Massachusetts Drug Injury Lawyers Blog

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.

The False Claims Act allows a whistleblower to get a percentage of what the government recovers with this type of lawsuit. Of the $500 million, Thankur will receive about $49 million.

Meantime, Ranbaxy’s US subsidiary has admitted to selling impure drugs made at two Indian manufacturing sites. Prosecutors say that the adulterated drugs included generic versions of medications for epilepsy, acne, nerve pain, and an antibiotic. The generic drug maker also admitted to improperly storing drug samples that were to be tested, delaying a voluntary recall of epilepsy drug Gabapentin (the recall would go on to involve over 73 million pills), making false statements to the FDA, and continuing to sell a drug that failed purity testing.

Also, out of the $500 million, $150 million is forfeiture and the criminal fine, with the rest, save for Thankur’s whistleblower settlement, to go to the civil claims submitted by the US government and all the states.

Whistleblower Fraud
If you are aware of a Medicare billing fraud that is being perpetuated against the state of Massachusetts or the federal government, contact our Boston whistleblower law firm right away to ask for your free, no obligation case consultation.

The False Claims Act’s “qui tam” provision lets US citizens sue on behalf of the federal government while entitling them to a percentage of what is recovered. The Commonwealth of Massachusetts has similar legislation for state violations. State and federal acts cover fraud against state and federally funded programs. Tax fraud, however, is not included.

Read the Settlement Agreement with the US Government (PDF)

Ranbaxy case: Whistleblower to get $49 m of penalty money, AP/Hindustan Times, May 14, 2013

Generic Drug Maker Pleads Guilty in Federal Case, New York Times, May 13, 2013

More Blog Posts:
Nursing Home to Pay $2.7M for Medicaid Fraud Claims Brought to Light By Whistleblower , Boston Injury Lawyer Blog, March 23, 2013

Pfizer Settles Whistleblower Claim Alleging Pharmaceutical Fraud Related to Detrol, Boston Injury Lawyer Blog, October 19, 2013

$25M Whistleblower Settlement Reached in Hospice Fraud Case Against Odyssey Healthcare Inc., Boston Injury Lawyer Blog, March 25, 2012

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:

• 2.2% suffered bleeding during surgery
• 5.5% developed vaginal and pelvic hematomas
• 1.6% sustained bladder injury during the procedure
• 5 patients developed rectal damage
• 1 patient suffered ureteral damage

Post-vaginal mesh surgery, complications included:

• 4.8% experienced mesh erosion
• 2.4% experienced painful intercourse
• 4 patients developed pelvic abscesses
• 7 patients experienced mesh shrinkage

The US Food and Drug Administration says vaginal mesh erosion is the most common complication related to this device when used for pelvic organ repair. Also referred to as surgical mesh protrusion, exposure, or extrusion, this problem involves the mesh device eroding through the vaginal wall, potentially causing infection, pain, bleeding, incontinence, painful sex, prolapse relapse, vaginal scarring, neuro-muscular issues, and vaginal shrinkage.

One possible cause of vaginal mesh erosion is that manufacturers may not have conducted the necessary clinical trials to test the safety of the mesh material for use in the pelvic area. The FDA says that 10% of these mesh devices may fail within a couple of years of implant. Some studies say their failure rate may be as high as 17%.

Already, the federal agency has issued more than one safety warning about transvaginal mesh, first announcing that adverse effects related to the implant device had been reported, then later notifying the public that transvaginal mesh complications are not a rare occurrence. In that warning, the FDA also noted that transvaginal mesh devices used to treat pelvic organ prolapse may present risks not associated with more traditional non-mesh surgeries.

Thousands of women have filed vaginal mesh lawsuits to recover compensation for the harm they have suffered. In addition to a Boston products liability claim against the manufacturer, you may also have grounds for a Massachusetts medical malpractice case if medical mistakes or negligence played a part in causing your complications.

Your case assessment with our Boston transvaginal mesh injury law firm is free. Contact us today.

