit claimed that the plaintiff contracted Hepatitis C as a direct result of product misuse related to unsafe clinical practices from reuse of 50 mL vials of propofol.

Propofol is a short-acting, intravenously administered hypnotic agent often used during the induction and maintenance of general anesthesia. It is also commonly used as sedation for mechanically ventilated adults, and for procedural sedation during colonoscopy and endoscopy.

According to attorneysfor the plaintiff, the 50 mL Propofol vials manufactured and distributed by Teva and Baxter were packaged with inadequate warnings against re-using or “double-dipping’ for more then one patient.  Nurses were alleged to have administited multiple doses of the drug one patient, then used the remaining amounts of the 50 mL vial on other patients. The plaintiffs said  that Teva and Baxter knowingly manufactured and distributed 50 ML vials of propofol to these endoscopy centers, fully aware that only 10 ML vials were needed. The plaintiffs also maintained that this encouraged multi-dosing.

At least nine and possibly as many as 114 other patients were infected with the Hepatitis C during a 2008 outbreak. Additionally fifty thousand other patients were notified that they might be infected.

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals and active pharmaceutical ingredients. Teva is among the top 15 pharmaceutical companies and among the largest generic pharmaceutical companies in the world.  The Company enjoys a firmly established international presence, operating through a carefully tailored network of worldwide subsidiaries. Headquartered in Israel, above 80% of Teva’s sales, which totaled US$13.9 billion in 2009, are in North America and Europe. Teva has over 35,000 employees worldwide and production facilities in Israel, North America, Europe and Latin America.

Baxter International is valued at more than $26 billion and netted $2.2 billion in 2009.

Teva and the drug Propofol were also the subject of a recent recall. On Dec 10, 2009 the FDA warned Teva Pharmaceutical of “significant” manufacturing violations in their California manufacturing facility that makes Propofol. Inspectors found that Teva had not screened every lot of their raw materials for bacterial endotoxins. 

The FDA had previously issued an alert in June of 2007 regarding reports of clusters of patients who have experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia.

Teva voluntarily recalled two lots of Propofol Injectable Emulsion 10 mg/mL 100 mL vials on 7/17/2009 due to presence of elevated endotoxins. Customers were instructed to cease using the product and return it to their distributor. A shortage of Propofol followed the 2009 recall.