Frequently Asked Questions

Claims must be reported as soon as reasonably possible.  Please contact us by mail, email, or fax.  

Attn: Claims Reporting
4795 Meadow Wood Lane, Suite 335 West
Chantilly, Virginia 20151

Email:  ClaimsReporting@Medmarc.com

Fax: (703) 652-1389

If you have questions about whether to report a claim, please refer to your policy, which includes requirements for reporting occurrences, claims, and lawsuits.  Medmarc's claims staff are also available to answer your questions and provide reporting advice.

Please contact our Claims Department at (800) 356-6886.

You can request a loss run via our Loss Run Request page. Please select “Loss Run Request” in the subject line and submit dates and name of insured in the additional information box.  You must be the Insured or the current Broker of Record to make this request.  You will receive your loss run report within one business day of request. 

Online loss run access can also be accessed via our online portal for eligible brokers or insureds. To request access you can contact MedmarcWeb@medmarc.com.

We have built a network of top-tier attorneys to defend your cases.  All of our attorneys are selected for their expertise in defending medical device and pharmaceutical companies in products liability litigation.  We leverage our buying power in order to secure you with reasonable hourly rates, and our attorneys are required to communicate with you regularly on the status of your claim.

Many of our network counsel have written and lectured on various aspects of product liability.  Some have medical or nursing degrees.  Many also have medical malpractice defense expertise.

They are skilled trial attorneys, but they also have negotiating and case resolution skills that can achieve rational business outcomes at mediation and settlement conferences. 

Please select subject "Contact Underwriting" in the Request More Information Form on this page. 

Please provide information for your “primary contact,” including your contact’s first and last name, title, address, phone number, fax number, and email address.  If applicable, please also provide this information for any additional contacts for SIR billing, claims, risk management, and loss runs.

We have approved network counsel in many foreign countries.  In addition, when servicing foreign claims, we rely on a number of international resources for loss investigation and litigation control.  These include: 

• GAB Robins Worldwide
• Baker & McKenzie Worldwide Legal Network
• Lex Mundi Directory of Foreign Counsel
• American Law Firm Association (ALFA)
• International Legal Network

Medmarc offers Products/Completed Operations Liability (“Products Liability”) and Manufacturers’ Errors and Omissions Liability (“E&O”) for medical technology and life sciences companies.

For more information on each coverage type, go to our Insurance Solutions.

Coverage for FDA recalls may be found in two types of Medmarc coverage offerings. 

• Products Liability — Medmarc offers product-withdrawal-expense coverage as an endorsement to our products liability policy.  This endorsement, subject to terms and exclusions, covers expenses incurred by the insured to remove its product from the marketplace due to a Class I product recall, including expenses associated with communicating the recall to the public.
• Manufacturers’ Errors & Omissions (E&O) — Medmarc offers recall coverage for third-party financial loss that results from the insured’s error or omission, such as when the insured’s customer incurs expenses for undertaking a recall that arises as a result of the insured’s negligence in manufacturing or servicing of a product.
  

Please talk to your Medmarc Underwriter your client has a need for this coverage or would like to learn more. 

We typically assign the claim to a claim examiner upon receiving it.  The claim examiner will review and analyze the claim for coverage, liability, and damages issues and contact you normally within 24 hours.  

In litigated cases, we assist you in the selection of defense counsel, with whom we work closely until your matter is resolved.  Your input is crucial to a successful defense strategy, and your claim examiner will update you throughout the life of your claim—but no less frequently than on a quarterly basis—about the progress of bringing your claim to resolution.

Yes.  Medmarc has a team of experienced claim examiners dedicated to the life sciences industry, who handle only life sciences claims.  Each examiner has a minimum of ten years’ experience and hold a variety of degrees and designations including law degrees, actuarial degrees, and Associate in Claims (AIC) designations.  To remain on the cutting edge of developments in the law and the life sciences, Medmarc’s claim examiners participate regularly in industry educational programs. Medmarc is a proud corporate member of DRI, ALFA, and USLAW organizations.

Our risk management services are intended for use by our insureds.  On a limited basis, however, we will provide products liability risk management services on a fee-for-service basis. 

For more information, please contact our Risk Management Department at RiskManagement@Medmarc.com or at 703-652-1362.

FDA approval of a product is important to the underwriting analysis, as is the regulatory history of the company, but it is not sufficient information for Medmarc’s underwriters to provide a coverage quote. In order to understand the company’s risk profile and coverage needs, underwriters also will require information about the company’s size, financial condition, management team, operations, loss history, and other information related to the company’s history and product lines.

Medmarc offers $10 million limits on our products liability, manufacturers’ errors and omissions (E&O) policy, combined form (products/completed operations and errors & omissions), and excess policies.

Capacity is subject to underwriting and is not available for all applicants. 

