How Does the Recall Process Work for Food and Drugs?

There are three different ways food products, medical drugs, and medical devices can be recalled:

  1. At the initiative of the manufacturer of the defective food or drug
  2. At the request of the Food and Drug Administration (FDA)
  3. Upon order of the Food and Drug Administration (FDA), pursuant to its authority under federal law

The way in which a food or drug recall happens depends in part on what type of recall is at issue.  The FDA divides recalls into three different classes, based on the likelihood that the defect in the food product or drug will cause serious injury or death.

  • Class I recalls occur when there is a reasonable probability that the dangerous food or drug will cause serious illness or death.  An historic example of a Class I recall is the infamous Tylenol recall of 1982, when the company pulled 31 million bottles of Tylenol from retail shelves after learning that some unknown quantity of bottles had been deliberately contaminated with cyanide.
  • Class II recalls occur when use of the dangerous food or drug would cause temporary or medically reversible illness or when the chance of serious illness is remote.  An example of a Class II recall would be if a company pulled frozen dessert bar products because the labeling information failed to include required details about artificial coloring products.
  • Class III recalls occur when the food or drug defect is unlikely to cause any adverse health effects but still violates FDA manufacturing or labeling standards.  A common example of a Class III recall is when an imported food product is pulled from the shelves because it does not include ingredient information in English.

You can sign up to receive email alerts about food recalls or drug recalls from the FDA.

Contact Shaffer & Gaier After a Serious Accident

If you or a loved one has suffered injury due to a defective food product or pharmaceutical drug, Shaffer & Gaier can help.  To set up a free initial consultation, contact our office online, call our Philadelphia office location at 215-751-0100, or call our New Jersey office at 856-429-0970.

Safer Automobiles Might Actually Sell Better

Last month, ailing U.S. automakers and their workers accepted huge concessions in return for a $17.4 billion federal rescue package meant to buy them time to survive. As part of the package, GM received $9.4 billion and Chrysler $4 billion. In the interim, Ford opened the door to receiving additional aid. Upon receipt of the bailout, GM’s CEO, Rick Wagoner, admitted that the automobile maker has significant work to do and that federal loans were a blue print to the company’s continued success. However, looking back at the automobile manufacturer’s attitudes toward product safety it is hard to imagine how they can be saved from themselves.

During the hand ringing that led to the bailout, there was considerable discussion about Detroit’s failure to recognize and, in fact, participate in the green movement which led to the industry’s demise. The Big Three automakers have been fighting low emission and fuel economy standards for decades. Thankfully, the Obama Administration pushed the Big Three into the 21st Century by reversing the Bush Administration’s horrendous policies on these standards. Many people ascribe Detroit’s refusal to make more fuel efficient cars as the biggest reason that the automobile manufacturers are losing huge parts of their market share. One other issue that certainly has affected the marketability and profitability of the Big Three is their absolute reluctance to embrace safety and make their cars safer for the public.

Can anyone really say that they purchased an American car because it’s safer than other foreign cars? Until being acquired by Ford, Volvo has centered its marketing campaign around safety. Volvo had countless commercials and promotions extolling passenger safety in accidents. Before being acquired by Ford, Volvo did tremendously well with that campaign. Of course, Ford’s influence on Volvo squelched their focus on safety and their profitability suffered.

Every since the National Highway Traffic Safety Administration (NHTSA) was charged with regulating the safety of automobiles over 40 years ago, Detroit has been kicking and screaming at every turn. For the past decades, the automobile industry has been fighting seatbelts and then airbags which, now, are uniformly embraced by the automobile insurance industry and consumer groups alike.

In 1971, when Lee Iacocca was President of Ford Motor Company, he so strongly opposed automobile airbags that he personally appealed to then President Richard Nixon and persuaded the President to kill a pending federal regulation mandating airbags for U.S. cars. Of course, Iacocca did not know that Nixon was taping the conversation. At the time, automakers predicted that a single driver’s side airbag would add $1,000 to the cost of a new car. The industry predicted that benefits would be marginal and that the consumers would not want or pay for them. Now, airbags are standard in every vehicle and it’s hard to imagine buying a new car without this safety feature.

