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Pradaxa Bleeding Lawsuits Progress in Federal Multidistrict Litigation

More than 1,700 personal injury lawsuits are pending against pharmaceutical company Boehringer Ingelheim in Illinois. Plaintiffs filing in the in federal multidistrict litigation allege that the company’s blood-thinning medication Pradaxa caused internal bleeding.

These lawsuits are part of multidistrict litigation in U.S. District Court, Southern District of Illinois. On November 4, the court established a protocol for selecting bellwether cases, directing both sides to select up to three lawsuits as possible candidates. In January 2014, the court will select four of those cases for the first bellwether trials, which are scheduled to commence in August 2014.

According to court records, at least 1,767 lawsuits are pending in the litigation. The complaints allege that Boehringer Ingelheim failed to adequately warn doctors and patients about internal bleeding as a side effect of Pradaxa and about the lack of an available antidote.

The Food and Drug Administration recorded more than 582 deaths and 3,292 reports of other adverse events involving Pradaxa in 2012, according to the Institute for Safe Medicine Practices. The figure exceeds the adverse reports of any other drug tracked in 2012.

According to news reports, regulators in several countries have issued warnings regarding the side effects of the drug, especially concerning internal bleeding.

Pradaxa has been sold as an alternative to warfarin, an established blood-thinning medication. Blood-thinning medications are prescribed to prevent strokes caused by blood clots. Some research has found Pradaxa to be more effective than warfarin at preventing such strokes. However, internal hemorrhaging caused by warfarin can be treated with vitamin K; there is no such effective treatment for stopping internal bleeding caused by Pradaxa.

U.S. District Judge David Herndon recently ruled that Boehringer Ingelheim must pay a fine of almost $1,000,000 for withholding or failing to preserve “countless” files sought by the plaintiffs. Judge Herndon said that the company acted in bad faith and that its efforts to safeguard the documents were grossly inadequate.

The documents in question concerned the drug maker’s development and marketing of Pradaxa. Judge Herndon said that the failure to preserve them was “egregious.”

Boehringer Ingelheim said that there were unintentional and unexpected discovery problems in the litigation, and that the plaintiffs were not prevented from obtaining access to the central documents in the case.

A key allegation in the lawsuits is that Boehringer executives were aware of the risk of death from internal bleeding when they brought the drug to market in 2010. Pradaxa has generated sales of more than $1,000,000,000 for the German, family-owned firm.

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Pfizer Sued Over Birth Injury that Resulted in Death

An Illinois couple has filed a lawsuit against Pfizer after a birth injury resulted in their son’s death. The plaintiffs assert that their son was exposed to the antidepressant Zoloft, manufactured by Pfizer, and that he suffered from syndactyly and hypoplastic left heart syndrome, which eventually led to his death.

The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania and names the distributors and manufacturer of Zoloft as defendants. The claims include negligence, wrongful death, design defect, breach of warranty and failure to warn. The plaintiffs request damages for medical expenses and other losses. The case is joined with other similar cases in the Zoloft multidistrict litigation (MDL).

The lawsuit claims that Pfizer had a duty to warn the medical community as to the safety of Zoloft, and that the generic version of Zoloft, known as sertraline, contained package inserts that omitted information and contained misleading and false statements. The lawsuit states that the defendants knew or should have known that drugs such as Zoloft have a greater risk of side effects in children, and that they should have provided a warning of the risks to the developing fetus if a pregnant woman takes Zoloft.

According to the lawsuit, women who took Zoloft during pregnancy have given birth to children with birth injuries, such as heart defects and persistent pulmonary hypertension of the newborn (PPHN). The lawsuit alleges that the defendants failed to disclose data to consumers, the medical community and the FDA.

Paul Greenberg is a Chicago birth injury lawyer and Chicago birth injury attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

Feds Sue Chicago Doctor in Prescription Drug Kickback Case

Federal authorities have charged a Chicago doctor with taking kickbacks.

Federal authorities filed suit against Dr. Michael J. Reinstein, a Chicago psychiatrist, on November 15, alleging that in exchange for kickbacks from drug companies, he prescribed a potentially dangerous psychotropic drug to thousands of Chicago-area nursing home patients with mental illnesses.

