Defective Bayer Warnings Led To Leg Amputation, Suit Says

Below is an article about an interesting case we recently filed in Morris County which has been picked up by Law 360.

Law360, Clifton, N.J. (June 15, 2017, 6:11 PM EDT) — Bayer AG provided inadequate warnings or instructions on its “Dr. Scholl’s” padded callus removers about the potential risks to diabetics, leading a New Jersey man with diabetes who used the product to lose part of his left leg, according to a medical malpractice action filed against the company in state court.
William O’Dowd alleged in his complaint that Bayer knew or should have known of the risk of injury to diabetics from the foot pads and the salicylic acid contained in the pads, claiming that “the defective warning and labeling on the pads were substantial factors” in causing his leg to be partially amputated.

“The packaging fails to adequately warn, as the fine print lettering on back is barely discernible, based upon location, color and font size. The danger of applying acid on a pressure [bruise] puts the diabetic at significant risk of amputation which in this case could have been prevented but for the neglect and failure to warn,” O’Dowd’s attorney, Philip G. Mylod, told Law360 on Thursday.

“It is our sincere hope that we can effectuate justice not only for our client but other unwary diabetic consumers of this product,” Mylod added.

Bayer said Thursday in a statement, “We are confident in the safety and efficacy of Dr. Scholl’s Callus Remover Pads, and have seen no scientific data to support these allegations. We have not been served with the complaint, but plan on defending our product vigorously.”

The complaint, filed on June 9 in Morris County Superior Court, also names Dr. David H. Sims, a podiatrist, and his practice, Parsippany Foot and Ankle, as defendants. Sims could not immediately be reached for comment Thursday.

O’Dowd, whose wife also is named as a plaintiff, said Sims advised him to buy “some foot padding” to treat a callus on his left foot that formed after wrapping was misapplied following hammertoe surgery performed by the doctor, but Sims did not instruct O’Dowd regarding the type or kind of padding he was to purchase.

“Doctor Sims breached his duty of care owed to plaintiff by failing to properly apply the postoperative wrapping and failing to advise or warn plaintiff regarding foot pads, with no other warning of potential risks in choosing certain popular, name brand pads,” according to the complaint.

After O’Dowd underwent the same-day surgery on April 10, 2015, Sims and/or his staff wrapped O’Dowd’s left foot to above his ankle and O’Dowd was discharged from the hospital, the complaint states.

Throughout the weekend following the surgery, O’Dowd said his left foot was “throbbing.” O’Dowd was in “extreme pain” on April 13 when he visited Sims, who advised him that the foot was “not wrapped right,” according to the complaint.

A nurse re-wrapped the bandage up to O’Dowd’s calf that day, but “it was still very tight,” the complaint states. The next day, O’Dowd visited Sims and it was noted that a callus had formed under the fifth metatarsal, the complaint states.

On April 23, Sims removed the bandage and said, “oh that’s bruised,” according to the complaint. The doctor advised “no further wrapping,” and told O’Dowd “to go and purchase ‘some foot padding’ and to place the padding on the affected callus,” the complaint states.

But that day, Sims failed to identify or offer to provide the necessary padding for O’Dowd’s foot, and he did not provide any oral or written instruction to O’Dowd regarding the type or kind of padding he should purchase, the complaint states. Sims also did not warn O’Dowd to avoid using medicated padding, the complaint states.

“After April 23, 2015, plaintiff followed defendant, Doctor Sims’ advice and purchased ‘some foot padding’, namely Dr. Scholl’s Callus Remover Pads at a local store,” according to the complaint.

Two days later, O’Dowd returned to the medical office “complaining of extreme pain in his left foot,” and he was seen by Dr. Kiran D. Poylangada, the complaint states. Poylangada “reported ulceration of lateral left 5th metatarsal joint caused by the foot pads, which contained corn removal medication,” according to the complaint.

On April 28, Poylangada ordered an MRI of O’Dowd’s foot, which was conducted the following day, the complaint states.

“At this point, the hammertoe surgical site was fine, but plaintiff had a pressure wound on the left side of his foot and the exterior outside of his foot was black,” the complaint states.

Poylangada on April 30 referred O’Dowd to an infection disease doctor, who diagnosed him on May 6 with a pressure ulcer, according to the complaint. Later that month, O’Dowd was admitted to Morristown Medical Center, where “it was determined that he would need surgery and angioplasty to open veins,” the complaint states. He was discharged from the hospital on June 8, the complaint states.

