Archive for June, 2009

On June 9, 2009, the NAACP and nine class representatives filed a motion for class certification in the United States District Court for the Southern District of Indiana, Indianapolis Division, on behalf of an estimated 2,000 current and former employees of the Eli Lilly Company, one of the world’s largest pharmaceutical companies.  The plaintiffs also filed an amended complaint alleging that pervasive discriminatory practices by the company affected African-American employees in pay, promotion and promotion-related opportunities, thus denying these employees an equal opportunity to advance within the company. 

Additionally, more than 100 members of the class filed certified declarations describing their experiences with discrimination while at the company.  The plaintiffs are seeking declaratory and injunctive relief, back pay, front pay, attorneys’ fees, and other costs and expenses.   Plaintiffs’ spokesperson Cassandra Welch, who worked at Lilly from 1992 until she was let go in 2004, stated that she was subjected to years of racist comments and threats – including having a dark-colored doll with a noose around its neck left on her desk.  The other class representatives and the declarations all have similar stories, and claim that complaints to supervisors were never properly investigated.  According to co-lead class counsel for plaintiffs, “Lilly discriminates against its African-American employees by advancing the company’s white employees more quickly, and by denying African-American employees equal job assignments, promotional opportunities, training, compensation and other benefits of employment.”

Whether or not these allegations have merit is yet to be seen, but the number of similar declarations filed and potential class members nationwide cannot be ignored.  Discriminatory employment practices should not be tolerated, and praise must go out to those who are stepping forward to bring light to the situation, particularly those who are still currently employed by Lilly and have to deal with the pressures of going against the employer.  If you have experienced or observed questionable and illegal business practices at your company, you may want to speak to one of our whistleblower attorneys to determine if there are any legal options.

Connecticut Attorney General Richard Blumenthal announced an investigation into recent changes made by Craigslist to its erotic services section.  Following a murder and assault in Boston committed by a perpetrator looking for victims in the erotic services section, Craigslist, an online classified ad website, vowed to eliminate its erotic services section, and open an “adult services” section that would be closely monitored for pornography and potentially dangerous behavior.

Blumenthal, who had previously led a multistate effort with the assistance of 39 other states to deter prostitution ads on Craigslist, vowed continued vigilance over adult listings.  “We will be monitoring closely to make sure that this measure is more than a name change from erotic to adult and that the manual blocking is tough and effective to scrub prostitution and pornography. Our continuing investigation will assure that these steps are substance, not just spin, and that Craigslist really shuts down its open online red light district,” Blumenthal said.

In response to the initial multistate investigation in 2008, Craigslist vowed to assist the National Center for Missing and Exploited Children to identify missing persons and block inappropriate image uploads.  Arizona, Arkansas, Colorado, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming joined Connecticut in the initial coalition to reform Craigslist.  However, following the Boston killing, Blumenthal pressured the website further, believing that Craigslist’s lax monitoring could have contributed to the killing.

Phillip Markoff, a Boston University medical student, is currently being held without bail while awaiting trial for the murder of Julissa Brisman, a masseuse from New York City who advertised on the site.  It is alleged that Markoff found Brisman on Craigslist, shot and robbed her, and kept her personal belongings as souvenirs.

A jury in Newport News, Virginia awarded the family of a retired Navy sailor, Gerald Gray, $1.2 million in a lawsuit against a ship parts manufacturer alleging that Mr. Gray died of lung cancer caused by asbestos exposure.  Mr. Gray was age 75 when he died.  Unfortunately, he did not survive long enough to see the jury return the verdict against John Crane, Inc., an Illinois parts manufacturer of gaskets and others parts used on ships in shipyards that shipyard workers like Gray repaired. 

The total jury award was $4 million against five manufacturers.  The jury, however, was instructed to assign blame to each shipyard related asbestos manufacturer and apportioned $1.2 million of liability to John Crane, Inc.  The jury did not know that the remaining four manufacturers already settled out of court for undisclosed amounts and, therefore, the liability findings against them will not become part of the final judgment.   The jury concluded that ship part manufacturer John Crane, which fought the case, was responisible for 30% of the damages in the case.  Read more about asbestos in shipyards.