Urogynecologic Surgical Mesh Implants, FDA

European Association of Urology

More Blog Posts:
Products Liability Claims in Pelvic Mesh Lawsuit Against Boston Scientific Corp. Can Proceed, Drug Injury Lawyers Blog, April 12, 2013

Woman Awarded $3.35 million in Vaginal Mesh Case against Johnson & Johnson, Boston Injury Lawyer Blog, April 11, 2013

Bard Avaulta Transvaginal Mesh Lawsuit to Go to Trial in New Jersey, Drug Injury Lawyers Blog, February 20, 2013

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

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.

A long-term study of Tekturna and patients with impaired kidneys and type 2 diabetes showed that the risks of kidney impairment, raised potassium levels, low blood pressure, stroke, and death went up in patients that took the medication. Researchers found that it is the mix of angiotensin-converting enzyme inhibitors, angiotensis II receptor blockers, and aliskiren that is not safe for patients suffering from chronic kidney disease or Type 2 diabetes. (However, other patients might also be at risk of Valturna’s more serious side effects). The risk of injury to study subjects was so high that the testing had to be stopped. Novartis stopped marketing and selling the drug last year.

Other serious Valturna side effects may include: coronary artery disease, heart failure, nervous system damage, fluid retention, kidney stones, blurred vision, muscle damage, hepatitis, seizures, renal complications and breathing problems. Patients that have sustained permanent damage to their kidneys may have to undergo a transplant or dialysis. Less serious side effects can include nausea, slowed/less even heart rate, fainting, stomach pain, skin problems, heartburn, diarrhea, back pain, joint pain, and cold-like symptoms.

Signs that taking Valturna may be damaging your kidney:
• Problems excreting potassium
• Metabolic acidosis
• Arrhythmias
• Hyperkalemia
• Ventricular fibrillation
• Ventricular tachycardia
• Uremia
• Pericarditis
• Hypocalcaemia
• Anemia
• Lower red blood cell count
• Appetite loss
• Fatigue
• Lethargy
• Coma

Off-Label Marketing of Valturna
Novartis had marketed Valturna for off-label uses for patients with type 2 diabetes (meaning that the US Food and Drug Administration did not test or approve the drug for such purposes). Diabetics were persuaded that not only would the drug reduce their blood pressure levels but also assist them with their renal problems. However, no scientific evidence exists to show that the drug is safe for diabetics or that it can actually help their renal health issues.

In addition to a products liability case against Novartis, you may have reason to pursue medical malpractice damages if your physician prescribed Valturna to you despite knowing that you had a history of diabetes or kidney issues.

Novartis Didn't Properly Test Hypertension Drugs, Suit Says, Law 360, April 16, 2013

Valturna, FDA

More Blog Posts:
Products Liability Claims in Pelvic Mesh Lawsuit Against Boston Scientific Corp. Can Proceed, Drug Injury Lawyers Blog, April 12, 2013

Bard Avaulta Transvaginal Mesh Lawsuit to Go to Trial in New Jersey, Drug Injury Lawyers Blog, February 20, 2013

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyer Blog, June 19, 2012

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.

The family’s ear implant defect case is the first of numerous similar cases to go to trial. Of the family's $7.25 million verdict, $6.25 million is in punitive damages for the manufacturer's allegedly reckless disregard of patients and their safety, $750,000 is for Sadler’s pain and suffering, $236,325 for medical bills, and approximately $10,000 is for her parents’ lost income and travel costs.

In early 2006, several weeks after Sadler received her implant, Advance Bionics voluntarily recalled its HiRes 90Kdevices. In 2008, the manufacturer paid a $1.1 million fine to the US Food and Drug Administration over allegations that it did not tell the regulator that it had a new parts supplier.