In a statement, acting U.S. Attorney Gary Shapiro said the lawsuit is “the largest civil case alleging prescription medication fraud against an individual ever brought in Chicago.”

In a 2009 joint investigation, the Chicago Tribune and ProPublica found that Reinstein relied very heavily on clozapine, a risky and powerful psychotropic drug. In 2007, Reinstein prescribed the medicine more than all the doctors in Texas combined, according to the investigation.

The lawsuit, filed recently in U.S. District Court in Chicago, alleges that Reinstein made no less than 140,000 false Medicare and Medicaid claims for antipsychotic drugs he had prescribed based on kickbacks from the manufacturers of the drugs, without regard to his patients’ needs.

Authorities further allege that he submitted at least 50,000 Medicare and Medicaid claims falsely stating that he had monitored his patients at Chicago-area nursing homes and long-term care facilities.

Authorities are seeking triple damages under the False Claims Act, in addition to civil penalties for every alleged false claim. The total damages could quickly reach seven or even eight figures.

Novartis, the maker of Clozaril, a brand name for clozapine, had a longstanding agreement with Reinstein to pay him to promote the drug, according to authorities.

The lawsuit described Clozaril as a “drug of last resort” and claims that despite this fact Reinstein routinely had thousands of patients taking clozapine at any given time.

In 1998, the patent on Clozaril expired, and generic versions of clozapine hit the market. But Reinstein “resisted pharmacy and drug company efforts to switch his patients to generic clozapine and continued to be the largest prescriber of Novartis’s Clozaril to Medicaid recipients in the United States,” according to the lawsuit.

In the summer of 2003, Novartis stopped paying Reinstein to promote Clozaril. At that time, Florida-based IVAX Pharmaceuticals Inc. tried to persuade Reinstein to switch to the firm’s generic form of clozapine.

Reinstein agreed, and for the next several years, IVAX paid him $50,000 per year under a “consulting agreement,” the suit alleged.

“After reaching this kickback agreement with IVAX, Reinstein immediately began switching his patients from Clozaril to IVAX’s clozapine,” the suit said. He soon became “the largest prescriber of generic clozapine in the United States.”

The lawsuit alleged that IVAX and its eventual parent company, Teva Pharmaceutical Industries, paid for at least three trips to Miami for Reinstein and several associates, including hotel, airfare, cruises, and dinners.

After the 2009 publication of the Tribune-ProPublica investigation into Reinstein, he told Teva to stop paying him, the suit says.

A spokeswoman for Teva released a statement saying the company was cooperating with investigators.

Paul Greenberg is a Chicago medical malpractice lawyer and Chicago medical malpractice attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

Flame Retardants May Be a Danger to Human Health

Between 1970 and 2004, levels of some flame retardants in the blood of American adults doubled every two to five years. American babies are born with some of the highest levels for all infants in the world. According to a UC-Berkeley public health study, babies exposed to flame retardants in the womb have lower birth weights.

The weight decrease found by the study to be associated with flame retardants was close to the weight decrease caused by mothers who smoke during pregnancy. While most of the babies studied weighed more than 5.5 pounds, and therefore were not considered low birth weight babies, their decreased weight could put them at greater risk of being underweight.
Low birth weight babies can have greater challenges with cognitive and social development.

Flame retardants are found in baby products, foam furniture, carpet padding, electronics and other common household items. Flame retardants are in so many everyday products that they can now be found in household dust. Even dogs and cats have tested positive for this type of chemical.

A National Health Institutes director said the greatest concern with flame retardants is their impact on developmental and reproductive potential. Exposure in early childhood is of particular concern. Some very young children may be exposed to flame retardants over long periods of time and this exposure could interfere with their brain development. Researchers also believe these chemicals could be associated with some types of cancer.

Defenders of flame retardants say they save lives by delaying ignition of flammable materials. This delay of a number of seconds could allow a person to get out of a burning room filling with smoke and therefore survive, instead of being engulfed in fumes and smoke, passing out, and dying in a fire.