On June 16,2009, the Acting U.S. Attorney for the Western District of Missouri in Kansas City announced that a Nevada company an its owners, Sally Qing Miller and her husband, Stephen Miller, and their company, Chemnutra, Inc. pleaded guilty to charges from a February 6, 2008 indictment. 

The indictments and now guilty pleas come after a 2007 dog and cat food recall that resulted in manufacturers recalling more than 150 brands of dog and cat food.  There is no coordinated national tracking system to monitor the number of pet deaths from the melamine contaminated pet food but the FDA suggests that approximately 1,950 cats and 2,200 dogs died after eating pet food contaminated with melamine.  Melamine is an unsafe food additive that is approved manufacturing purposes but has no approved use as an ingredient in human or pet foods in the United States.  Melamine more recently received extensive attention after melamine turned up in infant milk formula in China, causing the deaths of many children.  

The charges against the Millers centered around more than 800 metric tons of melamine tainted wheat gluten that the couple imported into the United States in 13 shipments from China.  The invoices for the contaminated gluten totaled nearly $850,000.  The couple received the melamine-tainted gluten in Kansas City, Missouri and then sold and shipped it to customers across the United States.  The Milers’ customers then used the gluten to manufacturer various brands of pet food. 

The Millers face upt to two years in jail and only up to $200,000 in fines.  ChemNutra faces only a fine of up to $400,000 but can also be ordered to pay restitution (assuming it has the ability to pay, which is doubtful).  Congratulations to Assistant U.S. Attorneys Gene Porter and Joseph Marquez for sticking with prosecutions that have taken years and were undoubtedly not the most glamorous but definitely satisfy to pet owners whose pets died from the recall.

On June 10, 2009, a New York City jury found Dr. Kevin Niksarli liable to Johnson Devadas for $2,360,000 in lost income and $3,1000,0000 for pain and suffering after Dr. Niksarli committed Lasik malpractice.  Dr. Niksarli wrongly decided that Mr. Devadas was a candidate for Lasik surgery.  The jury also awarded Saramma Devaddas $120,000 for her lost consortium claim.  The total award was for nearly $6 million.  Mr. Devadas is a pharmacists from Queens, New York.  Judge Doris Ling-Cohan presided over the trial in New York County Supreme Court.  The Lasik malpractice verdict is reported to be the second largest New York Lasik malpractice verdict in history and possibly the largest Lasik malpractice verdict in United States in history.

The Lasik malpractice trial lasted about 10 days and the plaintiff presented evidence through experts that he was in fact misdiagnosed as a candidate for Lasik surgery.  His experts claimed he suffered from fruste keratoconus, which is contraindicated for Lasik surgery candidates.  After the Lasik surgery, the plaintiffs cornea developed post-Lasik ectasia, which is a progressive thinning of the cornea.  Ectasia can cause blurriness, halos, double vision, glare, contrast sensitivity, starbursts and other problems over the distortion of light passing through the damaged cornea.

Perhaps most alarming and what may have helped justify the significant verdict, plaintiffs presented evidence that Dr. Niksarli intentionally and artifically aged a note in his chart concerning a conversation he allegedly had with the the plaintiffs concerning the risks, benefits and the alternatives to Lasik surgery.

The U.S. Attorney’s Office in the Eastern District of Pennsylvania announced yesterday that a grand jury incited Norian Corporation, Synthes, Inc. and four top Synthes executives, including Michael Huggins, Thomas Higgins, Richard Bhner and John Walsh with conducting medical device clinical trials without FDA approval.  Norian is charged in 52 felony counts of the indictment and the parent company, Synthes, is charged in 44 misdemeanor counts.  Each of the executives are charged with misdemeanors. 

The allegations center around obstructing an FDA investigation of adulterated and misbranded Norian XR and Norian SRS bone cements used in treating fractures.  The defendants allegedly prevented “the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provied by FDDA oversight of clinical trials.”

Synthes is a Delaware Corporation based in West Chester, Pennsylvania.  It is the U.S. branch of a large multinational medical device manufaturer that specializes in trauma products to treat damaged human bone.  Norian is a subsidiary of Synthes that specializes in the manufactuer of osteobiologic medical devices. 