Cochlear Ear Implant Cases
A number of Cochlear ear implants have been recalled over the past years because of parts defects. Some of these devices have been linked to injuries, pain, and discomfort. Symptoms of a possible Cochlear implant defect may include:

• Loud noises in the ear
• Cracking or popping sounds
• Shocks to the face
• Pain
• Reduced hearing
• Violent outbursts

Kids are the primary users of the Cochlear ear device, of which about 4,000 have been implanted. The device is for people who are profoundly deaf and don’t get much benefit from hearing aids. The implant is supposed to electrically stimulate nerves in the inner ear and generate hearing sensations. Currents activate the auditory nerve, which transmits a signal to the brain.

In Massachusetts, contact our defective medical device law firm today.

Jury awards $7.25M for hearing aid that severely shocked, USA Today, April 18, 2013

Cochlear Implants

More Blog Posts:
Products Liability Claims in Pelvic Mesh Lawsuit Against Boston Scientific Corp. Can Proceed, Drug Injury Lawyers Blog, April 12, 2013

Family of Teen Girl Who Committed Suicide Following Sexual Assault and Cyberbullying, Intends to File a Wrongful Death Lawsuit Against Her Alleged Teen Assailants, Boston Injury Lawyer Blog, April 18, 2013

Steelworker Rushed to Hospital After Falling Off Roof at Duxbury, MA High School, Massachusetts Workers' Compensation Lawyer Blog, March 21, 2013

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.

Among the plaintiff’s contentions are that Boston Scientific made and distributed a product that had erosive traits, resulting in the mesh device’s failure that then allegedly caused her health complications. Her vaginal sling lawsuit notes that before undergoing the original implant procedure in 1998, the medical device manufacturer had already started preparing for a safer, newer, mesh product than the one she was given.

Vaginal Sling Injuries
Vaginal mesh slings have been linked to injuries and serious health complications in thousands of women. Among the side effects reported:

• Infection
• Urinary problems
• Mesh erosion
• Vaginal pain
• Pelvic pain
• Organ injury
• Problems and pain during sex
• Mesh hardening
• Vaginal scarring
• Fistulas
• Prolapsed organs
• Itching
• Vaginal migration
• Vaginal wall erosion
• Vaginal scarring

In addition to revision surgery, which can involve not just removing the defective mesh product, but also replacing it and repairing any damage done, a woman adversely affected by a medical implant device also might have to undergo blood transfusions, IV therapy, drainage procedures, as well as risk additional health complications and take time off work and her other responsibilities to recover.

The US Food and Drug Administration has even warned about serious complications related to surgical mesh devices. After putting out a notice in 2008 that there were serious complications linked to surgical mesh inserted transvaginally to treat SUI and POP, in 2011, the federal agency issued an update noting that serious complications related to surgical mesh to treat POP are not rare. The FDA has even ordered the manufacturers of vaginal mesh implants to conduct internal studies of the injuries associated with their products.

You want to work with an experienced vaginal sling injury lawyer that knows how to pursue your compensation from a negligent manufacturer, physician, and/or others.

Ohio Judge Upholds Negligence Claim in Transvaginal Mesh Lawsuit Against Boston Scientific, Public Health Watchdog, April 12, 2013

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011

More Blog Posts:
Woman Awarded $3.35 million in Vaginal Mesh Case against Johnson & Johnson, Boston Injury Lawyer Blog, April 11, 2013

Bard Avaulta Transvaginal Mesh Lawsuit to Go to Trial in New Jersey, Drug Injury Lawyers Blog, February 20, 2013

Woman Files Vaginal Mesh Lawsuit Against Boston Scientific For Her Pain and Permanent Injuries, Boston Injury Lawyer Blog, July 11, 2012

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.

ABG II Modular-Neck Hip Stems
Plastic-on-ceramic in design, this hip implant device has two parts that are set up in mental-on-metal fashion. The ABG II modular-neck hip stem, along with Stryker’s Rejuvenate, was fast tracked through the Food and Drug Administration’s Special 510(k) process in 2008. Both medical devices did not undergo tough pre-market testing because they were enough like other devices that were already FDA-approved.

Health complications reported by ABG II hip implant patients include:
• Inflammation
• Swelling
• Metallosis
• Tissue damage
• Bone damage

Some ABG II implant patients are saying that Stryker made fraudulent statements by claiming that the stem and metal neck parts of the device were not likely to corrode or fret.

