Drug Injury Lawyers Blog

June 10, 2013

Whistleblower Awarded $48 Million in Case Against Generic Pharmaceutical Company, Ranbaxy

Dinesh Thakur, a former employee of Ranbaxy, will receive $48.6 million for his role as the lead whistleblower in the case against the India-based generic-drug company. The company pleaded guilty to seven counts of “selling adultered drugs with the intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government.” Ranbaxy paid a total $500 million in criminal penalties.

Thakur began his work at Ranbaxy in early 2004 after he was recruited from the brand-name pharmaceutical company Bristol-Myers Squibb (BMY) based out of New Jersey. As the new director of project information and management, he learned Ranbaxy was in trouble in August 2004, during a meeting with his boss Dr. Rajinder Kumar, Ranbaxy’s head of research and development. Kumar disclosed to Thakur that during an inspection of Vitma Laboratories (a clinical testing lab Ranbaxy hired to test its antiretroviral-ARV-AIDS medication) the World Health Organization (WHO) had discovered that Vitma had fabricated test results. Kumar also disclosed to Thakur that the fabricated test results were not limited to the ARVs Ranbaxy had been producing; rather inventing false data and covering up original test data had been a common practice throughout the company for years.

After the initial allegations from the Vitma incident, Thakur assigned project managers to compare the data Ranbaxy had about its other various drugs with data collected by regulators. Thakur also met with a company official where he was informed that the basic company culture was to manipulate data to achieve the results it wanted in order to have the drugs approved and put on the global market. The company regularly forged, backdated and lied to regulators about its operating and manufacturing procedures. Ranbaxy’s scientists also made it known to Thankur that it frequently substituted ingredients in medications for less expensive, low quality ingredients in order to manage production costs, as well as manipulated testing parameters by substituting brand-name drugs for their own drugs in order to accomplish better testing results. Some drugs made by Ranbaxy had never been tested, and the company essentially put millions of patients at risk.
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June 6, 2013

Indian Pharmaceutical Company Ranbaxy to pay $500 million in Criminal and Whistleblower Case

by Altman & Altman

The Indian generic-drug company, Ranbaxy has pleaded guilty to seven criminal charges after it fraudulently manufactured and sold adultered generic drugs in the United States and throughout the global pharmaceutical market. The company was also charged with making false statements to government officials, inventing drug test data, as well as intentionally producing and distributing drugs without accurately testing them. After a long and arduous investigation by the FDA, Ranbaxy was ordered to pay $500 million in criminal and civil penalties to resolve both a criminal and whistleblower case.

Ranbaxy, which is based in India, was the first foreign generic-drug manufacturer to sell drugs in the United States. Currently it is the number six largest generic-drug maker in the country, selling over $1 billion in drugs to the United States just last year. Though the company has been condemned for its unethical practices, the company has still been allowed to manufacture and distribute its prescription medications. It currently has over 150 generic and brand-name drugs on the market today and manufactures a host of different types of medications including antivirals, AIDS medications, narcotics, and heart and cholesterol medications. Most recently its cholesterol-lowering medication, Lipitor, was recalled after tiny glass particles were found in dozens of batches of the drug.

The case against Ranbaxy began after the former director of project information and management, Dinesh Thakur, was made aware that the company was operating unethically, by fraudulently producing and selling adultered drugs, inventing false test results to put on drug applications (that were subsequently passed by the FDA), and blatantly lying to FDA regulators about its practices as a generic-drug company. Though Thakur filed a complex complaint with the FDA in 2004, the investigation took eight years to complete. In 2008, a court filing by the Justice Department outlined the initial evidence of Ranbaxy’s fraud. The evidence included a compilation of more than 1,000 documents in the form of internal reports, memos, emails, and hundreds of pages of FDA documents as well as testing data.

The evidence uncovered by investigators was overwhelming and showed not only a lack of regulation on behalf of the company, but also the stark reality of the pharmaceutical industry; in that many drug companies often cheat the system and intentionally distribute unsafe or futile medications. In his initial contact with the FDA, Thakur stated that Ranbaxy knowingly sold “untested, spurious, and ineffective medication.” Not only was the company inventing and manipulating data to pass drugs onto the global market, the company was also playing the system by acting in any way the deemed fitting to achieve the results they wanted. They knowingly carried out unsafe practices that put in danger the lives of millions of patients.
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May 14, 2013

Generic Drug Manufacturer Ranbaxy Will Pay $500M To Settle in False Claims Act and Whistleblower Allegations Involving Medicaid/Medicare Fraud & Pharmaceutical Fraud

by Altman & Altman

Ranbaxy USA Inc., the American subsidiary of Ranbaxy Laboratories Limited, an Indian generic pharmaceutical maker, has agreed to pay $500 million to settle fines related to claims that it made false statements to the FDA about its manufacturing practices abroad and sold substandard medications and pay penalties. The US Justice Department, which announced the terms of this resolution, said that Ranbaxy also pleaded guilty to criminal charges involving federal drug safety violations.

