Archive for June 2011

Philly Woman Diagnosed with Stevens-Johnson Syndrome After Taking Children’s Motrin

June 29, 2011

PHILADELPHIA, PA – On April 30th, Judge Jan E. DuBois of the U.S. District Court for the Eastern District of Pennsylvania ruled that the failure-to-warn claim is not preempted because manufacturers failed to show that the Food and Drug Administration would have rejected a stronger warning.

In this case, Kiley Wolfe alleges that over-the-counter Children’s Motrin caused her to develop Stevens-Johnson Syndrome, a rare and serious skin disorder. SJS starts out mimicking flu-like symptoms, and is usually accompanied by a painful red rash that spreads and blisters. Talk about a headache!

Kiley Wolfe developed a virus in May of 1996 and was prescribed OTC Children’s Motrin by her doctor. Even though she developed a facial rash and her symptoms did not improve, the nurses at her doctor’s office advised her mother, Janet Leland, to keep administering the Motrin to Wolfe. A few days later Wolfe was diagnosed with SJS at the hospital, and eventually required a liver transplant.

In 2006, the FDA recommended that the warnings for the OTC Children’s Motrin – and all ibuprofen products in general – be strengthened to include skin rashes and blisters, as well as urging consumers to consult with a medical professional if an allergic reaction occurs.

During Wolfe’s injury, the FDA-approved label included warnings to “call your doctor if your child does not get relief within the first day of treatment, or pain or fever gets worse…”

Leland testified that the the box and bottle did not have anything on there that mentioned any warnings. Wolfe sued the manufacturers, McNeil-PPC, McNeil Consumer Healthcare, and Johnson & Johnson Inc., alleging negligence, strict liability, breach of express warranty, breach of implied warranty of merchantability, violation of consumer protection law, and punitive damages.

The judge concluded that the FDA stated that drugs like Children’s Motrin “should be improved to warn of the risks of severe skin reactions associated with ibuprofen products.” Therefore the manufacturers did not present clear evidence that the FDA would have rejected a stronger label.

The judge also says that a reasonable jury could conclude that a stronger warning label would have been necessary, and would have prevented the injuries that occurred.

Judge DuBois granted manufacturers summary judgment on the negligence claim, manufacturing defects claim, design defect claim, misrepresentation claim, and breach of warranty claims. However, she denied manufacturers’ motion as to the punitive damages claim because they concealed data from the FDA.

“Plaintiff has presented evidence that defendants concealed from the FDA two cases of SJS found in patients during a massive study it commissioned on the safety of OTC ibuprofen use,” Judge DuBois explained. The manufacturers received these reports, yet a Clinical Study issued by McNeil had no mention of these findings.

There goes our tax dollars hard at work. We fund these pharmaceuticals to conduct studies to ensure our safety, and if they yield findings detrimental to their drug, they mask them? How is that fair??

If you have been diagnosed with Stevens-Johnson Syndrome after taking Children’s Motrin or would like to learn more, stop by our website.


Nexium May Cause Bone Deterioration and Bone Fractures

June 22, 2011

HOUSTON, TX – April 19: Ginny Begin, 58, has sued AstraZeneca L.P. And AstraZeneca Pharmaceuticals L.P. – manufacturers of Nexium – in federal court, alleging that the acid reflux drug caused her to suffer from loss of bone density and bone fractures. Begin filed the complaint in the U.S. District Court for the Southern District of Texas.

Between 2003 and 2011, Begin took Nexium everyday to treat her acid reflux. On July 11, 2005, Begin was walking when a bone in her leg inexplicably snapped in half. In June 2007, the same bone broke in the same place while walking down a flight of stairs. Three bones in her ankle also shattered unexpectedly. Talk about a “tough break!” As a result of these injuries, Begin still experiences severe pain in her leg and ankle.

Nexium is a prescription-strength proton pump inhibitor, or PPI, which decreases the amount of acid produced in the stomach. The U.S. Food and Drug Administration issued an April 11th safety alert stating use of PPIs (Nexium included) results in an increased risk of fractures.

In May 2010, the FDA “ordered PPI manufacturers, including AstraZeneca, to include safety information and warnings about the increased risk of osteoporosis and fractures associated with PPIs.”

The complain states that “As early as 2006, studies found PPIs, by reducing hydrochloric acid in the stomach, interfere with the body’s ability to absorb calcium, thus speeding up bone loss and leading to an increased number of fractures. In total, six studies found the risk of fracture significantly increased for those patients over 50 who took a prescription-strength PPI, like Nexium, or who took any PPI regularly for more than one year.” Pretty “bone-chilling” results, isn’t it?

Begin claims that AstraZeneca marketed and sold Nexium without warning consumers of the significant risks of bone deterioration despite having knowledge of the risks. Her complaint states that “defendants were negligent in failing to use ordinary care in manufacturing a safe product for the ultimate user; in failing to inspect, supervise and/or carry out health and safety inspections of its product; in failing to adequately warn foreseeable ultimate users of potentially harmful side effects associated with its products; in failing to use ordinary care in selling a safe product for the ultimate user; and in failing to adequately advise foreseeable ultimate users on how to properly use its products.”

If you or a loved one have taken Nexium and have experienced any of these side effects, you may be eligible to file a dangerous drug claim.A dangerous drug attorney can help you review your situation, as well as determine if you can file a lawsuit for a dangerous drug injury.

At Gacovino Lake & Associates we have formed a dedicated network of personal injury lawyers to serve clients nationwide for their injury claims. Our New York office serves residents of the 5 boroughs with their auto accident, medical malpractice, defective product, premises liability, and Workers’ Compensation claims. For experienced help when filing your defective product claim, contact us today at 1 -800-246-4878, or stop by our website.