Paul Greenberg is a Chicago product liability lawyer and Chicago personal injury attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

FDA Budget Includes New Money for Food Safety Initiatives

The Food and Drug Administration’s fiscal year 2013 budget includes priorities that would improve food safety, protect patents and ensure import safety from China.

The new budget includes $364 million in a “protecting patents initiative” that will help review biosimilar products. There will also be money for research to protect customers and patients. There is an additional $253 million for a “transforming food safety initiative” that could be a boost for the Food Safety Modernization Act.

The protecting patients program and the food safety initiative both would pour in about $10 million in new money toward a collaboration with China to increase the FDA’s presence there. This would help improve the safety of the drugs and food produced that is then imported to the United States from China.

Finally, the “medical countermeasures initiative” is slated for another $3.5 million to help protect Americans from emerging infectious diseases. The new money in the FY 2013 budget will help medical countermeasure development timelines and will assist the FDA to expand a program that helps developers focus on medical countermeasures.

Chicago personal injury lawyer Robert Briskman is experienced at helping people who have been hurt by unsafe products. To learn more, call 877-595-HURT (4878) or visit more of http://www.briskmanandbriskman.com.

Consumer Groups Demand Redesign of Dangerous Baby Seat

The Bumbo International Baby Seat is in trouble again.

The makers of the Bumbo had to recall the baby seats in 2007 for new labeling because children were falling in the seats from elevated surfaces. The original product’s packaging showed the seat on a raised surface.

Many of the more than 30 skull fractures and other injuries sustained when children fell out of the Bumbo happened when the product was being used on a table or other raised surface. Now, consumer advocates are insisting the product be completely redesigned since children are still being injured when they fall out of the seat on the floor.

There are no safety standards or product testing with seats like the stationary Bumbo. Many parents may assume that all children’s products undergo the same scrutiny that high chairs, bouncer seats and booster seats need to pass.

Consumer groups are pushing for the Bumbo to be redesigned so that no children are injured in the future. The groups believe a redesign would fix the Bumbo’s problems. Five groups have added their name to the list of concerned consumers: Consumer’s Union, Kids In Danger, Consumer Federation of America, Public Citizen and US PIRG, which is a coalition of state public interest research groups.

Chicago defective products attorney Paul Greenberg has experience in helping parents whose children have been hurt by kids toys and other products. To learn more, call 877-595-HURT (4878) or visit more of http://www.briskmanandbriskman.com.

NTSB Suggests Ban on All Portable Electronic Devices for Drivers of Any Vehicle

The National Transportation Safety Board recently called for a total ban on driver use of portable electronic devices – both hands-free and hand-held – in all motor vehicles.

Distraction-related accidents took the lives of about 3,000 people on America’s highways last year, according to NTSB Chairwoman Deborah Hersman.

The agency’s press release calling for the ban included examples of deadly crashes, injury accidents and near misses caused by distracted drivers, pilots and engineers.

The NTSB does not have the authority to make state law, but the agency’s recommendations can be used when legislators bring the issue up in capital buildings across the country.

For example, a motorcoach driver slammed into a low bridge in 2004 while using a hands-free device and injured 27 high school students. A commuter train conductor texting on his phone hit a freight train head on in 2008, killing 25 in California. Two airline pilots using their laptop computers were distracted and overflew their destination by 100 miles in 2009. A tugboat mate killed two tourists while he was using a laptop computer when his tug pushed a barge over their duckboat in the Delaware River in 2010.

The NTSB report outlined the different mishaps in assorted transportation types in an effort to show the many ways that portable electronic devices can distract the operator of a vehicle. The agency set the deadlines across all modes of transportation.

The Department of Transportation banned the use of smartphones by professional truck and motorcoach drivers in the fall. That rule was created by the Pipeline and Hazardous Materials Safety Administration and the Federal Motor Carrier Safety Administration.

Researchers say the statistical evidence backs up the NTSB’s recommendations. An analysis of 300 studies on mobile phones showed no evidence that people using hands-free devices were any less distracted than people holding a phone to their ear, according to the Associated Press.

