Bloomberg News (2/21, Feeley ) reported that Teva Pharmaceutical Industries Ltd. “will pay more than $250 million to settle more than 80 lawsuits alleging the drugmaker sold the anesthetic Propofol in a way that led colonoscopy patients to develop hepatitis C, Officials Teva said, “The world’s largest maker of generic drugs reportedly “agreed last week to resolve claims by Las Vegas residents that the company intentionally sold Propofol in vials large enough to be reused by doctors.” The settlement also “resolves a May 2010 case over Teva’s sales of the anesthetic that spawned a jury award of more than $500 million against the Israeli drug makers, according to the people familiar with the settlements and a filing with the Nevada Supreme Court.”

        The AP (2/21) added that a Clark County district judge approved the settlements coming out of what the state supreme court had termed a “global settlement conference” out of cases involving reuse of the large Propofol vials by three now-bankrupt Nevada outpatient endoscopy clinics.

 It’s meant to limit how much Tylenol can be drawn into a plastic syringe, ” But ” parents or caregivers have complained that a protective cover on the top of the bottles didn’t work correctly.  ” The recall affects 574,000 bottles of grape-flavored liquid Infants’ Tylenol.

Mistakes in hospitals happen. Everyone is human and it is inevitable that some mishap will impact all of
us. The critical piece to all of this is that large medical facilities have protocols and procedures in place
to eliminate mistakes and minimize the impact a mistake can have on a patient’s life. Medical errors can
have devastating, life altering consequences in the neonatal or pediatric unit when these protocols and
procedures are ignored.

It was not until their baby failed to reach milestones in development that that family became suspicious
that something devastating happened in the hospital but went unreported to the family. The Maher
Law Firm was asked to review the medical record and simply determine if anything looked inappropriate
in the care of a newborn. No one at the hospital shared with the family what really happened to the
baby in the first few days of life that resulted in severe permanent brain damage.

After close review and with the help of nationally recognized experts, we were able to use the medical
record to show that a staff person in the neonatal unit performed a procedure on the infant without a
physician’s order that directly resulted in the baby being without oxygen for an extended period of time
resulting in severe brain damage. The firm worked hard to recover restitution for this family. Now the
child can remain at home with family and is provided round the clock nursing and attendant care as well
as ancillary services to promote growth and development.

Mistakes happen. Full disclosure of these events should follow so that families can provide early
intervention to achieve the optimal outcome to minimize lifelong consequences of tragic errors.

Pearl S. Buck

The Maher Law firm has focused on representation of our most vulnerable
members of our community for over two decades. The elderly as well and children
and adults with special needs have relied on our firm to seek restitution for events
suffered at the hands of unqualified, unskilled, or uncaring caregivers. Injuries
occur and go unnoticed and unreported until someone steps in to expose the
abuse and educate families on prevention of life altering events.

Special needs children cover a broad definition. One group always in need of
advocacy is the group of children who cannot communicate on their own. Cerebral
palsy (CP), autism, birth injury, or genetic defect can leave children defenseless.
Their inability to share daily events makes them most vulnerable to continued
harm.

In the past, we have been asked to intervene for families whose profoundly
autistic children sustained injuries after placement in “seclusion rooms.” This
was done without the parents’ knowledge or consent. It has been demonstrated
that the use of seclusion rooms has had extremely negative and sometimes tragic
consequences. Because a child cannot verbally communicate does not mean that
he does not feel pain, experience terror, or suffer trauma.

We were able to recover for these families and now they can explore alternative
placement for their children to have care providers and educators who are fully
aware of the special circumstances required to maximize progress for independent
activities of daily living, employment opportunities, and social success.

The FDA warned today that the use of proton pump inhibitors (PPI’s) like Nexium, Prilosec, & Prevacid may increase the risk of Clostridium Difficile associated with diarrhea.

Many of the adverse event reports involved patients who were elderly, had existing medical conditions, or were taking antibiotics.  All of those factors could have contributed to the risk of difficult-associated diarrhea, but the PPI’s could not be excluded.

The FDA is currently working with the drug makers to modify the labels to include possible risk of C difficult-associated diarrhea.

HealthDay (1/31, Dallas) reports, There remains a possibility that some HIV medications might cause birth defects, such as cleft lip and palate, according to a study published in the January issue of Cleft Palate–Craniofacial Journal.

To analyze the possible association between antiretroviral drugs and birth defects;  Vassiliki Cartsos, (an associate professor and director of graduate orthodontics at Tufts University School of Dental Medicine in Boston) and colleagues examined adverse events compiled by the US Food and Drug Administration over a five year period.

They found that the seven antiretroviral drugs (lamivudine (Epivir); efavirenz (known as EFV); nelfinavir (Viracept); and the combination of abacavir (Ziagen), sulfate, lamivudine and zidovudine (Retrovir) were associated with 26 incidents of cleft lip and palate  but “the authors noted, uncovering an association does not prove a cause-and-effect relationship.”

The Food and Drug Administration (FDA) must approve a drug before it can be introduced into the market.  The drugs in question must undergo rigorous testing for potential side effects prior to FDA approval.  Unfortunately, many drugs do not immediately present side effects, and are approved.

A drug recall is when a product is removed from the market because it is either defective or potentially harmful. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns.

Simply recalling a drug does not make up for the damage that it has already caused to the health of a consumers. If you have, or are taking a medicine that has been recalled, talk to your medical professional about the best course of action. If you’ve suffered a personal injury as a result of a dangerous or defective drug, contact the drug recall attorneys at The Maher Law Firm today.

The Miami Herald (1/28, Tasker) reported that “one current TV pharmaceutical ad, for the plaque psoriasis drug Humira [adalimumab], shows visuals of a group of friends at a cabin on a pretty mountain lake while a voiceover warns of such possible side effects as cancer, liver damage and heart failure.” The FDA, in an effort to better understand the issue, convened a panel of TV ad experts to study how much people are influenced during direct-to-consumer prescription drug ads by studying  ’images, scene changes, words on the screen and music that occur at the same time as an audio presentation of risk information.’” According to a “June 2011 report, the panel found evidence that ads with the most-positive visuals gave viewers positive feelings about the drugs,” but “because of a flaw in the experiment, the group said it could draw no conclusions on a key question: whether the tone of visuals affected comprehension of risks.”

The Duluth (MN) News Tribune(1/28, Lundy) reported, “The shortage of Adderall [dextroamphetamine/amphetamine], Ritalin [methylphenidate] and similar drugs has been playing out nationwide for months. It peaked in the fall after first surfacing in May, said Erin Fox, manager of the University of Utah’s Drug Information Service, which tracks drug availability nationwide for the Food and Drug Administration.