Drugs And Medical Device Recalls | www.reinerinjurylaw.com

Zicam Cold Remedies Linked to Loss of Smell

Posted under: Drugs and Medical Device Recalls — tslaughter @ 3:29 pm

The U.S. Food and Drug Administration issued a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm">strong warning</a> to the American public on June 16, 2009 not to use certain Zicam Cold Remedies for any purpose. Over 130 reports of loss of the sense of smell, potentially permanent, have been received by the agency. The involved <a href="http://www.reinerinjurylaw.com/html/defective-drugs.html">defective products</a> are:

Zicam Cold Remedy Nasal Gel
Zicam Cold Remedy Nasal Swabs
Zicam Cold Remedy Swabs, Kids size (already discontinued).

Any persons who have experienced a loss of smell is advised to seek advise from their doctor or other health care professional.

Our office has already heard reports of consumers in Northern California that have suffered loss of smell from this over-the counter cold remedy. Such a sensory loss could have a substantial impact on the quality of life. Such things as strong toxic chemicals, smoke or gas would no longer be detectible. Please check your medicine cabinets to see if you have purchased these products in the past. They should be thrown out immediately.

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Supreme Court Holds Defective Drug Manufacturers Responsible

Posted under: Drugs and Medical Device Recalls, Legal Issues — tslaughter @ 12:02 pm

In a remarkable change of vision, the U.S. Supreme Court reversed its previous course and refused to exonerate Drug Manufacturers from liability for injuries caused by defective drugs or inadequate labeling under the Federal Preemption doctrine.

In a 6-3 decision, the Supreme Court ruled that pharmaceutical giant Wyeth could not escape liability for its defective labeling of the drug Phenergan simply by asserting that the FDA’s approval of the drug “pre-empted the field,” thus precluding state court actions against the manufacturer. In making this ruling, the Supreme Court confirmed a 2004 $6 million verdict in favor of Diana Levine that was rendered against the pharmaceutical manufacturer by a Vermont jury. This ruling is being hailed by consumer protection groups around the nation.

For background on this case, Wyeth v. Levine, see our previous post.

The Court’s ruling today appears to set a new tone about corporate/manufacturer’s responsibility. In response to Wyeth’s (and many other manufacturers) criticism that state court tort actions “substitutes a lay jury’s decision about drug labeling for expert judgment of the FDA,” the Supreme Court rebuked the corporate “hand-wringing” with the following:

Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet . . . it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label and with ensuring that its warnings remain adequate as long as the drug is on the market.

The Court went on to recognize that:

[S]tate-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings. . . [In this regard,] the FDA stated that it did “not believe that the evolution of state tort law [would] cause the development of standards that would be at odds with the agency’s regulations.” . . . [T]he FDA traditionally regarded state law as a complementary form of drug regulation.

At bottom, it appears that the corporate effort to end-run responsibility for defective products has been dealt a heavy, if not potentially fatal blow. This is good news for consumers.

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FDA Directs Bayer to Stop Misrepresenting “Heart Advantage” Aspirin-based Drugs

Posted under: Drugs and Medical Device Recalls — tslaughter @ 3:29 pm

Last week the U.S. Food and Drug Administration sent a warning letter to the German-based drug maker, Bayer, to stop misrepresenting that its “Heart Advantage” aspirin product can control cholesterol and that its “Bayer’s Woman’s” aspirin “fights” osteoporosis and strengthens bones. Further background is at the InjuryBoard.

To make these marketing statements, Bayer combined its aspirin in Heart Advantage with the supplement phytosterols. The FDA, however, does not review the efficacy of supplements and vitamins before they are distributed in the market. By combining these supplements to their over-the-counter aspirin products, Bayer is making representations about their drugs that have not specifically been approved by the FDA.

The issue rose to the top when Congressional Representatives John Dingell and Bart Supak of Michigan asked Bayer to turn over its research proving the products had a positive impact on cholesterol and osteoporosis.

Whether the FDA will pursue the matter further is unknown. Since I saw ads for these products running just today, I assume that the new products have not been pulled off the shelf. With trusted brand names like “Bayer,” you would think that the companies would be much more circumspect about their marketing schemes, particularly if the claims are not based upon study and tests.

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Thoratec Recalls HeartMate II Blood Pump

Posted under: Drugs and Medical Device Recalls — tslaughter @ 11:43 am

Thoratec Corporation of Pleasanton, California, issued a firm press release through the FDA advising of the worldwide recall of its HeartMate II LVAS blood pump. These Left Ventricular Assist Systems (LVAS) have been distributed since the initial clinical trials in 2003. The manufacturer warns that wear and tear of the percutaneous lead connecting the pump to the System Controller has been found to result in damage that could cause the pump to fail. The probability of failure increases with the length of usage.

Thoratec warns that failure of the lead could result in disruption of pump function and require re-operation. The company reports there have been five failure related deaths.

Patients with these pumps should consult their physicians immediately to determine the extent of damage, if any, to the percutaneous leads. An Urgent Medical Device Correction letter is being sent to hospitals. Further information can be obtained from Thoratec at 1.800.528.2577.

The Redding lawyers at Reiner, Simpson & Slaughter have extensive background in heart related health care, and endeavor to keep the Northern California public informed of current developments in this field.

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Blog

June 24, 2009

Zicam Cold Remedies Linked to Loss of Smell

March 4, 2009

Supreme Court Holds Defective Drug Manufacturers Responsible

November 4, 2008

FDA Directs Bayer to Stop Misrepresenting “Heart Advantage” Aspirin-based Drugs

October 26, 2008

Thoratec Recalls HeartMate II Blood Pump