The recent peanut butter salmonella outbreak has become part of an alarming trend. Many fear the trend will continue and even intensify given the global nature of our food industry and the transportation of food across state borders.

Many  are also correctly concerned that the outbreak du jour from the tainted peanut butter and the reported 677 cases of salmonella and 9 deaths don’t tell the whole story.

This is due, in part, to the fact that few people go to the doctor for what may be confused as flu-like symptoms and even fewer doctors run  salmonella  tests for the symptoms typical to salmonella poisoning.  Increased testing could prevent additional cases by determining the source of the salmonella earlier while also establishing how widespread a problem officials are addressing.

According to Louisiana Governor Bobby Jindal, the state of Louisiana is asking for 30 million dollars in federal grant money to help nursing homes and hospitals buy large generators to run air conditioners.

Power outages are common during storms such as Gustav, Rita and Katrina. Nursing homes residents and hospital patients generally have failing health, are frail and are medically needy. Most are evacuated if they are in the direct path of a storm. However, many end up in central Louisiana and north Louisiana, which can sustain severe wind and water damage.

Power outages can last days or even weeks. For a medically compromised person, 98 degree heat can be fatal. Currently, the Department of Health and Hospitals require these facilities to have small generators to operate refrigerators and medical equipment. Many of these facilities cannot afford large generators to operate air conditioners.

Having experienced four days without power during Gustav, I know the heat can be terrible and surely can be life threatening for sick or frail individuals.

I applaud the State’s effort to protects its citizens in their time of need.  The State is applying for the money through the Federal  Emergency  Management Agency’s Hazard Mitigation Grant Program. Hopefully the generators can be in place for the 2009 hurricane season.

In yet another preemption victory for consumers, the Supreme Court has vacated an adverse preemption decision and remanded the case for further consideration in light of Wyeth v. Levine, 555 U.S. __ (2009).

The case is PA EMPLOYEES BENEFIT TRUST FUND V. ZENECA, INC., ET AL. and involved a Trust Fund bringing claims against Zeneca and AstraZeneca Pharmaceuticals  asserting that the defendants engaged in deceptive conduct in the advertising of its drug Nexium.

The plaintiffs alleged (1) unlawful advertising under the Delaware Consumer Fraud Act;  (2) violations of the consumer protection statutes of the 50 states for false, misleading, and deceptive advertising; (3) unjust enrichment, and stated claims under Delaware common law for restitution, disgorgement, and constructive trust; and (4) negligent misrepresentation.

The District Court dismissed the complaint with prejudice.  The Third Circuit affirmed finding that the district court was correct in concluding that, under implied conflict preemption, the Nexium advertisements (that complied with the FDA-approved labeling) were not actionable under the state consumer protection laws.

Now, in the wake of Wyeth v. Levine, the Third Circuit will have to reconsider its holding and presumably the case will be reinstated.

Last week, in Wyeth v. Levine, a case closely watched by industry and mass tort counsel across the country, the United States Supreme Court ruled on a key preemption issue and decided not to grant sweeping immunity to drug manufacturers. The Court rejected Wyeth’s claim that it could not be sued if a product and its label had been approved by the FDA.

Today, the  Court summarily vacated  the Third Circuit’s decision in Colacicco v. Apotex , which  held that consumers’ claims against manufacturers of antidepressants were preempted. Colaciccohas now been remanded for further proceedings in light of Wyeth v. Levine. In a related legislative development, last week the Medical Device Safety Act was introduced in the Senate by Senators Kennedy and Leahy (S. 540) and in the House by Representatives Waxman and Pallone (HR 1346).

The proposed legislation is designed to restore the rights of victims of faulty medical devices which have been threatened by the Supreme Court’s preemption decision in Riegel v. Medtronic. Hopefully, this recent Supreme Court activity and legislative action will collectively put an end to the preemption attack on our tort system.

Merck said Monday that it would acquire Schering-Plough for $41.1 billion, uniting the makers of cholesterol drugs Zetia and Vytorin.  The combined 2008 revenue of the two companies totaled $47 billion.  The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public corporation.  Merck and Schering-Plough expect to complete the transaction in the fourth quarter of 2009.  Merck’s CEO, Richard Clark, will lead the combined company.

For years, the whisper on Wall Street was for Merck and Schering-Plough to join forces.  The Vioxx litigation must have put this on the back burner followed by the fall-out with Vytorin.  Schering-Plough and Merck are long term partners in a cholesterol joint venture involving Vytorin.  Vytorin and Zetia sales plunged last year along with the share price of the two companies after a pair of clinical trials lead to questions about the effectiveness of the medicines.  Answers regarding the medication will not be available until a major study in 2011 or 2012.

The deal between Merck and Schering-Plough comes just six weeks after Pfizer, Inc. agreed to pay $68 billion for fellow drug maker Wyeth.  Analysts have forecasted increase consolidation in the pharmaceutical industry for some time as companies struggle with slumping sales, fierce competition, and generics.

If you wear a nicotine or any of the 60 kinds of drug patches sold in the U.S., you risk getting burned during an MRI according to the latest alert from the FDA’s new-drug office. Many of the patches contain tiny metal fragments which can cause the patch to overheat during the MRI scan and burn the skin underneath the patch. The FDA will soon require that all patch products carry the burn warning on the patch itself.