Metallosis
When metals in an ABG II implant rub together, chromium particles can be emitted, which may be absorbed into the white blood cells. Should Corrosion and oxidization occur, this could cobalt. Genotoxic and very soluble, cobalt can destroy bones and cells, leading to bone loss, inflammation, and pain.

When such serious complications arise, a patient will likely have to undergo revision surgery, which usually requires the removal of the defective hip implant and the insertion of a new device. Such a procedure comes with its own complications and risks—not to mention there is the tedious process of learning how to walk with the new implant. Then, of course, there are the associated costs: more medical bills, physical therapy, lost wages, and other resulting expenses.

You want to work with an experienced hip implant injury law firm that can help you recover your personal injury losses.

Stryker Initiates Voluntary Product Recall of Modular-Neck Stems, FDA, July 6, 2012

Medical Devices, FDA

More Blog Posts:
After $8.3 Million Verdict, Experts Say Jury Litigation Will Cost Johnson & Johnson Billions for Faulty ASR Hip Replacement Device, Drug Injury Lawyers Blog, March 14, 2013

Hip Replacement Surgery Risks Among Many Reasons Why Stryker Rejuvenate System Defects are a Problem for Patients, Drug Injury Lawyers Blog, January 31, 2013

Johnson & Johnson Must Pay $8.3M Hip Defect Verdict to Retired Prison Guard, Boston Injury Lawyer Blog, March 15, 2013

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.

While there are serious risks involving removing a Mirena IUD from women that are pregnant, leaving the device in could lead to other complications, including:

• Septic abortion: A miscarriage involving serious uterine infection
• Preterm labor
• Organ injury
• Infection
• Adhesion formation
• Sepsis
• Premature delivery
• Congenital anomalies in the baby
• Pelvic inflammatory disease
• Tubal damage
• Death

Mirena IUD
The Mirena device is an intrauterine contraception that is supposed to provide birth control for up to five years. This small, t-shaped plastic product needs to be inserted in a woman’s body by a trained health care professional. Approved by the US Food and Drug Administration, Mirena is recommended for women who have already had one child and for women who experiencing heavy menstrual bleeding and want to use an intrauterine device as their birth control method.

Unfortunately, serious side effects have been linked to this contraception that can involve the device migrating from where it was originally placed to elsewhere in the body or perforation of/embedment in the uterus. Should the device move out of the uterine cavity, scarring could result, which can make a woman infertile. In some cases, a woman may have to undergo a hysterectomy to repair the damage caused to her body. Other serious side effects from a Mirena IUD may include abscesses, vaginal erosion, membrane inflammation, and intestinal injuries.

In 2010, the FDA sent a warning letter to Bayer about the manufacturer’s live consumer-directed program that involves representatives going to the homes of consumers to talk about Mirena. The federal agency warned that during what it considered misleading presentations, representatives were overstating Mirena’s efficacy while minimizing its risks.

You should know that failure to warn about a medical device’s risks can be grounds for a defective medical device lawsuit. It is important that you work with an experienced Mirena IUD law firm.

Mirena, Drugs.com

FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users, FDA, October 1, 2009

American Journal of Obstetrics and Gynecology

More Blog Posts:
Generic Drug Injury Lawsuits Are Again Examined by the US Supreme Court, Drug Injury Lawyers Blog, March 20, 2013

Bayer Faces Mirena IUD Lawsuits, Drug Injury Lawyers Blog, December 5, 2012

Boston Dangerous Drug Lawsuits: YAZ, Ocella, and Yasmin Birth Control Pills Linked to Deep Vein Thrombosis, Pulmonary Embolism, Stroke, Heart Attack, and Myocardial Infarction Side Effects, Boston Injury Lawyer Blog, June 19, 2012

The US Supreme Court has just heard arguments in Mutual Pharmaceutical Co. v. Bartlett, a dangerous drug lawsuit involving a woman who was awarded $21 million verdict for serious injuries she sustained after taking the generic version of the drug Clinoril. The plaintiff, Karen L. Bartlett, developed Stevens-Johnson Syndrome and Toxic Epidermal Necrolosis.