The medical devices at issue, Norian XR and Norian SRS were used to treat “vertebral compression fractures of the spine (”VCFs”), a painful condition commonly suffered by elderly individuals.”  The surgeries were allegedly done despite the FDA-cleared label for the Norian XR specifically exclusing the device for this use and “in the face of serious medical concerns about the safety of the devices when used in the spine.”  Early studies in animals and by other means showed that the bone cement reacted chemcally with blood to cause clots.  Despite knowledge of this problem, the company allegedly prceeded to market the device for VCFs without putting it through FDA required testing. 

The company allegedly did not stop marketing the Norian XR until a third patient had died on the operating table in January 2004.  Indeed, even after the third patient died, the indictment allegeds that Synthes did not recall the Norian XR from the market because doign so would have required the company to disclose details of the three deaths to the FDA.  The defendants allegedly compounded their crimes by carrying out a coverup in which they lied to the FDA during official inspections in 2004. 

One of Synthes’s own surgeron consultants that conducted a “test market” of the device pleaded with the company that doing such tests would “amount to human experimentation whose only defense seems to be that it will be a small study.”  If the surgeron consultant had simply retained a whistleblower lawyer and reported the potential crime to the government, perhaps deaths could have been avoided.

In what promises to be an issue subject to much debate and controversy, New York state legislators are considering a statute that would create a new one-year window for victims of childhood sexual abuse to seek redress in civil courts, regardless of when the abuse occurred.  Thus, although the statute of limitations to bring a criminal action against a child abuser might have expired, the new legislation would allow a claimant to bring a civil action against an alleged abuser many years later.  Not only that, but the claimant would also be able to bring a civil suit against schools, dioceses and other organizations, claiming negligence in supervising their employees or agents who may have committed the abuse in the performance of their duties.  This law provides potentially significant means of recovery for victims of sexual abuse.

Two states have already passed such legislation.  In 2002, California created a one-year statute to provide victims with expired claims an opportunity to file a civil lawsuit, and in 2007, Delaware allowed victims two years to bring their actions.  Many other states, including New York, are considering similar measures. 

While opponents voice concerns about using stale evidence in such cases, some states have felt compelled to consider these “window laws” due to the many high-profile sexual abuse scandals involving Catholic priests.  Rev. Nicholas DiMarzio, bishop of the Diocese of Brooklyn, New York and outspoken opponent of the bill, thinks that the Catholic Church is being unfairly targeted: “People believe we have deep pockets and are responsible for individuals that might have been representing the Catholic Church.”  Defense attorneys echo his sentiments, stating that the only purpose in these cases is to get money from the Catholic Church.  Some say that these lawsuits are almost impossible to defend, noting that many of the cases that were brought due to the California and Delaware statutes named perpetrators and religious superiors who are dead or retired. Also of concern is the huge financial burden it may cause on some of these organizations to settle cases from long ago.  More than 800 lawsuits were filed following the California legislation, and the Archdiocese of Los Angeles alone paid a settlement of more than $660 million in 2007 to people who were abused.

On the other hand, childhood sexual abuse is heinous and ought to be punished and deterred.  Because of the nature of sexual abuse, which may cause many child victims to feel too ashamed to report it, creating a window law gives victims an added opportunity to take action against their abusers.  Additionally, the availability of such lawsuits would be in the public interest to aid in deterrence, compelling schools, dioceses and other organizations to address abuse complaints more quickly and effectively, and take more care in screening applicants for certain positions.  While it may seem unfair if an organization may be found liable for the despicable acts of one of its agents, if a victim cannot recover directly from the abuser, doesn’t it make sense that the one who put the abuser in the position that enabled the harm to occur be responsible?  Can there be a price put on the cost of protecting children? 

Read more about child safety and diseases here.

On June 10, 2009, a Food and Drug Administration (FDA) panel supported the use of Seroquel, a mood-stabilizing medicine manufactured by AstraZeneca, in children and adolescent, stating that the drug was “acceptably safe” and useful to treat schizophrenia and bipolar disorder.  At this time, FDA has not officially approved Seroquel for use in children and adolescents.

Seroquel is an oral medication used to control the symptoms associated with schizophrenia.  Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008.  AstraZeneca is asking FDA to approve to market Seroquel in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.