American privacy laws have made it difficult for researchers to gather thorough data on motor vehicle accidents caused by cellphone distraction. Studies conducted in Australia and Canada have shown drivers are four times more likely to crash if they are talking on the phone regardless of whether it was hands-free or handheld.

A Carnegie Mellon study from 2008 also backed up claims that hands-free devices are just as dangerous as hand-held ones. That research showed it is the brain, not the hand, that is distracted. Driving while talking on the phone is distracting because the brainpower is being divided. Research done in driving simulators showed a loss of skills when drivers were subjected to voices talking to them, according to the AP. Investigators see personal electronic devices in increasing numbers of accident scenes.

Paul Greenberg is a Chicago car accident lawyer and Chicago car accident attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

FDA Warns Consumers About 20 Dangerous Weight Loss Supplements

Consumers should be extremely wary of taking weight loss supplements as they could cause them serious harm. The FDA recently issued a warning in regards to 20 weight loss pills and supplements that have sibutramine. More than a year ago, the FDA pulled the weight loss medicine Meridia off the shelves because sibutramine increased the chances of a heart attack, stroke, and an unexpected death. The FDA notes that there are huge concerns when dietary supplements use the same active ingredients as FDA-approved drugs, but have not gone through the FDA’s rigorous testing process.

Especially for individuals that are trying to lose weight and have a history of stroke, heart failure, coronary artery disease, and arrhythmias, these weight loss supplements should be thrown away. Do not be fooled by labels that say 100 percent natural. If it contains sibutramine, it is not a natural pill for weight loss.

The FDA has sent out warning letters to manufacturers who sold this product and will conduct seizures of the supplements and criminal prosecutions if the manufacturer does not stop selling the weight loss supplements “as is”. Part of the FDA’s review is to find supplements that are unapproved, misbranded, or contain adulterated dietary supplements. When manufacturers are found to be operating outside the law and do not have quality and safety practices in their supply chains, they can be liable for causing harm.

A Chicago defective products attorney and Chicago personal injury attorney should be contacted immediately to take legal action if you or a loved one is dealing with a serious injury or wrongful death due to taking these supplements. To learn more, call 877-595-HURT (4878) or visit more of http://www.briskmanandbriskman.com.

Children’s Overdose Rates High as FDA Issues New Measurement Guidelines

Children less than five years old total more than half of all emergency room visits due to medicine misuse and misdosing, reports the Substance Abuse and Mental Health Services Administration. The numbers are staggering given the amount of education and oversight that exists with over-the-counter and pharmaceutical medication. As a result, the Federal Drug Administration (FDA) has issued new guidelines on instructions, measurements, and packaging that manufacturers should adhere to in an effort to curb child overdoses.

FDA studies showed that for medicines that came with a measuring device, there were often discrepancies between the unit markings displayed on the device and those indicated in the dosing directions. The new guidelines call for devices to have the same units of measurement as the instructions and avoid all unnecessary markings. Measurements should be clearly visible on a device when a medicine is added. And, all liquid medicines bought over the counter should contain measuring devices for a parent’s convenience. Liquid cough syrups, cold medicines, pain relievers, and digestion aids are the most frequently used medicines and thus have been prioritized by the FDA for these new recommendations.

“Accidental medication overdose in young children is an increasingly common, but preventable public health problem,” said Dr. Karen Weiss, program director for the FDA’s Center for Drug Evaluation and Research Safe Use Initiative.

Confusing packaging and instructions can cause parents to use household spoons or devices that did not come with the medicine, which can also lead to medication mistakes. Overall, measurement discrepancies can lead to sickness and, in some instances, a wrongful death. The Journal of the American Medical Association published a study showing that confusion can lead to a 10-fold increase in overdose for even minor discrepancies, such as instructions listing .5 and 0.5 milliliters in various areas of their product. Dosing variations based on a child’s weight can add to the confusion. In addition to the new guidelines to reduce child overdose, experts encourage parents to redouble their efforts to keep medicines out of reach of children.