Medmarc provides coverage for the manufacturers and distributors of medical devices, pharmaceuticals, biotechnology, in vitro diagnostics, personal hygiene products, and animal care products.  We cover both original equipment manufacturers (OEMs) and contract manufacturers.  We cover companies at every stage of their evolution—from clinical trial-stage startups to multi-national companies with extensive product lines.

Through our Risk Management Department, Medmarc helps medical technology and life sciences companies manage their products liability risks.  We can identify your potential products liability exposures through our risk assessment process and then help you develop and implement strategies to mitigate your risk.  

We provide assistance with areas of your operations that tend to give rise to products liability, such as supply chains, product warnings and instructions for use, and manufacturing procedures.  There is a close association between regulatory compliance and products liability.  For this reason, we offer a variety of services designed to help companies comply with FDA requirements. 

We also provide employee training that is designed to heighten awareness about products liability risk and the impact that it can have on your operations and bottom line.

Yes.  Medmarc is happy to accept applications from other carriers, but please be aware that we may require additional information.

We recommend that distributors purchase their own products liability insurance policies.  If a distributor is required to repackage or install a product, or if the distributor provides training on the use of the product, the distributor may have a potential exposure that is not typically covered under the manufacturer’s policy.  Furthermore, independent acts of negligence on the part of the distributor typically would not be covered under the manufacturer’s policy or by contractual indemnification agreements. A U.S. distributor that imports products from a manufacturer located outside of the United States should be aware that the foreign manufacturer’s policy may not provide coverage in the U.S. or may not provide coverage for the defense of claims in the U.S., which could become very costly. 

Medmarc’s Risk Management Department has published an article that explains distributor risks. The article is titled, “Why Distributors May Be More  Vulnerable to Products Liability than They Realize,” and it is available on Medmarc’s website in our Publications Page.

The actions or omissions of sales reps when acting in the scope of their employment are covered under Medmarc’s products liability insurance coverage. Such circumstances include when sales reps: (1) provide product consultations; (2) make device technical adjustments; (3) are present in operating rooms during surgeries to answer questions deemed essential for patient care; or (4) are present during patient monitoring visits to ensure compliance with clinical trial protocols by surgical staff and nurses.

For more information, see the Ask an Expert by Fran Stockwell, “Do distributors require professional liability insurance coverage in addition to products liability insurance coverage?”

Our products liability policy covers explantations (i.e., the surgical removal of implantable devices) only when the product causes the patient harm.

Insurance coverage can either be on a "claims made" or "occurrence" basis. Simply, these terms refer to what the policy covers during the policy period. A claims-made policy provides insurance for claims made during a policy year (or tail period) for losses that occurred after a specified retroactive (“retro”) date, and an occurrence policy provides insurance for losses that occurred only during the policy year (as specified on the declarations form) even if the claims arising out of those occurrences are made after the policy period. 

A "claims made" policy provides coverage for claims made (and reported) during the policy term as long as they arose out of occurrences that happened after the "retroactive date." (The retroactive date is the start date of the first claims-made policy obtained, so long as it has been kept active (via renewal).) That date remains the same and is not advanced as long as the policy is renewed. For example, if a client first obtains claims-made coverage on October 1, 2013, and it is now 2019 and they've maintained the same coverage, their claims-made policy covers all incidents since October 1, 2013. If the client no longer has coverage in 2020, and a patient sues in 2020 for an incident that occurred in 2013, the client does not have coverage for that incident (unless they purchased tail coverage). 

An "occurrence" policy, in contrast, covers incidents that occur (but do not necessarily give rise to claims) during the term the policy is in force. For example, if a client obtained an occurrence policy covering 2016-2017, and a patient is injured by the client's product in 2017, but does not sue for their injuries until 2019, the client has coverage from their 2016-2017 policy, even if they are no longer insured.

Because of our familiarity and long-standing connection with this industry, we recognize that life sciences companies sometimes have product lines that include non-medical products. Often, we can accommodate this coverage need.  Your Medmarc underwriter can answer any questions you might have about covering non-medical products and will walk you through specific coverage options for your insureds.

For clinical trial submissions, include the draft or final study protocol and the patient informed consent document in order to expedite our review.

The E&O application can be found here. Along with a completed application, your Medmarc underwriter simply needs a sample of your client’s contracts or purchase orders that they use with their customers.

Minimum premiums differ depending on several factors, such as a product’s risk profile and the state in which the company is located. 

If you have a small account and are interested discussing the cost of coverage in greater detail, please call George Ayd at (703) 652-1309.

A.M. Best* Rating
A (Excellent)

According to A.M. Best, an A (excellent) rated company has  "an excellent ability to meet their ongoing insurance policy and contract obligations."

For more information check out our Financial Strength page. 

*A. M. Best is the nation's leading independent insurance rating agency.