Former Ranbaxy Director (and Global Head, Research & Portfolio Management) Dinesh S. Thankur, who filed the whistleblower lawsuit, is the one who brought forward the allegations that the company violated Good Manufacturing and Laboratory Practices, leading to the making of subpar drugs and the falsification of drug information. He also contends that Ranbaxy submitted false claims for a number of adulterated drugs to government healthcare programs for payment, as well as turned in false information when no tests were conducted while falsifying data about backdating tests.

Thankur alleges that the generic drug manufacturer committed Medicare/Medicaid fraud and pharmaceutical fraud. He said that he was forced to notify healthcare authorities about the violations after his former employer didn’t act when he alerted them to the problems.

May 10, 2013

Russian Study Says Vaginal Mesh Implant Injury Risk is Higher for Younger Women, Hysterectomy Patients

by Altman & Altman

According to a new study by Russian scientists, younger women with less serious cases of pelvic organ prolapse and those who had hysterectomies appear to be more at risk of experiencing post-surgical complications after they are implanted with a vaginal mesh device than other patients. The scientists presented their findings at the annual Congress of the European Association of Urology earlier this year.

At Altman & Altman, LLP our Boston vaginal mesh injury lawyers represent women who have suffered serious health complications from an implant device. You may have grounds for a Massachusetts transvaginal mesh lawsuit against one of these manufacturers-Avaulta, Bard, Tyco, Sofradim, Gynecare, American Medical Systems, Boston Scientific, Johnson & Johnson’s Ethicon, Mentor, Uretex, and others. Vaginal mesh devices are also used to treat stress urinary incontinence.

The study group was comprised of 677 patients who underwent vaginal implant mesh procedures between 2006 and 2010 as part of their treatment for POP. One month after their surgeries, the scientists conducted follow up evaluations, and then again three months later. They found that 17% of the participants experienced vaginal mesh complications:

April 29, 2013

Though rare, Stevens – Johnson Syndrome (SJS) can be a life altering and even fatal skin disease

by Altman & Altman

Drug-Induced Stevens – Johnson Syndrome (SJS) is an immune-complex-mediated hypersensitivity disorder caused by an adverse allergic reaction to medications. While there may be several causes of general SJS, Drug-Induced SJS is caused by a severe allergic reaction to both over the counter and prescribed medications including Cox-2 Inhibitors, non-steroidal anti-inflammatory drugs, painkillers, sulfa-based antibiotics, fluoroquinolone antibiotics, and seizure medications.

Medications linked to Stevens – Johnson syndrome include:

Cox-2 Inhibitors used to treat osteoarthritis, rheumatoid arthritis, and sports injuries:
-Bextra -Celebrex -Vioxx -Arcoxia -Prexige
Non-steroidal anti-inflammatory drugs (NSAIDs):
-Children’s Motrin, Ibuprofen including Advil -Daypro -Aleve -Excedrin
Sulfonamides (Sulfa-based antibiotics):
-Penicillin -Amoxicillin -Zithromax / azithromycin (also known as Z-Pack)
-Doxycycline
Fluoroquinolone Antibiotics:
-Parfloxacin -Ciprofloxacin -Norfloxacin -Ofloxacin
Seizure and Anticonvulsant Medications:
-Tegretol -Phenytoin Sodium/Dilantin -Carbamazepine Continue reading

April 25, 2013

Valturna Lawsuit Seeks Damages for Kidney Failure

by Altman & Altman

Plaintiff Dottie Dodson is suing Novartis AG for dangerous drug injury compensation. In her products liability lawsuit, she contends that she developed kidney damage from taking Valturna.

Dodson claims that the drug maker did not adequately warn users about the possible side effects of the hypertension drug, which contains aliskiren, an active ingredient from Tekturna, which is also a drug. Novartis took Valturna off the market in 2012. Dodson started taking the medication in 2010.