Johnson & Johnson has particularly come under fire since more than 40 of its medicines have been recalled. Their popular children’s medicines such as Kids Tylenol, Motrin, PediaCare, and Mylanta have been subject to recalls during the past year. The U.S. Pharmacopeial Convention found that 46 percent of individuals did not understand dosage instructions across all medicines.

More parental education and open communication with your pediatrician, together with drug manufacturer improvements, are needed to prevent overdoses and wrongful deaths. In Illinois, Chicago wrongful death attorney and SuperLawyer Paul A. Greenberg, Esq., counsels individuals and family members after they’ve had a problem with a defective or unreasonably dangerous children’s product. Measurement discrepancies, design defects, and improper instructions can harm a loved one. At the law firm of Briskman Briskman & Greenberg, their Chicago wrongful death lawyers will tenaciously pursue a client’s rights when they have fallen victim to a dangerous product. For decades, they have taken on complex cases and helped families overcome the obstacles of losing a loved one.

Paul Greenberg is a Chicago wrongful death attorney and Chicago wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

Antidepressants Cause Heart Defects in Chicago and Illinois Newborns

The Illinois Department of Health shows that cardiac health defects are the highest type of birth defects affecting children in Chicago and the state. The Federal Drug Administration (FDA) recently published two studies showing that mothers who took the antidepressant drug Paxil were more likely to have a child with a heart defect. FDA classifies the drug as Category D, indicating positive evidence of fetal risk. When expecting mothers take Paxil within the first trimester, their baby is one and a half to two times more likely to have a heart defect. These cardiac defects include ventricular septal defects (VSDs) and atrial septal defects (ASDs).

VSDs are abnormal openings in the wall between the heart’s two lower pumping chambers, known as the ventricles. Sometimes these holes close on their own; otherwise, surgery is required to ensure that serious and sometimes life-threatening heart and lung problems do not occur. ASDs are abnormal openings in the wall between the heart’s two upper chambers, known as the atria. Like VSDs, ASDs sometimes close over time; but for significant defects, surgery is necessary so that heart complications and lung problems do not occur. Research by the Mayo Clinic shows that sometimes these defects are not apparent until adulthood, and then all of sudden a person can experience high blood pressure or even heart failure.

Paxil is not the only antidepressant of concern for expecting mothers. Other antidepressants such as Celexa, Lexapro, Prozac, Symbyax, and Zoloft have been linked to cardiac defects too. These selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed drugs to combat depression, says the FDA. SSRIs also can cause persistent pulmonary hypertension (PPHN). The FDA found that PPHN is six times more likely to occur in a newborn if the mother took the antidepressant after the 20th week of pregnancy. Babies also had a higher rate of irritability, difficulty feeding, and in some rare cases, difficulty breathing.

The FDA recommends that expecting mothers talk to their doctor about their use of antidepressants to determine if it is medically necessary to continue during pregnancy. Unfortunately, many expecting mothers who are taking SSRIs and antidepressant drugs are not told of the serious side effects posed by these drugs. When a child is born with a cardiac defect, sometimes the only remedy to help your child is to seek legal counsel to explore the available options.

Thousands of children are affected each year in Chicago and Illinois by heart defects. Parents are recommended to call a qualified Chicago birth injury lawyer to represent them and their newborn. Chicago birth injury attorney Robert I. Briskman, Esq. provides unparalleled personal attention and dedication to resolve the challenging situation of your child’s birth injury. At Briskman Briskman & Greenberg, their highly skilled lawyers have decades of trial experience and access to a world-class team of experts to get the compensation your child deserves for his or her past, present, and future medical needs.

Robert Briskman is a Chicago birth injury lawyer and Chicago birth injury attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

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The law firm of Briskman Briskman & Greenberg represents injured people throughout Illinois, including Chicago, the Chicagoland area, Joliet, Waukegan, Cicero, Evanston, Arlington Heights, Wheaton, Bolingbrook, and Naperville, as well as other cities within Cook County, Will County, DuPage County, Lake County and McHenry County. Briskman Briskman & Greenberg also represents injured people throughout Wisconsin, including Kenosha, Milwaukee, and Madison.
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