Not only did the Big Three oppose airbags, but if you go back even farther, their track records against safety have been consistently wrong. The automobile industry even opposed seatbelts years ago. The U.S. government started studying seatbelt use in the 1960’s, but the auto industry believed that safety would not sell and instead emphasized the cars comfort, style, and performance. In 1970, NHTSA proposed Federal Motor Vehicle Safety Standards that all vehicles have passive restraint, i.e. seatbelts, by January 1973. Over the next ten years, the standard was debated, delayed, altered and eventually rescinded by NHTSA in 1981. Finally, in 1984 NHTSA proposed that all vehicles have seatbelts by 1989.

It is undisputed that seatbelts and airbags have improved vehicles and enumerable studies have shown that these features save lives. Despite this fact, the automobile industry refuses to get ahead of the curve a make a safer car.

Despite these mandates, Detroit continues to refuse to prioritize designing and building a safer car. For example, the automobile industry is confronted with autos that are prone to rollover, roof crushes and tires that are defective due to tread separation. In addition, the rise of defective airbag cases has seen steady growth over the past ten years. One of the biggest reasons is because Detroit continues to scrimp and cut corners wherever and whenever it can and these decisions are affecting safety. For example, there are numerous cases being filed due to the airbags’ failure to deploy. Upon further review of these cases, it has become clear that the auto makers have cut corners by having inadequate sensors that detect the forces of an accident and make the airbag deploy. The Big Three’s attitude is that more sensors cost more money and are not needed. This is the exact same approach to business that got them in trouble in the first place.

The Bush administration’s lax rules and regulations over the automobile industry probably only rivals its abysmal regulation over the oil companies. However, since taxpayers are funding part of the bailout, not only should we insist on greener technology but we should also demand that NHTSA do its job and ensure that these vehicles are safer for consumers.

What’s next? It still remains to be seen if the Big Three can meet the challenges ahead and make the kind of cars that Americans want and deserve—because safer cars will sell better. Or, will the bailout just be a band aid so they can go back to their business as usual approach to technology and safety. Undoubtedly, if they go down that latter road – we can stop calling them Big Three because they won’t be so big and there sure won’t be three viable American automobile manufactures.

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Wall Street Bailout – Somebody Had To Cause This Problem

In this time of national economic crisis, the Bush administration and Congress are implementing a legislative package aimed at resolving the country’s current financial problems. However, the banks are seeking not only money from the taxpayers, but immunity from lawsuits concerning their unscrupulous lending practices.

It was a hard pill to swallow; $700B to bailout the huge companies that got themselves in this mess. However, when you hear about companies like AIG taking $400,000 junkets after receiving Federal assistance, it just makes your blood boil. However, the chickens need to come home to roost eventually and certainly the banks are beginning to run for cover. Seeing the vulnerability of their position, they are beginning to ask for immunity from lawsuits brought by defrauded investors and shareholders. Congress should do everything to prevent immunity to these lending institutions of investors and shareholders. At Shaffer & Gaier, we have represented consumers who were taken advantage of by these businesses.

Bala House Montessori School – Ground Breaking Ceremony

In addition to managing our law firm, Michael Shaffer also serves on the Board of the Trustees of the Bala House Montessori School in Bala Cynwyd, PA. Michael has three children, Sophie 8 years old and Sam and David, twins who are quickly approaching 5. All three of his children have attended this terrific school and Michael is proud to be on the Board of its Trustees.

Just last week, the Bala House Montessori School, after 20 years of saving, investing and raising money broke ground on a new wing. Michael is the Chairman of the Development Committee which has raised over significant monies toward this $3M project. One of the best things about the Bala House Montessori School is its diversity. Although its school is located on the Main Line, it boasts diversity of almost 40%; offering scholarships to economically disadvantaged children throughout the City of Philadelphia. At Shaffer & Gaier, we take our commitment to the community very seriously and sometimes this is the most rewarding work we do.

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