Patches containing medication that oozes into the skin over time have become more popular with patients. They are commonly used for delivering estrogen, pain medication, nicotine, Alzheimer and Parkinson drugs and anti-nausea medication for chemotherapy patients.

The patch alert advisory is the latest in a string of safety warnings involving MRIs due to the unpredictable effects of the increasingly powerful magnets used in the MRI devices. In one especially tragic case, a 6 year-old boy was killed at Westchester Medical Center when a metal oxygen tank flew into the MRI chamber attracted by the powerful magnets and struck him in the head.

It appears the FDA is finally getting it right in this situation in getting the appropriate warnings out to the public before there are a large number of injuries. The warning will hopefully prevent further burns to unsuspecting patients.

http://www.nytimes.com/2009/03/06/health/policy/06mri.html

Victims of the peanut butter salmonella outbreak may have more problems now. Recovering damages from  the Peanut Corporation of America (PCA) has been complicated by Chapter 7 Bankruptcy.

The company recently filed documents listing more than 12 lawsuits and more than 475 businesses claims. They also listed  some $11.4 million in assets and debts of nearly $5 million. It appears that $7 million of the assets are actually potential insurance coverage proceeds.

The question then becomes does that go to injured consumers or businesses that bought products that were recalled or both? It has been reported that the company may have other insurance which is separate from coverage for product insurance. Hartford has filed suit seeking a ruling on whether its $12 million policy covers the salmonella claims. Peanut Corp.’s conduct, according to Hartford, may have voided the coverage.

In the meantime,  lawyers have also sued Solon, King Nut , Kellogg, and PCA president, Stewart Parnell. In addition to the civil litigation, the FBI is conducting a criminal investigation of  PCA. Interestingly, a statement of PCA’s financial affairs included a $100,000 payment for criminal legal representation.

The National Transportation Safety Board (NTSB) in recognition of National Sleep Awareness Week, has reiterated its commitment to eliminating human fatigue in the transportation industry.  The NTSB has had a long concern about the effect of human fatigue in the transportation industry and its impairment effect on safety.

NTSB Board member, Deborah  Hersman, said “Fatigue can impair a person behind the wheel or at the helm much like alcohol or other drugs.  We must ensure that as much as possible is being done to protect our transportation system from the insidious effect of human fatigue.”

The quickest fix would be to reduce the work hour limits of those in the transportation industry.  For example, safety would mandate reducing the eleven hours that a truck driver can drive in a day that allows him to work up to a 14 hour work day.  Moreover, implementing technology in the use of onboard recorders, and installing new technology such as adaptive cruise control and collision warning systems would lead in the fight in reducing human fatigue accidents.

Since the inception of the most recent Peanut Butter outbreak, nearly every day reveals new facts with widespread and adverse consequences.

As more cases are reported, more peanut butter products continue to be taken off the shelves. Over 1700 products have been recalled, and it is estimated that over 20,000 people could be infected with salmonella.  Many understandably have questions. A few observations…

First, some groups are more at risk than others – such as infants, the elderly, and people with chronic diseases or immune system impairment.

Second, where can salmonella be found? Here are a few places…

• Foods of animal origin, such as beef, poultry, milk or eggs
• Any food, including vegetables, may become contaminated.  It is best to thoroughly wash produce and avoid eating raw or undercooked eggs, poultry or meat.
• In reptiles, such as turtles, lizards and snakes, and in chicks and ducklings. Be sure to wash your hands or your child’s hands immediately after handling one of these animals.

Third, what are the symptoms?

• Onset is about 12 hours to three days after infection
• Look for diarrhea, fever, abdominal cramps and headache
• Nausea, loss of appetite and vomiting can also occur

Symptoms can require treatment. Intravenous fluids may be needed and hospitalization is sometimes necessary.

It is important to contact your healthcare provider if you think you could be infected.

Two former executives of AM2PAT, Inc. were sentenced to 54 months in federal prison for their roles in selling bacteria-tainted syringes to unsuspecting patients. The heparin and saline-filled syringes were widely used as an anti-coagulant by patients with blood clotting problems.

Kumar Sharma, quality control director, and Aniruddha Patel, plant manager, pled guilty to mail fraud and knowingly sending misbranded medical devices with the intent to defraud. Sharma and Patel got shorter sentences in return for their cooperation in the ongoing investigation of AM2PAT, Inc. whose Angier, North Carolina plant was closed late last year.

AM2PAT’s former president, Dushyant Patel is the subject of an international manhunt after apparently skipping the country following his 10-count indictment.

The tainted syringes have resulted in numerous cases of spinal meningitis, permanent brain damage and other infections leading to death in some of the cases.  Sharma and the Patels labeled, shipped and sold the syringes as sterile when tests had not even been conducted on them. After the syringes were shipped, dates were falsified in production and shipping records to give the false impression the tests had been done.

The release of adulterated, tainted or misbranded medical devices onto an unsuspecting public in the name of profit is an outrage. If patients who rely on certain medical devices and drugs can’t trust the manufacturers that a product has been properly tested, it can literally mean the difference between life and death. And in this sad example of lack of adequate FDA oversight, at least four unsuspecting patients have died.