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J&J profits despite claims its talcum powder causes cancer

Johnson & Johnson told investors that it expects its 2018 sales to come in between $81 billion and $81.8 billion, an increase from its previous forecast of $80.6 billion to $81.4 billion. The company made the announcement after reporting first-quarter sales were up 12.6 percent year-over-year, to $20 billion, thanks in large part to its pharmaceutical arm. While the news is positive for investors, what is not worth celebrating is the company’s sagging baby-care product line, which includes the consumer health care giant’s staple product Johnson’s Baby Powder, which has been rife with bad press due mounting lawsuits alleging its talcum ... Read More

Janssen, Bayer ask judge to toss latest Xarelto side effects trial

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer asked a Philadelphia judge to toss a case currently in trial blaming the drug companies for not adequately warning about bleeding risks with their blood thinner Xarelto, arguing that there is no evidence that the prescribing physician in the case would have given the plaintiff a different medication if stronger warnings had been on the label, because he testified he didn’t even read the drug’s label. As a result, Janssen and Bayer argued, the plaintiff doesn’t have a case. The trial involves the case of Daniel Russell, who in April 2013 had a ... Read More

Certain endoscope connectors may spread patient infections

Gastrointestinal endoscope accessories known as 24-hour multi-patient use endoscope connectors should not be used because they can put patients at risk for cross-contamination, the Food and Drug Administration (FDA) cautioned health care providers and facilities in a Safety Communication. “The FDA has not received acceptable testing to demonstrate the safe use of these products and recommends against their use,” the agency stated. Endoscope connectors are small accessories used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. To mitigate the risk of contamination and possible infection between patients, the FDA recommends the ... Read More

Whistleblower Helps Medicare Recover $9.68 Million From Oxygen Supplier

Federal officials praised a whistleblower whose False Claims Act lawsuit against a Florida-based medical equipment supplier recovered $9.68 million for Medicare. U.S. Attorney Joseph Brown of the Eastern District of Texas said its multi-million-dollar settlement agreement with Rotech Healthcare Inc., a supplier of respiratory equipment and portable oxygen, resolves allegations that Rotech knowingly billed Medicare for portable oxygen supplies it provided to Medicare beneficiaries who didn’t need or use them. Rotech also admitted that it billed Medicare for oxygen supplies regardless of whether the supplies were delivered to beneficiaries. Medicare covers rentals of portable and stationary oxygen equipment for up ... Read More

Defibrillator firmware update fixes battery depletion, cybersecurity risks

A new update to firmware for certain heart defibrillators is now available to prevent battery depletion and potential exploitation of cybersecurity vulnerabilities. The update, for certain Abbott (formerly St. Jude Medical) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), is an effort to reduce the risk of patient harm from rapid battery failure and cybersecurity vulnerabilities that could affect how a medical device operates, the Food and Drug Administration (FDA) announced in a Safety Communication. ICDs and CRT-Ds are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ... Read More

Two ED supplements recalled, contain hidden drug

The Food and Drug Administration (FDA) has uncovered hidden pharmaceutical drugs in two different dietary supplements manufactured, marketed and/or distributed in the U.S. for male sexual enhancement, and has requested the companies issue recalls of the tainted products because they pose a risk to public health. AMA Wholesale Inc., is recalling Rhino 69 Extreme 50000 capsules because they were found to contain tadalafil, the active ingredient in the erectile dysfunction (ED) drug Cialis. Epic Products LLC is recalling all lots of Euphoric capsules, because testing revealed the products contained undeclared tadalafil as well as sildenafil, the active ingredient in the ... Read More

More kratom recalled, linked to Salmonella outbreak

Houston, Texas-based NutriZone LLC, is expanding its recall of various kratom dietary supplements to include more products that contain the same source material as the original recalled lots. That source material was linked to a multistate outbreak of Salmonella infections that have sickened at least 87 people in 35 states, 17 of whom required hospitalization. The investigation into the outbreak was launched in March by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and local and state agencies. Several manufacturers and distributors of kratom products have already issued recalls. About two dozen additional bottles and ... Read More

FDA bans bulk sales of highly concentrated, pure caffeine

Bulk sales of dietary supplements that contain highly concentrated or pure caffeine to consumers have been banned because they pose a public health risk, the Food and Drug Administration (FDA) announced in a News Release. These potent caffeine products pose a high risk of use at excessive levels, which can be dangerous and even deadly. At least two deaths have been linked to the concentrated or pure caffeine, the agency said. “Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary ... Read More

Compounding pharmacy recalls all sterile drugs

The Food and Drug Administration (FDA) is alerting health care officials that all products marketed as sterile by the compounding pharmacy Coastal Meds are being recalled because particles were seen floating in some vials intended for injection. During a recent inspection of Costal Meds’ plant by the FDA, investigators observed visible particles and poor sterile production practices, which further raised concerns about the particulates in Costal Meds’ drug products for injection. The company initiated a voluntary recall of all products intended to be sterile, but failed to inform the public. Injecting a drug product containing particulate matter may result in ... Read More

Women seek centralization of Taxotere hair loss lawsuits

About 350 women suing Sanofi-Aventis and other drug companies for failing to warn about the risk of permanent hair loss from the breast cancer drug Taxotere are calling for the New Jersey Supreme Court to designate the lawsuits as a multicounty litigation under Superior Court Judge James F. Hyland in Middlesex County. Centralizing the lawsuits was recommended because of the large number of cases and the common issues in their claims. Centralized management would conserve judicial resources, provide all those involved with the benefits of coordinated discovery, and minimize duplication, the petition states. The vast majority of the state lawsuits are ... Read More