The two life-threatening conditions had caused her outer skin to burn off. Not only was at least 60% Bartlett’s body left as an open wound following the skin loss but she also now legally blind. Now, the justices are trying to decide whether generic drug manufacturers can be sued in state court for design defects—especially when the generic version is an exact copy of its brand-name counterpart that the federal government had already approved.

At issue is whether the Supreme Court should reinforce its 2011 ruling that protected generic drug manufacturers from state products liability claims accusing them of not warning about possibly dangerous side effects. In a 5-4 vote, the court had agreed with the defendants that they had no alternative but to use the exact same drug labels as the ones used by the brand drug makers. Following Bartlett’s verdict, which was upheld by 1st US Circuit Court of Appeals on the grounds that the plaintiff had pushed a different legal theory (concentrating on the danger of the drug and not whether or not the warning was accurate) and that even if the defendant could not have used a different warning label for Sulindac, it could have chosen to not manufacture the drug, the drug industry contended that the Supreme Court’s 2011 ruling had been disregarded.

This week, Supreme Court Justice Elana Kagan noted that the Federal Food, Drug, and Cosmetic Act doesn’t give drug manufacturers grounds to expect protection from traditional product defect cases filed under state law. Meantime, Chief Justice Roberts questioned the argument that Mutual couldn’t have complied with both federal and state law. A ruling is expected in June.

Drug Injury Lawsuits
Drug manufacturers are tasked with making sure that they medications that they sell are safe for consumers. In addition to warning of potential dangers, risks, and side effects, they also must design a drug in such a way that such dangers are minimized and with benefits that far surpass any risks.

Unfortunately, there are still pharmaceutical companies that will rush to get a product out there or keep it in the marketplace in order to make a profit—and it is the patients that suffer.

Patients’ Generic-Drug Lawsuits Questioned by High Court, Bloomberg, March 19, 2013

Mutual Pharmaceutical Co. v. Bartlett (PDF)

More Blog Posts:

Azithromycin Gets Tougher FDA Warning About Deadly Heart Rhythm Risk, Drug Injury Lawyers Blog, March 16, 2013

Fungal Meningitis Outbreak Update: Framingham, Massachusetts-Based Compound Pharmaceutical Company Now a Defendant in Dozens of Federal Drug Injury Lawsuits, Boston Injury Lawyer Blog, December 13, 2012

Jury Orders Merck to Pay $285,000 Fosamax Injury Verdict, Drug Injury Lawyers Blog, February 26, 2013

Continue reading "Generic Drug Injury Lawsuits Are Again Examined by the US Supreme Court " »

A tougher warning instituted by the US Food and Drug Administration this week cautions that azithromycin, a commonly prescribed antibiotic, most certainly can cause modifications to the heart’s electrical activity, which can cause some users to develop a deadly irregular heart rhythm. The federal agency had modified the drug’s warning labels last year.

Azithromycin (also known as Z-Pak) was requested in 55.3 million prescriptions last year alone. It is made by Pfizer.

This more stringent warning comes following the FDA’s review of a study published in the Spring of 2012 in the New England Journal of Medicine. Per the study, taking azithromycin over five days appears to slightly increase the changes of death compared to in other patients that were taking other antibiotics. Some of these azithromycin users suffered fatal heart attacks, cardiac death, strokes, and other cardiovascular conditions.

According to the study’s lead author, Vanderbilt University Preventive Medicine Professor Wayne Ray, many physicians prescribe azithromycin rather than amoxicillin because the former’s regimen is easier, involving less pills over less days. This generally means that the patient is likely to take all the pills, decreasing his/her chances of getting a bug resistant to the antibiotic (Azithromycin is usually ingested over five days, while many other antibiotics must be taken for 10 days.)