Her Valturna lawsuit accuses the pharmaceutical company of inadequately testing the drug before it was put out into the market and aggressively promoting it. She is contending negligence, breach of warranty, strict liability, fraudulent concealment, and state consumer protection law violations. Dodson wants compensatory and punitive damages.

April 19, 2013

$7.25M Cochlear Ear Implant Defect Verdict Awarded to Family of Girl Who Suffered Electric Shocks

by Altman & Altman

A jury has awarded the family of Breanna Sadler a $7.25 million defective ear implant verdict. The 11-year-old girl, who was born deaf, suffered electrical shock multiple times four years after she was implanted with a Cochlear ear implant. Because the defective medical device had to be taken out of her skull and replaced with a competitor model, Sadler was forced to undergo a lengthy open-head surgery.

In their Cochlear ear implant lawsuit against manufacturer Advance Bionics, they claim that the company kept selling the faulty device even after they knew there was a problem with it while delaying disclosure of the defect to make a profit. They say that one electric shock incident was so painful for Sadler she screamed that her face felt like it was melting and on fire. The implant had to be disconnected and for several weeks Breanna was forced to stay completely deaf until the removal/replacement surgery could take place.

Meantime, Advance Bionics unsuccessfully argued that medical device federal regulation pre-empted the family’s lawsuit. They also tried to place some of the blame on a supplier that provided the part that they believe caused the electric shock. Advance Bionics claims that Sadler’s ear implant failed because moisture got in through a “feed-through,” which is the part that transmits electronic signals into the inner ear.

April 12, 2013

Products Liability Claims in Pelvic Mesh Lawsuit Against Boston Scientific Corp. Can Proceed

by Altman & Altman

A federal judge says that a plaintiff’s defective design, manufacturing design, failure to warn, negligence, marketing defect, and strict product liability claims in one pelvic mesh case against Boston Scientific Corp can proceed. The manufacturer had sought to have a number of the defective medical device allegations thrown out.

In her transvaginal mesh device case, the plaintiff contends that she suffered serious complications because the Vesica kit vaginal sling she was implanted with in 1998 was defective. She had used the device to treat her stress urinary incontinence. However, by 2008, she started to experience a number of recurring symptoms. Her doctor told her then that she didn’t need additional treatment.

It wasn’t until after the woman began to experience greater incontinence, lower abdominal pain, and bleeding in 2011 that her doctors notified her that the mesh device was extruding. She underwent revision surgery and later filed her vaginal sling injury lawsuit.

April 3, 2013

Stryker ABG II Hip Lawsuit is Filed in Federal Court in Massachusetts

by Altman & Altman

Lisa Lincoln has filed the first federal Stryker ABGII hip lawsuit in the U.S. District Court for the District of Massachusetts. Her complaint comes nearly one year after Stryker recalled its Rejuvenate Modular and ABG II hip implant parts because of possible risks, such as corrosion/fretting of/around the modular-neck stems.

In her hip injury lawsuit, Lincoln claims that her ABG II system implant caused her to develop a number of health issues, including metallosis, and she has been forced to undergo revision surgery. (High cobalt levels in her blood indicate that this condition was caused by the stem and metal neck rubbing together.) She also said that not even two years after she was implanted with the hip replacement parts, she was already experiencing chronic pain and developed a pseudo-tumor on the back of the acetubular cup.

Meantime, her doctors reportedly found fluid accumulation around her hip implant, which are signs of early failure and loosening. Lincoln is suing for products liability, alleging negligence and breach of express and implied warranties. Her husband is seeking damages for loss of consortium.

March 27, 2013

Mirena IUD Injuries: New Case Study Reports on Risks

by Altman & Altman

A report published this month in the American Journal of Obstetrics and Gynecology talks about a pregnant woman who had to get a Mirena IUD surgically removed from her body when she was three months pregnant. She actually didn’t know the device was still in her because an ultrasound procedure had failed to detect it and she thought it had fallen out.

Instead, the intrauterine device had migrated elsewhere in her body where it resided there for years. Fortunately, the removal procedure went well. However, Mirena IUD removal from a woman who is pregnant does have its risks, including possible pregnancy loss.

If you or someone you love suffered serious health complications from an IUD, please contact our Mirena injury lawyers today to request your free case evaluation. Altman & Altman, LLP represents clients with defective medical device cases against manufacturers. Mirena is made by Bayer.