Drug Injury Lawyers Blog

March 20, 2013

Generic Drug Injury Lawsuits Are Again Examined by the US Supreme Court

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

March 16, 2013

Azithromycin Gets Tougher FDA Warning About Deadly Heart Rhythm Risk

by Altman & Altman

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.

March 14, 2013

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

by Altman & Altman

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

March 13, 2013

Court Awards $8.3 Million for Flawed DePuy ASR Metal Hip Replacement System

by Altman & Altman

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

March 6, 2013

Yaz-Related Blood Clot Forces Woman to Undergo Emergency Amputation of Her Arm

by Altman & Altman

A 32-year-old woman who had to have her arm amputated has filed a Yaz blood clot lawsuit against Bayer Healthcare Pharmaceuticals. She developed blood clots after taking the Yaz birth control pill.

The woman, who has a daughter, age 4, started using Yaz in 2007 and continued to do so until last December when she began to experience a tingling in her left arm. Even after going to the hospital right away, it was too late to save her arm. She had developed limb ischaemia, caused by blood clots.

In addition with dealing with the physical and emotional pain and life-altering changes that come with being forced to lose one’s hand, the plaintiff reportedly had to contend with the frustration of finding out that her insurance would not pay for a prosthetic. She is seeking Yaz injury compensation for medical costs and physical therapy expenses.

February 26, 2013

Jury Orders Merck to Pay $285,000 Fosamax Injury Verdict

by Altman & Altman

A federal jury wants Merck & Co. to pay $285,000 in the drug injury case filed by a plaintiff who contends that the manufacturer did not warn her doctors about the risks involved with taking Fosamax. However, the jury did not agree with Rhoda Scheinberg’s contention that the osteoporosis drug was defective. Her Fosamax injury attorneys argued that taking the drug caused her to sustain a bone disease of the jaw after she had a tooth extracted.

This trial is a bellwether case. According to Reuters, there are over 4,000 Fosamax lawsuits pending in state and federal courts from injuries allegedly resulting from use of this medication.

According to the jury, Merck’s failure to warn about the risks involved with taking Fosamax caused Scheinberg’s personal injury. However, following the verdict, an attorney for Merck stated that the manufacturer does, in fact, provide proper warnings and believes that whether or not Scheinberg had taken Fosamax, she still would have been at risk for developing jaw and dental problems.

February 20, 2013

Bard Avaulta Transvaginal Mesh Lawsuit to Go to Trial in New Jersey

by Altman & Altman

With another Avaulta transvaginal mesh injury trial against C.R. Bard scheduled for trial this month, women and defective medical devices attorneys all over the US will be watching to see what happens. Unfortunately, for what maybe thousands of women, the injuries caused to them by a Bard Avaulta TVM product cannot be undone. Hopefully, however, many of them will be able to also seek redress for the harm they have suffered.

Since at least 2005, the US Food and Drug Administration has received reports of complications linked to this mesh implant device. Already, hundreds of Bard Avaulta TVM cases have been submitted as part of multidistrict litigations.

Bard Avaulta Transvaginal Mesh

February 12, 2013

$63M Motrin Injury Verdict Awarded to Family of Girl Who Developed Toxic Epidermal Necrolysis After Taking Children’s Motrin

by Altman & Altman

A Plymouth, Massachusetts jury has awarded the family of Samantha Reckis $63 million dangerous drug verdict for the severe allergic reaction she experienced from taking Johnson & Johnson’s Children’s Motrin 10 years ago. Samantha T. Reckis was just 7 when she developed Toxic Epidermal Necrolysis (TEN).If the trial judge upholds the verdict, payment to the family, with interest, could be as high as $109 million.

Reckis developed the serious but rare medication reaction after taking the pain reliever to treat signs of a fever. She went on to experience fatigue and develop blisters on her body until most of her skin fell off and she went legally blind. According to Medical Daily, not only did doctors at the hospital have to drill a hole in her skull to alleviate pressure but she also suffered chronic short-term memory loss, damaged her lungs, which impaired her breathing capacity.

The jury determined that J & J and its McNeil Consumer & Specialty Pharmaceuticals, which makes the children’s ibuprofen, neglected to provide adequate warnings about the possible side effects that could result from this over-the-counter medication. Of the $63M Toxic Epidermal Necrolysis injury verdict, $50M is for Samantha and $13 million is for her parents.

February 7, 2013

$10M Stevens-Johnson Syndrome Verdict Upheld Against Johnson & Johnson Subsidiary in Children’s Tylenol and Motrin Case

by Altman & Altman

A judge has determined that no errors of law were made in the $10M dangerous drug verdict that was awarded to the family of Brianna Maya. The girl, then 3, reportedly showed symptoms of Stevens-Johnson syndrome after taking Children’s Tylenol and Children’s Motrin for a fever.

Maya was hospitalized after what began as redness close to her eyes and a rash became blisters on her skin and inside her body. She developed wounds on over 80% of her body, became blind in one eye, suffered organ damage, and experienced scarring on her skin, seizures, and periodic infections. She has also had to undergo a number of eye surgeries.

Her family sued Johnson & Johnson subsidiary McNeil Consumer Healthcare in 201l. A jury found that the defendant did not provide proper warnings that a consumer might develop SJS or Toxic Epidermal Necrolosysis and issued the $10M verdict.

January 31, 2013

Hip Replacement Surgery Risks Among Many Reasons Why Stryker Rejuvenate System Defects are a Problem for Patients

by Altman & Altman

At Altman & Altman, LLP, our hip implant defect lawyers represent clients throughout the US that have been injured because of faulty or dangerous medical devices. One of these devices, the Stryker Rejuvenate hip replacement system, is causing many patients post-implant complications.

Unlike many of the other hip replacement devices that have been associated with serious side effects, the Stryker Rejuvenate isn’t a metal-on-metal device. It does, however, have parts that are metal-on-metal and has been linked to a greater risk of metallosis.

Metallosis is a medical condition that causes metal debris to build up in the body’s soft tissue. It can lead to pain, hip joint failure, mobility limitations, bone dissolution, pseudo-tumors, chromosomal aberrations, and bone dissolution. The Stryker Rejuvenate hip replacement system is also associated with an early failure rate that is unusually high, meaning that some patients are having to get their implants replaced way earlier than is acceptable (within five years rather than in 15 to 20 years), which is forcing them to undergo revision (replacement) surgery. As a result, they are once more exposed to the risks that are involved with this type of surgical implant procedure. They also must then undergo rehabilitation and learn how to function with their replacement implant.