However, Ray believes that the risk of dying surpasses any convenience for at-risk patients, which are usually the ones who suffer from some kinds of cardiovascular disease. The drug is typically prescribed to combat bacterial infections, such as pneumonia, bronchitis, ear aches, and sore throat.

Ray and his colleagues, who examined Medicaid patients from ’92 – ’06 and studied millions of prescriptions, determined that patients taking azithromycin were 2.5 times more likely to die from a cardiovascular condition while on the drug than patients taking the drug amoxicillin. Also among those at risk of developing a deadly irregular heart rhythm while taking azithromycin are older people and patients with low magnesium or potassium levels in their blood, those with slow heart rates, and people taking meds that tend to stretch out the gaps between heart beats.

The new revised label for azithromycin label now includes stronger warnings, details from Ray’s study, and data from a study conducted by Pfizer.

At Altman & Altman, LLP, our dangerous drug lawyers represent patients and their families with products liability claims against drug manufacturers, distributors, sellers, and other liable parties. In some instances, there may be more than one party to pursue damages from. For example, your physician may have disregarded FDA warnings that a drug was dangerous, so you could have a medical malpractice case cases not just against the drug maker but also your doctor. There is no warranted reason why your use of a medication should kill a loved one or cause you serious injury.

F.D.A. Raises Heart Alert on Antibiotic in Wide Use, New York Times, March 12, 2013

FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms, FDA, March 12, 2013

Azithromycin and the Risk of Cardiovascular Death, New England Journal of Medicine, May 17, 2012

More Blog Posts:
After $8.3 Million Verdict, Experts Say Jury Litigation Will Cost Johnson & Johnson Billions for Faulty ASR Hip Replacement Device, Drug Injury Lawyers Blog, March 14, 2013

Drug recall from Qualitest for oversized pills, Drug Injury Lawyers Blog, September 11, 2012

Fungal Meningitis Outbreak Update: Framingham, Massachusetts-Based Compound Pharmaceutical Company Now a Defendant in Dozens of Federal Drug Injury Lawsuits, Boston Injury Lawyer Blog, December 13, 2012

A California jury ruled on March 8, 2013 that DePuy Orthopaedics knowingly produced and marketed a defective hip replacement device known as the DePuy ASR™ Hip Resurfacing System. The basis of the verdict was that DePuy (a subsidiary of Johnson & Johnson) failed to warn consumers of the dangerous effects that the metal device may have on the body.

During the trial, experts stated that the grinding of the metal apparatus caused dangerous metal toxins to be released into the bodies of patients who were implanted with the device, and caused various medical complications including dislocation, infection, and the need for a second replacement surgery. The jury spoke explicitly of Johnson & Johnson's responsibility.

Continue reading "After $8.3 Million Verdict, Experts Say Jury Litigation Will Cost Johnson & Johnson Billions for Faulty ASR Hip Replacement Device" »

Loren Kransky was awarded $8.3 million in a court settlement with Johnson & Johnson and its subsidiary DePuy Orthopaedics, Inc. for injuries, expenses, and damages he encountered relative to the DePuy ASR™ XL metal-on-metal hip replacement he received in 2007. This is the first of over 10,000 lawsuits that have been filed against Johnson & Johnson and DePuy since the ASR™ Hip Resurfacing System and the ASR™ XL Acetabular System were recalled in 2010. An estimated 93,000 patients worldwide were implanted with the ASR System.

The ASR Hip System was developed by orthopaedic surgeons and biomedical technicians for a procedure called resurfacing which is used by surgeons seeking an alternative method to the standard hip replacement for patients with severe arthritis and disease of the hip joint.

The major issue of the ASR Hip System as well as other hip replacement devices is its metal cup and ball components. Doctors and researchers have asserted that the design is flawed and has a high wear rate which causes complications such as dislocations, severe pain, infection, and often the need for a second revision surgery. Patients who have received the implant have also reported, which occurs when metal debris enters the bloodstream.

Continue reading "Court Awards $8.3 Million for Flawed DePuy ASR Metal Hip Replacement System" »