FDA Seizes Tainted Ultrasound Gel In Newark


Posted on 19th April 2012 by gjohnson in Uncategorized

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Well, here’s another case of a medical product being contaminated with bacteria, allegedly making hospital patients ill.

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized bottles of Other-Sonic Generic Ultrasound Transmission Gel, which were  located at Pharmaceutical Innovations Inc. in Newark, N.J. An FDA analysis had found that product samples contained dangerous bacteria, according to an FDA press release.


The gel was confiscated after the FDA received a report involving 16 surgical patients being infected with Pseudomonas aeruginosa, reportedly in Michigan. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using the Other-Sonic gel.

Under the Federal Food, Drug, and Cosmetic Act, the seized gel is adulterated, because product samples were contaminated with two strains of bacteria, not only Pseudomonas aeruginosa but Klebsiella oxytoca, the FDA said.

The gel is also misbranded because it is dangerous to health when used in the manner suggested in the labeling. These bacteria pose serious risks of infection to individuals exposed to the product, the FDA warned.

The seizure included all lots of the gel product manufactured between June 2011 and December 2011.

Until they were seized, the products were held under embargo by the New Jersey Department of Health and Senior Services at FDA’s request.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body. Ultrasound transmission gel improves the transmission of the ultrasound waves.

According to the complaint filed in the U.S. District Court for the District of New Jersey, FDA analysis of product samples collected in February revealed the presence of the two bacterial strains.

The affected gel products include 250 milliliter and 5 liter containers of Other-Sonic Generic Ultrasound Transmission Gel. The FDA warns health care professionals who perform ultrasound procedures to stop using Other-Sonic gel manufactured from June through December 2011, because of the risks posed by bacteria contamination.

The FDA issued a safety communication alerting health care providers that bacteria found in non-sterile Other-Sonic Generic Ultrasound Transmission Gel poses risks of infection.




Parents Settle Lawsuit Over Son’s Death In Contaminated Swab Case


Posted on 19th April 2012 by gjohnson in Uncategorized

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The family of a Houston toddler, who alleged that a contaminated alcohol swap caused their son’s death, have settled their suit against the Wisconsin company that made the wipes, according to the Milwaukee Journal Sentinel.

One left, another 10 to go.


Shanoop Kothari and his wife Sandy settled their litigation against Triad Group and its unit, H&P Industries. The terms of the settlement weren’t released.

The Kotharis’ 2-year-old son Harry died in December 2010. His death was one of 11 reported to federal authorities as possibly being linked to  products made by Triad, which denies that its swabs and wipes hurt anyone, according to the Journal Sentinel.

Triad still has about 10 lawsuits pending against it, according to the Milwaukee newspaper.

After the Food and Drug Administration discovered that some batches of alcohol swabs and wipes were contaminated, Triad and H&P voluntarily recalled them in January 2011, the Journal Sentinel reported. Some of the swabs had Bacillus cereus, the same bacteria that killed Harry Kothari.



Johnson & Johnson Fined $1.2 Billion Over Marketing Of Risperdal


Posted on 14th April 2012 by gjohnson in Uncategorized


Johnson & Johnson is taking a hit to its wallet over its antipsychotic drug Risperdal:  A judge last week fined the pharmaceutical giant $1.2 billion for misleading patients and doctors about the dangers of the drug.


The judge’s verdict was in Arkansas, and it ranks “among the largest on record for a state fraud case involving a drug company,” according to The New York Times. And it is just the latest in a series of legal hits Johnson & Johnson has taken regarding its marketing of Risperdal.

In the latest case, Arkansas Circuit Court Judge Tim Fox fined Johnson & Johnson $1.19 billion for roughly 240,000 violations of the state’s  Medicaid law, The Times reported. There was also a fine of $11 million for violating the Arkansas deceptive practices act.

In January Johnson & Johnson unit Janssen Pharmaceuticals settled a similar case in Texas for $158 million, according to The Times. And in South Carolina, a judge fined Janssen $327 million, while a Louisiana jury awarded roughly $258 million in damages.

According to The Times, Janssen issued a statement in response to the Arkansas ruling, saying it would ask for a new trial or appeal.

“The state did not show that any Arkansas patient was ever harmed by using Risperdal,” Janssen said.

Johnson & Johnson has been accused of  hiding the dangerous side effects of  using Risperdal, which is approved to treat schizophrenia, bipolar disorder and autistic children. Its risks include an increased risk of diabetes and stroke, as well as weight gain.



Tennessee ER Doctors Don’t Need Special Protection From Malpractice Suits


Posted on 1st April 2012 by gjohnson in Uncategorized

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In Tennessee, emergency room doctors may soon be given extra protection from malpractice suits, legislation that doesn’t leaves physicians culpable enough for their actions and mistakes.

Under the pending legislation, a patient in Tennessee would have to meet a pretty high test, proving gross negligence by a doctor in an ER, in order to bring a successful malpractice case, according to a recent story in the Johnson City Press.


The bill’s sponsors are two Republicans, Rep. Glen Casada and Sen. John Jackson, and they have trotted out the usual justification for this type of malpractice legislation: That it will put a damper of frivolous lawsuits and therefore help keep health care costs down.

Opponents of the bill, who I agree with, include the Tennessee Association for Justice. In the Johnson City Press, the president of the association, Keith Williams, maintains that under the proposed law, if you went to an ER with chest pains and were diagnosed with bronchitis — but then went home and died of a heart attack — your survivors would have no legal recourse.

As the the Association for Justice points out, ER doctors are already protected from frivolous malpractice suits in Tennessee. As the law stands now,  if ER doctors provide care “that is consistent with standards set by their peers” they would not be liable in a malpractice case, Johnson City Press reported.

Opponents of the pending Tennessee legislation are also disturbed, rightfully so, that the bill also provides extra protection to surgeons whose patients are admitted through the ER.

Even though an estimated 98,000 people die in Tennessee each year due to medical errors, the state seems to be bending over backwards to help doctors, not patients.

As the Johnson City Press pointed out, last year Tennessee legislators passed a law that limits non-economic damages, including pain and suffering, at $750,000 for medical malpractice cases. Punitive damages were capped at $500,000.

At first blush, $750,000 might sound like a lot of money. But if your spouse, or parent, or child died because of a doctor’s negligence, you wouldn’t think that $750,000 is enough for a life.

State lawmakers have already given the Tennessee medical community too much protection. They should not dole out any more breaks to doctors.