Schizophrenia afflicts about 1% or around 2.4 million Americans, specifically those in their late teens and early 20’s. Bipolar disorder is significantly more severe when found in children than adults and is characterized by frequent mood shifts and energy levels. It affects anywhere from 1-3 percent or around 5.7 million Americans.

In 1997, the FDA approved Seroquel for the treatment of schizophrenia.  However, the FDA has also reported that Seroquel has serious side effects when used by adult or elderly patients, including:

• An increased chance of death in elderly person
• Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem that can cause high fever, muscle stiffness, sweating, a fast or irregular heartbeat, a change in blood pressure and confusion
• An uncontrollable muscle movement condition known as tardive dyskinesia
• High blood sugar and diabetes

Seroquel lawsuits allege that AstraZeneca knew of Seroquel’s side effects, but did not take adequate steps to warn doctors and patients of them.  In addition, the lawsuits also allege that AstraZeneca aggressively marketed and promoted Seroquel for “off label” use, despite not getting FDA approval during that time.

The FDA panel also supports use of another drug Zyprexa, manufactured by Eli Lilly & Co., for use as a second-line treatment, or a second option after other drugs have failed in adolescents, because of concerns about significant weight gain in many adolescent patients.  In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults.  Zyprexa is Lilly’s top-selling drug with $4.7 billion in sales in 2008.  Lilly is seeking FDA’s approval for Zyprexa in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.

On June 9, 2009, the Minnesota Appeals Court dismissed a lawsuit from former Minnesota Occupational Safety and Health Administration (“MOSHA”) investigators who alleged that they were transferred from their position and dismissed contrary to federal anti-retaliation statutes.  The investigators had complained about their supervisors’ failure to pursue citations against a concrete plant that the investigators believed was conducting business contrary to MOSHA regulations.  The complaining investigators were subsequently denied raises.  MOSHA claimed that the transfers were done to centralize staff, and that the denial of raises was an appropriate management decisions.

However, the Appeals Court determined that the plaintiff in this case, Douglas Crosby, was unable to prove that his transfer and denied raise were connected to his previous complaints about his employer’s behavior.  If this connection had been proven, Crosby would be eligible to receive payment under the federal False Claims Act (“FCA”), which contains a qui tam provision allowing whistleblowers to collect 15-30% of damages awarded by federal courts.  It is unclear whether Crosby will appeal the Appeals Court’s decision.

Another similar lawsuit brought by MOSHA investigator Terrell Swanson is still ongoing.  Swanson’s allegations are similar; he was also denied a raise and transferred following his complaints about his supervisors’ behavior.

If you are aware of ongoing fraud against the government, you could have a whistleblower lawsuit. Contact an experienced whistleblower lawyer for a claim evaluation.

On June 10, 2009, the Endocrine Society announced that bisphenol A (“BPA”), a chemical used to harden plastics and found in products ranging from CDs and sunglasses to plastic bottles and the lining of metal cans, may cause serious health problems. According to studies presented at the society’s recent meeting in Washington DC, exposure to BPA can lead to malformations, infertility, diabetes, and heart problems.

The studies indicate that BPA disrupts the normal function of hormones leading to heart arrhythmia, and exposure to the chemical in children may affect their future development and fertility. Exposure during pregnancy may lead to birth defects. BPA has been shown to changes in the DNA of laboratory mice, indicating that health problems may be passed on to future generations.

The Food and Drug Administration had previously found BPA to be safe in levels found in common products, but recently agreed to revisit its position, and last year the Canadian government declared BPA toxic. Two states, Minnesota and Connecticut, have banned the chemical and bills are pending in several others. In March, the six main manufacturers of baby bottles voluntarily stopped using BPA in their products.

To limit BPA exposure, experts recommend that individuals, especially pregnant women, refrain from eating food from metal cans and drinking from hard plastic bottles. However, it is very difficult to completely avoid exposure to BPA because most people are exposed through unknown sources. One Endocrine Society study found that 93% of Americans tested had been exposed to BPA, many in levels greater than what is considered safe by the FDA. Chemical companies have responded to these findings by claiming that there are no conclusive studies showing that BPA causes these health problems, and more research should be conducted. Read more about child safety and diseases.