On June 10, O’Dowd was admitted to Hunterdon Medical Center and he stayed there overnight for “an angioplasty repair perforation of the vein,” the complaint states. On July 27, O’Dowd had “an amputation of his left leg performed below the knee,” the complaint states.

The O’Dowds are represented by Philip G. Mylod of Mylod & Fitzgerald PC.

Counsel information for the defendants was not immediately available.

The case is William O’Dowd and Loretta O’Dowd v. David Sims, DPM et al, case number L-1287-17, in the Superior Court of New Jersey, County of Morris.

–Editing by Kelly Duncan.

Intro to Land Use Law – Zoning Permits and Variances

Every town in New Jersey, under the Municipal Land Use Act, is required to adopt a comprehensive master plan and land use ordinance every 6 years. Each municipality must have a residential zoning law, commercial zoning law, industrial zoning law, open space zoning laws, public use zoning laws, and open use and agricultural zoning laws. As a property-owner, these laws and regulations dictate how you can use your property. A few examples of what is often dictated in the zoning laws include minimum and maximum sizes of properties, maximum height of buildings, and how close you may build to your property line (setback requirements). In order to build a new structure or alter an existing structure, for example, your home/dwelling, garage, shed, gazebo, or swimming pool, you must file for a zoning permit.

What is a Zoning Permit?

A Zoning Permit is a document that is required for the construction of a new building or the alteration of an existing structure. It indicates that the purpose of what you (the property owner) want to build, and the details of that building/structure are in conformity with the town’s Municipal Zoning Ordinances. A Zoning Permit is the town’s way of ensuring that a prospective new project will “fit in” with the current community scheme, as stated in the town’s master plan. A zoning


What is the process of applying for a Zoning Permit?

  1. Go to local municipal clerk
  2. Ask for zoning office
  3. Tell him/her you need zoning permit
  4. Fill out and submit your zoning application – usually included with this will be a survey of your property, Application fees, and building plans.
  5. If the zoning permit is issued, you are good to go
  6. If denied, you have the option to appeal to the Zoning Board of Adjustment. Your denial will say why your permit application was denied and what you need to do to get approval for your project. This typically involves filing for a variance.

What is a variance?

A variance is an exception to the zoning laws and restrictions in a town. If a variance is granted, it will allow a property owner to use their land in a way that is outside of the specified laws and restrictions placed upon the property. There are several different types of variances, and which type of variance you need will vary by case.

What are examples of situations that call for a variance?

A few examples of situations that could require a property owner to apply for a variance are if they have an undersized lot and want to build a home on said lot, or if a property owner wishes to build closer to their neighbors than is allowed by the zoning laws (they wish to build “within the setbacks”, or if a property owner wishes to build a home in which the height of the highest point of the roofline exceeds the height restrictions of the Zoning Code.

What is a “C” variance?

A “C” variance is one type of variance that relates only to the land itself. A “C” variance means there is something about the property that prohibits you from bringing it into compliance with the local zoning ordinances (wetlands, irregular shape, undersized lot). It has to relate to the property itself, otherwise chances of a property owner receiving that variance are much lower. Basically, when a property owner is asking for a “C” variance, they must show that something above and beyond the fact that you cannot maximize the use of the property, or that they  could enjoy your property more another way. In addition, the property owner must show no hardship or adverse negative consequences to neighbors or to the municipality.

How do I file for a variance?

If a property owner wants relief from a zoning law, they must file an appeal of your Zoning Permit denial to their local Board of Adjustment. First, they file the application, then they must give public notice to all individuals and property owners within 200 feet of the subject property. The Board of Adjustment in the town will require that a public hearing is held in which the neighbors and other members of the public in the town may attend and participate in. Those members are given a chance to voice their opinions, whether they are pro-variance or anti-variance. The property owner applying for the variance must put forward evidence and proof in front of the Board of Adjustment as to why they should receive a variance from the zoning law.

The law requires that the property owner produce legal evidence and proof to justify your variance request, if they fail to do so, the variance application will be denied. If there are objectors to the variance application, the town may not be in favor or your application and may throw in unreasonable demands. Many times, objectors to a variance will hire an attorney to introduce obstacles to the property owner’s application. This makes the process much more difficult.

Variance applications can be complicated both from a procedural aspect as well as substantively establishing the standard of proof.   An experienced land use attorney can help guide you through the process and properly provide the basis needed in order to obtain variance relief.